GB 11246-1989
Abolished
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
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
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
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