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YY 0053-2016 English PDF

YY 0053-2016 English PDF

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YY 0053-2016: Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

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Scope

This Standard specifies the technical requirements for haemodialysers,
haemodiafilters, haemofilters and haemoconcenrators used for human body; the
“instruments” involved in this document indicate the above-mentioned products.

Basic Data

Standard ID YY 0053-2016 (YY0053-2016)
Description (Translated English) Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.30
Word Count Estimation 19,183
Date of Issue 3/23/2016
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0053-2008
Quoted Standard GB/T 1962.2; GB/T 14233.1-2008; GB/T 16886.1; �л����񹲺͹�ҩ�� 2010���
Adopted Standard ISO 8637-2010, MOD
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration


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