ISO 14971 Risk Assesment Report

Epoluthon ISO 14971 risk assesment V1.0.
docx
ISO 14971 Risk assessment file
HI-031215
Author: EJ Authorizer: EJ AllRound Technology B.V.

Reviewer: RR Hengelosestraat 100-105, 7514AK,
Date Issued: 3-12-2015 Revision : 1.0 Netherlands
www.AllRoundTechnology.com
© AllRound Technology B.V. Page 1 of 84

Epoluthon ISO 14971 risk assesment V1.0.docx
Table of Contents
Table of Contents .............................................................................................................................................. 2
1. Risk management ...................................................................................................................................... 3
2. Intended use .............................................................................................................................................. 4
2.1. System construction .......................................................................................................................... 4
3. Risk evaluation........................................................................................................................................... 4
3.1. Overall residual risk assessment...................................................................................................... 22
4. Single fault risk assessment ..................................................................................................................... 23
4.1. Overall residual risk assessment single faults ................................................................................. 25
5. Appendix B ISO 60601 compliance check list .......................................................................................... 26
6. Appendix C MDD essential requirements compliance check .................................................................. 62
mmHg Millimeter Hydrargyrum (Mercury)
kPa Kilo Pascal

1. Risk management
Within this document Risk evaluation is based the likelihood and severity of the risk.
The likelihood is defined in the following steps running from low to high:
Incredible less than 1 in the 1.000.000 times the equipment is used
Improbable
Remote
Occasional
Probable
Frequent about 1 (or more) in the 10 times the equipment is used
The severity of the risk is defined by de consequence as shown in the following steps running from low to high
Negligible No noticeable consequence for normal use
Marginal Noticeable problem which can be easily corrected
Noticeable Noticeable problem for which things have to be redone
Severe Unnoticeable problem with minor consequences
Critical Unnoticeable problem with noticeable consequence or any problem with bodily harm which heals in a few days
CatastrophicAny problem resulting in bodily harm which does not heal in a few days
Based on these definitions the following graph is used to define the three regions as described in annex E and Z of the ISO 14971:2012. This based on the fact that the
device is used for critical applications where the current lack of this type of treatment results in high mortality rates >75% that can be reduced.
Frequent _________ _________ _________ _________ _________ _________
Probable _________ _________ _________ _________ _________ _________
Occasional _________ _________ _________ _________ _________ _________
Remote _________ _________ _________ _________ _________ _________
Improbable _________ _________ _________ _________ _________ _________
Incredible _________ _________ _________ _________ _________ _________
Negligible Marginal Noticeable Severe Critical Catastrophic
_________ Green region : Acceptable risk
_________ Yellow Region : Investigate further risk reduction or identify to user in the
manual and evaluate as part of the overall risk evaluation
_________ Red region : Unacceptable risk

2. Intended use
The intended use of the Epoluthon is:
Reduction and or removal of cancer cells in human cavities like Esophagus and rectal through selective release of oxygen radicals in the specific cells. Cells are targeted
based on cell metabolic speed and release is triggered by high intensity red light. Photo sensitizer administration and subsequent light therapy are administered by a
trained physician in a hospital setting.
2.1. System construction

The system consists of a control unit and a light tube. The control units controls light intensity and temperature of the light tube and give visual and audible feedback to
the user about the status of the light tube. The light tube consists of LEDs which generate the light with the right wavelength and is water cooled to ensure the right
temperature is maintained within the tube both for patient comfort as to prevent over temperatures within the patient.
3. Risk evaluation
Last used number is 34.
IR# Product Safety Identified Hazards Risk Estimation Risk Control Measures Residual Risk
Characteristics
Questions based on Identification of Sequences of events that lead to a hazardous Risk control measures adopted to reduce the Description of
Annex C. Examples in anticipated(known and situation and assessment of the severity and risks to an acceptable level residual risks
E.2 and H.2.4 can be foreseeable) hazards in both probability of occurrence. If this estimation is not which have
normal and fault conditions possible, list the possible consequences
used for additional been accepted
identification of A: Inherent safe by design
hazards
B: Protective measures

Characteristics
C: Information for safety
What is the intended use and how is the medical device to be used?
1 Intended use is cancer cell Oxygen radical release will damage both healthy Risk control measurement is identified below in
removal by release of oxygen and non-healthy cells, only the speed at which the more detail but the resulting risk form the
radicals within cancer cells, chemicals are removed from the cells is different device itself is limited and well within the green
triggered by high intensity light. between healthy and non-healthy cells where the
region for this type of life saving application.
non-healthy cells are slower in removal of the
chemical. When high intensity red light is used this
the chemical will produce free oxygen radicals
which will bind with the chemicals within the cells
resulting in damage to the cells followed by cell
death. Here, administering the wrong amount of
chemicals, timing between administration and
therapy, optical and electrical power introduced to
human body during therapy and removal of the
dead cell mass are the main risks for this kind of
treatment.
Is the medical device intended to be implanted? NA
Is the medical device intended to be in contact with the patient or other persons?

Characteristics
Biological contamination of the 1. The system itself has limited contact with 1. No further steps needed. The user manual
system and parts thereof may the patient and user and normal cleaning will contain a statement that the system
2 infect the body of a subject or practices are adequate to prevent cross itself can be cleaned, but cannot be
operator. contamination. For this probability is sterilized.
estimated at remote with at max impact
of Marginal so acceptable. 2. No further steps needed. The user manual
will contain a statement that the light tube
2. Light tube will be inserted in human must be cleaned.
cavities. For this, the light tube must be
clean, but sterility is not required for 3. No further steps needed. The user manual
these cavities to prevent an undesired will contain a statement that the light tube
reaction. For this probability is estimated must be sterilized before reuse with a
at remote with at max impact of Marginal subsequent patient.
so acceptable.
3. Cross contamination is the main risk for

the light tube, so sterilization is required
between patients. When not serialized
the severity is Critical and the probability
of it not being serialized is estimated as
Improbable so the remaining risk is
acceptable
Materials used in the system and The only element that normally comes into a No further steps needed. The user manual will
parts thereof may cause the short-term direct contact with the patient is the contain a statement that the light tube could
3 body’s immune system to react light tube, consisting of a medical grade silicone produce allergic reactions, and patients sensitive
in an adverse way. tube; the probability of an adverse reaction with a to silicones should be monitored.

Characteristics
critical result is improbable, so this risk is
acceptable.
What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?
See identified risks 2 and 3 for details
Is energy delivered to or extracted from the patient?

1. The device is powered by mains power. 1. The system is designed to comply with
This power is transformed to a lower IEC 60601-1. Verification is done by
4 The device could expose the voltage that energizes the LEDs within the checking each of the requirements by
patient or the operator to
light tube so earth leakage currents and means of a checklist.
dangerous voltages or currents
through contact with the device patient leakage currents (to earth) are
not possible. The resulting likelihood is improbable with the
or parts thereof.
severity being critical so the remaining risk is
2. The enclosure is fully made of conductive acceptable.
material, with a minimum shell thickness
of 1 mm. A proper ground connection is
mandatory. Resulting in a critical impact
with an improbable probability so is
acceptable.
The device could produce When the cooling of the light tube fails the (local) System must check that water temperature
sufficient heat to burn the temperature could rise above 40 ° Celsius. The use stays below 40 ° Celsius, water pressure is an
5 of water cooling will result in a controlled and

Characteristics
patient or the operator, or cause uniform temperature control. So when monitoring indication of continuous water flow, no further
a fire. both water temperature and flow the remaining actions needed
risk probability is improbable with critical outcome
so is acceptable
Device introduces a harmful Insertion of the light tube can result in damage to No further steps needed. The user manual will
mechanical force on the patient the patient. The minimize this risk user must do contain a statement that insertion of the light
6 this manually while checking for blockages. the tube must be done manually and with care.
remaining risk probability is improbable with
Severe outcome so acceptable
Device introduces trapping risk Only moving part are the water pump and a
due to moving parts cooling fan, which are both enclosed within the
7 housing of the control unit so no specific risks are
identified.
Device introduces harmful N.A.: no suspended masses

mechanical forces on the patient
8 due to suspended masses
Device introduces harmful (air) Only pressurized part of the system is the closed Design must limit the water pressure below 1.5
flows due to higher pressure loop water flow that controls the temperature of Bar.
9 the light tube. Upon breakage of the tube water
can enter the patient, human cavities are not No further steps needed. The user manual will
harmed due to water entry when the water is contain a statement that the water used for
clean. Water flowing out of the light tube at higher cooling should be clean and diluted with alcohol
pressure than common for water taps could to prevent microbial growth.
damage the patient so this must be limited to 1.5

