EN IEC 60601-2-35:2021/A1:2024

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or 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 et destinés au réchauffage des patients en usage médical

Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za odeje, blazine in posteljne vložke, namenjene ogrevanju v medicinski uporabi - Dopolnilo A1 (IEC 60601-2-35:2020/AMD1:2023)

General Information

• Status: Published
• Publication Date: 25-Jan-2024
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.140 - Hospital equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 26-Jan-2024
• Due Date: 30-Jun-2022
• Completion Date: 26-Jan-2024
• Ref Project: SIST EN IEC 60601-2-35:2021/A1:2024 - 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/AMD1:2023)

Relations

• Amends: 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: 26-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-35:2021/A1:2024
01-marec-2024
Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za odeje, blazine in posteljne vložke, namenjene ogrevanju v
medicinski uporabi - Dopolnilo A1 (IEC 60601-2-35:2020/AMD1:2023)
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/AMD1:2023)
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 (IEC 60601-2-
35:2020/AMD1:2023)
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 pati (IEC 60601-
2-35:2020/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 60601-2-35:2021/A1:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN IEC 60601-2-35:2021/A1:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-35:2021/A1:2024

---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-35:2021/A1:2024


EUROPEAN STANDARD EN IEC 60601-2-35:2021/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM January 2024
ICS 11.040.01; 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 or mattresses and intended for
heating in medical use
(IEC 60601-2-35:2020/AMD1:2023)
Appareils électromédicaux - Partie 2-35 : Exigences Medizinische elektrische Geräte - Teil 2-35: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs de réchauffage utilisant des wesentlichen Leistungsmerkmale von Decken, Matten und
couvertures, des coussins ou des matelas et destinés au Matratzen zur Erwärmung von Patienten in der
réchauffage des patients en usage médical medizinischen Anwendung
(IEC 60601-2-35:2020/AMD1:2023) (IEC 60601-2-35:2020/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 60601-2-35:2021; it was approved by CENELEC on 2024-01-25. 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, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-35:2021/A1:2024 E

---------------------- Page: 3 ----------------------
SIST EN IEC 60601-2-35:2021/A1:2024
EN IEC 60601-2-35:2021/A1:2024 (E)
European foreword
The text of document 62D/2088/FDIS, future IEC 60601-2-35/AMD1, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-35:2021/A1:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-10-25
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-01-25
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held respon
...