How Scary are the Device Safety Requirements in IEC 60601-1 Edition 3.1?

Yikes! Amendment 1 introduces over 20 new 
requirements and 60 modifications.
Few things are more frightening to an overwhelmed and under-resourced medical device manufacturer than a change to a regulatory standard, particularly if it’s a big one. (Cue creepy music.) Such is the case with IEC 60601-1 Edition 3.1, the internationally recognized standard that addresses the general requirements for medical electrical equipment and devices. Amendment 1, which was introduced in 2012, contains more than 250 changes to the text of the standard, many of which significantly alter the standard’s meaning and/or intent. Scary, right? Even scarier, the FDA will begin enforcing the new requirements as early as August 2016. Yikes!

As with any other standard change, failure to implement these new requirements promptly could cause costly delays in getting your device to market. Never fear, UL has created a white paper that provides an overview of the new and modified requirements, including an examination of the most significant changes and additions, as well as tips for addressing the mandated changes before the set transition date. Treat yourself to a good read; download the white paper here.

What’s Changed and Why?

Devices are becoming increasingly complex and interconnected, so regulations and standards must follow suit. The first edition of IEC 60601-1 was published in 1977 when the cost of a first-class postage stamp was 13 cents and “Laverne & Shirley” was the top-rated television show! Suffice to say, we—and our devices—have evolved. A second edition was published in 1988, and a third edition was released in 2005, prompted by the introduction of new technologies, such as software, in the 1990s. The third edition introduced new functional safety requirements, referred to as “essential performance,” and the use of risk management principles, consistent with those detailed in ISO 14971. Work on an amendment to the third edition began in the fall of 2008 in response to the many design and testing challenges identified by manufacturers and certification bodies in the third edition of IEC 60601-1.

Amendment 1’s Major Changes

The description of risk management (Subclause 4.2) has been rewritten to clarify how to apply ISO 14791’s risk management principles, and numerous references to risk management have been removed. Essential performance (Subclause 4.3) has been enhanced. Manufacturers are now required to establish specific performance limits for their medical electric equipment, and to evaluate essential performance characteristics under abnormal or fault conditions. The third significant change is Clause 14, which covers programmable electrical medical systems (PEMS). The amended standard incorporates many of the specific requirements of IEC 623304:2006, Medical device software—Software life cycle processes, and requires the adoption of a formal development life cycle process for software.

Other notable changes to the standard include several new or revised technical specifications for electrical and mechanical hazards and new product labeling and documentation requirements. All of these changes are expounded on in the white paper.

6 Tips for Transitioning to IEC 60601-1 Edition 3.1

The first tip, my tip, is a no-brainer—don’t procrastinate. Although the FDA has set a transition date of August 2016 in the U.S., contradictory legislation in the EU could force manufacturers to demonstrate compliance with the new requirements by the end of 2015. UL offers five additional tips:

-Conduct an internal audit of your current processes and practices for compliance to get an idea of how long the transition period will take you.

-Conduct a design review on your existing products that will need to be recertified to the amended standard to determine the number of technical modifications you will need to make. For new products or products in development, address compliance considerations early in the design process.

-The global transition to the amended standards is likely to vary from jurisdiction to jurisdiction, and may require you to certify your products to multiple versions of the standard. Familiarize yourself with the technical and regulatory requirements that apply to your key target markets.

-Conduct a regulatory gap analysis to determine where (i.e., on which products/markets) to concentrate your redesign and recertification efforts.

-Set up a contingency plan to minimize the risk or impact of unanticipated events or delays. 

You Can Open Your Eyes Now

Yes, the new requirements will impose additional compliance burdens on device makers. The changes may sound scary at first, but knowledge is power. How are you planning to handle the transition to IEC 60601-1 Edition 3.1? Any tips or tricks you’d like to share with the GxP Lifeline community?
Lisa Weeks, a marketing communications specialist at MasterControl,  writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. Connect with her on LinkedIn.