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SFS-EN 80601-2-35:2010:en Kumottu

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

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IEC 80601-2-35:2009 establishes particular basic safety and essential performance requirements, which minimize hazards to patients, and operators for heating devices using blankets, pads or mattresses and intended for heating in medical use and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible.

Tämän julkaisun valmistelusta Suomessa vastaa SESKO ry, puh. 050 571 6048.
Sidokset
Velvoittavat viittaukset
EN 60601-1-10:2008 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 60601-1-8:2007 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Direktiivi
93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »
Vahvistuspäivä
23.08.2010
Kumouspäivä
06.08.2021
Painos
1
Sivumäärä
73
Julkaisun kieli
englanti

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