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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Older Standard (superseded by this standard) | YY 0053-1991 |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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