IEC TC62: Electrical equipment in medical practice

• SC 62A: Common aspects of electrical equipment used in medical practice

ISO TC299 Robotics • SC52D: Electromedical equipment

MILITARY INDUSTRIAL ROBOTS PERSONAL CARE ROBOTS MEDICAL ROBOTS ME EQUIPMENT

JWG36: Rehabilitation
WG3: Industrial robots WG2: Personal care robot safety JWG9: MEE&S using robotic technology

Collaborative robot safety requirements for manufacturing

Professor Gurvinder Singh Virk

Trustee, CLAWAR Association Ltd, UK; gsvirk@clawar.org
Technical Director, InnotecUK, UK; gurvinder.virk@innotecuk.com
1) Convener: ISO TC 299/WG2: Personal care robot safety
2) Convener: IEC SC62A & ISO TC 299 JWG9: MEE & S using robotic technology
3) Convener: ISO TC 299/WG06: Modularity for service robots
4) Director: euRobotics Topic Group Standardisation for H2020
 Summary of presentation
• Changing world of robotics
– Industrial Service
• Role of regulation
• New requirements for personal care robots
– ISO 13482:2014
• New safety guidance for collaborative
industrial robots
– ISO TS 15066
• Conclusions
30 Nov 2016 Robot safety, Next-Generation Robotics & Automation, Birmingham, UK 2
Robot are dangerous: Impacts
 Traditional industrial robot applications

• Powerful machines operating at high speeds and

with great precision and dexterity
• Designed to operate in workcells separated from
humans for safety

Traditional robot workcell setup

Robot workcells

Human access to the

robot’s operational
space in the workcell
is strictly controlled
and regulated
Safety switches
Light curtains, lasers and pressure mats, etc
New ways of using industrial robots
KUKA KR500 heavy duty arm

KUKA Robocoaster Robot

 Trends in industrial robotics
Conventional industrial robots Collaborative industrial robots

Discrete safety Safety controllers Harmless manipulators

No HRC Limited HRC Full HRC

Absolute separation Mixed environment

ISO 10218-1, -2; 2011

ISO TS 15066: 2016

Handover window
 Future Needs: Manufacturing to Services

• Robots to do tasks that must be done but can’t

be done any other way
• Robots need to move out of the factory to
“everywhere”
• Robots need to do a WIDE variety of “service”
tasks rather than only “manufacturing”
operations
• Robotics has good potential because society is
“ageing” and more dependent on technology
– New tasks for robots emerging in everyday life
30 Nov 2016 Robot safety, Next-Generation Robotics & Automation, Birmingham, UK 7
 Industrial / service robots: Distinctions and
future requirements…. SAFETY issues

Industrial Robots Service Robots

Need:
Working
environments
Controlled and defined
environments
Information structured/
unstructured environments
Flexibility

Training for specified Training to cover wide range of

Users tasks in defined
environments
tasks in info structured/
unstructured environments
Usability

Machine dependent (ISO Dependent on the robot and the

Safety
10218-1) user (ISO 13482) Safety

To keep robots and Robots and humans must share Human-Robot

Working humans separated workspace for providing/ Collaboration
philosophy (see ISO 10218-1, -2; receiving the services (see ISO
ISO TS 15066) 13482)

Effectiveness
Flexible on
Machine Flexible on demand for generic
commissioning for
design tasks/ users
defined task
Reusable
 Role of regulation
• Countries need to regulate their own markets to ensure products
are safe and organisational procedures reduce environmental
impact to allow trade between countries to simplify procedures
and make things work.
• Allow consumers to benefit by the knowledge that state-of-the-
art practices are developed/adopted for global relevancy and
standards help this process
• Types of standards: Safety, Quality, and efficiency specifications
for products, services and systems
– Minimum acceptable requirements for: Health, Safety, Environment
– Metrics for assessing: Safety related performance, quality performance
– Guidance documents: Test procedures
– Other standards: Inter-operability, terminology
EC Directives
• Machinery Directive
• Medical Device Directive
 Generic safety design methodology
• ISO 12100 defines a standard approach to designing
machines to achieve safety requirements:
1. First, try to achieve the safety requirements by means of inherently safe design
2. If inherently safe designs are not possible, then try to achieve the requirements by
means of safeguarding or protective measures
3. If neither of these solutions are possible, then provide information for use to the
operator (warnings, instructions) to assist the operator in achieving acceptable safety
4. (implicit) If none of these are possible, then acceptable safety cannot be achieved and
the machine should not be used

