YY 0770.1-2009Filter materials for medical infusion equipment - Part 1: Fluid filter materials (English PDF)
医用输、注器具用过滤材料 第1部分：药液过滤材料
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY 0770.1-2009 is the English-translated version of 医用输、注器具用过滤材料 第1部分：药液过滤材料.
Part 1 of the YY 0770 series, YY 0770.1-2009, is a mandatory standard for the liquid filter materials fitted in medical infusion and injection equipment. It covers materials with a nominal pore size from 0.22 µm to 20 µm and treats them as two groups, filter membranes and filter media.
For each it fixes the classification and the marking, and the requirements on the material, on its physical, chemical and biological properties, and on marking and packaging.
The materials described hold back the insoluble particles in the liquid that are larger than the nominal pore size. The text is used with GB 6682, GB 8368, GB/T 14233.1, GB/T 14233.2, GB/T 16886.1, YY 0286.1-2007 and YY 0321.3-2000. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY 0770.1-2009
National Standard of the People's Republic of China
- ICS
- 11.040.20
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY 0770.1-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB 6682
GB 8368
GB/T 14233.1
GB/T 14233.2
GB/T 16886.1
YY 0286.1-2007
YY 0321.3-2000
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 8368Infusion sets for single use -- Gravity feed
- GB/T 14233.1Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY 0286.1-2007Infusion sets for special purpose - Part 1: Infusion sets for single use with micropore filters
- YY 0321.3-2000Single-use filter for anaesthesia
GB 6682
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Related Standards
GB 8368-2018 — Infusion sets for single use -- Gravity feed
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment 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
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YY 0770.1-2009
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