YY 0067-2007Micro-circulation microscopes (English PDF)
微循环显微镜
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
January 31, 2007
Implementation date
February 1, 2008
Scope
YY 0067-2007 is the English-translated version of 微循环显微镜.
YY 0067-2007 is the mandatory Chinese medical device standard for micro-circulation microscopes. It fixes the terms and definitions, the classification and marking, the requirements and the test methods for these instruments, and it also covers inspection rules, marking, the instructions for use, packaging, transport and storage.
Its scope takes in all types of microcirculation microscope, that is, products used to observe the microcirculation at the body surface. The standard is applied with GB/T 191-2000, GB 9706.1-1995, GB 9969.1-1998, GB/T 14710-1993 and GB/T 15464-1995.
It replaced the earlier edition YY 0067-1992. Issued on 31 January 2007, it has applied since 1 February 2008.
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Document preview — YY 0067-2007
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Replacing
- YY 0067-1992
Issued by: National Medical Products Administration of the People's Republic of China
1 Foreword
YY 0067-2007 was issued by National Medical Products Administration of the People's Republic of China on 31 January 2007 and has been in force since 1 February 2008.
It replaces the earlier edition YY 0067-1992.
2 Scope
This standard is the mandatory Chinese medical device standard for micro-circulation microscopes. It fixes the terms and definitions, the classification and marking, the requirements and the test methods for these instruments, and it also covers inspection rules, marking, the instructions for use, packaging, transport and storage. Its scope takes in all types of microcirculation microscope, that is, products used to observe the microcirculation at the body surface. The standard is applied with GB/T 191-2000, GB 9706.1-1995, GB 9969.1-1998, GB/T 14710-1993 and GB/T 15464-1995. It replaced the earlier edition YY 0067-1992.
3 Normative references
YY 0067-2007 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 191-2000
GB 9706.1-1995
GB 9969.1-1998
GB/T 14710-1993
GB/T 15464-1995
4 About this standard
Issued by: National Medical Products Administration of the People's Republic of China
English translation: about 15 pages
5 Related standards
Other editions:
YY 0067-1992 (earlier edition)
6 Classification and status
International classification (ICS): 11.040.70
Chinese Standard Classification (CCS): C 40
Prefix YY: mandatory standard.
......
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 191-2000Graphical symbols marking for handling and storage of packages
- GB 9706.1-1995Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9969.1-1998General principles for preparation of instructions for use of industrial products
- GB/T 14710-1993The environmental requirement and test methods for medical electrical equipment
- GB/T 15464-1995Gmeneral-purpose specification for the packaging instrumentation products
Editions of YY 0067
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0067-2007 | Micro-circulation microscopes | current edition | Current |
| YY 0067-1992 | Micro-circulation microscopes | previous edition | Superseded |
This page sells the current edition, YY 0067-2007. Earlier editions are listed for reference only.
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Related Standards
GB 9706.1-1995 — Medical electrical equipment--Part 1: General requirements for safety
GB 9969.1-1998 — General principles for preparation of instructions for use of industrial products
GB/T 14710-1993 — The environmental requirements and test methods for medical electrical equipment
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YY 0067-2007
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