YY 0464-2009 Replaced Industry standards-Medicine

YY 0464-2009 Disposable hemoperfutor

YY 0464-2009 Disposable hemoperfutor

Publish Date: 2009-06-16 Implement Date: 2010-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0464-2009

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: 2009-06-16

Implement Date: 2010-12-01

Pages: 11 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking and packaging, transportation, and storage of disposable blood perfusion devices.
This standard applies to disposable blood perfusion devices (hereinafter referred to as perfusion devices) that use activated carbon or adsorption resins as adsorbents. These perfusion devices are used in conjunction with blood perfusion devices to remove endogenous and exogenous drugs, toxins, and metabolic products from patients' bodies during blood perfusion.

Development Information

Word Count: 17 Thousand words Pages: 11 pages

Replace the following standards

YY 0464-2003 Single use hemoperfutor

Superseded by the following standards

YY/T 0464-2019 Disposable hemoperfutor

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 中华人民共和国药典(2005年版) GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration GB/T 13074-2009 Terms of blood purification GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 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 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 13074-2024 Blood purification terminology GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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