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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS intended for adults, hereafter referred to as MEDICAL BED as defined in 201.3.212. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

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)

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
03-May-2010
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
13-Apr-2010
Due Date
18-Jun-2010
Completion Date
04-May-2010

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SLOVENSKI STANDARD
SIST EN 60601-2-52:2010
01-junij-2010
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
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
SIST EN 60601-2-52:2010 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-52:2010
---------------------- Page: 2 ----------------------
SIST EN 60601-2-52:2010
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
---------------------- Page: 3 ----------------------
SIST EN 60601-2-52:2010
EN 60601-2-52:2010 - 2 -
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
__________
---------------------- Page: 4 ----------------------
SIST EN 60601-2-52:2010
- 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
---------------------- Page: 5 ----------------------
SIST EN 60601-2-52:2010
EN 60601-2-52:2010 - 4 -
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.
---------------------- Page: 6 ----------------------
SIST EN 60601-2-52:2010
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
CODE PRIX
ICS 11.140 ISBN 2-8318-1068-1
---------------------- Page: 7 ----------------------
SIST EN 60601-2-52:2010
– 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
---------------------- Page: 8 ----------------------
SIST EN 60601-2-52:2010
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 – Impactor .........................................................................................................69

Figure BB.3 – Schematic presentation of under MEDICAL BED clearance.................................72

---------------------- Page: 9 ----------------------
SIST EN 60601-2-52:2010
– 4 – 60601-2-52 © IEC:2009
Figure BB.4 – Recommendations and requirements regarding angles for different

sections of the MATTRESS SUPPORT PLATFORM ........................................................................74

Figure CC.1 – Wedge tool.....................................................................................................76

Figure CC.2 – V-shaped opening in relation to B...................................................................77

Figure CC.3 – Pass/fail in relation to area B .........................................................................77

Figure CC.4 – Positioning of wedge tool ...............................................................................78

Figure CC.5 – Pass/fail in relation to area C between HEAD BOARD and FOOT BOARD..............79

Figure CC.6 – Pass/fail in relation to area C between split SIDE RAILS ...................................80

Table 201.101 – Protection against PATIENT entrapment .......................................................24

Table 201.102 – Protection against inadvertent PATIENT falls ................................................44

Table 24 – Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED

PARTS....................................................................................................................................45

Table BB.1 – Normative and informative requirements for different APPLICATION

ENVIRONMENTS 1 to 5 .............................................................................................................67

---------------------- Page: 10 ----------------------
SIST EN 60601-2-52:2010
60601-2-52 © IEC:2009 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-52: Particular requirements for the basic safety
and essential performance of medical beds
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

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-52 has been prepared by IEC subcommittee 62D:

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical

practice, and by ISO technical committee 173: Assistive products for persons with disability.

It is published as double logo standard.

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.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/795/FDIS 62D/815/RVD
---------------------- Page: 11 ----------------------
SIST EN 60601-2-52:2010
– 6 – 60601-2-52 © IEC:2009

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table. In ISO, the standard has been approved by

20 P-members out of 20 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.

– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type.

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this collateral standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC

Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance

with this standard;

– “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.

The committee has decided that the contents of this publication will remain unchanged until

the maintenance result 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.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-52:2010
60601-2-52 © IEC:2009 – 7 –
INTRODUCTION

In 1996, the IEC published the first edition of the particular standard for electrically operated

hospital beds, IEC 60601-2-38. The publication was in response to demand in the field for a

universal standard addressing HAZARDS specific to the safety of the hospital bed. Used in

conjunction with a MANUFACTURER’S RISK ASSESSMENT, the standard was felt to be the current

thinking on establishing a basic safety benchmark for industry.

An amendment of IEC 60601-2-38 issued in 1999 recognized the need to mitigate against a

RISK of PATIENT entrapment in the SIDE RAILS, again combined with the use of the

MANUFACTURER’S RISK ASSESSMENT. Although this improved the particular standard, it still was

centered upon electrically operated hospital beds, and failed to take into account manually

operated hospital beds and products in other medical environments.

In 2000, the EN 1970 standard (Adjustable beds for DISABLED PERSONS – Requirements and

test methods) was published, which addressed beds used by DISABLED PERSONS to alleviate or

compensate for a disability or handicap. This standard offered a broadened scope in

conjunction with IEC 60601-2-38, but after the edition of Amendment 1 to IEC 60601-2-38, the

opportunity presented itself to combine the two standards to a common, international

standard.

As work began on the integration, the IEC adjusted its stance on BASIC SAFETY and ESSENTIAL

PERFORMANCE, integrating them into the third edition of IEC 60601-1. It therefore became

necessary to align the new standard with the third edition. The particular standard was given

a new number, IEC 60601-2-52, and work began on alignment to third edition.

This particular standard, therefore, 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. It

represents the current thinking in BASIC SAFETY and ESSENTIAL PERFORMANCE of the MEDICAL

BED as used to alleviate illness of PATIENTS and disability of DISABLED PERSONS. This is the

effort of a joint working group of the IEC and the ISO.
---------------------- Page: 13 ----------------------
SIST EN 60601-2-52:2010
– 8 – 60601-2-52 © IEC:2009
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-52: Particular requirements for the basic safety
and essential performance of medical beds
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

MEDICAL BEDS intended for adults, hereafter referred to as MEDICAL BED as defined in

201.3.212.

If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to

ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the

case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within

the scope of this standard are not covered by specific requirements in this standard except in

7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the General Standard.
201.1.2 Object
Replacement:

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.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 2 of this particular standard.
do not apply. All other published
IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10
collateral standards in the IEC 60601-1 series apply as published.
—————————

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

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
---------------------- Page: 14 ----------------------
SIST EN 60601-2-52:2010
60601-2-52 © IEC:2009 – 9 –
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particu
...

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