Characteristics
bar. The remaining risk probability is improbable
with Severe outcome so acceptable.
Device introduces harmful The system has no intended vibration but will
vibration include a pump. While the pump is placed in the
10 control unit no significant risk is identified.
Radiated or conducted It is likely that the system is used in the vicinity of Add in manual warning against large magnetic
electromagnetic fields could other electronic devices. The device was and electrical fields.
11 cause other equipment to fail to developed to comply with IEC 60601-1-2. So the
perform correctly in the likelihood that an external magnetic of
presence of the system electromagnetic field reduces device performance
or influences another device is improbable. This
combined with a noticeable severity, this while the
device will give not function and measurement
needs to be repeated, resulting in an acceptable
risk. For medical application specifically the large
fields generated by MRI equipment and the likes
can easily introduce a risk so caution against this
must be added in the manual
Are substances delivered to or extracted from the patient? NA
Are biological materials processed by the medical device for subsequent re-use, transfusion or transplantation? NA

Characteristics
Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable? Yes, see risk 2
Is the medical device intended to be routinely cleaned and disinfected by the user?
Aggressive chemical agents may Risks for housing are small while a metal housing is User will be instructed not to use aggressive
damage the system or cause used but fluid ingestion should be prevented cleaning agents for the control unit. This will
12 unsafe situations where possible. The light tube is suitable for reduce the likelihood to incredible so the
sterilization but chemicals can damage the tube so remaining risk is acceptable.
no aggressive chemicals can be used.
User will be instructed not to use aggressive
cleaning agents for the light tube. Also the user
will be instructed to check the light tube on
damage like tearing, non-transparent and
stiffness before use. This will reduce the
likelihood to incredible so the remaining risk is
acceptable.
Is the medical device intended to modify the patient environment? NA
Are measurements taken? No
Is the medical device interpretative? NA

Characteristics
Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?
The device is used in conjunction Only one type of light tube is available at this time A warning is placed in the manual that the
with chemicals that do reactive so only the chemical can be changed. Currently specific chemicals must be used. No further
14 to the specific light frequency there is only one chemical under investigation so steps needed.
emitted by the LED’s. So when with exactly specified accessories, the remaining
using the wrong chemical and risk probability is improbable with critical outcome
light frequency combination a so acceptable
risk could be introduced.
Are there unwanted outputs of energy or substances?
See identified risks 4 to 11
Is the medical device susceptible to environmental influences?

Electromagnetic disturbances Performance loss may represent itself in: The system was developed to comply with IEC
(conducted and radiated) may 60601-1-2. Special care is taken during the
15 cause the system to fail to - incorrect output data printed circuit board layout stage. Large ground
perform correctly. plane layers are used to block electromagnetic
signals coming from the environment.
- loss of output data
Very large electromagnetic disturbances may
still affect the system, resulting in performance
loss.

Characteristics
To reduce these effects further, the following
measures were taken:
- The processor loads it’s program code from

EPROM at powerup, and never has need to
access any external device for the code any
more. This reduces the chance of code
corruption due to electromagnetic interference.
If even so, the processor accesses unused code
space, a watchdog function will cause it to reset,
so that the system comes into a defined, usable
state again.
After implementing the described

countermeasures, the remaining likelihood is
improbable with the severity being noticeable so
the remaining risk is acceptable.
ESD pulses may cause the The device does not have any accessible The system was developed to comply with IEC
system to fail to perform conductive parts during normal operation. 60601-1-2.
16 correctly, or even break. Therefore a direct ESD discharge is not possible.
To reduce the effects further, the following
Performance loss or system damage due to ESD air measures were taken:
discharges may represent itself in:
- The processor loads it’s program code from
- incorrect output data EPROM at powerup, and never has need to
access any external device for the code any
- loss of output data more. This reduces the chance of code
corruption due to electromagnetic interference.

Characteristics
If even so, the processor accesses unused code
space, a watchdog function will cause it to reset,
so that the system comes into a defined, usable
state again.
The loss of data can be identified by the host

due to the use of a sample number which
switches from 1 – to 127 giving the host 1
second to detect missing datablock.
After implementing the described

Extreme temperatures or The system is designed for a specified operating A note about the operating temperature range
humidity during operation may temperature of +10ºC to +45ºC and a relative and relative humidity is placed in the user
17 damage the system humidity of 10% to 95% (non-condensing). This manual. No further steps are needed.
will cover the normal temperature and humidity
range found in home or clinical environments Use
outside the defined specifications has a likelihood
of remote with possible a noticeable so the
remaining risk is acceptable.
Extreme temperatures or The system is designed for a specified transport

humidity during transport or and storage temperature of -10ºC to +50ºC, and a
18 storage may damage the system relative humidity of 10% to 100%. This will cover
the normal temperature and humidity range found
during transport and storage. Use outside of the

Characteristics
defined specifications has a likelihood of
improbable with possible a noticeable so the
Wet environments like showers, The intended use of the device does not include A caution that the device is not to be used in wet
bath tubs etc. may damage the wet environments like showers, bathrooms etc. environments like showers, bath tubs etc. is
19 system or make the system when no special notes, are made the likelihood for placed in the user manual.
unsafe. this is deemed remote with a severity of
noticeable while this will result in a defect in the Also a warning is included that tells the user to
device but the likelihood that this results in bodily not use the device if somehow fluid ingress has
harm is incredible, so the risk for the user are happened, and to have it serviced by qualified
deemed acceptable. The risk for the device is technicians.
acceptable.
No further steps needed
Explosive / aggressive gasses in Device is non Ex, Markings will not show Ex and A caution that the device should not be used
the environment can result in user will be warned that the device is non Ex. within an Ex area must be entered within the
33 explosions when the device is Likelihood of this risk resulting in actual harm is user manual.
not Ex deemed incredible with critical results.
Does the medical device influence the environment?
See identified risks 4 - 11 for details

Characteristics
Are there essential consumables or accessories associated with the medical device?
20 Use of incorrect accessories can The light tube is a special unique design for which Within the manual the user is warned about the
result in incorrect measurement no alternatives are available, so risk of wrong possible impact of using wrong accessories
values or non-functional device. accessories is deemed incredible so remaining risk including the possible results.
is acceptable.
The remaining risk remains within the yellow

region.
Is maintenance or calibration necessary?
21 Calibration is needed on regular No calibration is needed

basis
Does the medical device contain software?
See identified risks 15 and 16 for details on the risk management
Does the medical device have a restricted shelf-life? NA

Characteristics
Are there any delayed or long-term use effects?
22 Pump has limited lifetime of Device is designed and released for clinical trials so User must be warned about limited life time of
correct operations all components are expected to have a longer the device, this will not change the remaining
lifespan than the trials themselves so no remaining risk but will result in better user expectations.
risk.
23 Components can deteriorate in Device is designed and released for clinical trials so
time resulting in failure of the all components are expected to have a longer
measurement or dangerous lifespan than the trials themselves so no remaining
situations risk.
To what mechanical forces will the medical device be subjected?

The system may be damaged or The system is not hand-held, it will normally be set
become unsafe from impacts, on a table
24 free falls or vibration
The chance that the system drops onto the floor

during use or when not operating, is remote. with
the severity without any extra counter
measurements being critical so the remaining risk
is acceptable.
The system might lose data or The system is not hand-held, it will normally be set
the ability to store further data on a table
25

Characteristics
from impacts, free falls or
vibration The chance that the system drops onto the floor
during use or when not operating, is remote. with
the severity without any extra counter
measurements being critical so the remaining risk
is acceptable.
Sharp edges or points could The system is not hand-held, it will normally be set Both the control unit and light tube should not
injure patient or operator on a table. So the control unit should not contain contain sharp edges.
26 any sharp edges but no further actions are
needed. The light tube must be smooth and
without sharp edges. After this is the probability is
remote. with the severity without any extra
counter measurements being critical so the
What determines the lifetime of the medical device?
See identified risk 22 for details
Is the medical device intended for single use? NA
Is safe decommissioning or disposal of the medical device necessary?

