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SIST EN 80601-2-35:2010/A11:2012

(Amendment)

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

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. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

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

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENO DELOVANJE NAPRAV ZA OGREVANJE, ki jih uporabljajo RJUHE, BLAZINE ali POSTELJNI VLOŽKI pri medicinski uporabi, prav tako imenovane kot ME OPREMA. GRELNE NAPRAVE, namenjene za predhodno gretje postelje, so vključene v področje uporabe tega mednarodnega standarda. Če je točka ali podtočka izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. V nasprotnem primeru tako točka ali podtočka veljata za ustrezno ME OPREMO in ME SISTEME. Če je točka ali podtočka posebej namenjena temu, da velja za izrecno opredeljen tip ME OPREME, kot je v primeru NAPRAV Z VENTILATORJEM, potem je točka ali podtočka ustrezno naslovljena. Točke ali podtočke, ki veljajo za vse tipe ME OPREME znotraj področja uporabe tega standarda, niso posebej naslovljene. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV znotraj področja uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

Status
Published
Publication Date
14-Nov-2011
ICS
11.140 - Hospital equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
15-Nov-2011
Due Date
20-Jan-2012
Completion Date
15-Nov-2011
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
EN 80601-2-35:2009/A11:2011 - 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

Amends
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
11-Oct-2011
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
Amends
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
28-Jan-2023
Revised
SIST EN 80601-2-35:2010/A1:2017 - 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 80601-2-35:2009/A1:2016)
Effective Date
10-Mar-2015
Amends
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

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80601-2-35:2010/A11:2012
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQH]DKWHYH]DUMXKHEOD]LQHLQSRVWHOMQHYORåNHQDPHQMHQH]DRJUHYDQMHSUL
PHGLFLQVNLXSRUDEL
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
Ta slovenski standard je istoveten z: EN 80601-2-35:2009/A11:2011
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 80601-2-35:2010/A11:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 80601-2-35:2010/A11:2012

---------------------- Page: 2 ----------------------

SIST EN 80601-2-35:2010/A11:2012

EUROPEAN STANDARD
EN 80601-2-35/A11

NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM

ICS 11.140


English version


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



Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-35: Exigences particulières pour Teil 2-35: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des dispositifs de réchauffage Leistungsmerkmale von Decken, Matten
utilisant des couvertures, des coussins ou und Matratzen zur Erwärmung von
des matelas chauffants et destinés au Patienten in der medizinischen
réchauffage des patients en usage Anwendung
médical




This amendment A11 modifies the European Standard EN 80601-2-35:2009; it was approved by CENELEC on
2011-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member.

This amendment exists in three official versions (English, F
...

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