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
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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
Pages: 85 pages

Scope

This part applies to the basic safety and basic performance of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems, respectively).
This part applies to the electromagnetic compatibility of ME equipment and ME systems.
Note: The chapters and articles marked with an asterisk (*) in this part are described in Appendix A.

Development Information

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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