YY 9706.240-2021 Active Industry standards-Medicine

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 9706.240-2021 Medical electrical equipment—Part 2-40:Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

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
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Basic Information

Standard Code: YY 9706.240-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical electronic instruments and equipment
ICS Name: Diagnostic equipment
Publish Date: 2021-03-09
Implement Date: 2023-05-01
Pages: 21 pages

Scope

Replacement:
This part specifies the basic safety and basic performance requirements for myoelectric and evoked response equipment (hereinafter referred to as ME equipment). This part applies to the basic safety and basic performance requirements of ME equipment.
Note: Myoelectric feedback equipment, which captures muscle contractions based on myoelectrography, falls within the scope of this standard.
If a clause or sub-clause is specifically intended to apply only to ME equipment or only to ME systems, the title and content of the clause or sub-clause will indicate this. Otherwise, the clause or sub-clause applies to both ME equipment and ME systems.
The following ME equipment is excluded:
ME equipment intended for transcutaneous nerve electrical stimulation and muscle electrical stimulation (see YY 9706.210).

Development Information

Word Count: 40 Thousand words Pages: 21 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 9706.210-2021 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 9706.247-2021 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 IEC 60318(所有部分) ISO 15004-2

Adopt standards

IEC 60601-2-40:2016

Related Standards

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