EN 60601-2-50:2009

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

• Status: Published
• Publication Date: 19-May-2009
• Withdrawal Date: 30-Apr-2012
• ICS: 11.040.60 - Therapy 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: 20-May-2009
• Completion Date: 20-May-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-50:2009 - Medical electrical equipment - Part 2-50: Particular requirements for basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2009)

Relations

• Replaces: EN 60601-2-50:2002 - Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 60601-2-50:2021 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 23-Jan-2023
• Amended By: EN 60601-2-50:2009/A11:2011 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-50:2009/A1:2016 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-50:2009
01-julij-2009
1DGRPHãþD
SIST EN 60601-2-50:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]DRWURãNRIRWRWHUDSHYWVNRRSUHPR,(&
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
SIST EN 60601-2-50:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-50:2009

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SIST EN 60601-2-50:2009

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

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SIST EN 60601-2-50:2009
EN 60601-2-50:2009 - 2 -
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
EN 60601-2-50:2009 further provides consistency with the four other particular standards related to
pediatric equipment for which the committee is responsible.
The following dates were fixed:
– latest
...