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BeaconMedaes – Atlas Copco

Medical Gas Solutions
February 2021
 Welcome to
BeaconMedaes
• www.beaconmedaes.com
International Standards
for Medical Devices
We Supply all common standards
Common Standards:
• HTM 2022 - United Kingdom (now…HTM 02-01 from Spring 2006)
• NFPA 99 - United States (incoming…NFPA 99 2012 edition)
• ISO 7396-1 - Generic International Standard.
• EN 737-3 - Generic European Standard (replaced by above)
Other Standards:
• AS 2896 - Australia
• NF S90-155 - France
• JIS T7101 - Japan

• SIS HB 370 - Sweden

• CAN/CSA -Z305.1-92 - Canada

Risk Management is Central to All the Standards

Basic principles of design

Patient safety is paramount in the design, installation,

commissioning and operation of medical gas pipeline systems.

The basic principles of safety are achieved by ensuring:

• Quantity of supply
• Identity of supply
• Continuity of supply
• Quality of supply
Medical Gas Standards Comparison
What is a Medical Gas?

A medical gas a medicinal product (pharmaceutical) used for treating or

preventing disease and for life support of human beings

Medical air is regulated as a drug under the European Pharmacopoeia

Medical air is the only drug manufactured in a hospital; by a medical air

plant
Standards and Costs

• A good standard should ensure basic safety

for patients and staff.
Life Cycle
The Limits of Standards
• Meeting the standards is left to the designer,
installer, manufacturer, and operator.

• Choose vendors by their qualifications.

• Have the systems verified and the maintenance

staffs trained (6040 or equivalent)
Installation & Operation
What’s included in installing according to standards?

 Testing and commissioning

 Purity testing

 Hand over (in-service)

 Operation and maintenance

- Periodic testing
- Leaks
 Training & Qualification
Who installs?
HTM • Competent Persons / 6010 NFPA/ASSE
HTM Who manages and maintains?
• Authorized Persons / 6040
• The “Permit to Work” system
HTM Who verifies the installation?
• The Pharmacist / 6030
Standards and Money

 “Following standards costs money that not following standards

‘saves’”.

 Think how much money you could save if you bought a car with
no brakes!
Standards Differences
• ISO 7396
HTM 02-01 Parts A and B NFPA
• NFPA 99 99

• HTM 2022
• HTM 02-01
 Standards Differences
ISO 7396 NFPA 99 HTM 2022 HTM 02-01
Non-Medical Device
MGPS in the Standard Medical Device
(Electro Mechanics)
Medical Device Medical Device

Air Source Intake Any air, any source. Cleanest available outdoor air Air from indoors but at ceiling level Air from indoors but at ceiling level.
Oil less( Oil-Free) compressor Any compressor Any compressor (oil less
Compressor Type Any compressor.
that adds no contamination (oil less commended) commended)
Clean up to
Pharmacopeia Clean up if necessary when Clean up to Pharmacopeia Clean up to Pharmacopeia
Pharmacopeia
requirements tested (meet Pharmacopeia requirements. requirements.
requirements.
Continuously monitor Continuously monitor Carbon
monitoring Continuously monitor dew point. Continuously monitor dew point.
dew point. Monoxide and dew point.
Air Plant

Maintenance is a single Maintenance is not a fault -

Maintenance is not a fault - system Maintenance is a single fault -
fault - normal operation system operation may be
Maintenance operation may be limited while normal operation and full
and full redundancy is limited while maintenance is
maintenance is being done. redundancy is required
required being done.

All gas sources are Triplex

Air plant ,Duplex or Medical Air compressors are duplex Medical Air compressors are Triplex
plus a “maintenance Medical Air sources are Duplex
Triplex with cylinder reserve with cylinder reserve
supply assembly”.

not allowed , separate medical

Combined Air Plant Allowed Air plant (4) bar and separate Allowed Allowed
( 4 & 7 bars)
surgical air pant (7) bar
 Standards Differences
ISO 7396 NFPA 99 HTM 2022 HTM 02-01
Vac plant ,Duplex or All gas sources are Triplex plus a
Vac Plant

Vacuum sources are duplex Vacuum sources are duplex Vacuum sources are triplex
Triplex “maintenance supply assembly”.

85 lpm , Minimum pipe size

Vacuum Flow 25 lpm 40 lpm 40 lpm
20 mm ID

Only one receiver is ever
Receivers required.
Oxygen Sources are triplex or
Oxygen Source quadruplex.
ISO is the only standard not to
stipulate materials of
construction other than
Jointing Techniques “metallic”
Brazing (methods are not in the
7396 - one must reference a
different standard)
Welding
Can use Venture system driven
AGSS (WAGD) by Air
Only one receiver is ever Only one receiver is ever Multiple receivers are
required. required. required.
Oxygen sources are duplex or Oxygen sources are duplex or Oxygen Sources are triplex or
triplex. triplex. quadruplex.
Copper only for medical gases,
Copper only Copper only
allows stainless for vacuum
Brazing, with inert gas purge Brazing, with inert gas purge Brazing, with inert gas purge
Gas Tungsten Arc Autogenous
Welding
Axially swaged fittings
Cryogenic shrink fittings
AGS (WAGD) Plant AGS Plant AGS Plant
Maintenance as a “Single Fault”

