YY 0671.1-2009
Sleep apnoea breathing therapy.Part 1:Sleep apnoea breathing therapy devices (English Version)

Standard No.
YY 0671.1-2009
Language
Chinese, Available in English version
Release Date
2009
Published By
Professional Standard - Medicine
Status
 2024-05
Replace By
YY 9706.270-2021
Latest
YY 9706.270-2021
Scope
The scope given in Chapter 1 of GB 9706.1-2007 is applicable, with the following additions: This part of YY 0671 specifies special requirements for sleep apnea treatment equipment applicable to the home and health care sectors. This part of YY 0671 does not apply to various equipment covered by the GB 9706.28 standard. This part of YY 0671 does not consider high-frequency jet ventilators and high-frequency oscillation ventilators. Part 2 of YY 0671 sets out requirements for masks and application accessories. This part of YY 0671 does not apply to external breathing equipment described in GB/T 4999-2003.

YY 0671.1-2009 Referenced Document

  • EN 556 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
  • EN 739 Low-pressure hose assemblies for use with medical gases Includes Amendment A1: 2002
  • EN ISO 8185 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
  • EN ISO 9360-1 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
  • GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
  • GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization
  • GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
  • GB 7144-1999 Coloured cylinder mark for gases
  • GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
  • GB/T 3767-1996 Acoustics--Determination of sound power levels of noise sources using sound pressure--Engineering method in an essentially free field over a reflecting plane
  • GB/T 3785-1983 Electric,sonic properties and measuring methods for sound level meters
  • GB/T 4999-2003 Anaesthetic and respiratory equipment vocabulary
  • GB/T 5332-2007 Method of test for ignition temperature of flammable liquids and gases
  • YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
  • YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
  • YY 1040.1-2003 Anaesthetic and respiratory equipment-Conical connectors-Part 1:Cones and sockets
  • YY 1040.2-2008 Anaesthetic and respiratory equipment.Conical connectors.Part 2:Screw-threaded weight-bearing connectors

YY 0671.1-2009 history

YY 0671.1-2009 Sleep apnoea breathing therapy.Part 1:Sleep apnoea breathing therapy devices was changed to YY 9706.270-2021 .

Sleep apnoea breathing therapy.Part 1:Sleep apnoea breathing therapy devices



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