• Harmonised safety standards for robots

– EN ISO 10218-1:2011, Safety requirements for industrial robots –
Robots
– EN ISO 10218-2:2011, Safety requirements for industrial robots –
Robot systems and integration
– ISO TS 15066:2016, Collaborative industrial robots
– EN ISO 13482:2014, Safety requirements for personal care robots
 Traditional industrial robots
ISO 10218-1, -2: Industrial robot safety
• Humans and operational industrial robots to be
kept separated except when robot is in
collaborative mode:
– Visual indication of collaborative mode
– Robot shall stop
– Hand guiding mode
– Maintain determined speed and separation distance
from operator
– Power and force limiting mode

30 Nov 2016 Robot safety, Next-Generation Robotics & Automation, Birmingham, UK 11

 Safety requirements for personal care robots
WG2: Personal care robot safety (non-medical). EN ISO 13482: 2014
1. Mobile servant robot: personal care robot that is capable of travelling to
perform serving tasks in interaction with humans, such as handling objects
or exchanging information
2. Physical assistant robot (PAR): personal care robot that physically assists a
user to perform required tasks by providing supplementation or
augmentation of personal capabilities
– restraint type PAR: PAR that is fastened to a human during use
– restraint-free type PAR: PAR that is not fastened to a human during use
3. Person carrier robot: personal care robot with the purpose of transporting
humans to an intended destination.

Mobile servant Physical assistant Person carrier robots

 Exoskeleton operational spaces (ISO 13482)

Maximum Space

Personal care robots

Monitored
Space

ROBOT
Protective
stop space

Safeguarded Space
HUMAN

Restricted Space
Safety related
object

Physical
assistant robots
 Specific safety clauses in 13482
Safety requirements and protective
measures. Hazards due to:
• Charging battery
• Energy storage and supply
• Robot shape
• Emissions
• Electromagnetic interference
• Stress, posture and usage
• Robot motion
• Insufficient durability
• Incorrect autonomous actions
• Contact with moving
components
• Lack of awareness
• Environmental conditions
• Localization & navigation errors
Safety related control system
requirements for:
• Robot stopping
• Safety related speed control
• Safety related environmental
sensing
• Stability control
• Safety related force control
• Singularity protection
• Design of human interface
• Manual control devices
• Operational modes
EN ISO 13482: Safety
requirements for personal care
robots published in Feb 2014
 New safety for collaborative industrial robots

ISO TS 15066: Safety requirements for industrial robots – Collaborative operation

• Aimed at combining repetitive performance of industrial robots with skills of people
– People have excellent capability for solving complex and imprecise tasks
– Industrial robots exhibit precision, power and endurance
• To achieve safety, robotic applications mainly exclude operator access to operations
area while robot is active (ISO 10218-1, -2). Hence a variety of operations requiring
human intervention often cannot be automated using robot systems
• TS 15066 provides guidance for collaborative robot operation where a robot system
and people share the same workspace. In such operations the integrity of the safety-
related control system is of major importance, particularly when process parameters
such as speed and force are being controlled
• A comprehensive risk assessment is required to assess not only the robot system itself
but also its operational environment; this can often lead to ergonomic advantages, e.g.
improvements of worker posture.

30 Nov 2016
 Key definitions in TS 15066
• collaborative workspace: space within the operating space
where the robot system (including the workpiece) and a human
can perform tasks concurrently during production operation
• quasi-static contact: contact between an operator and part of a
robot system where the operator body part can be clamped
between a moving part of a robot system and another fixed or
moving part of the robot cell
• transient contact: contact between an operator and part of a
robot system where the operator body part is not clamped and
can recoil or retract from the moving part of the robot system
• body model: representation of the human body consisting of
individual body segments characterized by biomechanical
properties v
rel

F
 Collaborative application design
Design of robot system and associated work cell
shall take into consideration:
• the established limits (three dimensional) of the
collaborative workspace
• collaborative workspace, access and clearance
• ergonomics & human interface with equipment
• use limits
• transitions (time limits)

30 Nov 2016 Robot safety, Next-Generation Robotics & Automation, Birmingham, UK 17

 Types of collaboration operation

ISO
Main means of risk
10218-1, Type of collaborative operation
reduction
clause

No robot motion when

Safety-rated monitored stop
5.10.2 operator is in collaborative
(Example: manual loading-station)
work space

Hand guiding Robot motion only through

5.10.3
(Example: operation as assist device) direct input of operator

Robot motion only when

Speed and separation monitoring
5.10.4 separation distance above
(Example: replenishing parts containers)
minimum separation distance

Power and force limiting by inherent

In contact events, robot can
design or control
5.10.5 only impart limited static and
(Example: ABB YuMi® collaborative
dynamics forces
assembly robot)

