YY 9706.111-2021 Active Industry standards-Medicine

YY 9706.111-2021 Medical electrical equipment—Part 1-11:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

YY 9706.111-2021 Medical electrical equipment—Part 1-11:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Publish Date: 2021-03-09 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: YY 9706.111-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Medical equipment
Publish Date: 2021-03-09
Implement Date: 2023-05-01
Publisher: 国家药品监督管理局
Technical Committee: 全国医用电器标准化技术委员会(SAC/TC 10)
Pages: 45 pages

Scope

本部分规定了在家庭护理环境中使用的医用电气设备和医用电气系统(以下简称ME设备和ME系统)的基本安全和基本性能的要求。
本部分适用于按制造商的使用说明书中指出的预期在家庭护理环境中使用的ME设备和ME系统。本部分的应用不考虑ME设备或ME系统是由无经验的操作者使用还是由经过培训的医护人员使用。
家庭护理环境包括:
——患者生活的住所;
——患者所处的其他室内和室外环境,不包括只要患者来访就有经过培训的操作者接待的专业医疗机构。
本部分不适用于预期仅在YY 9706.112所述的紧急医疗服务环境或GB 9706.1(不包括YY 9706.112或本部分的附加内容)所述的专业医疗机构中使用的ME设备和ME系统。但ME设备或ME系统预期可用于多种使用环境,只要也可用于家庭护理环境,就在本标准范围内。
示例:预期用于家庭护理环境和专业医疗机构的ME设备或ME系统。
注1:家庭护理环境中的ME设备和ME系统可能经常会被用于电源不稳及接地保护不可靠的地方。
注2:星号(*)作为标题的第一个字符或段落或表格标题的开头,表示在附录A中有与该项目相关的指南和原理说明。

Development Information

Drafting Units:

上海市医疗器械检测所、北京怡和嘉业医疗科技股份有限公司

Drafting Persons:

何骏、陈蓓、陈兴文、侯丙营、顾征宇

Word Count: 85 Thousand words Pages: 45 pages

Same series standard

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 YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment YY 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators YY 9706.220-2021 Medical electrical equipment—Part 2-20:Particular requirements for the basic safety and essential performance of infant transport incubators YY 9706.221-2021 Medical electrical equipment—Part 2-21:Particular requirements for the basic safety and essential performance of infant radiant warmers YY 9706.233-2021 Medical electrical equipment—Part 2-33:Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis YY 9706.234-2021 Medical electrical equipment—Part 2-34:Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment YY 9706.235-2021 Medical electrical equipment—Part 2-35:Particular requirements for the basic safety and essential performance of heating devices using blankets,pads or mattresses and intended for heating in medical use YY 9706.240-2021 Medical electrical equipment—Part 2-40:Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment YY 9706.247-2021 Medical electrical equipment—Part 2-47:Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems YY 9706.250-2021 Medical electrical equipment—Part 2-50:Particular requirements for the basic safety and essential performance of infant phototherapy equipment YY 9706.252-2021 Medical electrical equipment—Part 2-52:Particular requirements for the basic safety and essential performance of medical beds YY 9706.257-2021 Medical electrical equipment—Part 2-57:Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,diagnostic,monitoring and cosmetic/aesthetic use YY 9706.262-2021 Medical electrical equipment—Part 2-62:Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment YY 9706.269-2021 Medical electrical equipment—Part 2-69:Particular requirements for basic safety and essential performance of oxygen concentrator equipment YY 9706.270-2021 Medical electrical equipment—Part 2-70:Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment YY 9706.272-2021 Medical electrical equipment—Part 2-72:Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

Referenced Standards

GB/T 2423.5-2019 Environmental testing—Part 2:Test methods—Test Ea and guidance:Shock GB/T 2423.7-2018 Environmental testing—Part 2:Test methods—Test Ec:Rough handling shocks,primarily for equipment-type specimens GB/T 2423.56-2018 Environmental testing—Part 2:Test methods—Test Fh:Vibration, broadband random and guidance GB/T 4208-2017 Degrees of protection provided by enclosure(IP code) 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 1474-2016 Medical devices—Application of usability engineering to 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 7000:2014 ISO 7010:2011+A1:2012+A2:2012+A3:2012+A4:2013+A5:2014 GB 4824-2004 Industrial, scientific and medical(ISM) radio-frequency equipment—Electromagnetic disturbance characteristics—Limits and methods of measurement GB 4824-2013 Industrial,scientific and medical(ISM) radio-frequency equipment—Disturbance characteristics—Limits and methods of measurement GB 4824-2019 Industrial,scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance 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 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment GB 4824-2025 Industrial, scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement

Adopt standards

IEC 60601-1-11:2015

Related Standards

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