EN 60601-2-52:2010

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

Medizinische elektrische Geräte - Teil 2-52: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Betten (IEC 60601-2-52:2009)

Appareils électromédicaux - Partie 2-52: Exigences particulières pour la sécurité de base et les performances essentielles des lits médicaux (CEI 60601-2-52:2009)

La CEI 60601-2-52:2009 s'applique à la sécurité de base et aux performances essentielles des lits medicaux destinés aux adultes. Cette première édition annule et remplace la première édition de la CEI 60601-2-38, parue en 1996, et son Amendement (1999). Elle constitue une révision technique. La CEI 60601-2-52:2009 est la réalisation d'un travail important d'alignement et d'ajustement de domaines d'application entre la CEI 60601-2-38, la EN 1970, et la troisième édition de la CEI 60601-1.

Medicinska električna oprema - 2-52. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinskih postelj (IEC 60601-2-52:2009)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKIH POSTELJ, namenjenih odraslim, v nadaljevanju MEDICINSKA POSTELJA, kot je opredeljena v 201.3.212. Če je klavzula ali podklavzula posebej namenjena temu, da se uporablja le za MEDICINSKO POSTELJO ali le za ME SISTEME, vsebina te klavzule ali podklavzule tako navaja. V nasprotnem primeru tako klavzula ali podklavzula veljata za ustrezno MEDICINSKO POSTELJO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja MEDECINSKE POSTELJE ali ME SISTEMOV znotraj področja uporabe tega standarda, niso zajete z posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

• Status: Published
• Publication Date: 08-Apr-2010
• Withdrawal Date: 31-Mar-2013
• ICS: 11.140 - Hospital equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 09-Apr-2010
• Completion Date: 09-Apr-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-52:2010 - Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

Relations

• Replaces: EN 60601-2-38:1996 - Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-2-38:1996/A1:2000 - Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
• Effective Date: 28-Jan-2023
• Replaces: EN 62739-1:2013 - Test method for erosion of wave soldering equipment using molten lead-free solder alloy - Part 1: Erosion test method for metal materials without surface processing
• Effective Date: 23-Jan-2023
• Amends: EN 60335-2-75:2004 - Household and similar electrical appliances - Safety - Part 2-75: Particular requirements for commercial dispensing appliances and vending machines
• Effective Date: 07-Jun-2022
• Amended By: EN 60601-2-52:2010/A1:2015 - Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
• Effective Date: 28-Jan-2023
• Corrected By: EN 60601-2-52:2010/AC:2011 - Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2010
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ELVWYHQHODVWQRVWLPHGLFLQVNLKSRVWHOM,(&
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and
essential performance of medical beds (IEC 60601-2-52:2009)
Medizinische elektrische Geräte - Teil 2-52: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von medizinischen Betten (IEC
60601-2-52:2009)
Appareils électromédicaux - Partie 2-52: Exigences particulières de sécurité de base et
de performances essentielles des lits médicaux (CEI 60601-2-52:2009)
Ta slovenski standard je istoveten z: EN 60601-2-52:2010
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-52
NORME EUROPÉENNE
April 2010
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 60601-2-38:1996 + A1:2000, EN 1970:2000

English version
Medical electrical equipment -
Part 2-52: Particular requirements for basic safety and essential
performance of medical beds
(IEC 60601-2-52:2009)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-52: Exigences particulières Teil 2-52: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des lits médicaux von medizinischen Betten
(CEI 60601-2-52:2009) (IEC 60601-2-52:2009)

This European Standard was approved by CENELEC on 2010-04-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
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 Central Secretariat or to any CENELEC member.

This European Standard 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 Central Secretariat 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CEN-CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2010 CEN-CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CEN-CENELEC members.
Ref. No. EN 60601-2-52:2010 E
Foreword
The text of document 62D/795/FDIS, future edition 1 of IEC 60601-2-52, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-52 on 2010-04-01.
This European Standard supersedes EN 60601-2-38:1996 + A1:2000 and EN 1970:2000.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2011-01-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2013-04-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-52:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standards indicated:
IEC 60601-2-38 NOTE  Harmonized as EN 60601-2-38
__________
- 3 - EN 60601-2-52:2010
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Addition to Annex ZA of EN 60601-2:
Publication Year Title EN/HD Year

IEC 60068-2-31 2008 Environmental testing - EN 60068-2-31 2008
Part 2-31: Tests - Test Ec: Rough handling
shocks, primarily for equipment-type
specimens
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives

This European Standard has been prepared under a mandate given to CENELEC by the
European Commission and the European Free Trade Association and within its scope the
standard covers all relevant essential requirements as given in Annex I of the EC Directive
93/42/EEC except the following:
– Essential Requirement 7.1
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products
falling within the scope of this standard.

