БДС EN 80601-2-35:2010

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

Scope

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.

Directives and Regulations

When the standard is harmonized under a directive or regulation, the word Harmonized appear. When such an inscription does not appear, it means that the standard is related to / supporting the relevant directive or regulation.