IEC 60601-2-52:2009
(Main)Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
IEC 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. The contents of the corrigendum of September 2010 have been included in this copy.
Appareil électromédicaux - Partie 2-52: Exigences particulières de sécurité de base et de performances essentielles des lits médicaux
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. Le contenu du corrigendum de septembre 2010 a été pris en considération dans cet exemplaire.
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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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
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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 978-2-88910-226-6
– 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.58
Figure AA.6 – Angle measurement example of B .58
Figure AA.7 – Placement of measurement TOOL for measurement of D .59
Figure AA.8 – Example of area D measurement that passes .59
Figure AA.9 – Example of area D measurement that fails.59
Figure AA.10 – Example of area D measurement that fails (on limit) .60
Figure AA.11 – Example of potential PATIENT entrapment in area A within the SIDE RAIL .60
Figure AA.12 – Example of potential PATIENT entrapment in area A below the SIDE RAIL .60
Figure AA.13 – Example of potential PATIENT entrapment in area B.60
Figure AA.14 – Example of potential PATIENT entrapment in area C between split SIDE
RAIL .60
Figure AA.15 – Example of potential PATIENT entrapment in area C between SIDE RAIL
and HEAD BOARD .61
Figure AA.16 – Example of potential PATIENT entrapment in area D.61
Figure AA.17 – Example of potential PATIENT entrapment in area A below a single
piece SIDE RAIL .61
Figure BB.1 – Other areas of possible impact testing.68
Figure BB.2
...
IEC 60601-2-52
Edition 1.1 2015-03
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 pour la sécurité de base et les performances
essentielles des lits médicaux
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.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
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 corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
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committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
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IEC 60601-2-52
Edition 1.1 2015-03
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 pour la sécurité de base et les performances
essentielles des lits médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.140 ISBN 978-2-8322-2456-4
IEC 60601-2-52
Edition 1.1 2015-03
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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 pour la sécurité de base et les performances
essentielles des lits médicaux
– 2 – IEC 60601-2-52:2009
+AMD1:2015 CSV IEC 2015
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
201.1 Scope, object and related standards. 9
201.2 Normative references . 11
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 17
201.7 ME EQUIPMENT identification, marking and documents . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 22
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 48
201.11 Protection against excessive temperatures and other HAZARDS . 48
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 50
201.13 HAZARDOUS SITUATIONS and fault conditions . 51
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 51
201.15 Construction of ME EQUIPMENT . 52
201.16 ME SYSTEMS. 55
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 55
Annexes . 55
Annex AA (informative) Particular guidance and rationale . 56
Annex BB (normative) Design requirements and recommendations for MEDICAL BEDS . 71
Annex CC (informative) Particular guidance for assessing risk of entrapment in v-
shaped openings . 79
Bibliography . 85
Index of defined terms used in this particular standard. 86
Figure 201.101 – APPLIED PART . 11
Figure 201.102 – MEDICAL BED, general arrangement (example, schematic presentation
only) . 13
Figure 201.103a – Cone tool . 15
Figure 201.103b – Cylinder tool . 15
Figure 201.103 – Entrapment test tools. 16
Figure 201.104 – Loading pad . 17
Figure 201.105 – Graphic symbol for maximum PATIENT weight and SAFE WORKING
LOAD . 18
Figure 201.106 – MEDICAL BED function controls and/or actuators: guidelines for
creating graphic symbols . 20
Figure 201.107 – Example of MEDICAL BED with segmented or split SIDE RAIL . 25
Figure 201.108 – Example of MEDICAL BED with single piece SIDE RAIL . 27
Figure 201.109 – Allowable spacing for fingers in areas of normal reach around the
perimeter of the MATTRESS SUPPORT PLATFORM . 32
+AMD1:2015 CSV IEC 2015
Figure 201.110 – Example using barriers for clearance measurement around the
perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment . 33
Figure 201.111a – Foot and toe clearance area between moving parts and the floor . 33
Figure 201.111b – Toe clearance area between moving parts and the floor . 34
Figure 201.111 – Clearance areas . 34
Figure 201.112 – Lateral stability test along the side of the MEDICAL BED . 36
Figure 201.113 – Longitudinal stability test with removable FOOT BOARD . 36
Figure 201.114 – Longitudinal stability test with fixed HEAD/FOOT BOARDS . 37
Figure 201.115 – Distribution of SAFE WORKING LOAD for tests . 41
Figure 201.116 – Position of loading pad (see Figure 201.104) . 44
Figure 201.117 – Application of forces for test of SIDE RAIL. 46
Figure 201.118 – Height of SIDE RAIL . 47
Figure 201.119a – Angle γ between the back section and the leg section of the
MATTRESS SUPPORT PLATFORM . 53
Figure 201.119b – Angle γ between the back section and the upper leg section of the
MATTRESS SUPPORT PLATFORM . 53
Figure 201.119c – Angle γ between the angled back section and upper leg section of
the MATTRESS SUPPORT PLATFORM . 53
Figure 201.119d – Angle γ between the angled back section and the leg/upper leg
section of the MATTRESS SUPPORT PLATFORM . 54
Figure 201.119 – Configurations of the MATTRESS SUPPORT PLATFORM . 54
Figure 201.120 – Physical description of an ADULT . 19
Figure AA.1 – Marking to select recommended mattresses specified by the
MANUFACTURER . 58
Figure AA.2 – Marking for detachable SIDE RAILS specified by the MANUFACTURER . 59
Figure AA.3 – Resultant forces without mattress . 62
Figure AA.4 – Resultant forces with mattress . 62
Figure AA.5 – Example of 60 mm gap measurement of B . 62
Figure AA.6 – Angle measurement example of B . 62
Figure AA.7 – Placement of measurement TOOL for measurement of D .
...
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