YY/T 1844-2022 Active Industry standards-Medicine

YY/T 1844-2022 Anaesthetic and respiratory equipment—General requirements for airways and related equipment

YY/T 1844-2022 Anaesthetic and respiratory equipment—General requirements for airways and related equipment

Publish Date: 2022-10-17 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1844-2022
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: 2022-10-17
Implement Date: 2023-10-01
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: 24 pages

Scope

本文件规定了导气管和相关设备的通用要求。
本文件适用于特定标准引用了本文件的那些设备。

Development Information

Drafting Units:

上海市医疗器械检验研究院、美敦力(上海)管理有限公司

Drafting Persons:

王伟、徐畅、杨晓庆、钱心依

Word Count: 42 Thousand words Pages: 24 pages

Referenced Standards

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 7396-1 ISO 10524-1 ISO 10524-3 ISO 14155:2011/Cor.1:2011 ISO 80369-7 EN 1041 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 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices YY/T 0586-2005 Medical polymer products—Test methods of radiopacity YY/T 0586-2016 Medical polymer products-Test methods of radiopacity YY/T 0882-2013 Anaesthetic and respiratory equipment—Compatibility with oxygen YY/T 0987.1-2016 Implants for surgery—Magnetic resonance compatibility—Part 1:Safety marking YY/T 0987.2-2016 Implants for surgery—Magnetic resonance compatibility—Part 2:Magnetically induced displacement force test method YY/T 0987.5-2016 Implants for surgery—Magnetic resonance compatibility—Part 5:Magnetically induced torque test method YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices

Adopt standards

ISO 18190:2016

Related Standards

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