Characteristics
27 Product is disposed of in an Devices will be returned to producer. This in Further risk reduction is possible by addressing
incorrect way. according to the WEEE Article 13.2 and then are correct disposal within the user manual keeping
disposed of by the producer. the risk acceptable
Does installation or use of the medical device require special training or special skills?
Inadequate, insufficient or The design of the manual is in accordance with Verification is done by means of checklist.
incomplete operating IEC60601-1. The manual contains all necessary
28 instructions could lead to warnings, cautions and instructions that should
ensure safe and effective operation and contains
potentially unsafe use of the
all items required by the standards and AIMDD
system. 90/385/EEC.
Use by unskilled personnel could System can only be used by a trained user. The user manual provides enough information
lead to potentially unsafe use of Insertion of light tube is by definition a medical for a trained user to use the system safely and
29 the system. procedure that will only be performed by medical effectively. See also identified risk 28.
personnel. When the light tube is activated within
insertion there is no risk to damage to user of
patient. So probability of any damage is
improbable so the remaining risk is acceptable
How will information for safe use be provided?
See identified risk 28 and 29 for details

Characteristics
Will new manufacturing processes need to be established or introduced?
30 Construction of light tube could Main risks are short circuit within the light tube The new production method does introduce
introduce risks itself resulting in no risk to the patient or user so additional risk; these can be mitigated within the
acceptable. Issues with the gluing of the different engineering tests described as part of the 60601-
parts of the light tube can result in electrical
1 compliance and during production by visual
conductivity to the patient.
inspection of conformity of production to
design. So with these checks the likelihood is
deemed improbable and the resulting risk is
acceptable
Is successful application of the medical device critically dependent on human factors such as the user interface?
Unclear or complex operation of The system complexity is limited. So clear
the system may lead to unsafe feedback should be enough to make resulting risk
31 situations. acceptable. Clear status feedback and errors need to be
indicated.
Can the user interface design features contribute to use error?
See identified risk 31 and 32 for details, there is only one tube in available with other parts fitting in only way as defined within the module design
Is the medical device used in an environment where distractions can cause use error? NA

Characteristics
Does the medical device have connecting parts or accessories?
Does the medical device have a control interface?
Does the medical device display information? NA
Is the medical device controlled by a menu? NA
Will the medical device be used by persons with special needs? NA
Can the user interface be used to initiate user actions? NA
Does the medical device use an alarm system?

Characteristics
An unclear device state may lead There are no device states that can cause direct
to unsafe situations. risk to the patient or operator.
32 The different states of the device (power on/off,
normal working, battery ok/low) need to be
clearly indicated on the front panel of the
device. after implementing the described
In what way(s) might the medical device be deliberately misused?
No new risks identified based on identified risks 1 - 32
Does the medical device hold data critical to patient care? NA
Is the medical device intended to be mobile or portable?
Essential performance specifications defined within the 60601-1 checklist so no additional risk identified, risks for data loss are handled within risk 16.
Does the use of the medical device depend on essential performance? NA

3.1. Overall residual risk assessment
Due to the limited risks that are identified in combination with the high benefits of the device no residual risk is identified.

4. Single fault risk assessment

Based on the schematics shown below:

For the single fault analysis, any result which makes the device inoperable is deemed acceptable as also described within risk 1. Risk assessment is done based on the
functional blocks with a detailed examination of the blocks that can make contact with the patient when outer isolation of the light tube is damaged and a conducting path
is created between the patient and the device. While this is a prototype only the most significant errors are discussed.
Based on this the following risk / single fault conditions are identified:
1. LED’s are driven by a pulse width modulated 125 kHz signal through a capacitor of 2 times 2,2uF. So when the pulses stop there will be no current flowing, and no
DC voltage will be connected to the LEDs and under the first fault condition of a broken light tube isolation the likelihood of a DC voltage being available is deemed
improbable so the remaining risk is acceptable
2. When there is a short circuits within the power supply patient current can be too high. Ground is connected to power supply ground and worse case the 230V is
connected through bridge to the output stage. Most likely this will result in failure within the device and short circuit which will protect the patient against excess
currents. The risk on this is deemed improbable with the impact being critical this is deemed acceptable. In combination with D12 and D16 this is risk is even
further reduced.
3. When under normal conditions the light tube isolation fails the system applies an AC voltage to the patient. This at 125 kHz at which frequency the patient body
does only limiting responds to the electrical current, See 606012 for details so the question is if the r.m.s. current is limited to 10 mA according to the 60601. While
Led current is floating around ground maximum voltage is 24 / 2 is 12V or 8.5V r.m.s.. When the patient is not grounded through the bloodstream worse case
resistance assumption (60601) is 100 Ohm resulting in a patient leakage current of 85 mA r.m.s. so this is unacceptable in worse case condition. The resulting risk
has a probability of occasionally with catastrophic consequences so well in the yellow region and further risk reduction is needed. When the patient is not
electrically grounded resistance to the ground will be 1000 Ohm minimum so the remaining current is 8.5 mA r.m.s. so acceptable reducing the consequence to
critical so resulting in an acceptable risk. Warning should be placed in the manual that no other electrical non-floating connections can be made to the patient
during treatment and that defibrillation equipment must be available.
4. The power supplies to the Peltier temperature control and the pump can result in electrical contact to the water and thus to the patient in single fault condition.
To prevent this both the pump, as the water connections as the closest conducting part of the Peltier element need to be either isolated or connected to ground
with a minimum of one connection.
5. The other risks that can be identified all result in a defective device without increase patient risk, further risk evaluation will be done during series design of the
device.

4.1. Overall residual risk assessment single faults

There is a single fault risk that could worse case introduce a current through the patient that is too high. This current is at 125 kHz so actual risks are small while no
physiologic parts within the human body can respond to this frequency but even then the current can result in patient harm. When applying the risk reduction activities
described in combination with the availability of defibrillation equipment, the defibrillation success rates for electrical induced heart failure is high, see below, while the
lack of the device will increase mortality rates this risk is deemed acceptable at this time for the clinical trials. Further risk reduction needs to be performed during volume
design and the following risk reduction activities need to be taken:
1. Warning should be placed in the manual that no other electrical non-floating connections can be made to the patient during treatment
2. Warning should be placed in the manual that defibrillation equipment must be available during treatment.
3. Water is grounded and any electrically controlled part is either isolated or also grounded.

5. Appendix B ISO 60601 compliance check list

The list below is based on engineering evaluation and for volume design needs to be validated.
§ Requirement Impact on design Validation (P)ass Note

method
(F)ail
NA
1.1 60601 covers medical electrical systems, not in vitro diagnostics nor implantable Applicable See this list P
parts
1.3 Specifically list all applied collateral standards within the declaration of Input for declaration of Design P
conformity conformity review
Note: all references to chapter 2 are based on the amended ISO 60601
2 IEC 60065:2001, Audio, video and similar electronic apparatus – Safety Depending on design Design NA
requirements 4) review
Amendment 1:2005
Amendment 2:2010
2 IEC 60068-2-2:1974 2007, Environmental testing – Part 2-2: Tests – Test B: Dry Depending on design Design NA
heat review
Amendment 1 (1993)
Amendment 2 (1994)
2 IEC 60079-0, Electrical apparatus for explosive gas atmospheres – Part 0: General Depending on design Design NA
review
requirements


method
(F)ail
NA
2 IEC 60079-2, Electrical apparatus for explosive gas atmospheres – Part 2: Depending on design Design NA
Pressurized review
enclosures “p”
2 IEC 60079-5, Electrical apparatus for explosive gas atmospheres – Part 5: Powder Depending on design Design NA
filling “q” review
2 IEC 60079-6, Electrical apparatus for explosive gas atmospheres – Part 6: Oil- Depending on design Design NA
immersion “o” review
2 IEC 60083, Plugs and socket-outlets for domestic and similar general use Depending on design Design NA
standardized in member countries of IEC review
2 IEC 60085, Electrical insulation – Thermal classification Depending on design Design NA

review
2 IEC 60086-4, Primary batteries – Part 4: Safety of lithium batteries Depending on design Design NA
review
2 IEC 60112, Method for the determination of the proof and the comparative Depending on design Design NA
tracking indices of solid insulating materials review
2 IEC 60127-1, Miniature fuses – Part 1: Definitions for miniature fuses and general Depending on design Design NA
requirements for miniature fuse-links review
2 IEC 60227-1:1993 2007, Polyvinyl chloride insulated cables of rated voltages up to Depending on design Design NA
and including 450/750 V – Part 1: General requirements 5) review


