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