IEC 60601-2-52:2009/AMD1:2015

Amendment 1 - Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

Amendement 1 - Appareils électromédicaux - Partie 2-52: Exigences particulières de sécurité de base et de performances essentielles des lits médicaux

General Information

• Status: Published
• Publication Date: 17-Mar-2015
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.140 - Hospital equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 4 - TC 62/SC 62D/JWG 4
• Current Stage: PPUB - Publication issued
• Start Date: 31-Mar-2015
• Completion Date: 18-Mar-2015

Relations

• Amends: IEC 60601-2-52:2009 - Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-52
Edition 1.0 2015-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-52: Particular requirements for the basic safety and essential performance
of medical beds
Appareils électromédicaux –
Partie 2-52: Exigences particulières de sécurité de base et de performances
essentielles des lits médicaux

IEC 60601-2-52:2009-12/AMD1:2015-03(en-fr)

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,

77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: [e-mail].
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient plus de 30 000 termes et définitions en
Spécifications techniques, Rapports techniques et autres
anglais et en français, ainsi que les termes équivalents dans
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
15 langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.

Recherche de publications IEC - www.iec.ch/searchpub
Glossaire IEC - std.iec.ch/glossary
Plus de 60 000 entrées terminologiques électrotechniques, en
La recherche avancée permet de trouver des publications IEC
en utilisant différents critères (numéro de référence, texte, anglais et en français, extraites des articles Termes et
comité d’études,…). Elle donne aussi des informations sur les Définitions des publications IEC parues depuis 2002. Plus
projets et les publications remplacées ou retirées. certaines entrées antérieures extraites des publications des

CE 37, 77, 86 et CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished

Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just
Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
[e-mail].
IEC 60601-2-52
Edition 1.0 2015-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-52: Particular requirements for the basic safety and essential performance

of medical beds
Appareils électromédicaux –
Partie 2-52: Exigences particulières de sécurité de base et de performances

essentielles des lits médicaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.140 ISBN 978-2-8322-2390-1

– 2 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1186/FDIS 62D/1232/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.
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 web site 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.
_____________
201.1.1 * Scope
Replace the existing text of the first paragraph with the following:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL BEDS as defined in 201.3.212, intended for ADULTS as defined in 201.3.219.
201.1.2 Object
Replace the existing text of the replacement with the following:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for MEDICAL BEDS as defined in 201.3.212 intended for ADULTS as
defined in 201.3.219.
201.3 Terms and definitions
Add the following new term and definition:
201.3.219
* ADULT
PATIENT having a physical size equal to or more than 146 cm, a mass equal to or more than
40 kg and a body mass index (BMI) equal to or more than 17

201.4 General requirements
Replace the existing text of the clause by the following:

© IEC 2015
Clause 4 of the general standard applies, except as follows:
201.4.2.2 * General requirement for RISK MANAGEMENT
Addition:
The MANUFACTURER shall include, in the RISK MANAGEMENT PROCESS, HAZARDS related to
PATIENTS taller than 185 cm.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.

Figure 201.103 – Entrapment test tools
Replace the existing figure by the following new figure:
Dimensions in millimetres
Ø120 -0,5
228 ±1
115 ±1
IEC
Key
1 Total weight 5,1 kg ±0,05 kg
2 Marked centre line
3 Surface roughness 1,6
4 Drilling hole for weight adjustment
Figure 201.103a) – Cone tool schematic
Ø60 -0,5
– 4 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
Dimensions in millimetres
+1
318 0
1 3
IEC
Key
1 Total weight 3,34 kg ±0,05 kg
2 Marked centre line
3 Surface roughness 1,6
4 Drilling hole for weight adjustment
Figure 201.103b) – Cylinder tool schematic
Figure 201.103 – Entrapment test tools
201.7 ME EQUIPMENT identification, marking and documents
201.7.2.2 Identification
Add, after 201.7.2.2.106, the following new subclause:
201.7.2.2.107 Marking on the MEDICAL BED for ADULTS
The MEDICAL BEDS shall be marked on a prominent place with the symbol indicated in Figure
201.106.
IEC
Figure 201.120 – Physical description of an ADULT
Ø60 -0,5
Ø43,9 ±0,2
© IEC 2015
201.7.9.2 Instructions for use
201.7.9.2.1 General
Add the following new item:
e) a description of the intended PATIENT group(s).

