Strategies for a successful changeover to the 3rd edition
As Medical Devices continue to become more complex and advanced, the relevant regulations and standards that ensure patient and user safety have to evolve in step. The IEC 60601, a series of technical standards for ensuring the safety and effectiveness of medical electrical equipment, is a prime example of this. First published in 1977 by the International Electrotechnical Commission (IEC), the IEC 60601-1 has been regularly updated to keep up with the evolving generally accepted state of the art. The changes involved are often complex and require a higher level of compliance. The learning curve involved in understanding and complying with new standards often provides challenges to Medical Device manufacturers, which may result in costly delays to a product launch.
The IEC 60601-1, 3rd edition, is a comprehensive revision of the 2nd edition, which dates from 1988. The IEC published the 3rd edition of the IEC 60601-1 standard in 2005 and subsequently Amendment 1 in 2012. From June 2012 onwards, the leading importing countries started to change over to the 3rd edition. In the EU, the United States, Canada, Japan, Brazil, Australia and New Zealand, the IEC 60601-1:2005 is already recognised as a general standard (see info box). Today, the standard represents the basis used most often to provide evidence of compliance with many of the essential requirements set forth in the Medical Device Directive (MDD).
The 3rd edition of the standard introduced the risk management (RM) and essential performance (EP) modules. This means that for each device, manufacturers must now list over 150 references specific to the risk management and furnish evidence of conformity with the IEC 60601-1 in risk management tables.
According to the IEC 60601-1 standard, Medical Device manufacturers must also establish a risk management system in accordance with the ISO 14971:2007 standard. In this context, they must note that they cannot satisfy the risk management requirements set forth in the IEC 60601-1, 3rd edition, by auditing the risk management process or certification according to ISO 14971:2007. While the IEC 60601-1 standard requires product-related evaluation of the relevant requirements of the standard, an ISO 14971 audit is process-focused.
Given this, successful product certification requires effective handling of risk management requirements set forth in both the IEC 60601-1 and the ISO 14971:2007 standard. Without thorough understanding of these requirements, Medical Device manufacturers may find it challenging to complete their documentation, including the comprehensive risk management tables as required by the standard. In practice, nonconformities in documentation are frequently not detected before the test phase, i.e. shortly before the scheduled product launch. However, at that stage the correction of data and tables may require an inordinate amount of work and time. Given this, manufacturers are advised to work on a thorough understanding of the standard at an early stage and cooperate closely with their testing laboratory to ensure full conformity with the IEC 60601-1 standards.
2nd. edition of IEC 60601-1: FDA extends transition period
Up to December 31, 2013, the FDA continues to recognise declarations of conformity in accordance with IEC 60601-1, 2nd edition:1988 (+ A1:1991 + A2:1995) and its collaterals and part 2 standards. The transition period was thus extended by six months. From 2014 onwards, ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 und A2:2010/(R)2012, "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance" will replace the previous edition of the IEC.