EN 60601-2-50:2009
(Main)Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
IEC 60601-2-50:2009 establishes particular basic safety and essential performance requirements for infant phototherapy equipment, which reduce the safety hazards to patients and operators as much as possible, and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a technical revision. The main purpose of this new edition is to provide consistency with the third edition of the general standard. This edition further provides consistency with the four other particular standards related to pediatric equipment for which the committee is responsible. The contents of the corrigendum of August 2010 have been included in this copy.
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten
Appareils électromédicaux - Partie 2-50: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés
La CEI 60601-2-50:2009 établit des exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés, afin de réduire autant que possible les dangers pour les patients et les opérateurs, et spécifie des essais pour démontrer la conformité à ces exigences. Cette deuxième édition annule et remplace la première édition parue en 2000. Cette édition constitue une révision technique. L'objectif principal de cette nouvelle édition est d'assurer la cohérence avec la troisième édition de la norme générale. De plus, la présente édition assure la cohérence avec les quatre autres normes particulières relatives aux appareils pédiatriques dont le comité est responsable. Le contenu du corrigendum d'août 2010 a été pris en considération dans cet exemplaire.
Medicinska električna oprema - 2-50. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za otroško fototerapevtsko opremo (IEC 60601-2-50:2009)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OTROŠKE FOTOTERAPEVTSKE OPREME, kot je določeno v 201.3.203 tega standarda, prav tako imenovanih
ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Prav tako glej 4.2 splošnega standarda. Ta določen standard določa varnostne zahteve za OTROŠKO FOTOTERAPEVTSKO OPREMO, vendar alternativne metode skladnosti z določeno točko z dokazovanjem enakovredne varnosti ne bodo ocenjene kot neskladne, če je PROIZVAJALEC predstavil v svojem DOKUMENTU OBVLADOVANJA TVEGANJA, da je TVEGANJE, predstavljeno z NEVARNOSTJO, sprejemljive stopnje v primerjavi s koristjo terapije naprave.
Ta konkretni standard ne velja za:
- naprave, ki dovajajo toplote prek ODEJ, BLAZIN ali POSTELJNIH VLOŽKOV pri medicinski uporabi, za informacije
glej IEC 80601-2-35;
- OTROŠKE INKUBATORJE; za informacije glej IEC 60601-2-19;
- PRENOSNE INKUBATORJE; za informacije glej IEC 60601-2-20;
- OTROŠKE SEVALNE OGREVALNIKE; za informacije glej IEC 60601-2-21.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
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SIST EN 60601-2-50:2002
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Medical electrical equipment - Part 2-50: Particular requirements for basic safety and
essential performance of infant phototherapy equipment (IEC 60601-2-50:2009)
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten
(IEC 60601-2-50:2009)
Appareils électromédicaux- Partie 2-50: Exigences particulières de sécurité de base et
de performances essentielles des appareils de photothérapie pour nouveau-nés (CEI
60601-2-50:2009)
Ta slovenski standard je istoveten z: EN 60601-2-50:200X
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 60601-2-50
NORME EUROPÉENNE
May 2009
EUROPÄISCHE NORM
ICS 11.040.60 Supersedes EN 60601-2-50:2002
English version
Medical electrical equipment -
Part 2-50: Particular requirements
for the basic safety and essential performance
of infant phototherapy equipment
(IEC 60601-2-50:2009)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-50: Exigences particulières Teil 2-50: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des appareils de photothérapie von Säuglings-Phototherapiegeräten
pour nouveau-nés (IEC 60601-2-50:2009)
(CEI 60601-2-50:2009)
This European Standard was approved by CENELEC on 2009-05-01. 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, 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.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: Avenue Marnix 17, B - 1000 Brussels
© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-50:2009 E
Foreword
The text of document 62D/736A/FDIS, future edition 2 of IEC 60601-2-50, 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 60601-2-50 on 2009-05-01.
This European Standard supersedes EN 60601-2-50:2002.
Specific technical changes from EN 60601-2-50:2002 include:
– requiring graphical representation of the spectral irradiance in the instructions for use (this was
previously optional; see 201.7.9.2.5 b));
– requirements for support and mounting brackets for ACCESSORIES (see 201.9.8.101);
– requiring restoration of any preset values upon interruption and restoration of the power supply, if
applicable (see 201.11.8); and
– corrections to the first four exposure limits (ELs) listed in Table AA.1.
Minor changes from EN 60601-2-50:2002 include replacing the figure containing the eye protection
symbol with a reference to this same symbol in IEC 60878 (see 201.7.2.101), defining an INFANT (see
201.3.202) and clarifying the titles for subclauses 201.5.4.102 and 201.5.4.103.
The main purpose, however, is to provide consistency with the general standard EN 60601-1:2006. This
pediatric equipment for which the committee is responsible.
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) 2010-02-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-05-01
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 MDD (93/42/EEC). See Annex ZZ.
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).
- 3 - EN 60601-2-50:2009
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular 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.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-50:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60335-2-27 NOTE Harmonized as EN 60335-2-27:1997 (not modified).
IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (not modified).
IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified).
ISO 3743-1 NOTE Harmonized as EN ISO 3743-1:1995 (not modified).
__________
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.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replace the reference to IEC 60601-1-2 by:
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
Standard: Electromagnetic compatibility -
Requirements and tests
- 5 - EN 60601-2-50:2009
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.
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 60601-2-50 ®
Edition 2.0 2009-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential performance
of infant phototherapy equipment
Appareils électromédicaux –
Partie 2-50: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de photothérapie pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
U
CODE PRIX
ICS 11.040.60 ISBN 2-8318-1034-3
– 2 – 60601-2-50 © IEC:2009
CONTENTS
FOREWORD.3
INTRODUCTION.6
201.1 Scope, object and related standards .7
201.2 Normative references .9
201.3 Terms and definitions.9
201.4 General requirements.10
201.5 General requirements for testing of ME EQUIPMENT.11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents.11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.14
201.10 Protection against unwanted and excessive radiation HAZARDS.15
201.11 Protection against excessive temperatures and other HAZARDS.16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.16
201.13 HAZARDOUS SITUATIONS and fault conditions.19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19
201.15 Construction of ME EQUIPMENT .19
201.16 ME SYSTEMS .20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .20
202 Electromagnetic compatibility .20
Annexes .20
Annex AA (informative) Particular guidance and rationale.21
Bibliography.26
Index of defined terms used in this particular standard.28
Figure 201.101 – Example of a measuring grid .17
Figure 201.102 – Layout of weight test devices.19
Table 201.101 – List of symbols, abbreviations and acronyms .10
Table AA.1 – UV radiation exposure limits and spectral weighting function .24
60601-2-50 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment
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)”). The
...
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