YY 9706.102-2021 Active Industry standards-Medicine

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 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests

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 9706.102-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Hospital 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(SAC/TC 10)
Pages: 85 pages

Scope

本部分适用于医用电气设备和医用电气系统(以下分别称ME设备和ME系统)的基本安全和基本性能。
本部分适用于ME设备和ME系统的电磁兼容性。
注:本部分中带星号(*)的章和条在附录A中有相关说明。

Development Information

Drafting Units:

上海市医疗器械检测所、通标标准技术服务(上海)有限公司、西门子医疗系统有限公司、北京通用电气华伦医疗设备有限公司、中国电子技术标准化研究院、深圳迈瑞生物医疗电子股份有限公司

Drafting Persons:

高中、王伟明、蒋岁、李艳华、赵倡、任杰、崔强、罗积浩、陈信元、张尉强、蔡舒文

Word Count: 161 Thousand words Pages: 85 pages

Same series standard

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 9706.240-2021 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 5465.2-2008 Graphical symbols for use on electrical equipment—Part 2:Graphical symbols GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 17626.4-2018 Electromagnetic compatibility—Testing and measurement techniques—Electrical fast transient/burstimmunity test GB/T 17626.6-2017 Electromagnetic compatibility—Testing and measurement techniques—Immunity to conducted disturbances,induced by radio-frequency fields 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 GB 4343.1-2003 Electromagnetic compatibility—Requirements for household appliances, electric tools and similar apparatus—Part 1:Emission GB 4343.1-2009 Electromagnetic compatibility—Requirements for household appliances,electric tools and similar apparatus—Part 1:Emission GB 4343.1-2018 Electromagnetic compatibility requirements for household appliances,electric tools and similar apparatus—Part 1:Emission GB 4343.1-2024 Electromagnetic compatibility requirements for household appliances,electric tools and similar apparatus—Part 1:Emission GB 4824-2004 Industrial, scientific and medical(ISM) radio-frequency equipment—Electromagnetic disturbance characteristics—Limits and methods of measurement GB 4824-2013 Industrial,scientific and medical(ISM) radio-frequency equipment—Disturbance characteristics—Limits and methods of measurement GB 4824-2019 Industrial,scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement GB/T 6113.102-2008 Specification for radio disturbance and immunity measuring apparatus and methods—Part 1-2:Radio disturbance and immunity measuring apparatus—Ancillary equipment—Conducted disturbances GB/T 6113.102-2018 Specification for radio disturbance and immunity measuring apparatus and methods—Part 1-2:Radio disturbance and immunity measuring apparatus—Coupling devices for conducted disturbance measurements GB 9254-1998 Information technology equipment—Radio disturbance characteristics—Limits and methods of measurement GB/T 9254-2008 Information technology equipment—Radio disturbance characteristics—Limits and methods of measurement GB/T 9254.1-2021 Information technology equipment,multimedia equipment and receivers—Electromagnetic compatibility—Part 1:Emission requirements GB/T 9254.2-2021 Information technology equipment,multimedia equipment and receivers—Electromagnetic compatibility—Part 2:Immunity requirements GB 17625.1-2003 Electromagnetic compatibility—limits—Limits—for harmonic current emissions(equipment input current≤16A per phase GB 17625.1-2012 Electromagnetic compatibility—Limits—Limits for harmonic current emissions(equipment input current ≤16 A per phase) GB 17625.1-2022 Electromagnetic compatibility—Limits—Part 1:Limits for harmonic current emissions(equipment input current ≤16 A per phase) GB 17625.2-1999 Electromagnetic compatibility Limits Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current≤16A GB/T 17625.2-2007 Electromagnetic compatibility (EMC)—Limits—Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection GB/T 17626.2-1998 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.2-2006 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.2-2018 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.3-1998 Electromagnetic compatibility—Testing and measurement techniques-Radiated, radio-frequency, electromagnetic field immunity test GB/T 17626.3-2006 Electromagnetic compatibility—Testing and measurement techniques—Radiated, radio-frequency, electromagnetic field immunity test GB/T 17626.3-2016 Electromagnetic compatibility—Testing and measurement techniques—Radiated,radio-frequency,electromagnetic field immunity test GB/T 17626.3-2023 Electromagnetic compatibility—Testing and measurement techniques—Part 3:Radiated,radio-frequency,electromagnetic field immunity test GB/T 17626.5-1999 Electromagnetic compatibility—Testing and measurement techniques—Surge immunity test GB/T 17626.5-2008 Electromagnetic compatibility—Testing and measurement techniques—Surge immunity test GB/T 17626.5-2019 Electromagnetic compatibility—Testing and measurement techniques—Surge immunity test GB/T 17626.8-1998 Electromagnetic compatibility—Testing and measurement techniques—Power frequency magnetic field immunity test GB/T 17626.8-2006 Electromagnetic compatibility—Testing and measurement techniques—Power frequency magnetic field immunity test GB/T 17626.11-1999 Electromagnetic compatibility—Testing and measurement techniques—Voltage dips, short interruptions and voltage variations immunity tests GB/T 17626.11-2008 Electromagnetic compatibility—Testing and measurement techniques—Voltage dips,short interruptions and voltage variations immunity tests GB/T 17626.11-2023 Electromagnetic compatibility—Testing and measurement techniques—Part 11:Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase GB 17743-1999 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment GB/T 17743-2007 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment GB/T 17743-2017 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment GB/T 17743-2021 Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment GB 4824-2025 Industrial, scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement GB/T 6113.102-2025 Specification for radio disturbance and immunitymeasuring apparatus and methods—Part 1-2:Radio disturbance and immunity measuring apparatus—Coupling devices for conducted disturbance measurements

Adopt standards

IEC 60601-1-2:2007

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