method
(F)ail
NA
Amendment 1 (1995)
Amendment 2 (1998)
2 IEC 60245-1:2003, Rubber insulated cables – Rated voltages up to and including Depending on design Design NA
450/750 V – Part 1: General requirements 6 review
Amendment 1:2007
2 IEC 60252-1, AC motor capacitors – Part 1: General – Performance, testing and Depending on design Design NA
rating – Safety requirements – Guide for installation and operation review
2 IEC 60320-1, Appliance couplers for household and similar general purposes – Depending on design Design NA
Part 1: General requirements review
2 IEC 60335-1:2001 2010, Household and similar electrical appliances – Safety – Depending on design Design NA
Part 1: General requirements review
2 IEC 60364-4-41, Electrical installations of buildings – Part 4-41: Protection for Depending on design Design NA
safety – Protection against electric shock review
2 IEC 60384-14:2005, Fixed capacitors for use in electronic equipment – Part 14: Depending on design Design NA
Sectional specification: Fixed capacitors for electromagnetic interference review
suppression and connection to the supply mains
2 IEC 60417-DB:2002 , Graphical symbols for use on equipment 7) Design P

review


method
(F)ail
NA
2 IEC 60417, Graphical symbols for use on equipment. Available from: Design P
<http://www.graphicalsymbols.info/equipment> review
2 IEC 60445, Basic and safety principles for man-machine interface, marking and Depending on design Design NA
identification – Identification of equipment terminals and of terminations of review
certain designated conductors, including general rules for an alphanumeric
system
2 IEC 60447, Basic and safety principles for man-machine interface, marking and Depending on design Design NA
identification – Actuating principles review
2 IEC 60529:1989, Degrees of protection provided by enclosures (IP Code) 8) Depending on design Design P
Amendment 1 (1999) review
2 IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for Applicable EMC testing P Design review
safety – or design
review
Collateral standard: Electromagnetic compatibility – Requirements and tests
2 IEC:2005+A1:2012(E) Depending on design Design NA

review
2 IEC 60601-1-3, Medical electrical equipment – Part 1-3: General requirements for Depending on design Design NA
basic safety and essential performance. Collateral standard: General review
requirements for Radiation protection in diagnostic X-ray equipment


method
(F)ail
NA
2 IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for Depending on design Design P Simple design, see risk
safety – review management for
details
Collateral standard: Usability
2 IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for Not applicable NA P
safety –- Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
2 IEC 60664-1:1992 2007, Insulation coordination for equipment within low-voltage Depending on design Design NA1
systems – Part 1: Principles, requirements and tests 9) review
Amendment 1 (2000)
Amendment 2 (2002)
2 IEC 60695-11-10, Fire hazard testing – Part 11-10: Test flames – 50 W horizontal Depending on design Design NA
and vertical flame test methods review
2 IEC 60730-1:1999 2010, Automatic electrical controls for household and similar Depending on design Design NA
use – Part 1: General requirements 10) review
Amendment 1 (2003)
1 Insulation demands for medical equipment are part of the ISO 60601-1


method
(F)ail
NA
2 IEC 60825-1:1993 2007, Safety of laser products – Part 1: Equipment classification Depending on design Design NA
and review
requirements and user's guide 11)
Amendment 1 (1997)
Amendment 2 (2001)
2 IEC 60851-3:1996 2009, Winding wires – Test methods – Part 3: Mechanical Depending on design Design NA
properties 12) review
Amendment 1 (1997)
Amendment 2 (2003)
2 IEC 60851-5:1996 2008, Winding wires – Test methods – Part 5: Electrical Depending on design Design NA
properties 13) review
Amendment 1 (1997)
Amendment 2 (2004)
2 IEC 60851-6:1996, Winding wires – Test methods – Part 6: Thermal properties Depending on design Design NA
review
Amendment 1 (1997)


method
(F)ail
NA
2 IEC 60878:2003, Graphical symbols for electrical equipment in medical practice Applicable Design NA2
review
2 IEC 60884-1, Plugs and socket-outlets for household and similar purposes - Part 1: Depending on design Design NA
General requirements review
2 IEC 60950-1:2001, Information technology equipment – Safety – Part 1: General Depending on design Design NA
requirements review
2 IEC 61058-1:2000, Switches for appliances – Part 1: General requirements 14) Depending on design Design NA
review
Amendment 1:2001
Amendment 2:2007
2 IEC 61558-1:1997, Safety of power transformers, power supply units and similar – Depending on design Design NA
Part 1: review
General requirements and tests 15)

Amendment 1 (1998)
2 IEC 61558-2-1, Safety transformers, power supply units and similar – Part 2: Depending on design Design NA
Particular review
requirements for separating transformers for general use
2 This norm is the compiled from the IEC 60417 and ISO 7000 which are referenced separately


method
(F)ail
NA
2 IEC 61672-1, Electroacoustics – Sound level meters – Part 1: Specifications Depending on design Design NA
review
2 IEC 61672-2, Electroacoustics – Sound level meters – Part 2: Pattern evaluation Depending on design Design NA
tests review
2 IEC 61965, Mechanical safety of cathode ray tubes Depending on design Design NA
review
2 IEC 62133, Secondary cells and batteries containing alkaline or other non-acid Applicable Design NA
electrolytes – Safety requirements for portable sealed secondary cells, and for review
batteries made from them, for use in portable applications
2 IEC 62304:2006, Medical device software – Software lifecycle processes Applicable Design P Proto type design
review specific, further actions
need to be taken
during volume design
2 ISO 31 (all parts), Quantities and units Applicable Design P

review
2 ISO 780, Packaging – Pictorial marking for handling of goods Applicable Design P
review
2 ISO 1000, SI units and recommendations for the use of their multiples and of Applicable Design P
certain other units Review


method
(F)ail
NA
2 ISO 1853, Conducting and dissipative rubbers, vulcanized or thermoplastic – Depending on design Design NA
Measurement of resistivity Review
2 ISO 2878, Rubber, vulcanized – Antistatic and conductive products – Depending on design Design NA
Determination of Review
electrical resistance
2 ISO 2882 16), Rubber, vulcanized – Antistatic and conductive products for hospital Depending on design Design NA
use – Review
Electrical resistance limits
2 ISO 3746, Acoustics – Determination of sound power levels of noise sources using Depending on design Design NA
sound Review
pressure – Survey method using an enveloping measurement surface over a

reflecting plane
2 ISO 3864-1:2002, Graphical symbols – Safety colours and safety signs – Part 1: Depending on design Design NA
Design applicable for work Review
instructions
principles for safety signs in workplaces and public areas
2 ISO 5349-1, Mechanical vibration – Measurement and evaluation of human Depending on design Design NA
exposure to handtransmitted vibration – Part 1: General requirements Review
2 ISO 7000-DB:2004 17), Graphical symbols for use on equipment – Collection of Applicable Design P
symbols Review


method
(F)ail
NA
2 ISO 7010:2003 2011, Graphical symbols – Safety colours and safety signs – Depending on design Design NA
Registered applicable for work Review
instructions
safety signs used in workplaces and public areas
2 ISO 9614-1, Acoustics – Determination of sound power levels of noise sources Depending on design Design NA
using sound intensity – Measurement at discrete points Review
2 ISO 10993 (all parts), Biological evaluation of medical devices Depending on design Design NA
Review
2 ISO 11134, Sterilization of health care products – Requirements for validation and Depending on design Design P
routine Review
control – Industrial moist heat sterilization
2 ISO 11135, Medical devices – Validation and routine control of ethylene oxide Depending on design Design NA
sterilization Review
2 ISO 11135-1:2007, Sterilization of health care products – Ethylene oxide – Part 1: Depending on design Design NA
Review
Requirements for development, validation and routine control of a sterilization
process for medical devices
2 ISO 11137, Sterilization of health care products – Requirements for validation and Depending on design Design NA
routine Review
control – Radiation sterilization


method
(F)ail
NA
2 ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Depending on design Design NA
Requirements for development, validation and routine control of a sterilization Review
process for medical devices
2 ISO 13852, Safety of machinery – Safety distances to prevent danger zones being Depending on design Design NA
reached by the upper limbs review
2 ISO 13857:2008, Safety of machinery – Safety distances to prevent hazard zones Depending on design Design NA
being review
reached by the upper and lower limbs
2 ISO 14971:2000 2007, Medical devices – Application of risk management to Applicable Design P
medical devices review
2 ISO 15223, Medical devices – Symbols to be used with medical device labels, Applicable Design P
labelling and information to be supplied review
2 ISO 15223-1:2012, Medical devices – Symbols to be used with medical device Applicable Design P
labels, review
labelling and information to be supplied – Part 1: General requirements
2 ISO 17665-1:2006, Sterilization of health care products – Moist heat – Part 1: Applicable Design NA
Requirements for the development, validation and routine control of a review
sterilization process for medical devices


