YY/T 1153-2009DNA microarray for in vitro diagnostics (English PDF)
体外诊断用DNA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 1153-2009 is the English-translated version of 体外诊断用DNA微阵列芯片.
YY/T 1153-2009 is the recommended Chinese medical device and pharmaceutical industry standard for DNA microarrays used in in vitro diagnostics. It sets out the terms and definitions for these products together with requirements, test methods, marking, labeling and instructions for use, and the conditions for transport and storage.
Its scope covers in vitro diagnostic DNA microarray chip products built on a planar substrate acting as the carrier and used for qualitative detection. The Chinese classification C44 and the international classification 11.100 place it among clinical laboratory products.
It quotes GB/T 191. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 1153-2009
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 1153-2009 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
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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