The Current Status and Timeline of the IEC 60601 Amendments
I have been writing and talking about the IEC 60601 series of standards for a very long time, but I have presented on this subject more often in the last couple of years since there is so much changing on a regular basis.
New medical device standards are being developed at an ever‑increasing rate, some existing standards are being updated in shorter time frames (i.e., the rules for IEC standards development has changed to allow for shorter development cycles), and national medical device regulations (including guidances) keep changing at a faster pace. As a result, it is getting harder and harder for medical device manufacturers of all sizes as well as medical device consultants to keep up to date with the proliferation of changes. Ultimately, this impacts the manufacturer’s quality systems and technical documentation, increases product development cycle times, and stretches out product time to market.
This article will focus on the IEC 60601 series of medical electrical standards within The Amendments Project, a project currently being undertaken by Sub Committee 62A (SC62A). The Amendments Project covers the general standard (IEC 60601‑1) and most of the collateral standards (IEC 60601‑1‑XX, except for IEC 60601‑1‑3). The Amendments Project schedule was originally set for 36 months but has now been expanded to 43 months, as will be explained later in this article.
It is important to note that any future dates provided here are current as of the time that this article goes to press, and are subject to change.
About the Amendments Project
The Amendments Project covers the standards and editions shown in Table 1.
|The Amendments Project|
|Standard||Current Version||Amended Version|
|IEC 60601-1||Edition 3.1||Edition 3.2 = 3rd ed. + A2|
|IEC 60601-1-2||Edition 4.0||Edition 4.1 = 4th ed. + A1|
|IEC 60601-1-6||Edition 3.1||Edition 3.2 = 3rd ed. + A2|
|IEC 60601-1-8||Edition 2.1||Edition 2.2 = 2nd ed. + A2|
|IEC 60601-1-9||Edition 1.1||Edition 1.2 = 1st ed. + A2|
|IEC 60601-1-10||Edition 1.1||Edition 1.2 = 1st ed. + A2|
|IEC 60601-1-11||Edition 2.0||Edition 2.1 = 2nd ed. + A1|
|IEC 60601-1-12||Edition 1.0||Edition 1.1 = 1st ed. + A1|
Table 1: Summary of the IEC 60601-1 Amendments Project
Let’s start with some history with where the project started. IEC 60601‑1, 3rd Edition was originally published in 2005 and Amendment 1 in 2012. This can also be stated as IEC 60601‑1:05 + A1:12 or IEC 60601‑1, Ed. 3.1. Since IEC 60601‑1, Ed. 3.1 was issued, the Secretariat of SC62A has been collecting comments, suggestions and questions from a variety of sources, including National Committees (NCs) and SC 62A Working Group 14 (WG 14), which addresses interpretations of IEC 60601‑1. The membership of WG14 is heavily weighted towards test houses, but also has some manufacturers, a few independent consultants and a few regulators. In comparison, for many standards committees, the heaviest weighting is primarily manufacturers, then some test houses, a few independent consultants, and maybe a regulator or two.
At the 2015 meeting of SC62A held in Kobe, Japan 2015, we initiated a process to identify high‑priority issues (the “short list”) that needed to be considered in a new amendment to the standard that could be issued in advance of a 4th Edition (presently targeted for publication sometime after 2024). Following an April 2018 meeting of SC62A in London, it was additionally decided to address the issue of IEC 60950‑1 vs IEC 62368‑1. This change in the agenda added an additional seven months to the original schedule of the Amendments Project.
IEC 60950‑1 has been around for a long time (the first edition of IEC 60950 was published in 1986) and has served as the primary information technology equipment (ITE) safety standard in most major regulatory jurisdictions around the world. However, IEC 60950‑1 is slated to be replaced by IEC 62368‑1, Audio/video, information and communication technology equipment – Part 1: Safety requirements. Since IEC 60601‑1 includes multiple references to IEC 60950‑1, a special ad hoc group (ahG 62368‑60601) was formed to determine how best to incorporate the requirements of IEC 62368‑1 into IEC 60601‑1.
One of the big questions the NCs had to address was how IEC 62368‑1 would be dealt with in the Amendments Project or in the 4th Edition of IEC 60601‑1. Ultimately, the NCs determined that it was important to evaluate the option of including specific requirements in both IEC 62368‑1 and IEC 60950‑1 in a second amendment to IEC 60601‑1 (IEC 60601‑1 Ed. 3.2). The ad hoc group subsequently drafted text that was used as a basis for the MT28, Electrical Hazards committee’s March 2019 meeting in Xi’an, China.
Where We Stand Now
The Committee Draft for Vote (CDV) 62A/1320/CDV for IEC 60601‑1, Ed. 3.2 was issued in May 2019. The Results of Voting (RVC) 62A/1350/RVC for IEC 60601‑1, Ed. 3.2 was issued at the end of August 2019, and all eight CDVs of the Amendments Project were approved. However, it’s unclear when the rest of these documents will be processed by the SC 62A Secretariat and officially issued by the IEC Central Office (CO).
