GB 12259-1990
Abolished
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
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
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 9706.111-2021 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 9706.112-2021 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 9706.220-2021 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
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
Related Standards
GB 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced