IEC 60601-2-50:2000

Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment

Specifies requirements applicable to infant phototherapy equipment which by means of visible radiation serve to reduce bilirubin in the body of infants suffering from icterus in the first months of life. The object of this Particular Standard is to establish requirements for infant phototherapy equipment which reduce the safety hazards to patients and operators as much as possible and to specify tests for demonstrating compliance with these requirements.

Appareils électromédicaux - Partie 2-50: Règles particulières de sécurité des appareils de photothérapie pour nouveau-nés

Spécifie les exigences applicables aux appareils de photothérapie pour nouveau-nés qui, par utilisation d'un rayonnement visible, servent à réduire la concentration en bilirubine dans l'organisme des nouveau-nés atteints d'un ictère dans les premiers mois de leur vie. La présente Norme Particulière est destinée à établir des exigences applicables aux appareils de photothérapie pour nouveau-nés afin de réduire autant que possible les risques pour les patients et les opérateurs et à spécifier des essais pour démontrer la conformité avec les présentes exigences.

General Information

• Status: Published
• Publication Date: 30-Jul-2000
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 24-Mar-2009

Relations

• Corrected By: IEC 60601-2-50:2000/COR1:2001 - Corrigendum 1 - Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-50:2009 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-50
First edition
2000-07
Medical electrical equipment –
Part 2-50:
Particular requirements for the safety
of infant phototherapy equipment
Appareils électromédicaux –
Partie 2-50:
Prescriptions particulières de sécurité des
appareils de photothérapie infantile

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
60601-2-50
First edition
2000-07
Medical electrical equipment –
Part 2-50:
Particular requirements for the safety
of infant phototherapy equipment
Appareils électromédicaux –
Partie 2-50:
Prescriptions particulières de sécurité des
appareils de photothérapie infantile

 IEC 2000  Copyright - all rights reserved
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 the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
T
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-50  IEC:2000(E)

CONTENTS
Page
FOREWORD . 4

INTRODUCTION .6

SECTION ONE – GENERAL
Clause
1 Scope and object . 7
1.1 Scope. 7
1.2 Object . 7
1.3 Particular Standards . 7
1.5 Collateral Standards. 8
*2 Terminology and definitions. 8
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES . 8
2.12 Miscellaneous. 9
4 General requirements for tests . 9
4.6 Other conditions . 9
5 Classification .10
6 Identification, marking and documents. 10
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts . 10
6.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts . 10
6.8 ACCOMPANYING DOCUMENTS . 10
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 13
24 Stability in NORMAL USE . 13
25 Expelled parts .14
26 Vibration and noise . 14

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
*32 Light radiation (including lasers) . 14
*33 Infrared radiation. 14
*34 Ultraviolet radiation .15
36 ELECTROMAGNETIC COMPATIBILITY . 15
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OR FLAMMABLE
ANAESTHETIC MIXTURES
60601-2-50  IEC:2000(E) – 3 –

Clause Page
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES

AND OTHER SAFETY HAZARDS
42 Excessive temperatures . 15

43 Fire prevention .16

SECTION EIGHT – ACCURACY OF OPERATING DATA AND

PROTECTION AGAINST HAZARDOUS OUTPUT

50 Accuracy of operating data . 17
50.101 Measuring principles . 17
*50.102 Spectral method. 17
50.103 Integral method. 18
50.104 Maximum TOTAL IRRADIANCE FOR BILIRUBIN E . 18
bi max
*50.105 Distribution . 18
51 Protection against hazardous output . 18
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS –
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions . 18
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
55 ENCLOSURES and covers . 19
56 Components and general assembly . 19
56.8 Indicators . 19
Annex L References – Publications mentioned in this standard . 21
Annex AA (informative) Guidance and rationale for particular subclauses. 22
Figure 101 – Graphical symbol: Eye protection for the PATIENT (see 6.1) . 19
Figure 102 – Example of a measuring grid . 20

– 4 – 60601-2-50  IEC:2000(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-50: Particular requirements for the safety

of infant phototherapy equipment

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-50 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/363/FDIS 62D/369/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annex AA is for information only.
The contents of the corrigendum of March 2001 have been included in this copy.

60601-2-50  IEC:2000(E) – 5 –

In this Particular Standard the following print types are used:

– requirements, compliance with which can be tested, and definitions: roman type;

– notes, explanations, advice, introductions, general statements, exceptions and references: smaller type;

– test specifications: in italic type;

–TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 60601-1 OR IN THIS PARTICULAR

STANDARD: SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until 2005.

At this date, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

– 6 – 60601-2-50  IEC:2000(E)

INTRODUCTION
This Particular Standard concerns the safety of INFANT PHOTOTHERAPY EQUIPMENT. The

minimum requirements specified in this Particular Standard shall ensure a reasonable degree

of safety during operation. This Particular Standard amends and supplements IEC 60601-1

(second edition 1988): Medical electrical equipment – Part 1: General requirements for safety,

as amended by its amendment 1 (1991) and its amendment 2 (1995), hereinafter referred to as

the General Standard. The requirements of this Particular Standard take priority over those of

the General Standard.
A guidance and rationale for the requirements of this Particular Standard is included in
annex AA.
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this standard.
An asterisk (*) by a clause or subclause number indicates that some explanatory notes are
given in the guidance and rationale section at the end of this Particular Standard.

