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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Older Standard (superseded by this standard) | YY 0053-2008 |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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