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AS/NZS IEC 60601.2.16:2015

Current Date published:


Medical electrical equipment - Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Establishes basic safety and essential performance requirements for haemodialysis, haemodiafiltration and haemofiltration equipment. It does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. The particular requirements of this Standard make reference to IEC 60601-1, which has been adopted as AS/NZS IEC 60601.1, and is essential for the application of this Standard. Identical to and reproduced from IEC 60601-2-16 Ed.4.0:2012.

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AS/NZS IEC 60601.2.16:2015

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