ISO 7396 NFPA 99 HTM 02-01

Maintenance is not a fault -
Maintenance is a single fault - Maintenance is a single fault -
system operation may be
normal operation and full normal operation and full
limited while maintenance is
redundancy is required. redundancy is required.
being done.
Jointing Techniques
ISO 7396 NFPA 99 HTM 02-01
ISO is the only standard not to
stipulate materials of Copper only for medical gases,
Copper only
construction other than allows stainless for vacuum
“metallic”

Brazing (methods are not in

the 7396 - one must reference a Brazing, with inert gas purge. Brazing, with inert gas purge.
different standard)

Gas Tungsten Arc Autogenous

Welding
Welding

Axially swaged fittings

Cryogenic shrink fittings

Quality and Regulatory Controls
• In the US, the FDA do not consider medical gas equipment to be medical
devices
• The FDA does not regulate the products or the companies making them

• In Europe, most authorities consider medical gas products to be medical

devices
• Medical gas products therefore and regulated under the medical device

• directive 93/42/EEC
• Medical devices companies in Europe must have a stringent ISO 13485 quality
management systems that are regularly audited

• US medical gas pipeline equipment making NFPA 99 equipment are not

required to have any formal quality management system

Would you take the risk?

Quality and Regulatory Controls
• In the US, the FDA do not consider medical gas equipment to be medical
devices
• The FDA does not regulate the products or the companies making them

• In Europe, most authorities consider medical gas products to be medical

devices
• Medical gas products therefore and regulated under the medical device

• directive 93/42/EEC
• Medical devices companies in Europe must have a stringent ISO 13485 quality
management systems that are regularly audited

• US medical gas pipeline equipment making NFPA 99 equipment are not

required to have any formal quality management system

Would you take the risk?

Medical Air Quality
• Medical Air Dew Point (water concentration)
• NFPA allows a water concentration of 1833 ppm whereas HTM 02-01 and European Law
states the maximum water concentration should be 67 ppm
• European Law limits are 27 times lower than NFPA 99!
• Why?
• A very low dew point inhibits bacteria survival and growth, reducing infection
• At low ambient temperatures, liquid water could form if the air is too humid
• Anesthesia machines and ventilators are damaged by liquid water
• At freezing temperatures ice can form, blocking the pipeline
• Higher humidity promotes oxidation of the inside of piped distribution system
• (copper oxide), which will inevitably contaminate the supply
• Would you take the risk?
Fault Tolerance Levels

• Periodic maintenance of compressors and vacuum pumps is required to

protect your investment and maximise service life
• Single fault tolerance should be assured during maintenance
• NFPA 99 requires only a single level of fault tolerance on supply systems
• During maintenance of a supply there is an unacceptable risk of supply failure
• HTM 02-01 as well as European and International Standards require a single level of
fault tolerance to be maintained during maintenance
• What would happen if a compressor or vacuum pumps fails during
maintenance of another?
• NFPA – the supply would fail – patients are at risk
• HTM 02-01 – the supply is maintained - patients are unaffected
Ignition Testing

• High pressure oxygen cylinders require pressure regulators to reduce

the pressure before distribution to a pipeline
• A significant risk of explosion exists unless the pressure regulator is
designed to tolerate high temperature during adiabatic compression
• HTM 02-01 and other International Standards mandate auto-ignition
testing is performed to prove the pressure regulator design
• NFPA 99 does not mandate such a test is performed
• Would you take the risk?
Anaesthetic Gas Scavenging

• Exhaled anaesthetic gas mixtures are captured and removed from

breathing circuits to prevent ill health of clinical staff subjected to long-
term exposure
• HTM 02-01 and International Standards mandate a dedicated pipeline
system and plant for this purpose
• NFPA 99 allows the use of the medical vacuum system for this purpose
• o The mixture of high oxygen concentration with anaesthetic agents in
contact with high temperature oil in vacuum pumps is believed to have led
to many fires in hospital plant rooms
• Would you take the risk?
Summary

• The two major standards for medical gas pipeline systems

contain many differences
• HTM 02-01 was developed with a view to maximise patient
safety and product reliability
• The differences between the standards are subtle, the
consequences may not be
• Would you take the risk?
 Medical Gas Standards Comparison
NFPA 99 (US) vs. HTM 02-01 (UK)

• There are two main standards in use internationally that provide best practice guidance for
medical gas systems and products – NFPA 99 (US) and HTM 02-01 (UK)

• How does each standard maximise the safety of users and patients?
HTM 02-01 Parts A and B NFPA
99
 The Standards Compared
Overview and Principles NFPA 99 HTM 02-01

Date of First Publication 1984 1972

Years of Embedded Experience 21 34
Number of Pages Dedicated to Medical Gases 136 330
Published by a Government Agency  
Management Structure Defined - CP, AP, AE roles  
Products Regulated – CE Mark to the MDD  
Quality Control Pharmacist Verification of Gas Purity  
European Pharmacopoeia Quality Compliance  
Risk Management to ISO 14971  
 The Standards Compared
Design Elements NFPA 99 HTM 02-01

