GB 9706.219-2021 Active

This document applies to the basic safety and performance requirements of infant incubators, such as the equipment defined in Article 201.3.209 of this document, also known as ME equipment.
If a chapter or an article explicitly states that it only applies to ME equipment or ME systems, the title and the body of the chapter or article will specify this. If this is not the case, the relevant chapter or article applies to both ME equipment and ME systems.
Except for 7.2.13 and 8.4.1 in the general standard, the hazards (sources) caused by the intended physiological effects of ME equipment or ME systems within the scope of this document are not specifically required in this document.
Note: See General Standard 4.2.
This document specifies the safety requirements for infant 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 equipment, a compliance alternative method demonstrating equivalent safety through a special clause is considered compliant.
This document does not apply to:
——Medical heating equipment heated by blankets, pads, and mattresses, see YY 9706.235;
——Infant radiant warming tables, see IEC 60601-2-21;
——Infant transport incubators, see YY 9706.220;
——Infant phototherapy equipment, see YY 9706.250.