Medical Standard Challenges - IEC60601: understanding the changes from 2nd to 3rd edition

   General standard IEC 60601 is the accepted standard for medical equipment, especially for medical electrical equipment and general requirements for basic patient safety. It is a widely accepted benchmark series for medical electrical equipment, and compliance with IEC60601 has become a de-facto requirement for the commercialization of electrical medical equipment in many countries

   The 3rd edition of this medical safety standard was first published by the IEC in 2005 (IEC60601-1:2005) and was adopted by the European Union in 2006 and published as EN60601-1:2006. The USA version was also published in 2006, but unlike 2nd edition, not by UL. It is published by the American Association for Medical Instrumentation (AAMI) and appears as ANSI/AAMI ES60601-1:2006. Canada published the standard in 2008 as CAN/CSA60601:2008.

   Engineers need to be acutely aware that when using these standards, there are a number of key dates specified for the implementation of the 3rd edition, and that these vary by region:

   In Europe, as of the 1st June 2012 the 2nd edition (EN60601-1/A2:1995) will be withdrawn, called the cessation date, and all products will need to be certified to the 3rd edition, EN60601-1:2006.  This includes both new products introduced to the market and products already on sale.

   The situation is rather different in the United States. The cessation date for 2nd edition (UL60601-1:2003 1st ed) is 30June 2013 but, unlike the EU, the FDA only requires that new products brought to market after this date will need to be 3rd edition certified (ANSI/AAMI ES60601-1:2005). In Canada the cessation date for 2nd edition (CAN/CSA C22.2 No. 601.1) is 1 June 2012, but again the 3rd edition (CSA‐C22.2 NO. 60601‐1:08) is only needed for products new to the market after this date.

   Another complicating factor for designers is that the particular standards that are part of the 60601 family. These are commonly referred to as "part 2's" and will have the standard number 60601-2-xx, such as IEC60601-2-46, particular requirements for the safety of operating tables. Where these are applicable the equipment needs to be certified to these standards and therefore the date for 3rd edition adaption will be dictated by the date that the 2nd edition part 2 is withdrawn. 

   This could be before the main date or after it. Some countries are, to date, not adopting 3rd edition. This means that equipment will need to be certified to IEC60601-1/A2:1995 2nd edition for those regions, because after 1st June 2012 EN60601-1 2nd edition will be withdrawn and UL60601-1 will be withdrawn in June 2013.

   One of the most significant changes that the 3rd edition introduces is that equipment manufacturers must now follow a formal risk management procedure that follows the ISO 14971 model, which effectively means compliance with a process standard as well as the fundamental product standard.

   Click on "Medical Standard Challenges - IEC60601: understanding the changes from 2nd to 3rd edition" to read the entire article, which originally appeared at EE Times-Europe.

About the author

Peter Blyth has been with XP for over 12 years and has had various roles within the company. Blyth joined in 1997 as an applications engineer, and became the Industry Manager for Medical in 1998. Between 1998 and 2002 he was the Senior Industry Manager - Medical for Europe and in late 2002 moved to the USA to become the Industry Director - Medical for North America. In 2009 Blyth was promoted to Global Medical Industry Director and he also relocated to the UK. He is currently based in Barnstaple, North Devon where his responsibilities include management of XP's global medical business, marketing, product development (marketing input) and technical support to customers. Prior to working at XP, he worked for the UK Ministry of Defence for three years and a small broadcast electronics company in the UK.

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