IEC 60601-1 3rd Edition, Part 1 Differences

Posted by on November 20, 2012 in Regulatory & Standards Compliance

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What was so special about June 1, 2012? No, you didn’t forget your anniversary! On that date, the requirements of IEC 60601-1 3rd edition came into effect in Europe and Canada (and will be in the U.S. by 6/30/2013). If you are in the process of developing a new electronic medical device or are currently revising an existing device, you need to pay close attention. I am often asked, “What’s new in the 3rd Edition?” This is primarily because the 2nd Edition has been around so long (published in 1988) and although the 3rd Edition was published in 2005, it didn’t become a requirement for (7) years. I’ve condensed my answer to “what’s new” to three fundamental areas:

  • Risk Management
  • Usability
  • Software

One key aspect of each of these areas is that they are full lifecycle, meaning they are not one-time or even short term events (like EMC or Electrical Safety testing). They are aspects of the product design that continue through the lifecycle of the product. And that can be a long time (at least we hope so).

A second key aspect of each of these areas is that they cannot be confirmed through testing and inspection of the product, as was possible with many aspects of the 2nd edition. Rather, each of these areas represents a process which needs to be in place and producing results that demonstrate conformance to the Standards.

So here’s the tip:

Put in place processes within your product development process that address each of these areas throughout the product lifecycle.

More details on IEC 60601-1 3rd Edition Differences

As mentioned in our Device Tip, the 3rd Edition of IEC 60601-1 is now in effect. Issued in 2005, European and Canadian companies were given until June 1, 2012 to comply with the new standard (US companies have until 6/30/13 to comply). The latest edition of the standard mandates (3) fundamental “new” requirements:

  • Risk Management
  • Usability
  • Software

As an aside, it’s rather curious to consider these “new” requirements since a) the 3rd Edition was published in 2005 and b) FDA has required Risk Management and Software Validation since the 1990’s and c) great products have always utilized Risk Management, Usability Engineering and excellent Software Development processes for competitive advantage.

In the 1988 (2nd edition) of the standard, companies could confirm compliance through inspection and testing of the product. Not so with the latest standard. Each of these new requirements needs to be incorporated directly into your design, manufacturing, and post-production processes. These processes are necessary in order to produce objective evidence in order to demonstrate compliance with the Standard.

The 3rd Edition addresses these (3) areas in two ways:

  1. Directly within the 3rd Edition itself; or
  2. By requiring conformance to a Collateral Standard

With respect to these (3) areas, the applicable Collateral Standards are:

  1. Risk Management: ISO 14971 (current latest Edition 2012)
  2. Usability:
    1. IEC 60601-1-6 (current latest Edition 2010)
    2. IEC 62366 (current latest Edition 2007)
  3. Software
    1. IEC 60601-1-4 (current latest Edition 2000)
    2. IEC 62304 (current latest Edition 2006)

I will cover details of each of these (3) areas in subsequent Device Tips. For now it is important to understand that these (3) are not separate areas in and of themselves. Rather, they are so interdependent that one needs to think in terms of implementing processes that integrate all (3) into your ongoing product development process.

The key backbone to the Standard is full lifecycle Risk Management. I’ll cover this in more detail in subsequent Device Tips, but for now:

  1. Implement a Risk Management process that starts at product concept and continues throughout post-production monitoring.
  2. Implement a Usability Engineering process that starts at product concept and continues throughout post-production monitoring, and
    1. Reduces Usability risks to as low as is reasonably practicable
    2. Identifies, evaluates and implements Usability improvements that make the product better
  3. Implement a Software Engineering process that starts at product concept and continues throughout post-production monitoring, and
    1. Reduces Software-related risks to as low as is reasonably practicable
    2. Identifies, evaluates and implements Software improvements that make the product better

This can be a daunting and expensive task. The experts at BDA are here to help. Please call us at (858) 487-1859 to schedule your free consultation.

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