YY 0770.2-2009Filter materials for medical infusion equipment - Part 2: Air filter materials (English PDF)
医用输、注器具用过滤材料 第2部分：空气过滤材料
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY 0770.2-2009 is the English-translated version of 医用输、注器具用过滤材料 第2部分：空气过滤材料.
YY 0770.2-2009 is the mandatory Chinese medical device standard that governs air filter materials for medical infusion and injection equipment.
As Part 2 of the YY 0770 series it sets the classification and the marking of these materials, and it states the requirements placed on the material itself, on its physical, chemical and biological properties, and on marking and packaging.
The filter materials it covers serve to retain the particles and micro-organisms carried in air. Its checks refer to GB/T 6682, GB 8368, GB/T 14233.2-2005 and GB/T 16886.1.
The part sits under the Chinese classification C31 and the international classification 11.040.20. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY 0770.2-2009
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 0770.2-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 6682
GB 8368
GB/T 14233.2-2005
GB/T 16886.1
......
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/T 6682Water for analytical laboratory use - Specification and test methods
- GB 8368Infusion sets for single use -- Gravity feed
- GB/T 14233.2-2005Test 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
Similar standards
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Related Standards
GB 8368-2018 — Infusion sets for single use -- Gravity feed
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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YY 0770.2-2009
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