The EN 60601-2-20 standard published by the International Electrotechnical Commission (IEC) describes the requirements and test methods for the basic safety and required performance of baby carrying incubators. This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-2-20 Electrical medical equipment - Part 2-20: Specific features for the basic safety and required performance of baby transport incubators.
This standard describes the safety requirements for baby transport incubators (incubators). This standard has replaced the IEC 60601-1 standard and introduced significant changes to this standard.
EN 60601-2-20 constitutes a technical revision. It has been revised to be structurally compatible with the IEC 60601-1 standard. The requirements described in the standard are followed by specifications for the relevant tests. General guidance for the requirements of this standard is included in the appendix. It is expected that knowledge of the reasons for these requirements will not only facilitate the proper application of this standard but also expedite any revisions that may be necessary over time as a result of changes in clinical practice or advances in technology.
This standard does not cover the following devices: medical devices that provide heat through blankets, pillows and mattresses (IEC 80601-2-35 standard), baby incubators not used for carrying babies (IEC 60601-2-19 standard), baby radiant heaters (IEC 60601-2 -21 standard) and baby photography (IEC 60601-2-50 standard).
In short, the purpose of this standard is to establish certain basic safety and performance requirements for baby transport incubators that minimize dangers to the patient and the operator, and to provide test methods by which compliance can be verified.
Within the scope of laboratory services, our organization also provides testing services for the basic safety and required performance of EN 60601-2-20 baby carrying incubators.
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