RO
SR EN IEC 60601-2-35:2021
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
IEC 60601-2-35:2020 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 document. 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 be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then 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. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of
Status :
Valid
Approval date : 9/30/2021
Number of pages : 78
ICS : 11.040.01 Medical equipmet in general,11.140 Hospital equipment
Technical Committee : 22 - Electrical equipment in medical practice
- Replaces SR EN 80601-2-35:2010
- Replaces SR EN 80601-2-35:2010/A1:2017
- Replaces SR EN 80601-2-35:2010/A11:2012
- Replaces SR EN 80601-2-35:2010/AC:2015
- Amended by SR EN IEC 60601-2-35:2021/A1:2024