IEC 60601-2-35:2020/AMD1:2023

IEC 60601-2-35 ®
Edition 2.0 2023-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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
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
IEC 60601-2-35:2020-09/AMD1:2023-12(en-fr)

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IEC 60601-2-35 ®
Edition 2.0 2023-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01, 11.140 ISBN 978-2-8322-8001-0
– 2 – IEC 60601-2-35:2020/AMD1:2023
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

AMENDMENT 1
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 60601-2-35:2020 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
© IEC 2023
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2088/FDIS 62D/2108/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications/.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

___________
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and the
amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1815/RR.

___________
– 4 – IEC 60601-2-35:2020/AMD1:2023
© IEC 2023
201.1 Scope, object and related standards
Replace the existing footnote 1 with the following new footnote:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance.
201.1.3 Collateral standards
Replace the existing second paragraph with the following new paragraph:
IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, IEC 60601‑1‑8:2006,
IEC 60601‑1‑8:2006/AMD1:2012, and IEC 60601‑1‑8:2006/AMD2:2020, IEC 60601‑1‑10:2007,
IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 apply as modified in
Articles 202, 208 and 210 respectively. IEC 60601-1-3 does not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replace, in the existing third paragraph, "IEC 60601‑1:2005 and
IEC 60601‑1:2005/AMD1:2012" with "IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020".
201.2 Normative references
Replace the existing references to IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-10 with the
following new references:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for the development of
physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-10:2007/AMD2:2020
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
201.3 Terms and definitions
Replace, in the existing first paragraph, "IEC 60601‑1:2005 and IEC 60601‑1:2005/AMD1:2012"
with "IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020".
201.7.2.1.101.2 CONTROLLERS
Replace the two existing paragraphs of item a) with the following new item:
a) The HOSE shall be marked within 15 cm of the NOZZLE to caution that the NOZZLE needs to
BLANKET. The safety sign ISO 7010-M002 (see IEC 60601-1:2005, Table
be connected to a
D.2, safety sign 10) shall accompany the "NO FREE HOSING" safety sign shown in Annex
D of this particular standard.

© IEC 2023
201.7.4.2.101 Additional requirements for control devices
Replace the existing last paragraph with the following new paragraph:
For FORCED AIR DEVICES, each heated temperature control position shall be marked in °C. Such
marking shall be CLEARLY LEGIBLE.
201.13.1.2.101.5 * Blockage of a fluid circulation system
Replace the existing second paragraph with the following new paragraph:
Compliance is checked under CONDITIONS OF ADEQUATE HEAT DISCHARGE, by setting the
temperature control to maximum until steady-state conditions are reached, blocking the
circulation system between the fluid heater and the applied part for 10 s, then removing the
blockage and measuring the surface temperature immediately above the fluid inlet of the applied
part.
201.15.4.2.1.101 * Temperature and overload control devices – Additional requirements
for application
Replace, in the existing first paragraph, “IEC 60601-1-10:2007 and IEC 60601-1-
10:2007/AMD1:2013” with “IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and IEC
60601-1-10:2007/AMD2:2020”.
201.15.4.102 Ruck-resistant BLANKETS
Replace, in the subclause title, "Ruck-resistant BLANKETS" with "RUCK-RESISTANT BLANKETS".
Replace, in the existing first paragraph, "RUCKING" with "rucking" and "RUCK-RESISTANCE" with
RUCK resistance".
"
Figure 201.108 – Positions of a BLANKET for the RUCK-RESISTANCE test
RUCK-RESISTANCE" with "RUCK resistance".
Replace, in the existing figure title, "
201.15.4.103 UNDER-BLANKETS
Replace the existing first paragraph with the following new paragraph:
UNDER-BLANKETS, other than RUCK-RESISTANT BLANKETS, FORCED AIR DEVICE BLANKETS, and
circulating liquid BLANKETS, shall be provided with means to prevent rucking. The means used
for this purpose shall be permanently attached, ensure that the BLANKET cannot RUCK in any
direction, and not cause damage to the BLANKET in NORMAL USE. If tapes or similar means are
provided for this purpose, they shall be so positioned and of such a length that the BLANKET can
size for which it is intended. Pins
be readily and effectively secured to the maximum mattress
shall not be used.
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests
Replace the existing text of this clause, including 202.8.9, with the following new text:
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply.
NOTE A HEATING DEVICE is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.

– 6 – IEC 60601-2-35:2020/AMD1:2023
© IEC 2023
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
Replace the existing text of this clause with the following new text:
IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020
apply, except as follows:
210 * Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS
Replace, in the existing first paragraph, “IEC 60601-1-10:2007 and IEC 60601-1-
10:2007/AMD1:2013” with “IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and IEC
60601-1-10:2007/AMD2:2020”. (2 occurrences)
AA.2 RATIONALE FOR PARTICULAR CLAUSES AND SUBCLAUSES
Subclause 210 – Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS
Replace, in the existing title of this clause, “subclause” with “clause”.
Replace, in the existing first paragraph, “IEC 60601-1-10:2007 and IEC 60601-1-
10:2007/AMD1:2013” with “IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and IEC
60601-1-10:2007/AMD2:2020”.
BB.1 LAGGING MATERIAL
Replace the existing second item of the first paragraph with the following new item:
– thermal conductivity 0,03 W/(mK) -10%…0,04 W/(mK) + 10%.
BB.2 Test procedure
Replace the existing introductory text of the list with the following new text:
The heat source is connected to the supply and the temperature rise is measured. The thickness
of the LAGGING MATERIAL is established when the following steady temperature rises are
recorded:
Annex HH (normative) ─ Safety test procedure for average CONTACT SURFACE
TEMPERATURE fo
...