YY 0671.2-2011
Sleep apnoea breathing therapy.Part 2:Masks and application accessories (English Version)

Standard No.

YY 0671.2-2011

Language

Chinese, Available in English version

Release Date

2011

Published By

Professional Standard - Medicine

Status

Be replaced 2024-05

Replace By

YY 0671-2021

Latest

YY 0671-2021

Scope

This part of YY 0671 applies to masks and their attachments for fastening and connecting sleep apnea treatment equipment to the patient. It specifies requirements for masks and accessories in detail, covering components used for any necessary connection, both to the patient interface and patient connection of a sleep apnea treatment device, and during sleep apnea treatment. Used parts such as nose masks, exhaust vents and headbands. The requirements for sleep apnea treatment equipment are found in Part 1 of YY 0671. See Figure A.1 for typical components involved in the two parts of the YY 0671 standard. This section does not include requirements for oral appliances.

YY 0671.2-2011 Referenced Document

• GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
• GB 9706.15-2008 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems
• GB/T 14574 Acoustics-Declaration and verification of noise emission values of machinery and equipment
• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
• GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.13 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices*， 2017-12-29 Update
• GB/T 16886.14 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
• GB/T 16886.15 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys*， 2022-12-30 Update
• GB/T 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
• GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
• GB/T 16886.18 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process*， 2022-12-30 Update
• GB/T 16886.19 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials*， 2022-12-30 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
• GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices*， 2015-12-10 Update
• GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
• GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
• GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
• GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
• GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals*， 2015-12-10 Update
• GB/T 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 Update
• GB/T 19974 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices*， 2018-05-14 Update
• 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
• YY 0671.1-2009 Sleep apnoea breathing therapy.Part 1:Sleep apnoea breathing therapy devices
• YY 1040.1 Conical fittings for anesthesia and respiratory equipment - part 1: cones and sleeves
• YY 1040.2 Anaesthetic and respiratory equipment.Conical connectors.Part 2:Screw-threaded weight-bearing connectors
• YY/T 0316-2008 Medical devices.Application of risk management to medical devices
• YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
• 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/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices

YY 0671.2-2011 history

• 2021 YY 0671-2021 Medical device sleep apnea treatment masks and application accessories
• 2011 YY 0671.2-2011 Sleep apnoea breathing therapy.Part 2:Masks and application accessories