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

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
Publisher: 国家药品监督管理局
Technical Committee: 全国麻醉和呼吸设备标准化技术委员会(SAC/TC 116)
Pages: 28 pages

Scope

本标准适用于将睡眠呼吸暂停治疗设备连接至患者的面罩及其附件。本标准详细规定了面罩和附件的要求,包括将睡眠呼吸暂停治疗设备上的患者连接口连接至进行睡眠呼吸暂停治疗的患者所需的任何连接件(例如鼻面罩、排气口和头带)。
对睡眠呼吸暂停治疗设备的要求见YY 9706.270。本标准和YY 9706.270构成睡眠呼吸暂停治疗系统的两部分,其所涉及的典型部件见图A.1。
本标准不包括对口腔矫治器的要求。

Development Information

Drafting Units:

天津怡和嘉业医疗科技有限公司、上海市医疗器械检测所

Drafting Persons:

庄志、赵伟栋、周明钊、王伟、贾文祥、徐畅

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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