YY 0465-2003 Replaced Industry standards-Medicine

YY 0465-2003 Single use membrane plasmaseparator

YY 0465-2003 Single use membrane plasmaseparator

Publish Date: 2003-06-20 Implement Date: 2004-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0465-2003

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: 2003-06-20

Implement Date: 2004-01-01

Pages: 20 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking and packaging, transportation, and storage of disposable hollow fiber plasma separators. This standard applies to disposable hollow fiber plasma separators (referred to as plasma separators). This product is used in conjunction with plasma separation devices to treat various immunological and metabolic disorders, as well as certain poisoning cases, for critically ill patients requiring therapeutic plasma exchange.

Development Information

Word Count: 27 Thousand words Pages: 20 pages

Superseded by the following standards

YY 0465-2009 Disposable membrane plasmaseparator

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 2828-1987 GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization ISO 8637:1989

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