YY 9706.220-2021 Active Industry standards-Medicine

YY 9706.220-2021 Medical electrical equipment—Part 2-20:Particular requirements for the basic safety and essential performance of infant transport incubators

YY 9706.220-2021 Medical electrical equipment—Part 2-20:Particular requirements for the basic safety and essential performance of infant transport incubators

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 9706.220-2021
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: 36 pages

Scope

This section applies to the basic safety and performance requirements of infant transport incubators, also known as ME devices.
If a chapter or clause explicitly states that it only applies to ME devices or ME systems, the title and the body of the chapter or clause will indicate this. If this is not the case, the relevant chapters or clauses apply to both ME devices and ME systems.
Except for general standards 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this section are not specifically required in this section.
Note: See General Standard 4.2.
This section specifies the safety requirements for infant transport incubators. However, if the manufacturer states in its risk management documents that the risks posed by the hazards are at an acceptable level compared to the therapeutic benefits of the device, a compliance alternative method demonstrating equivalent safety can be considered as meeting the requirements.
This section does not apply to:
——Medical heating devices heated by blankets, pads, and mattresses, for details, please refer to YY 0834;
——Infant incubators that are not infant transport incubators, for details, please refer to GB 11243;
——Infant radiant warming tables; for details, please refer to YY 0455;
——Infant phototherapy equipment; for details, please refer to YY 0669.

Development Information

Word Count: 64 Thousand words Pages: 36 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 9706.221-2021 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

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IEC 60601-2-20:2009+AMD1:2016

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