Note that, even though all the CDVs of the Amendments Project were approved, some negative NC votes were cast for IEC 60601‑1‑2 and IEC 60601‑1‑8. The negative votes and accompanying comments were reviewed by the applicable MTs and WGs during the October meetings in Shanghai. The CDV is the last point in the IEC process during which technical changes can be made, and no changes are possible in preparing documents for the FDIS, the last stage of the standards development process prior to publication. The MTs and WGs reviewed the comments, but can only accept and update the FDIS to address typos in the text with the consent of IEC CO editorial team. However, comments not accepted for the FDIS may be recommended for the 4th Edition IEC 60601 Series Project.
The current schedule for the Amendments Project, for each of the 8 standards, is as follows:
- CDV ballot closed September 2019
- Shanghai Meeting worked on CDV comments October 2019
- Submit FDIS January 2020
- FDIS ballot start March 2020
- FDIS ballot close May 2020
- Target publication of International Standard
The next piece of the IEC 60601 series puzzle is that the Particular Standards (i.e., IEC 60601‑2‑XX and IEC/ISO 80601‑2‑XX) are aligned with the changes to the Amendments Project. The majority of the Particular Standards are managed under SC62D, which is expected to firm up the proposed schedule to align the Particular Standards within 18 months of publication of the Amendments Project. This means targeting the publication of these Particular Standards by the end of 2021 or early 2022, which may well represent an overly‑aggressive schedule for some of the standards committees involved.
At the 2015 TC 62 meeting in Kobe, Japan, an ad hoc group was approved for the development of the architecture of the 4th Edition of the IEC 60601 series. The first meeting of this ad hoc group was held in London in June 2018, which resulted in the circulation of an initial version of the proposed architecture document 62/328/DC for the next edition of the IEC 60601 series of standards.
This architecture document for the IEC 60601 series is extremely important to manufacturers, regulators, test houses and other stakeholders. Some of the ideas that were discussed early on in the process include:
- One requirement (“shall” statement) per identifiable element (i.e., bullet, sub‑cl., etc.);
- Write clearer, less‑interlaced requirements (now has been changed to read “Reduce cross‑referencing within parts of the IEC 60601 series” and “Reduce referencing between parts of the IEC 60601 series”);
- Use clear testable requirements (type test standards IEC 60601 series) and separate from process standards (i.e., ISO 14971, IEC 62304, IEC 62366‑1);
- Integrate some Collaterals into IEC 60601‑1 (the General Standard); and
- Possible db standard (i.e., integrate General Standard with Collaterals and any applicable Particular Standards for specific product type, so that requirements for that product are integrated into one document that device manufacturers can apply to their specific product type).
The 62/328/DC document invited NCs and Liaison Bodies, such as the International Medical Device Regulators Forum (IMDRF), to comment on the proposal. The U.S. NC received over 220 comments from its members prior to the response deadline. The U.S. NC then spent several days working on a U.S. national position that reflects a general consensus of the comments it received. The number of comments processed by the U.S. NC reflect how important the document is to the U.S. national committee members. The comments received from all the NCs and Liaison Bodies including the Therapeutic Goods Administration of Australia (TGA) were circulated as a preliminary report in document 62/329/INF.
The ad hoc group and representatives from NCs and Liaison Bodies met in Lübeck, Germany in May 2019, and have subsequently held at least five additional virtual on‑line meetings to address the comments and revise the draft architecture. This resulted in a second version of the architecture document 62/333/DC, entitled “Architectural Specification for Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software used in Healthcare.” A number of the items listed above were included in this second version of the Architecture document.
Although originally intended to be published as a Technical Report, the officers of TC 62 have recommended that the document be posted as a “white paper” on the committee’s web page and was agreed upon at the Shanghai meeting. The material will be readily available to all stakeholders at no cost.
I suspect that the 4th Edition of IEC 60601‑1 will be delayed at least a couple years past 2024. Basically, the majority of the Particular Standards (i.e., IEC 60601‑2‑XX & IEC/ISO 80601‑2‑XX) won’t be aligned and published to the Amendments Project until about early 2022, and TC 62 won’t start work on the 4th Edition of IEC 60601‑1 until most (if not all) of the Particular Standards are aligned to IEC 60601‑1, Ed. 3.2 and the Collateral Standards. Additionally, many of the members of the Particular Standards committees are also members of SC62A, WG14, and the MTs and project teams that have been involved in the Amendments Project, and may well step down from their positions ahead of the beginning of the 4th Edition effort, further impacting delivery timelines.
It should be pretty obvious this is no small project to get the Amendments Project completed in a timely manner and to fully align the Particular Standards with the Amendments Project. As we move closer to the 4th Edition architecture, the hope is there will be closer ties between regulators, industry, standards developers, test laboratories and consultants. This can only help to improve and better serve the needs of all the applicable stakeholders around the standards development process for medical electrical standards.