YY 0053-2008 Replaced Industry standards-Medicine

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

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

Publish Date: 2008-04-25 Implement Date: 2009-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0053-2008

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical instruments and materials

Publish Date: 2008-04-25

Implement Date: 2009-12-01

Pages: 14 pages

Scope

This standard specifies the technical requirements for hemodialysis machines, hemodialysis filters, blood filters, and blood concentrators used on humans. In this document, the term "devices" specifically refers to the aforementioned products.

Development Information

Word Count: 25 Thousand words Pages: 14 pages

Replace the following standards

YY 0053-1991 Hollow fiber dialyzer

Superseded by the following standards

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

Referenced Standards

GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings GB/T 14437-1997 Single sampling procedures and tables by attributes for product quality audit GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity YY 0267-2008 Cardiovascular implants and artificial organs—Extracorporeal blood circuit for blood purification devices YY 0466-2003 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied 中华人民共和国药典 GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods

Adopt standards

ISO 8637:2004

Related Standards

GB 8662-1988 Replaced

GB 8662-1988 Fitting dimension between knife blades and knife handles

Publish Date: 1988-02-13

GB 2766-1995 Replaced

GB 2766-1995 Haemostatic forceps with box joint—General specifications

Publish Date: 1995-06-02

GB/T 10160-1995 Abolished

GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps

Publish Date: 1995-06-02

GB 9706.4-1999 Replaced

GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment

Publish Date: 1999-08-02

YY 0464-2003 Replaced

YY 0464-2003 Single use hemoperfutor

Publish Date: 2002-06-20

YY 0054-2003 Replaced

YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment

Publish Date: 2003-06-20