European standardization making medical devices safe thanks to the EN IEC 60601-series! 

“To be treated with safe Medical Devices” is identified by the European Commission as one of the ‘10 benefits the EU brings to patients’. European standardization in the field plays a crucial role to ensure that safety in the medical sector becomes reality.

CENELEC Technical Committee 62 on ‘Electrical equipment in medical practice’ (CLC/TC 62) is contributing directly to Patients’ safety in the EU. Peter Linders (Philips Healthcare), who chairs CLC/TC 62 on 'Electrical equipment in medical practice'  and is also chairing at international standardization level ISO TC/210 on ‘Quality management and corresponding general aspects for medical devices’, shares with us one of the main standardization achievements in his sector.

A Standard’s success story: EN IEC 60601 series related to ‘medical electrical equipment’

The EN IEC 60601-series of standards is a major contribution to the safety and essential performance of electrical equipment in medical practice. From the initial edition of the standard, published by the International Electrotechnical Commission (IEC) in 1977 - more than 40 years ago - this series has developed into what is called the "Safety Bible" for medical equipment and medical systems. The EN IEC 60601-series, rapidly approaching 100 individual standards, has greatly served more than 500 million European citizens over the past decades by helping to ensure safe and reliable medical equipment.

IEC collaborates intensively with the International Organization for Standardization (ISO) on many parts of this EN IEC 60601 series. At IEC and ISO level, European experts work with other international experts to develop these international standards, in the interest of safety for healthcare products.

Since its first edition, the EN IEC 60601 series has been kept up to date through revisions and amendments of the various parts of the series. The next update is scheduled to be published in 2019.

Benefits of standardization for patients and businesses within the EU Single Market in the medical equipment field

Almost all European standards for medical equipment are established at international level in IEC, and then adopted as European standards in CLC/TC 62, with almost no European amendments. Peter Linders explains why this is important: “It allows Europeans to benefit from the experience of experts across the world and facilitates international trade for European businesses in the field of medical equipment. (…) A full and respected set of Harmonised Standards, based on international standards and - where needed - homegrown European standards, is core to the concept of the New Legislative Framework (NLF), underlying many legislative acts for products and services in the European Single Market. Harmonised Standards, used in the context of EU legislation, are both the cement and the lubricant that keep our European Single Market regulatory system functioning.”

The EN IEC 60601-series has a high-value impact for patients and the healthcare system, being integral for making the European Single Market for medical equipment work.

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