YY/T 1159-2009Fibrinogen reagent(Kit) (English PDF)
纤维蛋白原检测试剂（盒）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 1159-2009 is the English-translated version of 纤维蛋白原检测试剂（盒）.
YY/T 1159-2009 is a recommended Chinese medical device and pharmaceutical industry standard covering fibrinogen reagents and kits. It sets out the general quality requirements for such reagents, together with the terms and definitions, test methods, marking, labelling and instructions for use, packaging, transport and storage.
It covers products used in routine clinical laboratory testing by the Clauss method, referred to as Fib reagents, in both freeze-dried and liquid form. Reagents that determine fibrinogen by physical, chemical or immunological methods fall outside it.
The text quotes GB/T 191, GB 6682 and YY 0466-2003. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 1159-2009
National Standard of the People's Republic of China
- ICS
- 11.100
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 1159-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 191
GB 6682
YY 0466-2003
......
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
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
YY 0466-2003 — Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1159-2009
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