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SIST EN 80601-2-35:2010/AC:2015

(Corrigendum)

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

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

Medizinische elektrische Geräte - Teil 2-35: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen zur Erwärmung von Patienten in der medizinischen Anwendung

Appareils électromédicaux - Partie 2-35: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destinés au réchauffage des patients en usage médical

Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in bistvene zahteve za rjuhe, blazine in posteljne vložke, namenjene za ogrevanje pri medicinski uporabi - Popravek AC

General Information

Status
Withdrawn
Publication Date
17-Jun-2015
Withdrawal Date
29-Jul-2024
ICS
11.140 - Hospital equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
30-Jul-2024
Due Date
22-Aug-2024
Completion Date
30-Jul-2024
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 80601-2-35:2009/AC:2015 - 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

Relations

Replaced By
SIST 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)
Effective Date
20-Jul-2021
Corrects
SIST EN 80601-2-35:2010 - Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses, intended for heating in medical use (IEC 80601-2-35:2009)
Effective Date
07-Jun-2022
Corrects
SIST EN 80601-2-35:2010 - Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses, intended for heating in medical use (IEC 80601-2-35:2009)
Effective Date
01-Jul-2015

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EN 80601-2-35:2010/AC:2015EN 80601-2-35:2010/AC:2015
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Corrigendum
EN 80601-2-35:2010/AC:2015
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-35: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen zur Erwärmung von Patienten in der medizinischen AnwendungAppareils électromédicaux - Partie 2-35: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destinés au réchauffage des patients en usage médicalMedical 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 use11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 80601-2-35:2009/AC:2015SIST EN 80601-2-35:2010/AC:2015en,fr01-julij-2015SIST EN 80601-2-35:2010/AC:2015SLOVENSKI
STANDARD
IEC 80601-2-35:2009/COR2:2015
– 1 –
 IEC 2015 INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE ____________
IEC 80601-2-35 Edition 2.0
2009-10
Medical electrical equipment –
Part 2-35: Particula
...

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This part of 60601 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 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 the general standard.
NOTE See also 4.2 of the general standard.
This document does not apply to:
– HEATING DEVICES intended for physiotherapy;
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1]2;
– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];
– cooling devices.

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NOTE 2   See also 4.2 of EN 60601-1:2006.
NOTE 3   Body length is measured from crown to sole.
1.2 Object
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