201.7.9.2.2 Warning and safety notices
Add the following new items:
e) The instructions for use shall provide a warning if a MEDICAL BED is limited to a specific
group of PATIENTS.
f) The instructions for use shall provide a warning that incompatible SIDE RAILS and
mattresses can cause an entrapment hazard

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Figure 201.107 – Example of MEDICAL BED with segmented or split SIDE RAIL
Replace the existing figure with the following:
IEC
Only applies when the area C above is < 60 mm.
A represents the different areas A , A , A , A , A and A
x
1 2 3 4 5 6
Key
1 Area of TOOL representing neck diameter (60 mm).
2 Area of TOOL representing chest breadth (318 mm).
3 Area of TOOL representing head breadth (120 mm).

– 6 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
4 MATTRESS SUPPORT PLATFORM
5 HEAD BOARD
6 FOOT BOARD
7 Mattress
8 SIDE RAIL
Figure 201.107 – Example of MEDICAL BED with segmented or split SIDE RAIL
Figure 201.108 – Example of MEDICAL BED with single piece SIDE RAIL
Replace the existing figure with the following:
IEC
Only applies when the area C is < 60 mm.
Key
1 Area of TOOL representing neck diameter (60 mm).
2 Area of TOOL representing chest breadth (318 mm).
3 Area of TOOL representing head breadth (120 mm).
4 MATTRESS SUPPORT PLATFORM
5 HEAD BOARD
6 FOOT BOARD
7 Mattress
8 SIDE RAIL
Figure 201.108 – Example of MEDICAL BED with single piece SIDE RAIL

© IEC 2015
201.9.8.3.2 *Static forces due to loading from persons
Add, after the existing second paragraph the following note:
NOTE It might be necessary to support assemblies that are connected to the assembly under test but do not
require such a high safety factor, e.g. an assembly under test requires a TENSILE SAFETY FACTOR of 4 and the
assembly supporting it is designed with a lower TENSILE SAFETY FACTOR. Use of additional support should be
explained in the test report.
Annex AA – Particular guidance and rationale
AA.2 Rationale for particular clauses and subclauses
Subclause 201.1.1 – Scope
Add, at the end of the existing third sentence, the phrase: ", a weight of equal to or more than
40 kg and a body mass index (BMI) equal to or more than 17."

Add the following new rationales:
Definition 201.3.201 – ADULT
The body mass index is calculated by the following formula:
m
BMI=
l
Where:
m in kg
l in m
The body mass index (BMI) as an additional measure for the shape of the human body was
included in IEC 60601-2-52, since the physical size of some patients is indeed inside the
limits of the first version of IEC 60601-2 52 (exceeding 146 cm and 40 kg) but nevertheless
due to their particular atypical anatomy there might be a risk of being entrapped in the side
rails.
The body mass index (BMI) is a measure for the human body shape based on an individual's
mass and height. BMI provides a simple numeric measure of a person's thickness or thinness,
allowing health professionals to discuss overweight and underweight problems more
objectively with their PATIENTS.
For an explanation see also 201.1.1.
Subclause 201.4.2 – RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
Possible HAZARDS may be: rolling over the SIDE RAIL, entrapment in MEDICAL BED extension and
HAZARDS related to the TRAPPING ZONES described in 201.9.2.2.

– 8 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
Subclause 201.9.101 – Protection against inadvertent PATIENT falls
Delete the existing fourth paragraph of this rationale.

_____________
– 10 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62D: Appareils électromédicaux, du
comité d'études 62 de l'IEC: Equipements électriques dans la pratique médicale.
Le texte de cet amendement est issu des documents suivants:
FDIS Rapport de vote
62D/1186/FDIS 62D/1232/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à l'approbation de cet amendement.
Le comité a décidé que le contenu de cet amendement et de la publication de base ne sera
pas modifié avant la date de stabilité indiquée sur le site web de l’IEC sous
"http://webstore.iec.ch" dans les données relatives à la publication recherchée. A cette date,
la publication sera
• reconduite,
• supprimée,
• remplacée
...