IEC 80601-2-35:2009/Amd 1:2016

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

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 — Amendement 1

General Information

• Status: Withdrawn
• Publication Date: 01-May-2016
• Withdrawal Date: 01-May-2016
• ICS: 11.140 - Hospital equipment
• Technical Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Drafting Committee: ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 21-Sep-2020

Relations

• Amends: IEC 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 or mattresses and intended for heating in medical use
• Effective Date: 09-May-2020
• Consolidated By: ISO 19574:2022 - Footwear and footwear components — Qualitative test method to assess antifungal activity (growth test)
• Effective Date: 06-Jun-2022

Standards Content (Sample)

IEC 80601-2-35
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 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 chauffants et destinés au réchauffage des patients en
usage médical

IEC 80601-2-35:2009-10/AMD1:2016-04(en-fr)

---------------------- Page: 1 ----------------------
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IEC 80601-2-35


Edition 2.0 2016-04




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




AM ENDMENT 1

AM ENDEMENT 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 chauffants et destinés au réchauffage des patients en

usage médical









INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040.01 ISBN 978-2-8322-3345-0



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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– 2 – IEC 80601-2-35:2009/AMD1:2016
© IEC 2016
FOREWORD
This amendment has been prepared by a joint working group of IEC subcommittee 62D:
Electromedical equipment of IEC technical committee 62: Electrical equipment in medical
practice and ISO subcommittee TC121/SC1: Breathing attachments and anaesthetic
machines, of ISO technical committee 121: Anaesthetic and respiratory equipment.
It is published as a double logo standard.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1328/FDIS 62D/1355/RVD

Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table. In ISO, the standard has been approved by 15 P-
members out of 15 having cast a vote.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

_____________

INTRODUCTION
Replace, in the second paragraph, “IEC 60601-1 (third edition, 2005)” by “IEC 60601-1”.
201.1 Scope, object and related standards
Replace, in footnote 1), “IEC 60601-1:2005” by “IEC 60601-1”.
201.2 Normative references
Replace “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
Replace “IEC 60601-1-8:2006” by “IEC 60601-1-8”.
Replace “IEC 60601-1-10:2007” by “IEC 60601-1-10”.

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IEC 80601-2-35:2009/AMD1:2016 – 3 –
© IEC 2016
Delete the following reference:
ISO 3743-1:1994, Acoustics – Determination of sound power levels of noise sources –
Engineering methods for small, movable sources in reverberant fields – Part 1: Comparison
method for hard-walled test rooms
201.3 Terms and definitions
Replace, in the first paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.7.2.1.101.2 CONTROLLERS
Replace the text in item a) by the following new text:
a) The HOSE shall be marked within 15 cm of the NOZZLE to caution that the NOZZLE needs to
be connected to a BLANKET. The following statement and the safety sign ISO 7010-M002
(see IEC 60601-1, Table D.2, safety sign 10) shall accompany the “NO FREE HOSING”
safety sign of IEC 60878, shown in Annex D of this particular standard:
201.8.5.1.2.101 * Additional requirements for MEANS OF PATIENT PROTECTION (MOPP)
Replace the first two paragraphs by the following:
The electrical circuit within the APPLIED PART shall be isolated from earth by at least one MOPP
and from MAINS by at least two MOPP. Where a transformer is used to achieve this isolation, it
need not meet 15.5.3.
201.12.3.104 Disconnection or short-circuiting of sensors ALARM CONDITION
Replace the second paragraph by the following:
HEATING DEVICE shall be equipped with an ALARM SYSTEM that includes at least a MEDIUM
The
PRIORITY TECHNICAL ALARM CONDITION for HIGH HEAT TRANSFER DEVICES and at least a LOW
PRIORITY ALARM for LOW HEAT TRANSFER DEVICES and FORCED AIR DEVICES that indicates when
leads to either the temperature control sensors or the THERMAL CUT-OUT sensors are damaged
or otherwise disconnected from the control unit.
202 Electromagnetic compatibility – Requirements and tests
Replace, in the first paragraph, “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
202.6.2.3 Radiated RF electromagnetic fields
Replace the number, title and entire text by the following new subclause number, title and
text:
202.8.9 IMMUNITY TEST LEVELS
Addition:
For radiated radio-frequency electromagnetic fields, the HEATING DEVICE and/or system shall

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– 4 – IEC 80601-2-35:2009/AMD1:2016
© IEC 2016
– continue to perform its intended function as specified by the MANUFACTURER at the level up
to 3 V/m for the frequency range of the collateral standard of EMC.
NOTE A HEATING DEVICE is not considered to be used in a HOME HEALTHCARE ENVIRONMENT.
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
Replace, in the first paragraph, “IEC 60601-1-8:2006” by “IEC 60601-1-8”.
210 Requirements for the development of physiologic closed-loop controllers
Replace both instances of “IEC 60601-1-10:2007” by “IEC 60601-1-10”.

Annex AA
(informative)

Particular guidance and rationale

Add, immediately after the annex title, the following new text and figure:
AA.1 Requirements and the safety concept of this standard
Compliance with the minimum safety requirements specified in this particular standard is
predominantly checked by measurement of physical quantities such as the temperature. In
most cases the spatial location of the measuring site or the temporal development of the
quantity is of interest. Therefore, the expert group of this standard considered it helpful to
provide a synopsis of the requirements of this standard. Hence, Figure AA.1 illustrates the
requirements and their schematic measuring sites or expected temporal development. The
requirements as given by their clauses are set in brackets.

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