EN 80601-2-35:2009/A11:2011
(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
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- Withdrawn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
- 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
Relations
- Effective Date
- 23-Jan-2023
- Effective Date
- 28-Jan-2023
- Effective Date
- 10-Mar-2015
Frequently Asked Questions
EN 80601-2-35:2009/A11:2011 is a amendment published by CLC. Its full title is "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 standard covers: D139/C149: BT approved the modified Annex ZZ for EN 80601-2-35:2009 2021: CLC legacy converted by DCLab NISOSTS
D139/C149: BT approved the modified Annex ZZ for EN 80601-2-35:2009 2021: CLC legacy converted by DCLab NISOSTS
EN 80601-2-35:2009/A11:2011 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 80601-2-35:2009/A11:2011 has the following relationships with other standards: It is inter standard links to EN IEC 60601-2-35:2021, EN 80601-2-35:2009, EN 80601-2-35:2009/A1:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 80601-2-35:2009/A11:2011 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 80601-2-35:2009/A11:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
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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
...
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