30 Nov 2016 Robot safety, Next-Generation Robotics & Automation, Birmingham, UK 18

 ISO TS 15066: Body model
Figure A.1 — Body Model Descriptions
Front/
Body Region Specific Body Area Rear
Skull and forehead 1 Middle of forehead Front
2 Temple Front
Face 3 Masticatory muscle Front
Neck 4 Neck muscle Rear
5 Seventh neck vertebra Rear
Back and shoulders 6 Shoulder joint Front
7 Fifth lumbar vertebra Rear
Chest 8 Sternum Front
9 Pectoral muscle Front
Abdomen 10 Abdominal muscle Front
Pelvis 11 Pelvic bone Front
Upper arms and elbow joints 12 Deltoid muscle Rear
13 Humerus Rear
16 Arm nerve Front
Lower arms and wrist joints 14 Radial bone Rear
15 Forearm muscle Rear
Hands and fingers 17 Forefinger pad D Front
18 Forefinger pad ND Front
19 Forefinger end joint D Rear
20 Forefinger end joint ND Rear
21 Thenar eminence Front
22 Palm D Front
23 Palm ND Front
24 Back of the hand D Rear
Quasi-static and transient contacts defined. 25 Back of the hand ND Rear
Thighs and knees 26 Thigh muscle Front
Power and force limits based on pain
27 Kneecap Front
sensitivity thresholds are presented for 29 Lower legs 28 Middle of shin Front
points on the body. These can be used to 29 Calf muscle Rear
establish limits for various body areas.
 Table A.2 – Biomechanical limits
Quasi-Static Contact Transient Contact
Maximum Allowable Maximum Allowable
Maximum Allowable Maximum Allowable
Body Region Specific Body Area Pressure Force (Fmax)
Pressure Multiplier PT Force Multiplier FT
(pmax) [N/cm2] [N]
(see NOTE 3) (see NOTE 3)
(see NOTE 1) (see NOTE 2)
Skull and 1 Middle of forehead 130 N/A
130 N/A
forehead 2 Temple 110 N/A
Face 3 Masticatory muscle 110 65 N/A N/A
Neck 4 Neck muscle 140 2
150 2
5 Seventh neck vertebra 210 2
Back and 6 Shoulder joint 160 2 2
210
shoulders 7 Fifth lumbar vertebra 210 2 2
Chest 8 Sternum 120 2
140 2
9 Pectoral muscle 170 2
Abdomen 10 Abdominal muscle 140 110 2 2
Pelvis 11 Pelvic bone 210 180 2 2
Upper arms & 12 Deltoid muscle 190 2
150 2
elbow joints 13 Humerus 220 2
14 Radial bone 190 2
Lower arms
15 Forearm muscle 180 160 2 2
and wrist joints
16 Arm nerve 190 2
17 Forefinger pad D 300 2
18 Forefinger pad ND 270 2
19 Forefinger end joint D 280 2
20 Forefinger end joint ND 220 2
Hands and
21 Thenar eminence 200 140 2 2
fingers
22 Palm D 260 2
23 Palm ND 260 2
24 Back of the hand D 200 2
25 Back of the hand ND 190 2
Thighs and 26 Thigh muscle 250 2
220 2
knees 27 Kneecap 220 2
Lower legs 28 Middle of shin 220 2
130 2
29 Calf muscle 210 2
Note 1: Limits from pain onset level studies, and represent the 75th percentile of the range of recorded values for a specific body area
Note 2: From literature study of 188 sources and based on body regions, not on specific areas. Could lead to minor injuries 1 on AIS.
Note 3: From literature sources, transient limits can be at least twice as quasi-static values for force and pressure
 ISO TS 15066 Body region characteristics

Table A.3 — Effective masses and spring constants for the body model (based on total weight of 75 kg)
Effective spring
constant[4] Effective mass[7]
Body region (k) [N/mm] (mH) [kg]
Skull and forehead 150 4.4 • Energy limit values to
Face 75 4.4 different body regions
Neck 50 1.2 (Table A.4)
Back and shoulders 35 40
• Relationship between
Chest 25 40
Abdomen 10 40 transferred energy to
Pelvis 25 40 different body regions
Upper arms and elbow joints 30 3 and robot speed
Lower arms and wrist joints 40 2 during transient
Hands and fingers 75 0.6 contact (Table A.5)
Thighs and knees 50 75
Lower legs 60 75

Note: Mass values for thighs, knees and lower legs are set to the full body weight, since
these body parts are not free to recoil or retract from impact while the operator is
standing.

30 Nov 2016 Robot safety, Next-Generation Robotics & Automation, Birmingham, UK 21

 Conclusions
• Robotics evolving to new applications and
new challenges emerging for
– Industrial robots: H-R collaboration
– Personal care robots (close H-R interaction+contact)
– Medical robots (safety and essential performance)
• Standardization vital for ensuring safety
and success for the new needed robots
– Safety requirements: ISO 10218-1, ISO 10218-2,
ISO TS 15066, ISO 13482
– Quality and efficiency metrics also needed
30 Nov 2016 Robot safety, Next-Generation Robotics & Automation, Birmingham, UK 22