YY 9706.210-2021 Active Industry standards-Medicine

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 9706.210-2021 Medical electrical equipment—Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

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 9706.210-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Physiotherapy and traditional Chinese medicine instruments and equipment
ICS Name: Treatment 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物理治疗设备分技术委员会(SAC/TC 10/SC 4)
Pages: 14 pages

Scope

GB/T 1的本部分规定了标准的结构、起草表述规则和编排格式,并给出了有关表述样式。
本部分适用于国家标准、行业标准和地方标准以及国家标准化指导性技术文件的编写,其他标准的编写可参照使用。
替换:
本部分规定了物理医学实践所用的神经和肌肉刺激器(以下简称ME设备)的安全要求。包含经皮电神经刺激器和电肌肉刺激器。
注1: 肌肉刺激器也可被认为是神经肌肉刺激器。
注2: 在“特殊指南和原理说明”部分对一些较为重要的要求作了注解,参见附录AA。
本部分不适用于下列ME设备:
——用于植入的或与被植入电极连接的ME设备;
——用于脑刺激用的ME设备(如电痉挛治疗ME设备);
——用于神经病学研究的ME设备;
——外部心脏起搏器(见YY 0945.2);
——用于诱发反应诊断的ME设备(见YY 9706.240);
——用于肌电图的ME设备(见YY 9706.240);
——心脏除颤ME设备(见GB 9706.8)。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、上海道生医疗科技有限公司、河南翔宇医疗设备股份有限公司

Drafting Persons:

段乔峰、高山、周会林、张赟、刘博、钱学波、李飞、杨国涓

Word Count: 26 Thousand words Pages: 14 pages

Same series standard

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Replace the following standards

Referenced Standards

GB/T 16679.1-2024 Industrial systems,installations and equipment and industrial products—Designation of signals—Part 1:Basic rules GB/T 17451-1998 Technical drawings—General principles of presentation—Views GB/T 20000.1-2002 Guide for standardization—Part 1:Standardization and related activities—General vocabulary GB/T 20000.1-2014 Guidelines for standardization—Part 1:Standardization and related actives—General vocabulary GB/T 20000.2-2001 Guides for standardization—Part 2:Adoption of international standards(ISO/IEC Guide 21:1999,MOD) GB/T 20000.2-2009 Guidelines for standardization—Part 2:Adoption of international standards GB/T 20000.3-2003 Guide for standardization—Part 3:Reference to documents GB/T 20000.3-2014 Guidelines for standardization—Part 3:Reference to documents GB/T 20000.3-2025 Rules for standardization—Part 3:Guidelines for referencing standards in regulations GB/T 20000.4-2003 Guide for standardization—Part 4:Safety aspects for their inclusion in standards GB/T 20000.5-2004 Guide for standardization—Part 5:Environmental aspects for their inclusion in product standards GB/T 20000.6-2006 Guide for standardization—Part 6:Code of good practice for standardization GB/T 20000.6-2024 Rules for standardization—Part 6:Guidelines for good practice GB/T 20000.7-2006 Guide for standardization—Part 7:Guidelines for the justification and development of management system standards GB/T 20000.8-2014 Guidelines for standardization—Part 8:Establishing principles and guidelines for use of stage code system GB/T 20000.9-2014 Guidelines for standardization—Part 9:Adoption of International Deliverables other than International Standards GB/T 20000.10-2016 Guidelines for standardization—Part 10:General rules for the English translation of Chinese national standards GB/T 20000.11-2016 Guides for standardization—Part 11:General presentation of the english translation of Chinese national standards GB/T 20001.1-2001 Rules for drafting standards—Part 1:Terminology GB/T 20001.1-2024 Rules for drafting standards—Part 1:Terminology GB/T 20001.2-2001 Rules for drafting standards—Part 2:Symbol GB/T 20001.2-2015 Rules for drafting standards—Part 2:Symbol standards GB/T 20001.3-2001 Rules for drafting standards—Part 3:Information classifying and coding GB/T 20001.3-2015 Rules for drafting standards—Part 3:Classification standards GB/T 20001.4-2001 Rules for drafting standards—Part 4:Methods of chemical analysis GB/T 20001.4-2015 Rules for drafting standards—Part 4:Test method standards GB/T 20001.5-2017 Rules for drafting standards—Part 5:Specification standards GB/T 20001.6-2017 Rules for drafting standards—Part 6:Code of practice standards GB/T 20001.7-2017 Rules for drafting standards—Part 7:Guide standards GB/T 20001.8-2023 Rules for drafting standards—Part 8:Evaluation standards GB/T 20001.10-2014 Rules for drafting standards—Part 10:Product standards GB/T 20001.11-2022 Rules for drafting standards—Part 11:Management system standards GB/T 20002.1-2008 Drafting for special aspects in standards—Part 1:Child safety GB/T 20002.1-2025 Guidelines for writing specific aspects in standards—Part 1:Addressing child safety GB/T 20002.2-2008 Drafting for special aspects in standards—Part 2:The needs of older persons and persons with disabilities GB/T 20002.3-2014 Drafting for special aspects in standards—Part 3:Addressing environmental issues in product standards GB/T 20002.4-2015 Drafting for special aspects in standards—Part 4:Safety aspects for their inclusion in standards GB/T 20002.5-2025 Guidelines for writing specific aspects in standards—Part 5:Addressing sustainability GB/T 20002.6-2022 Guidelines for writing special aspects in standards—Part 6:Addressing the needs of micro, small and medium-sized enterprises GB/T 20063.1-2006 Graphical symbols for diagrams—Part 1:General information and indexes GB/T 20063.2-2006 Graphical symbols for diagrams—Part 2:Symbols having general application GB/T 20063.3-2006 Graphical symbols for diagrams—Part 3:Connections and related devices GB/T 20063.4-2006 Graphical symbols for diagrams—Part 4:Actuators and related devices GB/T 20063.5-2006 Graphical symbols for diagrams—Part 5:Measurement and control devices GB/T 20063.6-2006 Graphical symbols for diagrams—Part6:Measurement and control functions GB/T 20063.7-2006 Graphical symbols for diagrams—Part 7:Basic mechanical components GB/T 20063.8-2006 Graphical symbols for diagrams—Part 8:Valves and dampers GB/T 20063.9-2006 Graphical symbols for diagrams—Part 9:Pumps,compressors and fans GB/T 20063.10-2006 Graphical symbols for diagrams—Part 10:Fluid power converters GB/T 20063.11-2006 Graphical symbols for diagrams—Part 11:Devices for heat transfer and heat engines GB/T 20063.12-2006 Graphical symbols for diagrams—Part 12:Devices for separating, purification and mixing GB/T 20063.13-2009 Graphical symbols for diagrams—Part 13:Devices for material processing GB/T 20063.14-2009 Graphical symbols for diagrams—Part 14:Devices for transport and handling of material GB/T 20063.15-2009 Graphical symbols for diagrams—Part 15:Installation diagrams and network maps ISO 7000 IEC 60027(所有部分) IEC 指南106 规定设备性能等级环境条件的指南 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 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

Adopt standards

IEC 60601-2-10:2012+AMD1:2016

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