The third edition of standard IEC 60601-1: General Requirements to Basic Safety and Essential Performance was published in 2005. Experience soon proved that the 3rd edition of the basic standard required corrections. IEC have recently published the Amendment 1 on July 13, 2012, with EN standard ratification from CENELEC soon following on October 1, 2012.
The Amendment 1 (A1) to Medical Equipment Basic Standard
The third edition of standard IEC 60601-1 was a radical departure from tradition. Instead of focusing on a number of tests as a proof of safety, it introduced a process-based approach. Many people got the impression that the process-based approach had gone into overdrive: when it was hard to define a meaningful safety test, the standard relied on the phrase, “compliance is checked by inspection of risk management file”. As it is not possible to find all single fault cases in testing, it was put up to the manufacturers themselves to establish the processes of product development and risk management to capture and prevent possible sources of hazard.
New problems were generated: Some of the tests involved in the third edition were excessive, some of the requirements unclear and the risk management approach over-employed. These issues were quickly realized when applying the standard. Work on the first amendment started back in 2005. On completion, A1 received a unanimous vote and has now been was published by the IEC on July 13, 2012, with CENELEC ratification as an EN standard following on October 1, 2012.
A1: the most important changes
A1 contains 496 separate changes to the third edition, although most are only editorial corrections or clarifications. However, 83 of the changes have been assessed as having “a moderate or significant impact on the users of the standard” and the most important changes include:
- In IEC 60601-1:2005 many of the normative references pointed to outdated references. A1 now updates these, for example, risk management according to ISO 14971:2001 has now been replaced by ISO 14971:2007.
- The definition and rationale of both ‘Essential Performance’ and ‘Expected Service Life’ has now been completely rewritten. This has been done with the intention not to change the concepts but to make them easier to understand and apply.
- Subclause 4.2 for ‘risk management and the related rationale’ has been almost completely rewritten. The description of the risk management process is now much more detailed and sets out the process requirements in compliance with ISO 14971 (with the exception that production, post-production monitoring and periodic reviews of the suitability of the risk management process are not required).
Impact of A1 on testing, documentation and certification
In addition to the restructured risk management process description, A1 now relies less on ‘inspection of risk management file’. Instead it implements many specific subclauses for tests or requirements for technical documentation.
Manufacturers need now to provide significantly more information to the user. A1 makes it mandatory that device labels additionally include:
- The contact information of the manufacturer
- The serial number, lot or batch information
- The date of manufacture or use by date
Technical information also needs to include what is the essential performance and how and when it should be tested.
Many of the electrical and mechanical tests have been re-defined to be less ambiguous to ensure that pass/fail criteria are less dependent on interpretation. These are welcome changes that introduce, for example, redefined tests for movement over a more realistic threshold: ie the height of the threshold has been reduced to 10 mm with rounded edges: If the manufacturer has not defined the method to pass the obstruction, equipment will be run to it at a speed of 0.8 m/s.
The IECEE organization operates the medical standards and CB system and it has already recognized the amended standard. While there is, as yet, no test report form available for the amended standard, it is possible to test and certify against it. But when it comes to harmonized standards within the EU system, the situation gets murkier. The European Commission has already made clear its dissatisfaction with CENELEC harmonized standards: especially the linking between the clauses of the standard and the essential requirements of the directives. In principle, this issue has been settled, however, for some time now the new harmonized medical standards have not been listed in the Official Journal of the EU. As a result, it is more complicated to use them for presumption of compliance.
The US and Canada are moving forwards with the introduction of the A1 and it is expected that ANSI/AAMI and CSA will publish the amendment soon.
Important advice to users of the standard
It is recommended to purchase the IEC 60601-1 standard edition 3.1 from the IEC web store now and take advantage of its clear outline of all the changes of Amendment 1, which are marked up in red. This document will help you tremendously to find out what has changed!