GB 11246-1989
Abolished
YY/T 0977-2023
Active
Industry standards-Medicine
YY/T 0977-2023 Anaesthetic and respiratory equipment—Oropharyngeal airways
YY/T 0977-2023 Anaesthetic and respiratory equipment—Oropharyngeal airways
Basic Information
Standard Code:
YY/T 0977-2023
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:
2023-09-05
Implement Date:
2024-09-15
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:
16 pages
Scope
本文件规定了塑料和/或橡胶材料制成的口咽通气道（包括带有塑料和/或金属材料制成的加强插入物的口咽通气道)的要求。
本文件未规定口咽通气道的易燃性要求。
注：在诸如易燃麻醉剂、电外科设备或激光使用中，口咽通气道的易燃性是公认的危害。这是临床管理的范畴，不在本文件范围内。
本文件不适用于金属口咽通气道以及无内部的、完整密封装置的上喉部通气道。
Development Information
Drafting Units:
上海市医疗器械检验研究院、河南驼人医疗器械集团有限公司、亚都控股集团有限公司、美敦力(上海)管理有限公司
Drafting Persons:
王伟、刘艳红、许慧、徐畅、杨晓庆、张菁、王俊霞、莫艳君
Replace the following standards
Referenced Standards
YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
ISO 7000
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 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
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 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 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
Adopt standards
ISO 5364:2016
Related Standards
YY 0339-2002
Replaced
YY 0339-2002 Suction catheter for use in the respiratory tract
YY/T 0337.1-2002
Active
YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors
YY/T 0337.2-2002
Active
YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube
YY/T 0338.1-2002
Replaced
YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults
YY/T 0338.2-2002
Replaced