IECEE – IEC Standards on medical safety recognized by US FDA

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Safety is crucial in the medical sector. For years, IECEE has based its assessment and certification of medical electrical equipment and devices on the IEC 60601 series of standards, accepted worldwide as a reference in that field.

FDA on board

IEC medical electrical equipment standards have been accepted in legislation throughout the world. For example, more than 60 IEC International Standards have been harmonized under the European Union’s Medical Device Directive 93/42/EEC and are recognized consensus standards by the US (United States) FDA (Food and Drug Administration).

The FDA has now recognized the third edition of IEC 60601-1, in the form of ANSI/AAMI/ES 60601-1, along with many collateral and particular parts of the 60601 series. The information was published in the US Federal Register on 10 June 2010. The FDA has set a transition period – until 30 June 2013 – for acceptance of declarations of conformity to the second edition of 60601, including amendments 1 and 2.

IEC provides universal reference in medical safety

The 1960s and the 1970s saw the emergence of new consumer and worker protection laws and regulations, mainly in industrialized countries. Many standards were developed to establish basic safety rules for various types of electrical devices and equipment, including medical electrical devices.

The medical sector was one where basic safety rules were badly needed. The greatest risk to hospital patients was often from electrical devices that malfunctioned or shut down unexpectedly.

The IEC had been aware of the urgency for a standard covering electrical equipment used in medical practice. Years of effort resulted in the publication, in January 1977, of the first edition of IEC 60601-1, Medical electrical equipment. Part 1: General requirements, which rapidly became the universal reference for the safety of medical electrical equipment.

Standards need Conformity Assessment and vice versa

But manufacturing products to standards is not sufficient guarantee of their safety. CA (Conformity Assessment) also plays an important role.

IECEE, the System of Conformity Testing and Certification for Electrotechnical Equipment and Components, has tested and certified millions of electrical products and systems to IEC International Standards. IECEE very early on incorporated the IEC 60601 series of International Standards into its CB Scheme for product test certificates. For many years manufacturers of medical electrical devices and equipment have counted on IECEE to demonstrate that their products are safe and reliable.

Evolution of IEC 60601-1

IEC 60601-1 has been revised twice. The second edition, published in 1988, made reference to safety in its title: Medical electrical equipment - Part 1: General requirements for safety.

Historically, the IEC approach had been to clearly separate basic safety standards from performance standards for electrical equipment in general, including medical devices. While working on the third edition of IEC 60601-1, the experts from IEC SC (Subcommittee) 62A: Common aspects of electrical equipment used in medical practice, recognized that the situation was different in the medical sector, with many items equally dependent on basic safety and essential performance. Examples include the accuracy with which equipment controls the delivery of energy or therapeutic substances to the patient or processes and displays physiological data that will affect patient management.

In 2005, the IEC published the third edition of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. In addition to the general requirements for basic safety and essential performance of medical electrical equipment, it also contains requirements for reliable operation to ensure safety.

Certain clauses of the standard allow the use of risk management processes in lieu of pre-specified performance requirements, in which case a complete description and justification of the risk management process and results must be provided.