Cover DIN EN IEC 60601-2-19 VDE 0750-2-19:2022-08
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DIN EN IEC 60601-2-19 VDE 0750-2-19:2022-08

Medical electrical equipment

Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

(IEC 60601-2-19:2020); German version EN IEC 60601-2-19:2021
Class/Status: Standard, valid
Released: 2022-08
VDE Art. No.: 0701386

This particular standard specifies safety requirements for infant incubators but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

Title Format
Entwicklung und Herstellung medizinischer Software
Prinz, Thorsten (Hrsg.)

Entwicklung und Herstellung medizinischer Software

Normen in der Medizintechnik
VDE-Schriftenreihe – Normen verständlich, Band 171

2017, 219 pages, Din A5, Broschur

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