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YY 0053-2008 English PDF

YY 0053-2008 English PDF

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YY 0053-2008: Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

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Scope

This Standard specifies the technical requirements for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators, which are used in
human body. “Devices” in this Standard refer to these products.
This Standard is not applicable to.
- Extracorporeal blood line;
- Plasma separator;
- Blood perfusion apparatus;
- Vascular access device;
- Blood pump;
- Pressure monitor of extracorporeal blood line;
- Air monitor;
- Dialysate preparation, supply and monitoring system;
- System used for hemodialysis, hemofiltration or hemodiafiltration;
- Further processing steps and equipment.
Note. Requirements for extracorporeal blood lines of haemodialysers, haemodiafilters
and haemofilters shall comply with provisions in YY 0267.

Basic Data

Standard ID YY 0053-2008 (YY0053-2008)
Description (Translated English) Cardiovascular implants and artificial organs - 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 15,172
Date of Issue 2008-04-25
Date of Implementation 2009-12-01
Older Standard (superseded by this standard) YY 0053-1991
Quoted Standard GB/T 1962.2-2001; GB/T 2828.1; GB/T 14233.1; GB/T 14437-1997; GB/T 16886.1-2001; GB/T 16886.4-2003; GB/T 16886.5-2003; GB/T 16886.7-2001; GB/T 16886.10-2005; GB/T 16886.11-1997; YY 0267-2008; YY 0466-2003
Adopted Standard ISO 8637-2004, MOD
Regulation (derived from) SFDA [2008] No. 192
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the use of the body's blood dialyzers, hemodialysis filtration device, hemofiltration, and hemoconcentrators technical requirements. Covered in this article of the "device" refers specifically to these products. This standard does not apply to: extracorporeal blood lines, plasma separator, blood perfusion apparatus, vascular access device, blood pump, extracorporeal blood tubing pressure monitor, air monitors, preparation, dialysate supply and monitoring system, used for hemodialysis, hemofiltration or hemodiafiltration system, further processing steps and equipment.


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