Terminal Unit and Gas Flow Schedules  

Auto Ignition Testing of High Pressure Regulators  
Halogenated Polymers Banned in HP O2 Service  
Bacteria Filters for Protection of Medical Vacuum  
Refrigerant Dryers Disallowed  
Medical Air Dew Point (ppm v/v) 1833 67
Minimum Pressure Vessel Sizes  
Liquid Sealed Pumps/Compressors Disallowed  
AGS and Medical Vacuum Supplies Separate  
Duplex Emergency Backup Manifolds  
 The Standards Compared
Operational Management Elements NFPA 99 HTM 02-01

Operational Policy  
Maintenance Contract Guidance  

Equipment Maintenance Procedures Defined  

Verification Procedures and Forms  

Permit to Work System  

Management Processes – CP, AP, AE, DNO roles  

Minimum Training Requirements Defined  

 The Standards Compared
Medical Air Safety Limits
Component NFPA 99 HTM 02-01*
19.5-23.5 % 20.4-21.4 %
Oxygen
Not specified 0.1 mg/m3
Oil
1833 ppm 67 ppm
Water
10 ppm 5 ppm
Carbon Monoxide (CO)
500 ppm 500 ppm
Carbon Dioxide (CO2)
Not specified 2 ppm
Nitrogen Dioxide (NO2)
Not specified 2 ppm
Nitric Oxide (NO)
Not specified 1 ppm
Sulphur Dioxide (SO2)

*HTM 02-01 Reflects European Law. Must be verified by an independent QC pharmacist.

 The Standards Compared
The Four Tenets NFPA 99 HTM 02-01

Continuity  

Adequacy  

Identity  

Quality  

Other Key Measures

Sustainability  

Useability  

Overall Value  

Oxygen Source Equipment
According to Standards
Oxygen Source Equipment – Large Systems
(On-site oxygen) VIE Liquid Oxygen Tanks
HTM 0201  should use 3 source of supply

13 days 6 days 4 hours

Primary + Secondary Third

(mounted on the same plinth) (local for high dependency or whole site.)
Oxygen Source Equipment – Large Systems
(On-site oxygen) Oxyplant (Oxygen Concentrator Systems)

+ + +

Primary Secondary Reserve

(determined following risk assessment)
Medical Gas Systems
Oxygen Source Equipment – Small - Medium Systems

Three Sources of Supply

– Oxygen supply with a VIE

+ + or

Primary Secondary Third

(local for high dependency)
Manifold Control Systems
Oxygen Source Equipment – Small Systems
 Three Sources of Supply
– Oxygen supply with cylinders.

+ + +

Tertiary (3rd)
Primary Secondary (local for high Option
dependency)
Medical Air Source Equipment
According to Standards
Medical Air Plant
Complete set of components

Always air according to Pharmacopoeia

• Medical Air (commonly 4 bar)
• Surgical air (commonly 7 bar)

Components
• Medical compressors
• Vessels
• MED+ purifiers
• ES-Medical central controller
Medical Air Source Equipment Large Systems
HTM 2022 & NFPA99

 

One Source of Supply Systems Design Flow Emergency Reserve

is Sustained Manifold
Primary Secondary Reserve
Medical Air Source Equipment Large Systems
HTM 02-01 & ISO 7396-1

 

One Source of Supply Systems Design Manifold Backup Enables

Flow is Sustained Maintenance of Compressor
in Double Fault Condition
Primary Secondary Reserve

+ Risk Assessment to Determine if Local Backup of

Critical Care Areas is Required
 Requirements of ISO7396-1 & HTM02-01

 Three independent sources of supply (three compressors)

 Two conditioning units (medical purifiers)
 Monitoring of medical and surgical lines

33% 33% 33% 33% 33%

50% 50% 50% 50%

100% 100% 100%

 Medical Gas Systems

Air plant system Systems

HTM 2022-NFPA99 Redundancy  one back-up compressor
Compressors in use
Back-up Compressors

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Medical Vacuum Equipment
According to Standards
 Medical Gas Systems

Medical Gas System Equipment

HTM 2022 & NFPA99 - sources of supply

or
 

One Source of Supply Inoperable Systems Design Flow

or undergoing maintenance is Sustained
(Single Fault Condition)

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 Medical Gas Systems

Medical Gas System Equipment

HTM 02-01 and EN ISO 7396-1 sources of supply

 

One Source of Supply One Source of Supply Systems Design

Undergoing Maintenance Inoperable Flow is Sustained
(A Normal Condition) (Single Fault Condition)

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 Medical Gas Systems

mVAC Medical Vacuum Systems

EN ISO 7396-1 and HTM 02-01 Redundancy  two back-up pumps

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 Medical Gas Systems

mVAC Medical Vacuum Systems

HTM 2022 & NFPA99 Redundancy  one back-up pump

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 Controllers according to HTM-0201
(this not mandatory in NFPA & ISO)

Technical fault alarm nurse / central

Loss of vacuum alarm room

Full live monitoring  Ethernet

CAN network

°°°

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