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

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
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医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages: 21 pages

Scope

替换:
本部分规定了肌电及诱发反应设备(以下简称为ME设备)的基本安全和基本性能专用要求。本部分适用于ME设备的基本安全和基本性能专用要求。
注: 肌电反馈设备,对肌肉收缩的捕获是基于肌电图,属于这个标准的范围。
如果一个条款或子条款专门预期仅适用于ME设备,或仅适用于ME系统,该条款或子条款的标题和内容将会说明。如果不是这样的话,该条款或子条款同时适用于ME设备和ME系统。
下述ME设备排除在外:
预期用于经皮神经电刺激和肌肉电刺激的ME设备(参见YY 9706.210)。

Development Information

Drafting Units:

美敦力(上海)管理有限公司、上海市医疗器械检测所、通用电气医疗系统(中国)有限公司

Drafting Persons:

石戴峰、张君、包晓江、赵扬

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

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