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 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