Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we all will not forget (thx COVID-19), the Fall update was delayed longer than normal. It was just published today (21 Dec 2020). I have been asking my associates at the S-CAP (Standards and Conformity Assessment Program) for the last several weeks / months when the update would show up and they haven’t been able to give me a straight answer. Finally, it showed up! Below is a spreadsheet of the standards that have updated as of 21 December 2020. 99 standards were added to the FDA standards db. The IEC 60601 Amendments IEC 60601-1-2 ed. 4.1, IEC 60601-1-6 ed. 3.2, IEC 60601-1-8 ed. 2.2, IEC 60601-1-10 ed. 1.2, IEC 60601-1-11 ed. 2.1, IEC 60601-1-12 ed. 1.1 have all been added to the db.

Surprisingly, IEC 60601-1 ed 3.2 is not included in the Recognized Consensus Standards db update. Only AAMI ES60601-1:2005 + A1:2012 (FR Recognition # 19-4) or the 60601-1 ed 3.1 with US national deviations is still in the db.

Update to post — 22 Dec 2020 — I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.

IEC 60601-1-9 ed. 1.2 is not on the FDA list as 60601-1-9 isn’t a Recognized Consensus Standard. Also, a reminder that IEC 60601-1-3 was not part of the original Amendments project but now is scheduled to be updated as an IEC standard in March 2021. So, FDA hopefully will add to their Spring 2021 update. It is a really minor update with mostly just references to updates of the general standard being updated to ed 3.2 (2020).

A proposal has been circulated, on 21-JAN-2011, for a vote to form a Joint Working Group between ISO/TC 184/SC 2, Robots and robotic devices (non-medical robots) and IEC/TC 62 and its subcommittees to establish a new Joint Working Group on Safety for medical devices using robotic technology.  The following info is only part of the complete proposal.  If you have further interest please contact Leo Eisner at Leo@EisnerSafety.com.

Some Background:

Currently published international standards only cover robots in industrial environments. However, the situation is changing and new types of service robots are emerging. In light of these developments, ISO/TC 184/SC2 established a new work group (WG 7) on personal care robots. That group has been focused on formulating safety requirement for non-medical personal care robots. That group is working on a new standard, ISO 13482, Robots and robotic devices – Safety requirements – Non-medical personal care robot. This document will be advancing to the Enquiry Stage (ISO DIS) in early 2011 and publication is expected in 2012.

While initially focused on non-medical applications, WG 7 recognized early that work was likely to be needed on medical devices utilizing robotic technology. In June 2008, a liaison with IEC/SC 62A was established. Prof. John Hedley-Whyte volunteered to serve as the liaison officer. In September 2009, ISO/TC 184/SC 2 established a WG 7 study group on medical care robots. The study group is comprised of experts from Canada, France, Germany, Japan, Korea, Romania, Switzerland, UK and USA. The Secretary of SC 62A has attended two of the study group’s meetings. Members of the study group also participated in a workshop on Medical Care Robots sponsored by the US Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and held at FDA’s offices outside Washington D.C. in February 2010.

The WG 7 study group has concluded that the time is appropriate to initiate formal work on safety standard(s) for medical devices using robotic technology. The study group made a series of proposals to ISO/TC 184/SC 2 that resulted in the resolution in Annex A (please contact Leo Eisner if you would like a copy of this Annex). The potential for a joint project between IEC/TC 62 and its subcommittees and ISO/TC 184/SC 2 was also discussed at the IEC/TC 62 Chairman Advisory Group meeting in October 2010 in Seattle.

The Proposal:

ISO/TC 184/SC 2 is proposing the formation of a JWG with IEC/SC 62A under IEC administrative lead to develop a new work item proposal for a Collateral Standard in the IEC 60601 family. The scope of this work would be:

Establish basic safety and essential performance requirements for medical electrical equipment and systems employing 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.

The current working definition of a robot is an “actuated mechanism programmable in more than one axis with a degree of autonomy, moving within its environment, to perform intended tasks”. Autonomy is currently defined as the “ability to control movement and communication to perform intended tasks without human intervention”. Before a meaningful new work item proposal can be circulated, the proposed JWG will need to refine these definitions so as to establish the appropriate boundaries for this work.

While the initial work would be with SC 62A dealing with the general aspects of medical robots, close liaison will be maintained with other TC 62 subcommittees, particularly SC 62D, looking forward to the potential for work on standards for particular medical robot applications.

If approved, it is expected that the experts currently serving on the study group would be transferred to the JWG and a New Call for Experts issued in IEC/SC 62A and ISO/TC 184/SC2.

National Committees are requested to provide their responses using the IEC electronic voting system by: 2011-04-22

So, if you would like to have some input to your National Committee you will need to contact them soon as national votes tend to be called for at least 1 month prior to the official deadline for the National Committees.