method
(F)ail
NA
2 ISO 23529, Rubber – General procedures for preparing and conditioning test Depending on design Design NA
pieces for physical test methods Review
2 ISO 80000-1:2009, Quantities and units – Part 1: General Applicable Design P

review
Note: all specifications below are applicable for normal use and reasonably
foreseeable misuse
4.2 ISO 14971 risk assessment will be done resulting in risk management file Applicable Design P
review
4.3 Essential performance are identified Identify essential Design P

performances that review
define the correct
working in medical
equipment
4.4 Defined expected life time of the device within the risk management file Applicable Design P
review
4.5 When using alternative risk method provide proof that this is equal or better than ISO 14971 and ISO NA
ISO 14971 and ISO 60601 60601 will be followed
4.6 Identify all applied parts within the risk management file including the ones Depending on design Design P
outside of the definition Review


method
(F)ail
NA
4.7 Include single fault analysis within the risk management file Applicable Design P
review
4.8 All components will Be used within the defined specifications or introduced risks Applicable Design P
are included in the risk management file review
4.9 When high-integrity components are needed these will be tracked in the risk Depending on design Design P
management file Review
4.10 Mains supply power supply protection will be in accordance with IEC 60364-4-41 Depending on design Design P
Review
4.11 Actual used power may not exceed 110% of rated power Applicable Design P
review
5.1 Performed type tests and needed combination of type tests are defined within Applicable Design P
the risk management file review
5.2 Number of performed type tests are defined within the risk management file Applicable Design P
review
5.3 Type test are also performed at extreme environmental condition Applicable Design P
review
5.4 Tests are performed under least favourable conditions as defined in specifications Applicable Design P
of the ME and the sub parts. review


method
(F)ail
NA
5.5 Supply tests are performed under least favourable conditions as defined in Applicable Design P
specifications of the ME and the sub parts. review
5.6 Medical equipment must be in original state before each performed test Applicable Design P
review
5.7 For tests 8.7.4 and 8.8.3 medical equipment is preconditioned to the environment Applicable Test design P
review
5.8 Tests are performed in such a sequence that the outcomes do not influence each Applicable Test design P
other review
5.9 Accessible parts are all parts that can be touched by the test finger or test hook Applicable Design P
review
6.2 The medical equipment, main parts and applied parts will be classified Class I, Applicable Design P
Class II or internally powered medical equipment review
6.3 The medical equipment, main parts and applied parts IP class will be defined Applicable Design P
review
6.4 The medical equipment, main parts and applied parts method of sterilization will Applicable Design P
be defined review
6.5 The medical equipment, main parts and applied parts suitability for oxygen rich Applicable Design P
environment will be defined. review


method
(F)ail
NA
6.6 The medical equipment, main parts and applied parts mode of operation, either Applicable Design P
continues or non-continues will be defined review
7.1.1 Usability of identifications, marking and documents will be validated Applicable Design P
review
7.1.2 Legibility of identifications, marking and documents will be validated Applicable Design P
review
7.1.3 Durability of identifications and marking will be validated Applicable Design P

review
7.2.1 Minimum markings will be placed on medical equipment or interchangeable part Applicable Design P
review
7.2.2 Medical equipment or interchangeable part will be identified on marking Applicable Design P
review
7.2.3 Medical equipment or interchangeable part will reference accompanying Applicable Design P
documents review
7.2.4 Accessories will be marked on product or package with name or trade-mark Applicable Design P
review
7.2.5 When external power is device dependant is needed applicable model or type Depending on design Design NA
reference will be marked on the medical equipment Review


method
(F)ail
NA
7.2.6 Rated voltages are marked on medical equipment including supply mains Depending on design Design NA
Review
7.2.7 Rated power is marked on medical equipment including supply mains Depending on design Design NA
Review
7.2.8 Output connectors will be marked on rated output voltage, power and frequency Depending on design Design NA
Review
7.2.9 IP classification will be marked on medical equipment Applicable Design P

review
7.2.10 Degree of protection is marked for all applied parts Applicable Design P
review
7.2.11 For non-continues operations duty cycle will be marked Applicable Design P
review
7.2.12 Fuses rating will be marked Depending on design Design NA

Review
7.2.13 Physiological effects that are not obvious needed to be marked Depending on design Design P
Review
7.2.14 High voltage terminals need to be marked Depending on design Design NA

Review


method
(F)ail
NA
7.2.15 Cooling conditions need to be marked Depending on design Design NA

Review
7.2.17 Protective packaging needs need to be marked Depending on design Design P

Review
7.2.18 External pressure source need to be marked Depending on design Design NA

Review
7.2.19 Functional earth terminals need to be marked Depending on design Design NA

Review
7.2.20 Removable parts are marked as being needed to be replaced. Depending on design Design P
Review
7.3.1 Heating elements and lamp holders will have marking within the medical Depending on design Design P
equipment Review
7.3.2 High voltage parts will have marking within the medical equipment Depending on design Design NA
Review
7.3.3 Battery type and mode of insertion will be marked within the medical equipment Depending on design Design P
Review
7.3.4 Fuses, thermal cut-outs and over current releases are marked within the medical Depending on design Design NA
equipment Review


method
(F)ail
NA
7.3.5 Protective earth terminals are marked within the medical equipment Depending on design Design P
Review
7.3.6 Functional earth terminals are marked within the medical equipment Depending on design Design P
Review
7.3.7 Supply terminals are marked within the medical equipment Depending on design Design P
Review
7.3.8 Any part with a temperature above 75 degree's Celsius are marked within the Depending on design Design NA
medical equipment Review
7.4.1 Power switches are marked on the medical equipment Depending on design Design P
Review
7.4.2 Control devices will be marked in the medical equipment Depending on design Design P
Review
7.4.3 Unit of measurement will be expressed in SI units. Deviation within specifications Depending on design Design P
must be described with risk management file Review
7.5 Non obvious risks are marked to the user Depending on design Design P
Review
7.6 Used symbols will must be explained within the manual Applicable Design P
review


method
(F)ail
NA
7.7 All used power associated wires will be coloured in accordance with the Depending on design Design P
applicable norms Review
7.8 Colour Red is used for all warnings that require immediate response Applicable Design P
review
Colour Yellow is used for warnings that require prompt response
Colour Green indicated ready for use

Other colours do not have the same meaning.
7.9.1 Equipment will be supplied with manual containing as minimum: Applicable Design P
review
Name or trade name of the manufacturer including address
Model or type reference
When digitally supplied remaining risk must be identified in risk management file
Special skills, training and knowledge for intended user
7.9.2 Manual shall contain: Applicable Design P

review
Intended use of medical equipment
The frequently used functions
Known contraindications
Specification of all used symbols
Warning and safety notices


method
(F)ail
NA
Power connections and when applicable specific power equipment
Electrical power source
Description of medical equipment
Medical equipment functioning
Significant physical and performance characteristics

Method of installation
Isolation from the supply mains
Start-up procedure
Operating instructions
System, error and fault messages
Shutdown procedure
Cleaning, disinfection and sterilization
Maintenance
Accessories, supplemental equipment and used materials

Environmental protection
References to technical description


method
(F)ail
NA
7.9.3 Manual shall contain technical description including: Applicable Design P

review
Environmental conditions for correct working
Characteristics including ranges accuracy and precision of the displayed values
Special installation requirement
Cooling liquid definition

Supply mains maximum values
Oil level checking if applicable
Warning against remaining hazards
Replacement of fuses, power supply cords and other parts

Technical details on repairable service parts including all documentation
Mains isolation
8.1 Under normal and single fault condition the voltages and current do not exceed Applicable Design P
the limits named below review
8.2.1 Separate power source is treated as integral part of the medical equipment Depending on design Design NA
Review
8.2.2 Wrong polarity connection will not result in any risk except for non function of Applicable Design P
the medical equipment review


method
(F)ail
NA
8.2.3 Applied parts are classified as CF (Cardiac application), BF (other physiological Applicable Design P
signals) or B review
8.4.2 Total patient (leakage) current will not exceed the values shown below Applicable Design P
review
8.4.3 When using a power plug, pins within the plug may not exceed 60V after 1 second Depending on design Design NA
of disconnection Review
8.4.4 Internal capacitive circuits may not exceed 60V after 1 second of disconnection Depending on design Design NA
Review
8.5.1 Each dangerous voltage within the device or within any connection shall have two Depending on design Design P
means of protection Review
8.5.2 There is no connection between patient applied parts and other applied parts or Applicable Design P
conductive parts of the medical equipment review
8.5.3 The maximum mains voltage is rated as minimum at 250V Depending on design Design NA
Review
8.5.4 Working voltage has been defined Depending on design Design P

