GB 9706.213-2021 Active National standards force_standard

GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation

GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation

Publish Date: 2021-12-01 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 9706.213-2021
Standard Type: National standards
Standard Status: Active
is_force_gb: yes
CCS Name: Surgical room equipment
ICS Name: Anesthesia, respiration, and resuscitation equipment
Publish Date: 2021-12-01
Implement Date: 2023-05-01
Publisher: 国家市场监督管理总局、国家标准化管理委员会
Technical Committee: 国家药品监督管理局
Pages: 84 pages

Scope

GB 9706的本部分规定了ME设备和ME系统的基本安全和基本性能的通用要求。
本部分适用于医用电气设备和医用电气系统(以下简称ME设备和ME系统)。
如果一章或一条明确指出仅适用于ME设备或ME系统,标题和 章或条的正文会说明。如果不是这种情况,与此相关的章或条同时适用于ME设备和ME系统。
除7.2.13和8.4.1外,本部分范围内的ME设备或ME系统的预期生理效应所导致的危险(源)在本部分中没有具体要求。
本文件适用于需要专业操作者持续参与的、用于管理吸入麻醉的麻醉工作站的基本安全和基本性能。
本文件规定了一个完整的麻醉工作站和下列麻醉工作站组件的专用要求。这些麻醉工作站组件可作为单独设备,也可能和其他相关的麻醉工作站组件组成一个麻醉工作站:
——麻醉气体输送系统;
——麻醉呼吸系统;
——麻醉气体净化系统;
——麻醉气体输送装置;
——麻醉呼吸机;
——监护装置;
——报警系统;
——保护装置。
注1:表AA.1 概述了监护装置、报警系统和保护装置。
考虑到通用标准,完整的麻醉工作站和其独立的组件都作为ME设备或ME系统。
注2:表AA.2给出了本文件的使用环境。
本文件也适用于制造商声称连接到麻醉工作站的附件,如果这些附件的特性影响麻醉工作站的基本安全和基本性能。
如果一章或一条明确指出仅适用于麻醉工作站组件,标题和章或条的正文会说明。如果不是这种情况,与此相关的章或条同时适用于麻醉工作站和其独立的组件。
除通用标准7.2.13和8.4.1外,本文件范围内的麻醉工作站和其独立的组件的预期生理效应所导致的危险在本文件中没有具体要求。
注3:见通用标准4.2。
本文件不适用于附录BB定义的预期使用

Development Information

Word Count: 162 Thousand words Pages: 84 pages

Same series standard

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Replace the following standards

Referenced Standards

YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 0664-2008 Medical device software—Software life cycle processes YY 0709-2009 Medical electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 2882 ISO 3864-1:2002 ISO 7000:2004 ISO 7010:2011 ISO 9614-1 ISO 80000-1:2009 IEC 60601-1-6 IEC 60730-1:2010 IEC 60851-3:2009 IEC 60851-5:2008 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 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests 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 9706.110-2021 Medical electrical equipment—Part 1-10:General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers 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 3836.4-2000 Electrical apparatus for explosive gas atmospheres—Part 4:Intrinsic safety“i” GB 3836.4-2010 Explosive atmospheres—Part 4:Equipment protection by intrinsic safety "i" GB/T 3836.4-2021 Explosive atmospheres—art 4:Equipment protection by intrinsic safety “i” GB 3836.11-1991 Electrical apparatus for explosive atmospheres-Method of test for ascertainment of maximum experimental safe gap GB/T 3836.11-2008 Explosive atmospheres—Part 11:Equipment protection by flameproof enclosures “d”—Method of test for ascertainment of maximum experimental safe gap GB/T 3836.11-2017 Explosive atmospheres—Part 11:Material characteristics for gas and vapour classification—Test methods and data GB/T 3836.11-2022 Explosive atmospheres—Part 11:Material characteristics for gas and vapour classification—Test methods and data GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary GB/T 7899-2006 Regulators for welding, cutting and the similar processes GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 15383-2011 Connection types and dimensions for gas cylinder valve outlets GB 50751-2012 Technical code for medical gases engineering YY 0339-2002 Suction catheter for use in the respiratory tract YY 0339-2009 Suction catheter for use in the respiratory tract YY/T 0339-2019 Suction catheters for use in the respiratory tract YY/T 0339-2024 Suction catheters for use in the respiratory tract YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators YY 0601-2007 Anaesthetic gas monitors YY 0601-2009 The basic safety and main performance specific requirements for medical electrical equipment respiratory gas monitoring devices YY 0636.1-2008 Medical suction equipment—Part 1:Electrically powered suction equipment—Safety requirements YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source YY/T 0664-2008 Medical device software—Software life cycle processes YY/T 0664-2020 Medical device software—Software life cycle processes YY/T 0755-2009 Anaesthetic vaporizers—Agent-specific filling systems YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases YY/T 0801.1-2010 Terminal units for medical gas pipeline systems—Part 1:Terminal units for use with compressed medical gases and vacuum YY/T 0801.2-2010 Terminal units for medical gas pipeline systems—Part 2:Terminal units for anaesthetic gas scavenging systems 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 ISO 407:2004 ISO 7396-2:2007

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ISO 80601-2-13:2011+AMD1:2015+AMD2:2018

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