GB 11246-1989
Abolished
YY/T 1873-2023
Active
Industry standards-Medicine
YY/T 1873-2023 Anaesthetic and respiratory equipment—Nitrous oxide inhalation sedation and analgesia equipment
YY/T 1873-2023 Anaesthetic and respiratory equipment—Nitrous oxide inhalation sedation and analgesia equipment
Basic Information
Standard Code:
YY/T 1873-2023
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:
2023-06-20
Implement Date:
2024-07-01
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
本文件规定了与附件组合使用的笑气吸入镇静镇痛装置的基本安全和基本性能。
本文件适用于笑气吸入镇静镇痛装置及组合使用的附件(如面罩、呼吸管路等)。此类装置预期向患
者呼吸系统输送笑气氧气混合气体进行镇静镇痛,其输送的笑气氧气混合气体浓度可调节。
本文件不适用于使用笑气进行吸入镇静镇痛的麻醉机、笑气氧气预混合气体吸入镇静镇痛装置。
Development Information
Drafting Units:
南京舒普思达医疗设备有限公司、上海市医疗器械检验研究院、国家药品监督管理局医疗器械技术审评中心
Drafting Persons:
孟保林、杨晓庆、钟佑锦、王伟、唐雪峰、王卫
Referenced Standards
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
GB/T 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane
GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.255-2022 Medical electrical equipment—Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors
GB/T 15383-2011 Connection types and dimensions for gas cylinder valve outlets
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
YY/T 0893-2023 Gas mixers for medical use—Standalone gas mixers
ISO 407
ISO 7000
ISO 7396-1
EN 15986
GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
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 0297-1997 Clinical investigation of medical devices
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators
YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases
YY/T 0978-2016 Anaesthetic reservoir bags
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/T 1474-2016 Medical devices—Application of usability engineering to medical devices
YY/T 1778.1-2021 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1:Evaluation and testing within a risk management process
YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability
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
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
GB 50751-2012 Technical code for medical gases engineering
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
YY/T 0297-2026 General requirements for clinical investigation of medical devices
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