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

D139/C149: BT approved the modified Annex ZZ for EN 80601-2-35:2009
2021: CLC legacy converted by DCLab NISOSTS

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• Status: Withdrawn
• Publication Date: 13-Oct-2011
• Withdrawal Date: 30-Sep-2014
• ICS: 11.140 - Hospital equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 16-Jul-2024
• Completion Date: 16-Jul-2024
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 80601-2-35:2010/A11:2012 - 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: 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
• Effective Date: 23-Jan-2023
• Amends: EN 80601-2-35:2009 - 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
• Effective Date: 28-Jan-2023
• Revised: EN 80601-2-35:2009/A1:2016 - 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
• Effective Date: 10-Mar-2015

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
...