Review
8.5.5 Defibrillator proof parts are tested with 5 kV in botch common and differential Depending on design Design NA
mode and with no more than 10% loss of defibrillator energy Review


method
(F)ail
NA
8.6.2 Protective earth will be included with the power supply and not be removable Depending on design Design NA
without tool Review
8.6.3 Earth connection to moving part only allowed when proved to remain in place for Depending on design Design NA
lifetime of the device Review
8.6.4 Earth cabling will be able to handle the current with a maximum voltage drop of Depending on design Design NA
6V Review
8.6.5 Surface coatings are removed when needed to guarantee correct conductivity Depending on design Design P
Review
8.6.6 When part of a plug protective earth connection will be made before the other Depending on design Design P
connections are made. Review
8.6.7 Potential earth equalizer shall be a separate connection that is easily handled and Depending on design Design P
stable under normal use. Review
8.6.8 Earth connection for protective and earth connection and functional or Depending on design Design P
equalization function can may not be combined Review
8.7.1 Patient leakage current are measured under worse case condition combining all Applicable Design P
inputs and connections review
8.7.3 Leakage currents are R.M.S. measure and shall not exceed 100uA under normal Applicable Design P
conditions and 500uA under first fault. review


method
(F)ail
NA
8.7.4 When Patient leakage currents can not be calculated based on the design the Applicable Design P
currents are measured with the measurement methods described in 8.7.4 review
8.8.1 All isolation that is part of the functional protection will be tested Applicable Design P
review
8.8.2 Isolation for voltages above 71V peak will be at least 0.4mm, will pass Depending on design Design NA
dielectrically strength test and have solid isolation. Review
8.8.3 Dielectrically strength of isolations that are part of the parts that functional Depending on design Design P
protection will be able to handle 1500V or mains power medical equipment, see Review
table for other rate voltages
8.8.4 All isolation that is part of the functional protection must maintain isolation value Applicable Design P
and mechanical shape at 75 degree's Celsius and 125 degree's Celsius for mains review
isolation, and will not be sensitive in reducing the isolation value due to
contamination
8.9 Minimum creepage distance will be 0.4mm for low voltage parts and 3 mm for Applicable Design P
mains parts. For special voltages and when designing in accordance with these review
minimum specifications check this paragraph for details
8.10 All components, wires and interconnections shall be fixated to prevent movement Applicable Design P
review
8.11.1 Isolation from main supply can be done in one safe action with complete isolation Depending on design Design NA
Review


method
(F)ail
NA
8.11.3 Sturdy standard power cords will be used and power inlet can not be pulled out Depending on design Design NA
Review
8.11.4 Permanently installed medical equipment will have suitable and protected mains Depending on design Design NA
connection Review
8.11.5 All medical class I and II equipment will be fused. Depending on design Design NA
Review
8.11.6 Internal wiring cross section will be suitable for the defined currents including Depending on design Design P
short-circuit currents. Review
9.2 Medical equipment can not crush the patient and / or user Depending on design Design NA
Review
9.4 See chapters for details when risk is identified
9.8
9.2 Medical equipment can not cut the patient and / or user due to shearing danger Depending on design Design P
Review
9.8
9.2 Medical equipment can not entangle the patient and / or user Depending on design Design P
Review
See chapters for details when risk is identified
9.2 Medical equipment can not trap the patient and / or user Depending on design Design P
Review
See chapters for details when risk is identified, for this acceptable gap is < 4mm


method
(F)ail
NA
9.2 Medical equipment can not stab or puncture the patient and / or user Depending on design Design P
Review
9.8
9.2 Medical equipment can not creating friction with or introduce abrasion for the Depending on design Design P
patient and / or user Review
9.3
9.5 Medical equipment will not expel any dangerous radiation, material or other Depending on design Design P
physical measureable influences with danger for the patient and / or user Review
9.7 High pressure liquids will not introduce any risk for the patient and or user. Depending on design Design P
Review
9.8 Medical equipment will not introduce any risks due to falling of the medical Depending on design Design P
equipment to the patient and / or user Review
9.4 Medical equipment will not introduce any risks due instability of the medical Depending on design Design P
equipment to the patient and / or user Review


method
(F)ail
NA
9.2 Medical equipment will not introduce any risks due on impacts to the patient and Depending on design Design P
/ or user Review
9.8
9.2 Medical equipment will not introduce any risks on involuntary patient movement Depending on design Design NA
Review
9.6 Medical equipment will not introduce excess vibration or noise Depending on design Design P
Review
10 Medical equipment will not introduce any unwanted or excessive radiation Depending on design Design NA
Review
11.1 None of the external parts will have a temperature above 43 degree's Celsius Applicable Design P
under normal and first fault condition and 48 degree's Celsius max for all internal review
parts.
11.2 When device will be used in oxygen rich environment see this paragraph for more Depending on design Design NA
demands Review
11.3 When a fire enclosure is applicable see his paragraph for more details Depending on design Design NA
Review
11.4 Medical equipment classified as being used within a flammable anaesthetics Depending on design Design NA
environment see this paragraph for more details Review


method
(F)ail
NA
11.5 Medical equipment classified as being used within a flammable agents Depending on design Design NA
environment see this paragraph for more details Review
11.6 When liquids are used within the design see this paragraph for more details Depending on design Design NA
Review
11.7 When medical equipment does come directly or indirectly in contact with Depending on design Design p
biological tissues, cells or body fluids the ISO 10993 is applicable. Review
11.8 Interruption of power supply will not introduce any other hazards than Applicable Design p
suspension of the function review
12.1 Accuracy of controls and instruments is addressed within the risk management Applicable Design p
file review
12.2 Usability and incorrect use will be addressed within the risk management file Applicable Design p
review
12.3 Needed alarm system will be identified within the risk management file Applicable Design p
review
12.4 Risks for hazardous output is addressed within the risk management file, see this Applicable Design p
paragraph for more details review
13.1 During any single fault condition the housing may not deform, dangerous Applicable Design p
materials may be released, temperatures may not rise above safety levels, power review
supplied to broken parts may be more than 15W, leakage current too high or
applied patient voltage to high.


method
(F)ail
NA
13.2 Evaluated Single fault condition do include: Applicable Design p

review
Failure of thermostat
Failure of temperature limiting devices
Leakage of liquids
Impairment of cooling
Locking of moving parts
Damage to motor capacitors
Motor over currents
Risk within Oxygen rich environment

Mechanical hazards
Continuous use for non continuous equipment
14.1 Programmable aspects are addressed within the risk management file Depending on design Design p
Review
14.2 Software development will follow V model approach Depending on design Design p
Review
14.3 When applicable risk management file will address the software development Depending on design Design p
and validation plan Review


method
(F)ail
NA
14.4 Software development process must include clear defined milestone included Depending on design Design p
needed actions including as minimum inputs, outputs, update of risk Review
management file and documentation requirements
14.5 CAPA process will include updating of software and associate documentation Applicable Design p
review
14.6 Software risk assessment do include: Depending on design Design p

Review
Failure of network communication
Undesired feedback
Unavailable data
Lack of integrity of data
Incorrect data
Incorrect timing of data
Unintended interaction within medical equipment

Unknown aspects of third party software
Unknown aspects of third party medical equipment
Lack of data security
14.7 Specifications are documented for the software Depending on design Design p
Review


method
(F)ail
NA
14.8 Architectural design of the software will include: Depending on design Design p
Review
Components with high-integrity
Fail safe functions
Redundancy
Diversity
Partition of functionality
Defensive design
Allocation of risk control to subsystems and components
Failure mode of components

Common cause faults
Systematic failures
Testing of interval duration and diagnostic coverage
Maintainability
Protection against foreseeable misuse
14.9 Sub components are defined including specific design and test specifications Depending on design Design p
Review


method
(F)ail
NA
14.10 Software verification plan will be available Depending on design Design P

Review
14.11 Software validation is successfully performed Depending on design Design p

