YY/T 1154-2009Laser confocal scanner (English PDF)
激光共聚焦扫描仪
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 1154-2009 is the English-translated version of 激光共聚焦扫描仪.
YY/T 1154-2009 is the recommended Chinese medical device and pharmaceutical industry standard for the laser confocal scanner. It gives the terminology and definitions for the instrument and sets its requirements, test methods, marking, labelling and instructions for use, packaging, transport and storage.
It applies to confocal laser scanners used as in vitro diagnostic medical devices, those working on the confocal laser scanning principle with a planar substrate as the carrier.
GB/T 191, GB 4793.1, GB/T 14710, YY 0466 and YY 0648 are quoted in the text. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 1154-2009
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 1154-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 191
GB 4793.1
GB/T 14710
YY 0466
YY 0648
......
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 191Graphical symbols marking for handling and storage of packages
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY 0466Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
- YY 0648Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Similar standards
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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YY/T 1154-2009
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