GB 8662-1988
Replaced
YY 0464-2003
Replaced
Industry standards-Medicine
YY 0464-2003 Single use hemoperfutor
YY 0464-2003 Single use hemoperfutor
Basic Information
Standard Code:
YY 0464-2003
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:
2002-06-20
Implement Date:
2004-01-01
Pages:
16 pages
Scope
This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking and packaging, transportation, and storage of single-use blood perfusion devices. This standard applies to single-use blood perfusion devices (hereinafter referred to as perfusion devices) that use activated carbon porous adsorption resins as adsorbents. This product is used in conjunction with blood perfusion devices (or hemodialysis devices) for blood perfusion (or in combination with hemodialysis) to remove endogenous and exogenous excess drugs, toxins, and metabolic products from patients' bodies.
Development Information
Superseded by the following standards
Referenced Standards
GB 8368-1998 Infusion sets for single use
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 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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 2828.2-2008 Sampling procedures for inspection by attributes—Part 2:Sampling plans indexed by limiting quality(LQ)for isolated lot inspection
GB/T 2828.3-2008 Sampling procedures for inspection by attributes—Part 3:Skip-lot sampling procedures
GB/T 2828.4-2008 Sampling procedures for inspection by attributes—Part 4:Procedures for assessment of declared quality levels
GB/T 2828.5-2011 Sampling procedures for inspection by attributes—Part 5:System of sequential sampling plans indexed by acceptance quality limit(AQL)for lot-by-lot inspection
GB/T 2828.10-2010 Sampling procedures for inspection by attributes—Part 10:Introduction to the GB/T 2828 series of standards for sampling for inspection by attributes
GB/T 2828.11-2008 Sampling procedures for inspection by attributes—Part 11:Procedures for assessment of declared quality levels for small population
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
GB/T 2829-2025 Sampling procedures and tables for periodic inspection by attributes(Apply to inspection of process stability)
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0054-2003
Replaced
YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment
YY 0465-2003
Replaced