Chair: Gurvinder S Virk, CLAWAR Association Ltd, UK
Mob:+46 705 406425; Email: / IEC TC 62:Electrical Equipment in Medical Practice
SC 62A:Common aspects of Electrical Equipment used in Medical Practice / ISO TC 184:Automation systems and integration
SC 2:Robots and robotic devices
JWG 9: Medical electrical equipment and systems using robotic technology, DRAFT Minutes Meeting #1
Venue: Toyota Motor Sales (HQ), 19001 S. Western Avenue, Torrance, CA, USA
Date: Day 0: 14 June 2011Visit to Intuitive Surgical, Sunnyvale, CA, USA09.00-14.00
Days 1-3: 15-17 June 201109.00-17.00

Attendance

JWG 9 Members, Representations
Gurvinder S Virk, CLAWAR Association Ltd, UK / Frank O’Brien, O’Brien Comp Management LLC, USA
Cornelia Beck, Kuka Laboratories GmbH, Germany / Mike Yramategui, Intuitive Surgical, USA
Sascha Kolb, Kuka Laboratories GmbH, Germany
Giancarlo Ferrigno, Politecnico Milano, Italy / Observers
KiyoyukiChinzei, AIST, Japan / Michael Bluemel, Seimens, Germany
YasuhiroOta, Toyota Motor Company, Japan / Kota Naheshima, Cyberdyne, Japan
Seungbin Moon, Sejong University, Korea / Hideaki Ono, Honda R&D, Japan
Jeon-Il Moon, Daegu-Gyeongbuk IST, Korea / WeixinQu, TZK, China
Thomas Jakob, Varian Medical Systems Imaging, Switzerland / YoshiyukiSankai, TsukubaUnivCyberdyne, Japan
Burkhard Zimmermann, Hocoma AG, Switzerland / Uwe Wagner, Siemens, Germany
Milan Bates, Bristol University Hospital, UK / Dongwon Yang, KIRIA, Korea
Roger Bostelman, NIST, USA / Shuping Yang, RIAMB, China

Apologies:Chris Harper, Abul Azad, FirasJamil, Julian Goldman, Charles Sidebottom, OsmanTokhi.

11/01 / Visit to Intuitive Surgical on 14 June 2011
Cornelia Beck, KiyoyukiChinzei, Sascha Kolb, Thomas Jakob, Frank O’Brien, GurvinderVirk andBurkhard Zimmermann attended the visit which was hosted by Dr Simon DiMaio (Manager), Applied Research, Mike Yramategui and other colleagues. There were several very informative and interesting presentations on the company’s history, current activities and future development plans, as well as hands on experience to operate the da Vinci system and a tour of the manufacturing facilities.
11/02 / Welcome/ Introductions/ Approval of Agenda/
11/02/01 / Yasuhiro Ota welcomed everyone to Toyota in LA and handed the chair to GSVirkwho welcomed everyone to the first meeting of the Joint WorkingGroup (JWG). All the delegates introduced themselves.
11/02/02 / The Agenda for the JWG9Meeting #1 was accepted as distributed.
11/02/03 / As a formality, the minutes of the WG7 Study GroupMeeting #5 were reviewed, accepted and signed. This was the final meeting of the SG which has now been disbanded and the work will continue within JWG9. Although all the matters arising were completed they have been superseded by the creation of JWG9 where new activities will be initiated and followed through as appropriate. Thanks were expressed to all the SG experts who have initiated this important work to widen the application of robotic systems to the medical sector.
11/03 / Background and future aims
11/03/01 / Three documents have been produced to assist JWG9, namely 1) a summary Powerpointprepared by GS Virkand 2) a detailed report prepared by Cornelia Beck and Roger Bostelmanboth describing SG’swork, and, 3) a report produced by Seungbin Moon describing related ISO work to extend the vocabulary for robotics.
11/03/02 / GSV presented hisoverview on the activities carried out by the ISO Study Groupfrom the time it was set up in September 2009 to complement the non-medical robot safety standardization work being carried out within WG7.Five meetings of the SG have been held which have investigated a range of issues felt to be important in medical robot standardization. These include the following:
  • Differences between the Machinery Directive (MD) and the Medical Device Directive (MDD)
  • Differences between medical robots and existing medical electrical equipment and systems (MEES)
  • Differences between medical robots and non-medical robots
  • Classification of medical robotics and definition of key terms

