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)

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)

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
• Public Enquiry End Date: 26-Jan-2023
• Publication Date: 01-Feb-2024
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.140 - Hospital equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 31-Jan-2024
• Due Date: 06-Apr-2024
• Completion Date: 02-Feb-2024
• Ref Project: 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

Relations

• Amends: 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: 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.

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

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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

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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
...

SLOVENSKI STANDARD
SIST EN IEC 60601-2-35:2021/oprA1:2023
01-januar-2023
Medicinska električna oprema - 2-35. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za odeje, blazine in posteljne vložke, namenjene za ogrevanje
pri medicinski uporabi - Dopolnilo A1
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 - Amendment 1
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 pati
Ta slovenski standard je istoveten z: EN IEC 60601-2-35:2021/prA1:2022
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN IEC 60601-2- en
35:2021/oprA1:2023
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-35:2021/oprA1:2023

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SIST EN IEC 60601-2-35:2021/oprA1:2023
62D/1982/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-35/AMD1 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-04 2023-01-27
SUPERSEDES DOCUMENTS:
62D/1876/CD, 62D/1965/CC

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if any, in this
CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.

TITLE:
Amendment 1 - 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

PROPOSED STABILITY DATE: 2028

NOTE FROM TC/SC OFFICERS:

1
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

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SIST EN IEC 60601-2-35:2021/oprA1:2023
IEC CDV 60601-2-35:2020 AMD1:2022
© IEC:2022
– 2 –

2 FOREWORD
3 This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
4 technical committee 62: Electrical equipment in medical practice.
5 The text of this amendment is based on the following documents:
Draft Report on voting
62D/XX/FDIS 62D/XX/RVD
6
7 Full information on the voting for its approval can be found in the report on voting indicated in
8 the above table.
9 The committee has decided that the contents of this document will remain unchanged until the
10 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
11 the specific document. At this date, the document will be
12 • reconfirmed,
13 • withdrawn,
14 • replaced by a revised edition, or
15 • amended.
16
17 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
18 organizations may need a transitional period following publication of a new, amended or revised IEC or
19 ISO publication in which to make products in accordance with the new requirements and to equip themselves for
20 conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
21 adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
22
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it
contains colours which are considered to
...