YY/T 1096-2007Temperature biofeedback equipment (English PDF)
温度生物反馈仪
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 31, 2007
Implementation date
January 1, 2008
Scope
YY/T 1096-2007 is the English-translated version of 温度生物反馈仪.
YY/T 1096-2007 is the recommended Chinese medical device standard for temperature biofeedback equipment. It defines the classification of these instruments and sets their requirements, test methods, inspection rules, marking, packaging, transport and storage.
Its scope is the temperature biofeedback instrument itself, filed under the Chinese classification C42 and the international classification 11.040.60 for medical equipment in general.
The normative references are GB/T 191-2000, GB 9706.1-1995, GB 9706.15-1999, GB/T 14710-1993, GB/T 16886.1-2001, GB/T 16886.5-2003, GB/T 16886.10-2005 and YY 0505-2005.
It replaces YY 91096-1999. Issued on 31 January 2007, it has applied since 1 January 2008.
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Document preview — YY/T 1096-2007
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Replacing
- YY 91096-1999
Issued by: National Medical Products Administration of the People's Republic of China
1 Foreword
YY/T 1096-2007 was issued by National Medical Products Administration of the People's Republic of China on 31 January 2007.
2 Scope
This standard is the recommended Chinese medical device standard for temperature biofeedback equipment. It defines the classification of these instruments and sets their requirements, test methods, inspection rules, marking, packaging, transport and storage. Its scope is the temperature biofeedback instrument itself, filed under the Chinese classification C42 and the international classification 11.040.60 for medical equipment in general. The normative references are GB/T 191-2000, GB 9706.1-1995, GB 9706.15-1999, GB/T 14710-1993, GB/T 16886.1-2001, GB/T 16886.5-2003, GB/T 16886.10-2005 and YY 0505-2005. It replaces YY 91096-1999.
3 Normative references
YY/T 1096-2007 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 9706.15-1999
GB/T 14710-1993
GB/T 16886.1-2001
GB/T 16886.5-2003
GB/T 16886.10-2005
YY 0505-2005 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
4 About this standard
Issued by: National Medical Products Administration of the People's Republic of China
English translation: about 15 pages
5 Classification and status
International classification (ICS): 11.040.60
Chinese Standard Classification (CCS): C 42
Prefix YY/T: recommended 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 9706.15-1999Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- GB/T 14710-1993The environmental requirement and test methods for medical electrical equipment
- GB/T 16886.1-2001Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.5-2003Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
Editions of YY/T 1096
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 1096-2007 | Temperature biofeedback equipment | current edition | Current |
| YY 91096-1999 | Temperature biofeedback equipment | previous edition | Superseded |
This page sells the current edition, YY/T 1096-2007. 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 9706.15-1999 — Medical electrical equipment Part 1: General requiements for safety 1. Collateral standard: Safety requirements for medical electrical systems
GB/T 14710-1993 — The environmental requirements and test methods for medical electrical equipment
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YY/T 1096-2007
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