60601-2-50  IEC:2000(E) – 7 –

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-50: Particular requirements for the safety

of infant phototherapy equipment

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply, except as follows:

1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard specifies requirements applicable to INFANT PHOTOTHERAPY EQUIPMENT
(as defined in 2.1.101) which by means of visible radiation serve to reduce bilirubin in the body
of infants suffering from icterus in the first mont
...

IEC 60601-2-50
Edition 1.0 2000-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-50: Particular requirements for the safety of infant phototherapy
equipment
Appareils électromédicaux –
Partie 2-50: Règles particulières de sécurité des appareils de photothérapie pour
nouveau-nés
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 la CEI ou du Comité national de la CEI du pays du demandeur.

Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette

publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: 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.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) 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 CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]
IEC 60601-2-50
Edition 1.0 2000-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-50: Particular requirements for the safety of infant phototherapy
equipment
Appareils électromédicaux –
Partie 2-50: Règles particulières de sécurité des appareils de photothérapie
pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
U
CODE PRIX
ICS 11.040.60 ISBN 2-8318-8253-2
– 2 – 60601-2-50 © CEI:2000
SOMMAIRE
AVANT-PROPOS .4

INTRODUCTION.10

SECTION UN – GÉNÉRALITÉS
1 Domaine d’application et objet .12

1.1 Domaine d’application.12

1.2 Objet.12
1.3 Normes Particulières .12
1.5   Normes Collatérales.14
*2 Terminologie et définitions .14
2.1 Parties d’APPAREILS, auxiliaires et ACCESSOIRES .14
2.12 Divers.16
4 Exigences générales relatives aux essais .16
4.6 Autres conditions .16
5 Classification.18
6 Identification, marquage et documentation .18
6.1 Marquage sur l’extérieur de l’APPAREIL ou des parties d’APPAREIL .18
6.2 Marquage sur l’intérieur de l’APPAREIL ou des parties d’APPAREIL .18
6.8 DOCUMENTS D’ACCOMPAGNEMENT .18

SECTION DEUX – CONDITIONS D’ENVIRONNEMENT

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES

21 Résistance mécanique.24
24 Stabilité en UTILISATION NORMALE.24
25 Projections d’objets .26

26 Vibrations et bruit .26

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS AUX RAYONNEMENTS
NON DÉSIRÉS OU EXCESSIFS
*32 Rayonnements lumineux (y compris les rayonnements laser) .26
*33 Rayonnements infrarouges .26
*34 Rayonnements ultraviolets .28
36 COMPATIBILITE ELECTROMAGNETIQUE.28

SECTION SIX – PROTECTION CONTRE LES RISQUES D’IGNITION
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES

60601-2-50 © IEC:2000 – 3 –
CONTENTS
FOREWORD.7

INTRODUCTION.11

SECTION ONE – GENERAL
1 Scope and object .13

1.1 Scope.13

1.2 Object.13

1.3 Particular Standards.13

1.5 Collateral Standards .15
*2 Terminology and definitions .15
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES .15
2.12 Miscellaneous .17
4 General requirements for tests.17
4.6 Other conditions.17
5 Classification.19
6 Identification, marking and documents .19
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts.19
EQUIPMENT or EQUIPMENT parts .19
6.2 Marking on the inside of
6.8 ACCOMPANYING DOCUMENTS.19

SECTION TWO – ENVIRONMENTAL CONDITIONS

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS

21 Mechanical strength.25
NORMAL USE.25
24 Stability in
25 Expelled parts.27
26 Vibration and noise .27

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
*32 Light radiation (including lasers).27
*33 Infrared radiation .27
*34 Ultraviolet radiation.29
LECTROMAGNETIC COMPATIBILITY.29
36 E
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OR FLAMMABLE
ANAESTHETIC MIXTURES
– 4 – 60601-2-50 © CEI:2000
SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES

ET LES AUTRES RISQUES
42 Températures excessives.28

43 Prévention du feu.30

SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE

PRÉSENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .32
50.101 Principes de mesure .32
*50.102 Méthode spectrale .32
50.103 Méthode intégrale .34
50.104 ÉCLAIREMENT TOTAL POUR LA BILIRUBINE maximal E .34
bi max
*50.105 Distribution .34
51 Protection contre les caractéristiques de sortie présentant des risques.34

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT –
ESSAIS D’ENVIRONNEMENT
52 Fonctionnement anormal et conditions de défaut .34

SECTION DIX – RÈGLES DE CONSTRUCTION

55 ENVELOPPES et capots .34
56 Composants et ensembles.36
56.8 Voyants lumineux .36

Annexe L Références – Publications mentionnées dans la prés
...