CENELEC/TC 62 has decided that, with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give ‘presumption of conformity’ with the European directives covered as of 1 June 2012. This is the so called DOCOPOCOSS (Date Of Cessation Of Presumption Of Conformity Of Superseded Standard), which is published in the Official Journal of the European Union. The CENELEC/TC 62 decision on the DOCOPOCOSS of 1 June 2012 was confirmed by the CENELEC Technical Board in October 2009 (decision D135/C228). Publication in the Official Journal of the European Union (OJEU) is necessary for this decision to enter into force. This publication is expected in spring of 2010. This Q&A addresses some practical aspects arising from this decision.

Q1: What is CENELEC/TC 62?

A: CENELEC/TC 62 is the Technical Committee within the European Standards Organization context responsible for European Standards relating to Electrical Equipment in Medical Practice. Such medical equipment is a subset of the devices that fall under the European Directives 90/385/EEC (AIMD) and 93/42/EEC (MDD). CENELEC/TC 62 is closely related to IEC/TC 62, at the international level, where most of the standards are developed.

Q2: Why did CENELEC/TC 62 take the decision it did?

A: Requirements in standards harmonized under one or more New Approach European Directives are supposed to represent the “state of the art”, as interpreted within the Directives. With some standards in the 60601-1 series being more than a decade old and with the publication of EN 60601-1:2006, CENELEC/TC 62 decided the 1990 version no longer represents the generally acknowledged “state of the art”.  However, devices should not be presumed to be unsafe simply because they were designed to comply with EN 60601-1:1990 when first introduced into the European market. Whether or not the safety of such devices represents the “state of the art” can only be determined through the application of Risk Management according to EN ISO 14971 and especially with regard to Clause 9 thereof.

Q3: Will this decision impact particular standards (“parts 2”) for EN 60601-1:1990?

A: Not directly. The part 2 standards referencing EN 60601-1:1990 will continue to give presumption of conformity with the directives until their DOCOPOCOSS; see also Q10 and Q11.

Q4: Was this decision inspired by the publication of European Directive 2007/47/EC, amending two existing Medical Device Directives?

A: No. CENELEC has the obligation to keep the standards harmonized under European Directives to reflect the “state of the art”. The decision is independent from the publication of the amending directive.

Q5: Does this Q&A also include EN 80601-standards?

A: Yes, it does. Not all EN 60601-standards adopted by CENELEC/TC 62 as EN’s have been developed by IEC exclusively. Some standards in this framework are the result of a joint effort between ISO and IEC, which is made more visible by replacing the first digit in the 60601-numbering into an “8”. For simplicity, this Q&A will only use the 60601-numbering but it also applies to all EN 80601 documents.

Q6: Q: Does this Q&A refer to both MDD (93/42/EEC) and AIMD (90/385/EEC)?

A: Yes, it does. EN 60601-standards have been harmonized under both directives, and the revision of the relevant standards affects the harmonization under both directives equally. For simplicity, this Q&A will only mention the MDD.

Q7: Am I required to utilize EN 60601-1:2006 for my medical devices since 12 September 2009?

A: No. The text in the foreword says “However, when Part 1 is used for appliances not covered by a part 2, EN 60601-1:1990 is not to be used after 2009-09-12". This was included to stimulate manufacturers to consider using the latest edition. In itself, that text does not constitute any legal obligation or a change in the right to claim presumption of conformity. The legal situation is that as long as EN 60601-1:1990 and its amendments have a current listing in the Official Journal of the EU, they will continue to provide presumption of conformity with the Essential Requirements of the MDD covered by the standard. In spite of their listing in the OJ, harmonized standards remain voluntary, so there is never a legal obligation to use them. Note that the foreword will change as part of the CENELEC/TC 62 decision. 

Q8: Are any of the collateral standards affected?

A: Yes. There are several collateral standards that relate to EN 60601-1:1990, for which the same DOCOPOCOSS applies as for EN 60601-1:1990. These are: EN 60601-1-2:2001, EN 60601-1-3:1994, EN 60601-1-6:2004, and EN 60601-1-8:2004 (all with their respective amendments).

There are two more collateral standards that relate to EN 60601-1:1990; these are EN 60601-1-1:2001 and EN 60601-1-4: 1996 (with A1:1999). The relevant parts of these two collateral standards were revised and updated, and included in EN 60601-1:2006. As a consequence, the same DOCOPOCOSS applies as for EN 60601-1:1990.  

Q9: What if a part 2 exists for my medical device?

A: For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive. One must consider that a part 2 is essentially the content of the main document (EN 60601-1), together with the content of all the relevant collateral standards (all EN 60601-1-x), and then modified by the content of the part 2. If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (‘superseded’) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 1 June 2012 date is not relevant.

Q10: If the part 2 DOCOPOCOSS is after 1 June 2012, can I still use EN 60601-1:1990?

A: Yes. Even if after 1 June 2012 EN 60601-1:1990 by itself will no longer give presumption of conformity, the normative reference to it in the part 2 is the deciding point. As long as the part 2 is a harmonized standard it may be used to claim presumption of conformity with the Essential Requirements covered by the part 2 standard. The presumption of conformity applies if a product satisfies the relevant requirements of the standard that is listed, including requirements that are introduced by normative references to other standards. Note that it is not necessary for normatively referenced standards to be listed in the Official Journal in their own right.

Q11: What if there is no part 2 for my medical device?

A: For products for which there is no (harmonized) part 2, compliance with the main standard and related collaterals can be used to claim presumption of conformity. The DOCOPOCOSS date of 1 June 2012 implies that, after that date, compliance with EN 60601-1:1990 will no longer give that presumption of conformity. Until that date, since both EN 60601-1:1990 and EN 60601-1:2006 are listed in the OJEU, either standard (with its set of collaterals, etc.) can be used to claim presumption of conformity.

Q12: I want to use the EN 60601-1:2006 with the old collateral standards; is that OK?

A: No, that is not possible. Since the main standard was substantially modified in its revision to the 2006 version, the collateral standards had to be modified as well. As a result, it is not possible to mix standards from different “era”. You are encouraged to check the normative reference clause of the collateral standards to find out which edition of the general standard is related to that edition. 

Q13: If the OJEU listing contains a standard as well as its successor, the superseding standard, with no DOCOPOCOSS date indicated, which standard should I use?

A: This situation is unusual but can occur. In this case, either standard may be used to claim presumption of conformity with the Essential Requirements it covers. It is recommended, however, to use the latest version of the standard.