IEC 60601-2-52
Edition 1.0 2009-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.140 ISBN 2-8318-1068-1
– 2 – 60601-2-52 © IEC:2009
CONTENTS
FOREWORD.5
INTRODUCTION.7
201.1 Scope, object and related standards .8
201.2 Normative references.9
201.3 Terms and definitions.10
201.4 General requirements .13
201.5 General requirements for testing of ME EQUIPMENT .13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS.15
201.7 ME EQUIPMENT identification, marking and documents .15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .21
201.10 Protection against unwanted and excessive radiation HAZARDS .44
201.11 Protection against excessive temperatures and other HAZARDS .44
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .46
201.13 HAZARDOUS SITUATIONS and fault conditions .47
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47
201.15 Construction of ME EQUIPMENT .48
201.16 ME SYSTEMS .51
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .51
Annexes .51
Annex AA (informative) Particular guidance and rationale.52
Annex BB (normative) Design requirements and recommendations for MEDICAL BEDS.67
Annex CC (informative) Particular guidance for assessing risk of entrapment in v-
shaped openings .75
Bibliography.81
Index of defined terms used in this particular standard.82

Figure 201.101 – APPLIED PART.10
Figure 201.102 – MEDICAL BED, general arrangement (example, schematic presentation
only) .
Figure 201.103a – Cone tool.14
Figure 201.103b – Cylinder tool .14
Figure 201.103 – Entrapment test tools.14
Figure 201.104 – Loading pad .15
Figure 201.105 – Graphic symbol for maximum PATIENT weight and SAFE WORKING
LOAD .16
Figure 201.106 – MEDICAL BED function controls and/or actuators: guidelines for
creating graphic symbols .18
Figure 201.107 – Example of MEDICAL BED with segmented or split SIDE RAIL .22
Figure 201.108 – Example of MEDICAL BED with single piece SIDE RAIL .23
Figure 201.109 – Allowable spacing for fingers in areas of normal reach around the
MATTRESS SUPPORT PLATFORM .28
perimeter of the
60601-2-52 © IEC:2009 – 3 –
Figure 201.110 – Example using barriers for clearance measurement around the
perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment .29
Figure 201.111a – Foot and toe clearance area between moving parts and the floor.29
Figure 201.111b – Toe clearance area between moving parts and the floor .30
Figure 201.111 – Clearance areas .30
Figure 201.112 – Lateral stability test along the side of the MEDICAL BED.32
Figure 201.113 – Longitudinal stability test with removable FOOT BOARD .32
Figure 201.114 – Longitudinal stability test with fixed HEAD/FOOT BOARDS.33
Figure 201.115 – Distribution of SAFE WORKING LOAD for tests.37
Figure 201.116 – Position of loading pad (see Figure 201.104).40
Figure 201.117 – Application of forces for test of SIDE RAIL.42
Figure 201.118 – Height of SIDE RAIL .43
Figure 201.119a – Angle γ between the back section and the leg section of the
MATTRESS SUPPORT PLATFORM.49
Figure 201.119b – Angle γ between the back section and the upper leg section of the
MATTRESS SUPPORT PLATFORM.49
Figure 201.119c – Angle γ between the angled back section and upper leg section of
MATTRESS SUPPORT PLATFORM .49
the
Figure 201.119d – Angle γ between the angled back section and the leg/upper leg
section of the MATTRESS SUPPORT PLATFORM .50
Figure 201.119 – Configurations of the MATTRESS SUPPORT PLATFORM .50
Figure AA.1 – Marking to select recommended mattresses specified by the
MANUFACTURER.54
Figure AA.2 – Marking for detachable SIDE RAILS specified by the MANUFACTURER .54
Figure AA.3 – Resultant forces without mattress .58
Figure AA.4 – Resultant forces with mattress.58
Figure AA.5 – Example of 60 mm gap measurement of B.
...