Certification and Registration
Standards for Testing Infant Medical Devices
Category:
Infant Medical Device
GB 9706.219-2021 Medical electrical equipment — Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
GB 9706.219 specifies the requirements for the basic safety and essential performance of infant incubators, as defined in 201.3.209 of this document. These devices are also referred to as ME equipment.
GB 9706.219 specifies safety requirements for infant incubators. However, if the manufacturer demonstrates through risk management documentation that the risks associated with relevant hazards are acceptable when compared with the therapeutic benefits of the device, an alternative compliance approach based on demonstrating equivalent safety through special provisions may be considered compliant.
GB 9706.219 does not apply to medical heating devices that provide heat through blankets, pads, or mattresses, infant radiant warmers, or infant phototherapy equipment.
The purpose of GB 9706.219 is to specify the essential safety and essential performance requirements for infant incubators defined in 201.3.209, minimize risks to patients and operators, and establish the tests required to verify compliance.
An infant incubator is a type of ME equipment that regulates the environmental conditions of infants by using heated air.
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 specifies the requirements for the basic safety and essential performance of infant transport incubators.
YY 9706.220 specifies safety requirements for infant transport incubators. However, if the manufacturer demonstrates through risk management documentation that the risks associated with relevant hazards are acceptable when compared with the therapeutic benefits of the device, an alternative compliance approach based on demonstrating equivalent safety through special provisions may be considered compliant.
YY 9706.220 does not apply to medical heating devices that provide heat through blankets, pads, or mattresses; infant incubators that are not intended for neonatal transport; infant radiant warmers; or infant phototherapy equipment.
The purpose of YY 9706.220 is to specify the essential safety and essential performance requirements for infant transport incubators defined in 201.3.208, minimize risks to patients and operators, and establish the tests required to verify compliance.
An infant transport incubator is a portable type of ME equipment equipped with an infant incubator and portable power supply. It regulates the infant’s environment primarily by heating the air inside the incubator.
SATISFY provides one-stop infant medical product testing services, including preliminary assessment, preparation and submission of technical documentation, complete test monitoring, report interpretation, data analysis, and corrective action recommendations.
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