Review
14.12 Modification management is addressed including retesting of all applicable Depending on design Design p
functions after any modification Review
14.13 For network connections the network connections are defined, risk are identified Depending on design Design p
which can occur to failure of the network and specific instruction in the manual Review
15.1 Layout of controls is evaluated within the risk management file Applicable Design p
review
15.2 Serviceability is taken into account within the mechanical design Applicable Design p
review
15.3 Essential mechanical part are tested on the paragraphs below Applicable Design p
review
15.3.2 Hand held equipment is tested in accordance with these paragraphs Depending on design Design p
Review
15.3.4
15.3.6
15.3.2 Portable equipment is tested in accordance with these paragraphs Depending on design Design NA
Review
15.3.3


method
(F)ail
NA
15.3.4
15.3.6
15.3.2 Mobile equipment is tested in accordance with these paragraphs Depending on design Design NA
Review
15.3.3
15.3.5
15.3.6
15.3.2 Fixed or stationary equipment is tested in accordance with these paragraphs Depending on design Design NA
Review
15.3.3
15.3.6
15.3.2 Housing can withstand 250N on a 30 mm diameter area Applicable Design p

review
15.3.3 Housing will survive drop from 1,3 m of a 500g ball of 50mm diameter Applicable Design NA
review
15.3.4 Housing will survive drop of 1m onto thick hardwood board from all three Depending on design Design P
different orientations Review
15.3.5 Housing can handle push against 40mm obstruction, drop of 40mm, vertical rigid Depending on design Design NA
support Review


method
(F)ail
NA
15.3.6 Mould stress relief is tested at 70 degree's Depending on design Design p

Review
15.3.7 Any materials to be expected to come into contact with the medical device under Applicable Design p
normal use will not result in long term deterioration or deformation resulting in review
any risk
15.4.1 Connectors are designed so they are not inter connectable Applicable Design p
review
15.4.2 Temperature controls and overload control devices are evaluated on second fault Applicable Design p See single fault analysis
condition review
15.4.3 For batteries the following aspects are evaluated: Depending on design Design p
Review
Housing will include openings for degassing of the batteries
Incorrect connection
Overcharging protection
For lithium batteries the IEC 60086-4 is applicable
Excessive current and voltage protection
15.4.4 Ready for normal use is indicated to user Applicable Design p

review
15.4.5 Risk of pre-set value is evaluated within the risk management file Depending on design Design p
Review


method
(F)ail
NA
15.4.6 All actuators shall be firmly fixed and limited in movement Depending on design Design p
Review
15.4.7 Foot operated controls will be sturdy and able to survive full human weight and Depending on design Design NA
be IPX1 as minimum. or IPX6 when electronics are integrated. Review
15.4.8 No aluminium wires of less than 16mm2 will are to be used Depending on design Design NA
Review
15.4.9 Oil containers shall be secured against leakage and if needed level control Depending on design Design NA
Review
15.5 Transformer and circuit design will prevent overheating under any short circuit Depending on design Design NA
condition or overvoltage condition Review
16.1 Unfavourable situation arising from combinations with other equipment will be Applicable Design p
evaluated in the risk management file review
16.2 Accompanying documents of the medical equipment will consist as minimum of: Applicable Design
review
Specifications of system
Intended use statement
Installation / assembly instructions
Cleaning and packaging instructions

Applicable safety requirements


method
(F)ail
NA
Preventive maintenance instructions
Warning and describing risk for only compatible designed equipment is used /
connected
Environmental conditions under which the equipment van be used.
Instructions not to tough the life parts and the patient at the same times
16.3 Any Power supply that is not an integral part of the product will be clearly Depending on design Design NA
identified Review
16.4 User accessible parts will not hold harmful voltages. Depending on design Design p
Review
16.5 Essential safety parameters as leakage current, creepage distances, maximum Depending on design Design p
voltages will be evaluated in worse combination of all possible connected Review
equipment.
16.6 Total leakage current will not exceed 100uA under normal conditions, and 500uA Applicable Design p
when an safety system fails. review
17 EMC properties are compliant with the IEC 60601-1-2 Applicable Design P Based on engineering
review evaluation, so extra
warning in manual
included.

6. Appendix C MDD essential requirements compliance check

(P)ass
Essential Requirements Compliance (F)ail

by
NA
I GENERAL REQUIREMENTS
1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, ISO 13479 p
they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other
persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the
ISO 60601-1
benefits to the patient and are compatible with a high level of protection of health and safety.
Specifications
This shall include:
— reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the
device is intended to be used (design for patient safety), and
— consideration of the technical knowledge, experience, education and training and where applicable the medical and physical
conditions of intended users (design for lay, professional, disabled or other users).
2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking ISO 13479 p
account of the generally acknowledged state of the art.

(P)ass

by
NA
In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: ISO 60601-1
— eliminate or reduce risks as far as possible (inherently safe design and construction), Specifications
— where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
— inform users of the residual risks due to any shortcomings of the protection measures adopted.
3. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way Specifications p
that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.
4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical ISO 13479 p
conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as
indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.
ISO 60601-1
Specifications

(P)ass

by
NA
8. Infection and microbial contamination
8.1. The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of ISO 13479 p
infection to the patient, user and third parties. The design must allow easy handling and, where necessary, minimize contamination of
the device by the patient or vice versa during use.
ISO 60601-1
Specifications
8.2. Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the NA
intended use of the tissues.*
8.3. Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate NA
procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions
laid down, until the protective packaging is damaged or opened.
8.4. Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method. NA
8.5. Devices intended to be sterilized must be manufactured in appropriately controlled (e. g. environmental) conditions. NA

(P)ass

by
NA
5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their ISO 13479 p
intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by
the manufacturer.
ISO 60601-1
Specifications
6. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended. ISO 13479 p
Specifications
6.a Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X. ISO 13479 p
ISO 60601-1
Specifications
II REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

(P)ass

by
NA
7. Chemical, physical and biological properties
7.1. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in ISO 13479 p
Section I on the ‘General requirements’. Particular attention must be paid to:
ISO 60601-1
— the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,
Specifications
— the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of
the device,
— where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.
7.2. The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to ISO 13479 p
the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the
product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure.
ISO 60601-1
Specifications

(P)ass

by
NA
7.3. The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases ISO 13479 p
with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer
medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned
ISO 60601-1
according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the
intended use.
Specifications
7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as NA
defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the
quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/
EC.*
7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from NA
the device.*
7.6. Devices must be designed and manufactured in such a way as to reduce, as much as possible, risks posed by the unintentional ingress ISO 13479 p
of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.
ISO 60601-1
Specifications
(P)ass

by
NA
8.6. Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the Specifications p
devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system must be suitable taking
account of the method of sterilization indicated by the manufacturer.
8.7. The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile ISO 13479 p
condition.
ISO 60601-1
Specifications
9. Construction and environmental properties
9.1. If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection ISO 13479 p
system must be safe and must not impair the specified performances of the devices. Any restrictions on use must be indicated on the
label or in the instructions for use.
ISO 60601-1
Specifications

(P)ass

by
NA
9.2. Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible: ISO 13479 p
— the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ISO 60601-1
ergonomic features,
Specifications
— risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences,
electrostatic discharge, pressure, temperature or variations in pressure and acceleration,
— the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given,
— risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy
of any measuring or control mechanism.
9.3. Devices must be designed and manufactured in such a way as to minimize the risks of fire or explosion during normal use and in single ISO 13479 p
fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to
substances which could cause combustion.
ISO 60601-1
Specifications

(P)ass

by
NA
10. Devices with a measuring function
10.1. Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability ISO 13479 p
within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be
indicated by the manufacturer.
ISO 60601-1
Specifications
10.2. The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended ISO 13479 p
purpose of the device.
ISO 60601-1
Specifications
10.3. The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council ISO 13479 p
Directive 80/181/EEC (1).
ISO 60601-1

(P)ass

by
NA
Specifications
11. Protection against radiation
11.1. General
11.1.1. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to radiation shall be ISO 13479 p
reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels
for therapeutic and diagnostic purposes.
ISO 60601-1
Specifications
11.2. Intended radiation
11.2.1. Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is NA
considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall
be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters.

(P)ass

by
NA
11.2.2. Where devices are intended to emit potentially hazardous, visible and/ or invisible radiation, they must be fitted, where practicable, NA
with visual displays and/or audible warnings of such emissions.
11.3. Unintended radiation
11.4. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of ISO 13479 p
unintended, stray or scattered radiation is reduced as far as possible.
ISO 60601-1
Specifications
11.5. Ionizing radiation
11.5.1. Devices intended to emit ionizing radiation must be designed and manufactured in such a way as to ensure that, where practicable, the NA
quantity, geometry and quality of radiation emitted can be varied and controlled taking into account the intended use.

