The TS EN 60601-2-19 standard, published by the International Electrotechnical Commission (IEC), describes the basic safety and performance characteristics and test methods of baby incubators. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-2-19 Electrical medical equipment - Part 2-19: Specific features for the basic safety and required performance of baby incubators.
The minimum safety requirements described in this standard provide a practical level of safety in the operation of infant incubator equipment (baby incubators). This special standard is a standard that complements the IEC 60601-1 standard. In this standard, the requirements are followed by the specifications of the relevant tests. General guidance and justification for the requirements of this standard is provided in the annex to the standard (Annex AA). Knowledge of the reasons for these requirements not only facilitates the proper application of this standard, but also accelerates a revision required as a result of changes in clinical practice or advances in technology over time.
Special standard TS EN 60601-2-19 specifies safety requirements for baby incubators and does not apply to the following equipment:
The purpose of this specific standard is to establish certain basic safety and basic performance requirements for infant incubators that minimize hazards to the patient and operator, and to provide test methods by which compliance with these requirements can be verified.
Two standards that are referred to as normative in the application of this standard and are indispensable for their implementation are: IEC 60601-1-2 and IEC 60601-1-10.
Our organization also provides basic safety and performance testing services of ISO 60601-2-19 baby incubators within the scope of laboratory services.
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