11/03/03 / Cornelia Beck and Roger Bostelman presented their report detailing the topics discussed within the SG over its five meetings. The report extended the issues described in 11/03/02 as well as including some views on where the new medical robot standard could fit, namely within the IEC 60601 family of documents. In addition, information onthe discussions regarding autonomy has been describedas this is felt to be a key point of difference between medical robots and existing medical electrical equipment, for this, Roger Bostleman presented the US ALFUS work on defining autonomy for unmanned systems and Milan Bates presented a surgeon’s perspective on the possible different levels of autonomy needed for medical robots to allow them to intervene for safety reasons.
11/03/04 / Seungbin Moon presented his report describing the background history for the area of robotics as presented in ISO 8373:1994 and the current on-going work in WG1 to extend this in line with the broadened scope of ISO TC 184/SC 2 from its previous industrial focus. This has led to having to define the fundamental term “robot” which was previously defined to be the same as “industrial robot”. To do this, the term “autonomy” has been introduced and work is continuing to refine several key definitions within WG1; JWG9 is invited to contribute to this work.
11/03/05 / It was felt that the reports presented gave the JWG9 experts a good summary of the work already carried out and the results obtained will be used to take the standardization work further. Following the work of the SG and its interaction with IEC SC 62A, ISO TC 184/SC 2 agreed to set up the JWG to continue the work. IEC balloted its members and the proposal to create the JWG was accepted by a simple majority of members with Germany, The Netherlands, Portugal, South Africa, Switzerland, UK and USA voting “Yes”. There was one negative vote from Japan but this was explained by KiyoyukiChinzeito be due to the scope for the proposed JWG not being clear enough and the feeling that more discussions were needed; Japan is however very interested in the work and had nominated IEC experts to join JWG9. The active ISO SG experts have been transferred to JWG 9 but if some have been missed,they should contact their national ISO or IEC member organisation to join JWG9.
11/03/06 / GSV presented the task allocated to JWG9, which is defined by the following statement: Develop general requirements and guidance related to the safety of medical electrical equipment and systems that utilize robotic technology. (i.e., medical robots). The work would encompass medical applications (including aids for the disabled) covering invasive and non-invasive procedures such as surgery, rehabilitation therapy, imaging and other robots for medical diagnosis and treatment.
11/04 / Open and group discussions to identify areas for further investigation
11/04/01 / Extensive discussions were carried out both in committee and I smaller groups (each of which was led by an IEC expert) to explore different issues important for JWG9. These included the following topics:
  1. When is Medical Electrical Equipment (MEE) not a medical robot?
  2. Existing 60601: Determine what is missing?
  3. Autonomy missing, “pre-programmed and automatic” vs programmable
  4. Define boundary for medical and non-medical (robot) applications
  5. Machinery Directive (MD) and Medical Device Directive (MDD)
  6. Basic Safety (BS) vs Essential Performance (EP) distinctions
  7. Existing ISO 13482 for personal care robot safety : what is missing or redundant
  8. Definitions: what to define and the actual definitions

11/04/02 / The conclusions from the various group discussions have been circulated during the JWG9 meeting itself but a summary of the work and the results obtained is given here:
  • Detailed knowledge of IEC 60601 is needed and experts are encouraged to familiarise themselves with the document; a brief introductory summary on 60601 was presented by Frank O’Brien
  • For issue 1) in 11/04/01: “When is Medical Electrical Equipment (MEE) not a medical robot?”, the following points were suggested:
  • autonomy is missing from current MEEand needs defining (possibly using a multi-axes approach as used in ALFUS) for medical and non-medical perspectives since they are likely to be different
  • there are additional hazards to consider for medical robots due to the environment being unique and unknown; mechanical hazards are critical and ISO 14971 needs to be used for the risk management
  • 60601 contains insufficient level of detail needed for medical robots especially for motions giving issues of mechanical and electrical safety
  • the scope of possibilities for medical robots may be too wide for a collateral standard
  • the safety factors in 60601 may be too restrictive and having people near the robots introduces new trapping zones which need to be addressed (with respect to patient, user and third party perspectives).
  • essential performance hazards for medical robots need investigation
  • For issue 2) in 11/04/01: “Define boundary for medical and non-medical (robot) applications”, the following points were suggested:
  • MD vs MDD considerations indicate that clinical benefit can be balanced with risk in medical robots however, MD robots need to cover MDD issuesand vice versa under appropriate situations
  • BS vs EP distinctions indicate that EP for medical robots need defining. Possible definition: EP is threshold of performance associated with clinical benefit necessary to maintain acceptable risk. However EP is application specific and is perhaps more suitable for particular standards. An exoskeleton example was considered to highlight BS and EP issues in medical and non-medical applications; the details of the example are as follows:
  • MDD: Young person uses an exoskeleton to gain physical assistance due to an injured knee. The walking does not need to be perfect but the exoskeleton cannot let the person fall since this will cause further injury; these type of issues are referred to as EP requirements.
  • MD: Here an exoskeleton is used to provide a lower level of physical support for walking to a fit but elderly person. The device must still be concerned with sources of harm such as tripping and falling but theseare now referred to as BS requirements
  • The current ISO/DIS 13482 does not cover emergency situations fully and the interaction between humans and robots may not be consistent with medical use (eg., cutting patient for surgery). Also any issues where the “patient” uses a medical robot for personal benefit are not covered. Collisionsare not allowed for multiple manipulators in MD but are accepted in medical applications (eg.,da Vinci) and there is always a single point of control in MD but not sure if this is needed in medical situations.
  • For issue 3) in 11/04/01: “Medical robot definitions”, it is felt that several terms need to be defined and the definition of medical electrical equipment should be used as the starting point. The main points made include the following:
  • Terms needing to be defined include intelligent, intelligence, robot technology, essential performance, degree of autonomy, etc.
  • Some suggestions to define the term “medical robot” were formulated, viz:
  • ROBOT or ROBOTIC DEVICE intended to be used as MEE or as MEDICAL ELECTRICAL SYSTEMS (MES)
  • INTELLIGENT actuated MECHANISM WITH AWARENESS OF ITS ENVIRONMENT and with degrees of AUTONOMY intended to be used as MEE or as MES.
  • Medical robots need to be classified in some systematic manner

