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
Basic Information
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.