YY 0601-2009
Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory gas monitors (English Version)

Standard No.
YY 0601-2009
Language
Chinese, Available in English version
Release Date
2009
Published By
Professional Standard - Medicine
Latest
YY 0601-2009
Replace
YY 0601-2007
Scope
Except for the following content, Chapter 1 of GB 9706.1-2007 applies. Modification (added at the end of 1.1): This standard specifies specific requirements for the basic safety and essential performance of respiratory gas monitors (RGMs) (defined by 3.15) intended for continuous operation and applied to patients. This standard specifies the following requirements: a) Anesthetic gas monitoring; b) Carbon dioxide monitoring; c) Oxygen monitoring. This standard does not apply to respiratory gas monitors intended for use with flammable anesthetics. The requirements of this standard replace or amend the relevant requirements of GB 9706,1-2007 and will take precedence over the corresponding general requirements. See Appendix CC for environmental aspects.

YY 0601-2009 Referenced Document

  • GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
  • 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 2423.5-1995 Environmental testing for electric and electronic products. Part 2: Test methods. Test Ea and guidance: Shock
  • GB/T 2423.56-2006 Environmental testing for electric and electronic products-Part 2:Test methods-Test Fh:Vibration,broad-band random(digital control) and guidance
  • GB/T 2423.8-1995 Environmental testing for electric and electronic products. Parts 2: Test methods. Test Ed: Free fall
  • GB/T 5332-2007 Method of test for ignition temperature of flammable liquids and gases
  • IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*2024-04-19 Update
  • ISO 7000:2004 Graphical symbols for use on equipment - Index and synopsis
  • YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
  • YY 0709-2009 Medical electrical equipment.Part 1-8:General requirements for safety.Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • YY/T 0753.1-2009 Breathing system filters for anaesthetic and respiratory use.Part 1:Salt test method to assess filtration performance
  • YY/T 0753.2-2009 Breathing system filters for anaesthetic and respiratory use.Part 2:Non-filtration aspects

YY 0601-2009 history

  • 2009 YY 0601-2009 Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory gas monitors
  • 2007 YY 0601-2007 Anaesthetic gas monitors
Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory gas monitors



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