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
Price: $ 48
Download

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
Pages: 14 pages

Scope

This part of GB/T 1 specifies the structure of standards, drafting expression rules, and formatting, and provides guidelines on expression styles.
This part is applicable to the preparation of national standards, industry standards, and local standards, as well as national standardized guidance technical documents. The preparation of other standards can be used for reference.
Replacement:
This part specifies the safety requirements for nerve and muscle stimulators (hereinafter referred to as ME devices) used in physical medicine practice. It includes transcutaneous electrical nerve stimulators and electrical muscle stimulators.
Note 1: Muscle stimulators can also be considered as neuromuscular stimulators.
Note 2: Some more important requirements are annotated in the "Special Guidelines and Principle Explanations" section, see Appendix AA.
This part does not apply to the following ME devices:
—— ME devices used for implantation or connected to implanted electrodes;
—— ME devices used for brain stimulation (such as ME devices for electroconvulsive therapy);
—— ME devices used for neurological research;
—— External pacemakers (see YY 0945.2);
—— ME devices used for evoked response diagnosis (see YY 9706.240);
—— ME devices used for electromyography (see YY 9706.240);
—— Heart defibrillation ME devices (see GB 9706.8).

Development Information

Word Count: 26 Thousand words Pages: 14 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 9706.111-2021 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

Contact Us