GB 11246-1989
Abolished
YY/T 1438-2026
Pending
Industry standards-Medicine
YY/T 1438-2026 Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
YY/T 1438-2026 Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
Basic Information
Standard Code:
YY/T 1438-2026
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Surgical room equipment
ICS Name:
Anesthesia, respiration, and resuscitation equipment
Publish Date:
2026-03-09
Implement Date:
2027-03-01
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
本文件规定了预期用于评价自主呼吸者的肺功能的呼气峰值流量计（PEFM）的要求。
本文件适用于所有用于测量自主呼吸者的呼气峰值流量的医疗器械，不论是综合肺功能医疗器械的一部分还是单独的一个医疗器械。
Development Information
Drafting Units:
赛客(厦门)医疗器械有限公司、上海市医疗器械检验研究院、广州红象医疗科技有限公司
Drafting Persons:
张惠荣、祝琰琤、赵亮兵、王伟、何明军、郁红漪
Replace the following standards
Referenced Standards
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
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 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
Adopt standards
ISO 23747:2015
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