Landmark medical standard overhauled

Standardization optimizes safety and performance of medical equipment

By Morand Fachot

ME (medical electrical) equipment and systems play an increasingly important role in healthcare. Safe operation and performance are central to the management of risks in the medical environment for patients and staff alike. IEC TC (Technical Committee) 62 and its SCs (Subcommittees) prepare International Standards for this area of technology.

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Ground-breaking International Standard

SC 62A: Common aspects of electrical equipment used in medical practice, has just published the consolidated version of IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. This publication follows closely the release of Amendment 1 to this International Standard in July (see article in e-tech).

As the object of IEC 60601-1 is to specify general requirements, it serves as the basis for standards that cover the whole range of ME equipment and systems: from equipment for radiotherapy, nuclear medicine and radiation dosimetry to electromedical equipment used to diagnose and monitor patients, to name just a few.

This International Standard details general and test requirements; the classification, equipment identification, marking and documentation of ME equipment and systems; protection against electrical and mechanical hazards, unwanted and excessive radiation hazards, excessive temperatures and other hazards from ME equipment and systems.

It also provides information on PEMS (programmable electrical medical systems) and advice to manufacturers about addressing the risks associated with the accuracy of controls and instruments.

The 60601 family

IEC 60601-1 has been prepared by SC 62A, which is part of IEC TC 62: Electrical equipment in medical practice.

In addition to the IEC 60601-1 series, which are the umbrella safety standards for ME equipment, TC 62 and its SCs prepare the IEC 60601-2-xx series of safety and performance standards for specific types of ME equipment and the IEC 60601-3-xx series of performance standards for individual types of ME equipment.

In the IEC 60601 series, some International Standards may modify, replace or delete requirements contained in IEC 60601-1, as appropriate for the specific piece of ME equipment under consideration, and may add other basic safety and essential performance requirements.

Specific requirements for ME equipment

The original IEC approach was to prepare separate basic safety and performance International Standards for ME equipment. This was a natural extension of the approach historically taken with other electrical equipment standards at national and international levels. In those cases, basic safety is regulated through mandatory standards but other performance specifications are regulated by market pressure.

However it is now recognized that separation of these two factors is somewhat inappropriate in addressing the hazards that result from inadequate ME equipment design. For many items of such equipment, this cannot be the right approach to take: responsible organizations have to depend on standards to ensure essential performance as well as basic safety.

Consolidated version puts user convenience uppermost

This edition has been significantly restructured. Requirements in the electrical section have been further aligned with those for information technology equipment covered by IEC 60950-1 and a requirement for including a risk management process has been added.

The technical content of this consolidated version is identical to that of the base (2005) publication. The new version consists of the 2005 edition and Amendment 1 plus the corrigenda of December 2006 and 2007. It bears the edition number 3.1 and optimizes user convenience. A vertical line in the margin shows where the base publication has been modified by Amendment 1. Additions and deletions are displayed in red, and deletions are struck through. This consolidated version is available in English now from the IEC webstore. The French version will follow shortly. 

Consolidated versions and FDIS (Final Draft International Standard), which are pre-release documents available during the approval stage, are two of the Value Added Products derived from official publications that are available through the IEC webstore.

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