YY 0601-2009Medical electrical equipment - Particular requirements for basic safety and essential performance of respiratory gas monitors (English PDF)
医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
June 1, 2011
Implementation date
June 1, 2011
Scope
YY 0601-2009 is the English-translated version of 医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求.
YY 0601-2009 is a mandatory Chinese medical device standard within the medical electrical equipment family, written for respiratory gas monitors.
It states the particular requirements for the basic safety and the essential performance of monitors that are intended for continuous operation and are applied to the patient, and it names three detection functions in scope: anaesthetic gas detection, carbon dioxide detection and oxygen detection.
Monitors intended for use with flammable anaesthetic agents are excluded. Where its requirements replace or amend requirements of GB 9706.1-2007, they take precedence over the corresponding general requirements.
It quotes GB/T 5332-2007, GB 9706.1-2007, YY 0505-2005, YY 0709-2009, YY/T 0753.1-2009 and YY/T 0753.2-2009, and it supersedes YY 0601-2007.
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Document preview — YY 0601-2009
National Standard of the People's Republic of China
- ICS
- 11.040.10
- Replacing
- YY 0601-2007
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY 0601-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 1962.2-2001
GB/T 2423.5-1995
GB/T 2423.8-1995
GB/T 2423.56-2006
GB/T 5332-2007
GB 9706.1-2007
GB/T 16273.1-2008
YY 0466-2000
YY 0505-2005
YY/T 0753.1-2009
YY/T 0753.2-2009
YY 0709-2009
IEC 60601-1-6
ISO 7000-2004
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 28 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.2-2001Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 2423.5-1995Environmental testing - Part 2: Test methods - Test Ea and guidance: Shock
- GB/T 2423.8-1995Environmental testing for electric and electronic products - Part 2: Test methods - Test Ed: Free fall
- GB/T 2423.56-2006Environmental testing - Part 2: Test methods - Test Fh: Vibration, broadband random and guidance
- GB/T 5332-2007Method of test for ignition temperature of flammable liquids and gases
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6 · ISO 7000-2004
Similar standards
Editions of YY 0601
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0601-2009 | Medical electrical equipment - Particular requirements for basic safety and essential performance of respiratory gas monitors | current edition | Current |
| YY 0601-2007 | Medical electrical equipment - Particular requirements for basic safety and essential performance of respiratory gas monitors | previous edition | Superseded |
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Related Standards
GB/T 16273.1-2008 — Graphical symbols for use on equipment -- Part 1: Common symbols
GB/T 1962.2-2001 — Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
GB/T 2423.8-1995 — Environmental testing for electric and electronic products - Part 2: Test methods - Test Ed: Free fall
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YY 0601-2009
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