YY/T 0671-2021 Active Industry standards-Medicine

YY/T 0671-2021 Medical devices—Sleep apnoea breathing therapy—Masks and application accessories

YY/T 0671-2021 Medical devices—Sleep apnoea breathing therapy—Masks and application accessories

Publish Date: 2021-09-06 Implement Date: 2024-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: YY/T 0671-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Surgical room equipment
ICS Name: Anesthesia, respiration, and resuscitation equipment
Publish Date: 2021-09-06
Implement Date: 2024-05-01
Pages: 28 pages

Scope

This standard applies to the connection of sleep apnea treatment devices to patients' face masks and their accessories. This standard details the requirements for face masks and accessories, including any connectors (such as nasal masks, exhaust ports, and headbands) needed to connect the patient to the sleep apnea treatment device.
The requirements for sleep apnea treatment devices are specified in YY 9706.270. This standard and YY 9706.270 constitute two parts of the sleep apnea treatment system, and the typical components involved are shown in Figure A.1.
This standard does not include requirements for oral appliances.

Development Information

Word Count: 54 Thousand words Pages: 28 pages

Replace the following standards

Referenced Standards

YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer ISO 3744:2010 GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 14574-2000 Acoustics—Declaration and verification of noise emission values of machinery and equipment GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 19974-2005 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 GB/T 19974-2018 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 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 1040.1-2003 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1040.2-2008 Anaesthetic and respiratory equipment—Conical connectors—Part 2:Screw-threaded weight-bearing connectors YY 9706.270-2021 Medical electrical equipment—Part 2-70:Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

Adopt standards

ISO 17510:2015

Related Standards

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