YY 0464-2009
Disposable hemoperfutor (English Version)
- Standard No.
- YY 0464-2009
- Language
- Chinese, Available in English version
- Release Date
- 2009
- Published By
- Professional Standard - Medicine
- Status
- 2020-10
- Replace By
- YY/T 0464-2019
- YY 0464-2019
- Latest
- YY/T 0464-2019
- YY 0464-2019
- Replace
- YY 0464-2003
- Scope
- This standard specifies the terms and definitions, requirements, test methods, inspection rules, markings, packaging, transportation, and storage of disposable hemoperfusion devices. This standard applies to disposable hemoperfusion devices (hereinafter referred to as perfusion devices) that use activated carbon or adsorbent resin as adsorbents. The perfusion device is used with a hemoperfusion device for hemoperfusion to remove endogenous and exogenous drugs, Toxins and metabolites.
YY 0464-2009 Referenced Document
- GB/T 13074 Terms of blood purification
- GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use.Part 1:Chemical analysis methods
- GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
- GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
- GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
- GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
- GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
- GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0464-2009 history
- 2019 YY/T 0464-2019 Disposable hemoperfusion device
- 2009 YY 0464-2009 Disposable hemoperfutor
- 2003 YY 0464-2003 Single use hemoperfutor
YY 0464-2009 Disposable hemoperfutor was changed to YY/T 0464-2019 Disposable hemoperfusion device.
