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DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Project

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 62D/1912/CD:2021); Text in German and English

Abstract

This part of IEC 60601 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment, hereafter referred to as haemodialysis equipment. It applies to haemodialysis equipment intended for use either by medical staff or under the supervision of medical experts, including haemodialysis equipment operated by the PATIENT, regardless of whether the haemodialysis equipment is used in a hospital or domestic environment.

Begin

2021-11-25

Planned document number

DIN EN IEC 60601-2-16

Project number

02230641

Responsible national committee

DKE/GUK 812.6 - Apparate für extrakorporale Zirkulations- und Infusionstechnik  

draft standard

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 62D/1912/CD:2021); Text in German and English
2022-10
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previous edition(s)

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2018); German version EN IEC 60601-2-16:2019
2020-05

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Contact

Dr.

Renate Förch

Merianstr. 28
63069 Offenbach am Main

Tel.: +49 69 6308-344

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