EN 60601-1:2006 Edition 2 Update
Posted: November 4, 2009
Mike Schmidt, a medical device consultant that serves as secretary of IEC Subcommittee 62D, Cochair of the AAMI Electrical Safety Committee, sent MD&DI an announcement regarding harmonization of the EN 60601-1: 2006 standard along with the many collateral and particular standards in the 601 series. Schmidt says, "There has been significant concern and discussion about when the 1988 Edition of 60601-1 will be withdrawn, due to  erroneous text in the foreword of the 2006 edition, which indicated this would happen in September of 2009. CENELEC has finally made an official recommendation for the date to end  the presumption of compliance with the device directives (harmonization) for the second edition." According to Schmidt, the withdrawal date is now officially set for June, 2012. This date aligns the regulatory use of the 60601-1 series in Europe and with the current policy of Health Canada. In the U.S., he says, FDA is expected to recognize the new standard within the next several months. The following link goes to a Q&A document on the CENELEC Web site: http://www.cenelec.eu/Cenelec/CENELEC+in+action/Horizontal+areas/ICT/Collateral_standards_under_MDD_AIMD.htm
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Mike, made some excellent and

Submitted by Ed Bills (not verified) on November 6, 2009 - 11:32pm.

Mike, made some excellent and timely comments on IEC 60601-1:2005 (EN 60601-1 Second Edition). The deadlines for change are approaching must faster than manufacturers realize. Why do I say this? Products being designed today may not reach the certification/test phase much before the deadlines in Europe and Canada. And the FDA will soon speak on the Third Edition. The FDA has announced a guidance on the Third Edition in their schedule for completion in 2010.

The use of the Third Edition has a requirement for a risk management process in compliance with the medical device risk management standard ISO 14971. While many companies are doing some risk management activities, often using FMEA, they are not in complete compliance with the standard. It would be tragic to reach the certification phase for a product and find the the early risk management activities did not comply with the standard, and would require corrective action.

Manufacturers should have audits of their risk management process performed now in order to reach compliance with the standard for products which are expected to comply with the Third Edition.

The FDA has also announced a guidance document in their 2010 schedule on risk management documentation to be submitted as part of pre-market submissions. It will no doubt have some human factors requirements, as FDA has been connecting risk management and human factors for at least 10 years. They have also participated in the development of usability standards IEC 62366 and AAMI HE74, both of which FDA recognizes. Additionally they have assisted in the development of AAMI HE75 soon to be released also in the area of human factors.

In short, manufacturers should now be ensuring their processes comply for products currently under development to avoid delays in release.

Mike's excellent comments on

Submitted by Edwin Bills (not verified) on November 6, 2009 - 6:48pm.

Mike's excellent comments on the new IEC 60601-1 should be recognized as warnings for manufacturers developing new electro-medical products. New products that are under development now should be developed to the new edition of IEC 60601-1 and its family of standards.

While test houses and certifying bodies are still finalizing the certification/test processes, the new products will need to meet the new edition in order to be placed on the market in 2012, which is just around the corner.

Among the requirements of the new standard is a risk management process that fully complies with the medical device risk management standard ISO 14971. While most companies at least perform FMEA on designs, many companies do not have a fully compliant process.

One other related area which is also receiving increased scrutiny by FDA is usability, which has related standards IEC 62366 and AAMI HE74. The collateral standard IEC 60601-1-6 is also related to these requirements. Usability has risk management implications and should be a part of the risk management process.

It would be difficult for companies to reach the final phases of design and find the early phases risk management process did not comply, and the company needed to have lengthy corrective actions to meet the IEC 60601-1 requirements.

Manufacturers need to perform compliance audits of their design and risk management processes so that the processes can be improved to meet the requirements now. Then the new design can move smoothly through the final test processes and be released according to the project plan.