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EVS-EN 80601-2-35:2010

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

General information
Withdrawn from 03.08.2021
Base Documents
IEC 80601-2-35:2009; EN 80601-2-35:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
03.08.2021
Main
03.01.2017
Amendment
07.05.2015
Corrigendum
02.11.2011
Amendment
04.03.2010
Main
Main
EVS-EN 60601-2-35:2001
This International Standard applies to the  BASIC SAFETY and  ESSENTIAL PERFORMANCE of HEATING DEVICES using  BLANKETS,  PADS or  MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this International Standard. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. If a clause or subclause is specifically intended to apply to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this standard are not specifically entitled.
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