(P)ass

by
NA
11.5.2. Devices emitting ionizing radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve NA
appropriate image and/or output quality for the intended medical purpose whilst minimizing radiation exposure of the patient and
user.
11.5.3. Devices emitting ionizing radiation, intended for therapeutic radiology shall be designed and manufactured in such a way as to enable NA
reliable monitoring and control of the delivered dose, the beam type and energy and where appropriate the quality of radiation.
12. Requirements for medical devices connected to or equipped with an energy source
12.1. Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of ISO 13479 p
these systems according to the intended use. In the event of a single fault condition (in the system) appropriate means should be
adopted to eliminate or reduce as far as possible consequent risks.
ISO 60601-1
Specifications
12.1a For devices which incorporate software or which are medical software in themselves, the software must be validated according to the ISO 13479 p
state of the art taking into account the principles of development lifecycle, risk management, validation and verification.
ISO 60601-1

(P)ass

by
NA
Specifications
12.2. Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state Specifications NA
of the power supply.
12.3. Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power P
failure.
12.4. Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert NA
the user of situations which could lead to death or severe deterioration of the patient's state of health.
12.5. Devices must be designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields which could ISO 60601-2 p
impair the operation of other devices or equipment in the usual environment.
12.6. Protection against electrical risks
12.6.1. Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during ISO 13479 p
normal use and in single fault condition, provided the devices are installed correctly.

(P)ass

by
NA
ISO 60601-1
Specifications
12.7. Protection against mechanical and thermal risks
12.7.1. Devices must be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, ISO 13479 p
for example, resistance, stability and moving parts.
ISO 60601-1
Specifications
12.7.2. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration ISO 13479 p
generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source,
unless the vibrations are part of the specified performance.
ISO 60601-1
Specifications

(P)ass

by
NA
12.7.3. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise ISO 13479 p
emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise
emitted is part of the specified performance.
ISO 60601-1
Specifications
12.7.4. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be P
designed and constructed in such a way as to minimize all possible risks.
12.7.5. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their ISO 13479 p
surroundings must not attain potentially dangerous temperatures under normal use.
ISO 60601-1
Specifications
12.8. Protection against the risks posed to the patient by energy supplies or substances

(P)ass

by
NA
12.8.1. Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow-rate can be NA
set and maintained accurately enough to guarantee the safety of the patient and of the user.
12.8.2. Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger. NA
Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an
energy and/or substance source.
12.9. The function of the controls and indicators must be clearly specified on the devices.
12.9.1. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual ISO 13479 p
system, such information must be understandable to the user and, as appropriate, the patient.
ISO 60601-1
Specifications
13. Information supplied by the manufacturer

(P)ass

by
NA
13.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and ISO 13479 p
knowledge of the potential users, and to identify the manufacturer.*
ISO 60601-1
Specifications
13.2. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to the ISO 13479 p
harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation
supplied with the device.
ISO 60601-1
Specifications
13.3. The label must bear the following particulars: ISO 13479 P
(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in ISO 60601-1
the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the
authorised representative where the manufacturer does not have a registered place of business in the Community; Specifications

(P)ass

by
NA
(b) the details strictly necessary to identify the device and the contents of the packaging especially for the users;
(c) where appropriate, the word ‘STERILE’;
(d) where appropriate, the batch code, preceded by the word ‘LOT’, or the serial number;
(e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;
(f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across
the Community;
(g) if the device is costum-made, the words ‘custom-made device’;
(h) if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;
(i) any special storage and/or handling conditions;
(j) any special operating instructions;

(P)ass

by
NA
(k) any warnings and/or precautions to take;
(l) year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial
number;
(m) where applicable, method of sterilization;
(n) in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.
13.4. If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the ISO 13479 P
instructions for use.
ISO 60601-1
Specifications
13.5. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of ISO 13479 P
batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components.
ISO 60601-1

(P)ass

by
NA
Specifications
13.6. Where appropriate, the instructions for use must contain the following particulars: ISO 13479 P
(a) the details referred to in Section 13.3, with the exception of (d) and (e); ISO 60601-1
(b) the performances referred to in Section 3 and any undesirable side effects; Specifications
(c) if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its
intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe
combination;
(d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the
nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times;
(e) where appropriate, information to avoid certain risks in connection with implantation of the device;

(P)ass

by
NA
(f) information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or
treatment;
(g) the necessary instructions in the event of damage to the sterile packaging and, where appropriate, details of appropriate methods
of resterilization;
(h) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and,
where appropriate, the method of sterilization of the device to be resterilized, and any restriction on the number of reuses.
Where devices are supplied with the intention that they be sterilized before use, the instructions for cleaning and sterilization must be
such that, if correctly followed, the device will still comply with the requirements in Section I.
If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to
the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are
needed, the information must be made available to the user upon request;
(i) details of any further treatment or handling needed before the device can be used (for example, sterilization, final assembly, etc.);
(j) in the case of devices emitting radiation for medical purposes, details of the nature, type, intensity and distribution of this radiation.
(P)ass

by
NA
The instructions for use must also include details allowing the medical staff to brief the patient on any contra-indications and any
precautions to be taken. These details should cover in particular:
(k) precautions to be taken in the event of changes in the performance of the device;
(l) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external
electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.;
(m) adequate information regarding the medicinal product or products which the device in question is designed to administer,
including any limitations in the choice of substances to be delivered;
(n) precautions to be taken against any special, unusual risks related to the disposal of the device;
o) medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;
(p) degree of accuracy claimed for devices with a measuring function;
(q) date of issue or the latest revision of the instructions for use.


ISO 14971 Risk Assesment Report

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ISO 14971 Risk Assesment Report

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Epoluthon ISO 14971 risk assesment V1.0.

ISO 14971 Risk assessment file

Author: EJ Authorizer: EJ AllRound Technology B.V.

© AllRound Technology B.V. Page 1 of 84

mmHg Millimeter Hydrargyrum (Mercury)

kPa Kilo Pascal

© AllRound Technology B.V. Page 2 of 84

© AllRound Technology B.V. Page 3 of 84

2.1. System construction

© AllRound Technology B.V. Page 4 of 84

C: Information for safety

Is the medical device intended to be implanted? NA

© AllRound Technology B.V. Page 5 of 84

3. Cross contamination is the main risk for

© AllRound Technology B.V. Page 6 of 84

See identified risks 2 and 3 for details

Is energy delivered to or extracted from the patient?

© AllRound Technology B.V. Page 7 of 84

Device introduces harmful N.A.: no suspended masses

© AllRound Technology B.V. Page 8 of 84

Are substances delivered to or extracted from the patient? NA

© AllRound Technology B.V. Page 9 of 84

Is the medical device intended to modify the patient environment? NA

Are measurements taken? No

Is the medical device interpretative? NA

© AllRound Technology B.V. Page 10 of 84

Are there unwanted outputs of energy or substances?

See identified risks 4 to 11

Is the medical device susceptible to environmental influences?

© AllRound Technology B.V. Page 11 of 84

- The processor loads it’s program code from

After implementing the described

© AllRound Technology B.V. Page 12 of 84

The loss of data can be identified by the host

After implementing the described

Extreme temperatures or The system is designed for a specified transport

© AllRound Technology B.V. Page 13 of 84

Does the medical device influence the environment?

See identified risks 4 - 11 for details

© AllRound Technology B.V. Page 14 of 84

The remaining risk remains within the yellow

Is maintenance or calibration necessary?

21 Calibration is needed on regular No calibration is needed

Does the medical device contain software?

See identified risks 15 and 16 for details on the risk management

Does the medical device have a restricted shelf-life? NA

© AllRound Technology B.V. Page 15 of 84

Are there any delayed or long-term use effects?

To what mechanical forces will the medical device be subjected?

The chance that the system drops onto the floor

© AllRound Technology B.V. Page 16 of 84

What determines the lifetime of the medical device?

See identified risk 22 for details

Is the medical device intended for single use? NA

Is safe decommissioning or disposal of the medical device necessary?

© AllRound Technology B.V. Page 17 of 84

How will information for safe use be provided?

See identified risk 28 and 29 for details

© AllRound Technology B.V. Page 18 of 84

Will new manufacturing processes need to be established or introduced?

Can the user interface design features contribute to use error?

© AllRound Technology B.V. Page 19 of 84

Does the medical device have connecting parts or accessories?