11/05 / Planning and organisation of future work activities
11/05/01 / As part of future planning and organisation of JWG9’s work, the following issues were agreed:
  1. Identify relevant standards needed and inform GSV
  2. Experts need to be familiar with the standards identified; currently these include the following: IEC 60601-1, IEC 60601-2-1 (clause 201.9), IEC 60601-2-54 (clause 201.9),ISO 10218-1, ISO 13482, ISO 14971, IEC 62304 and IEC 60513
  3. Aim to produce a “robust CD” usingthe SG’s report as a starting point for the new work item to develop the collateral standard for medical robots; this could be proposed in ≈18 months to IEC SC62A.

11/05/02 / The following plan was agreed:
  1. Thomas Jakobwill produce a single report summarizing the JWG9Mtg#1 and distribute a pdf mid-July to the JWG9 Experts.
  2. Homework: JWG9 Experts to insert individual comments on the report and submit these to Michael Bluemelby 31Aug11.
  3. Michael Bluemelwill combinethe comments and distributeas a single word document by 7Sept11
  4. JWG9 to discuss and resolve comments and produce a unified document at JWG9 Mtg #2 in Nuremburg
  5. Next: JWG9 will paste parts updated documents into the Collateral template in the appropriate clauses.
  6. GSV to get a template of Collateral standard.

11/06 / Any other business.
11/06/01 / Hideaki Ono presented the work being carried out by Honda to develop walking assistive devices, in particular the stride management and the bodyweight support systems were described.
11/06/02 / Thanks were expressed to Intuitive Surgical for the excellent site visit before the JWG Mtg #1.
11/06/03 / Thanks were expressed to Dr Yasuhiro Ota and his colleagues at Toyota Motors for the excellent facilities and support during the JWG9 meeting held in Los Angeles.
11/07 / Date of next meetings
11/07/01 / JWG 9 Meeting #2, 21-23 September 2011, Nuremburg, Germany
11/07/02 / JWG 9 Mtg #3, Feb 12, Orlando, USA, JWG 9 Mtg #4, June 2012, Milan or Verona, Italy
11/07/03 / e-meetings in between face-to-face meeting if needed and IEC System test planned
Summary of Actions from JWG9 Meeting #1
Action / Actionee
11/05/01.1 / Inform GSV about any standard identified for JWG9’s work / All
11/05/01.2 / Experts to familiarise themselves with standards identified / All
11/05/02.1 / Produce & distribute pdf summary report from Mtg#1 to JWG9 Experts by mid-Jul11 / Tomas Jakob
11/05/02.2 / Submit individual comments to Michael Bluemel by 31Aug11 / All
11/05/02.3 / Comments combined and single document distributed to JWG Experts by 7Sept11 / Michael Bluemel
11/05/02.6 / Obtain Collateral standard document / GSV
11/07/01 / Organise JWG9 Mtg #221-23 Sept, Nuremburg, Germany / GSV
11/07/03 / Test IEC e-mtg system / GSV

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