The standards delineated in the IEC 60601 series have established a broadly accepted benchmark for medical electrical equipment. IEC 60601-1 outlines the general standards expected to be met by all medical electrical equipment, while IEC 60601-2-XX provides particular standards which apply to specific types of medical electrical equipment.
IEC 60601-1 is continually reviewed, and standards may be added or changed through amendments. It is considered mandatory for most markets, including the EU, the US, and Canada to show evidence of safety and performance. It does not establish standards for effectiveness, but individual markets mandate a certain level of effectiveness in addition to the requirements of the IEC 60601 series.
The IEC 60601 series of standards perform important functions for assuring safety and performance of medical electrical devices:
IEC 60601 describes three types of standards – general in IEC 60601-1, collateral in IEC 60601-1-XX and particular in IEC 60601-2-XX.
IEC 60601-1 outlines the general safety and performance requirements of all medical electrical devices. Additional collateral standards in IEC 60601-1-XX are described in 8 parts and include topics such as radiation protection in diagnostic X-ray equipment, Electromagnetic disturbances – requirements & tests, and home healthcare environment. Each of the parts of IEC 60601-1 outlines a minimum standard for medical electrical equipment.
The particular standards IEC 60601-2-XX, however, address minimum requirements for specific medical electrical equipment. For example, IEC 60601-2-4 applies to cardiac defibrillators and IEC 60601-2-19 applies to infant incubators.
IEC 60601 is recommended in the US, Canada, and the EU. In the US, it applies only to new devices, where in the EU all medical devices must adhere to collateral standard EN 60601-1-11, regarding electrical devices used in the home healthcare environment.
In addition to IEC 60601 series, each market has other regulations for approval of medical electrical devices. For example, in the US, FDA requires proof of effectiveness in addition to the safety and performance standards found in the IEC 60601 series.
Compliance with the IEC 60601 series is not an optional task for medical device manufacturers who hope to bring a medical device to market, whether in the US, Canada, or the EU.
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