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

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Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

14-09-2015

Publisher

Standards Australia

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Adopts IEC 60601-2-16, Ed.4.0 to specify 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 take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. To be read in conjunction with AS/NZSIEC60601.1:2015.

Committee	HE-003
DocumentType	Standard
ISBN	978 1 76035 241 7
Pages	59
PublisherName	Standards Australia
Status	Current
Supersedes	DR AS/NZS IEC 60601.2.16:2015 AS/NZS 3200.2.16:1999

Standards	Relationship
IEC 60601-2-16 : 4.0	Identical
IEC 60601-2-16:2012	Identical

Originated in Australia as AS 3207—1981.Previous and first New Zealand edition AS/NZS 3200.2.16:1999.Jointly revised and redesignated as AS/NZS IEC 60601.2.16:2015. Originated in Australia as AS 3207-1981. Previous and first New Zealand edition AS/NZS 3200.2.16:1999. Jointly revised and redesignated as AS/NZS IEC 60601.2.16:2015