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IEC 60601-1

Medical electrical equipment standard

IEC 60601 is a standard published by the International Electrotechnical Commission. The standard consists of four parts, those being the base standard 60601-1 (general reuirements for electrical medical equipment), collateral standards numbered 60601-1-x (60601-1-9, for example, is a standard for Environmentally Conscious Design of Medical Electrical Equipment), particular standards numbered 60601-2-x (example: IEC 60601-2-2 is the standard for high-frequency surgical devices), and performance standards in the 60601-3-x range.

While IEC 60601 is an international standard, many countries have adopted it as a national standard, some with local additions or changes. In the United States, for example, the local version of IEC 60601-1 is the ANSI/UL 2601-1 standard.

The major thrust of the 60601-1 standard is to require two levels of protection to shield operators and patients from getting hurt. Note, however, that complying with the 60601-1 standard isn't the same as FDA approval. However, the FDA, which oversees the regulation of electrical medical devices, seems to accept certified 60601-1 compliance in lieu of certain test data.

How does this apply to computing equipment? Not directly, but adherence to certain 60601 design considerations and tests can be both a functional as well as a marketing advantage. Amrel, for example, has a whole lineup of "60601 compliant" PDAs, tablets, and notebook computers.

Medical Device Link has issued a Primer for IEC 60601-1.