YY/T 1151-2009Protein microarray for in vitro diagnostics (English PDF)
体外诊断用蛋白质微阵列芯片
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 1151-2009 is the English-translated version of 体外诊断用蛋白质微阵列芯片.
YY/T 1151-2009 is the recommended Chinese medical device standard covering protein microarrays intended for in vitro diagnostic use. It fixes the terms and definitions attached to these products and then sets product requirements, test methods, marking, labeling and instructions for use, along with transport and storage provisions.
The products in scope are in vitro diagnostic protein microarrays built on a planar substrate acting as the carrier and used for qualitative detection. Classification C44 in the Chinese system and 11.100 internationally place the document with laboratory medicine products.
GB/T 191 is the standard it cites. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 1151-2009
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 1151-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 191
......
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
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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