Medical electrical equipment - Part 2-16: Particular requirments for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 62D/884/CDV:2010); German version FprEN 60601-2-16:2008/FprA1:2010
Project begin
2011-04-13
Planned document number
DIN EN 60601-2-16/A1; VDE 0750-2-16/A1
Abstract
This draft applies to the basic of haemodialysis equipment. The safety requirements include single-patient suffering from kidney failure for haemodialysis, haemodiafiltration and haemofiltration equipment. Amendment 1 adresses alphabetical sorting of the definitions section, improving the reference to 60601-1-8 and to 60606-1-11, adding an appendix with a hazardous situation list, update several references to defined and improve terminology usage.
Responsible Committee
DKE/GUK 812.6 Apparate für extrakorporale Zirkulations- und Infusionstechnik
Notice of supersedure
Vorgesehen als Änderung von DIN EN 60601-2-16 (VDE 0750-2-16):1999-02
Draft standard
Previous Document(s)
Search in NA 022
Contact
Dr. rer. med.
Klaus Neuder
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