Role of IEC 60601-1-9 in relation to the third edition 60601-1:2005

The International Standard IEC 60601-1 has become the global benchmark for medical electrical equipment. Compliance with the IEC 60601-1 International Standard and/or the relevant national version does not equal medical device approval. However, it is a recognized step towards medical device approval in nearly all markets across the world. As a result, many companies view compliance with IEC 60601-1 as a de facto requirement in most markets for: product registration; “CE” “UL” “CSA” marking; contract tenders; defense against claims in the event of problems; etc.

New requirement for compliance with all collateral standards

The 3rd edition of IEC 60601-1 was published in 2005 and has already been adopted as a new national standard in the US (ANSI/AAMI ES 60601-1:2006) and as a new European standard in Europe (EN 60601-1:2006). The biggest change in the 3rd edition is that Clause 4.2 requires a manufacturer to have formal risk management process in place which complies with ISO 14971. The next biggest change is the introduction of essential performance into the scope.

Another new requirement is that the 3rd edition IEC 60601-1:2005 requires compliance with all collateral standards in order to maintain compliance with the main standard IEC 60601-1. Clause 1.3 of 60601-1:2005 states that

“Applicable collateral standards become normative at the date of publication and shall apply together with this standard.”

“When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with the collateral standards”

“When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation.”

Clause 1.3 has been included verbatim in the European standard EN 60601-1:2006 and the US standard ANSI/AAMI ES 60601-1:2006. As noted in the Journal of Medical Device Regulation May 2006, in effect Clause 1.3 allows for an unlimited number of amendments to add new general requirements to IEC 60601-1 because each new collateral standard becomes a normative part of IEC 60601-1 when published. This applies to the new collateral standard IEC 60601-1-9 Environmentally Conscious Design of Medical Electrical Equipment which was published in July 2007.

Transition dates

The US, Canada, Japan, Australia and New Zealand have not yet set transition dates for their national versions of this latest edition 60601-1, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9. However, the forward to the European version (EN 60601-1:2006) states that the transition date in the EU for equipment where there are no Particular Standards is September 2009. Hence a company that manufactures or sells medical electrical equipment in Europe and wishes to maintain its declaration of compliance with the parent standard EN 60601-1 must ensure that it is compliant with the new collateral standard IEC 60601-1-9 by September 2009.

Of course, companies that wish to declare compliance with the new version EN 60601-1:2006 in advance of the September 2009 deadline (e.g. to gain competitive advantage by demonstrating early compliance to their customers) must ensure that they are in compliance with the new collateral standard IEC 60601-1-9 earlier than this.

Eucomed is lobbying to change the forward to the European EN 60601-1 by including a statement that will countermand Clause 1.3 and instead state that a collateral standard does not become a normative part of the EN standard on the date of its publication. However, this would run counter to the decision published by IEC Subcommittee 62A in 2003 and would result in the European EN standard being out of step with national standards in the US and across the rest of the world.

Further information

A detailed paper by ENVIRON provides further explanation on the use of IEC 60601-1 in supporting approvals of medical electrical devices and the role of the new collateral standard IEC 60601-1-9. The paper covers:

  • the adoption of the 2nd edition IEC 60601-1:1988 in national standards and the use of these standards to support approvals of medical electrical devices in the US, Europe, Canada, Japan, Australia and other countries;
  • the need for companies to start using the 3rd edition IEC 60601-1:2005 and transition dates for certification to the new national standards in Europe, the US and other countries;
  • the normative role of collateral standards in the 3rd edition IEC 60061-1:2005 with particular reference to the new collateral standard IEC 60601-1-9 Environmentally Conscious Design of Medical Electrical Equipment.

For further information, please contact Dr Aidan Turnbull
Head of WEEE, RoHS & EcoDesign on +44 (0)1225 748420