YY/T 1158-2009Prothrombin time reagent(Kit) (English PDF)
凝血酶原时间检测试剂（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 1158-2009 is the English-translated version of 凝血酶原时间检测试剂（盒）.
YY/T 1158-2009 is the recommended Chinese standard of the medical device and pharmaceutical industry for prothrombin time reagents and kits.
It sets the common technical requirements used in their quality inspection and testing, along with terms and definitions, test methods, marking, labelling and instructions for use, packaging, transport and storage.
It applies to prothrombin time reagents, known as PT reagents, that work by the Quick one-stage method in routine clinical laboratory testing, in freeze-dried as well as liquid form.
Reagents for bedside point-of-care testing are outside its scope. GB/T 191, GB 6682 and YY 0466 are cited. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 1158-2009
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 1158-2009 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
......
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 1158-2009
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