EN IEC 60601-2-21:2021
(Main)Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT 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 ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern
Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés
IEC 60601-2-21:2020 est disponible sous forme de IEC 60601-2-21:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-21:2020 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des INCUBATEURS RADIANTS POUR NOUVEAU-NES, tels que définis au 201.3.204, également désignés sous le terme APPAREILS EM. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 7.2.13 et de 8.4.1 de la norme générale. L'IEC 60601-2-21:2020 spécifie les exigences de sécurité relatives aux INCUBATEURS RADIANTS POUR NOUVEAU-NES, mais des méthodes alternatives de conformité à un article spécifique, en démontrant un niveau équivalent de sécurité, ne sont pas considérées comme non conformes, si le FABRICANT a démontré dans son DOSSIER DE GESTION DES RISQUES que le RISQUE présenté par le DANGER s’est révélé avoir un niveau acceptable, lorsqu’il a été évalué par rapport aux avantages du traitement présentés par le dispositif. La présente norme particulière ne s'applique pas aux: - dispositifs délivrant de la chaleur par l'intermédiaire de COUVERTURES, COUSSINS ou MATELAS en usage médical; voir l’IEC 60601-2-35 à titre informatif; - INCUBATEURS POUR NOUVEAU-NES, voir l’IEC 60601-2-19 à titre informatif; - INCUBATEURS DE TRANSPORT POUR NOUVEAU-NES; voir l’IEC 60601-2-20 à titre informatif; - APPAREILS DE PHOTOTHERAPIE POUR NOUVEAU-NES, voir l’IEC 60601-2-50 à titre informatif. Les CAPTEURS DE TEMPERATURE CUTANEE appliqués au fonctionnement d’un INCUBATEUR RADIANT A REGULATION CUTANEE incluant la valeur affichée ne sont pas considérés comme un THERMOMETRE MEDICAL au sens de la norme particulière ISO 80601-2-56. L'IEC 60601-2-21:2020 annule et remplace la deuxième édition parue en 2009 et son Amendement 1 (2016). Cette édition constitue une révision technique. Cette édition inclut la modification technique majeure suivante par rapport à l'édition précédente: alignement avec l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD1:2012.
Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in bistvene lastnosti otroških sevalnih ogrevalnikov (IEC 60601-2-21:2020)
Standard EN-IEC 60601-2-21 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OTROŠKIH SEVALNIH OGREVALNIKOV, kot je določeno v točki 201.3.204, v nadaljevanju ELEKTROMEDICINSKA OPREMA. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri predvideni fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN 60601-2-21:2009
SIST EN 60601-2-21:2009/A1:2017
SIST EN 60601-2-21:2009/A11:2012
Medicinska električna oprema - 2-21. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti otroških sevalnih ogrevalnikov (IEC 60601-2-21:2020)
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers (IEC 60601-2-21:2020)
Medizinische elektrische Geräte - Teil 2-21: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglingswärmestrahlern (IEC
60601-2-21:2020)
Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs radiants pour nouveau-nés (IEC 60601
-2-21:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-21:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-21
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.10 Supersedes EN 60601-2-21:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-21: Particular requirements
for the basic safety and essential performance of infant radiant
warmers
(IEC 60601-2-21:2020)
Appareils électromédicaux - Partie 2-21: Exigences Medizinische elektrische Geräte - Teil 2-21: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs radiants pour nouveau-nés wesentlichen Leistungsmerkmale von
(IEC 60601-2-21:2020) Säuglingswärmestrahlern
(IEC 60601-2-21:2020)
This European Standard was approved by CENELEC on 2020-11-03. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-21:2021 E
European foreword
The text of document 62D/1766/FDIS, future edition 3 of IEC 60601-2-21, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-21:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
This document supersedes EN 60601-2-21:2009 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-21:2020 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 60601-2-19:2020 NOTE Harmonized as EN IEC 60601-2-19:2020 (not modified)
IEC 60601-2-20:2020 NOTE Harmonized as EN IEC 60601-2-20:2020 (not modified)
IEC 60601-2-35:2020 NOTE Harmonized as EN IEC 80601-2-35:2020 (not modified)
IEC 60601-2-50:2020 NOTE Harmonized as EN IEC 60601-2-50:2020 (not modified)
IEC 61672-1 NOTE Harmonized as EN 61672-1
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007 (not modified)
IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013 (not modified)
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
The Annex ZA of EN 60601-1:2006/A1:2013 applies with the following replacements:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-2-21 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers
Appareils électromédicaux –
Partie 2-21: Exigences particulières pour la sécurité de base et
les performances essentielles des incubateurs radiants pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-8722-4
– 2 – IEC 60601-2-21:2020 © IEC 2020
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 . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
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 . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 ME SYSTEMS. 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic disturbances – Requirements and tests . 23
Annexes . 24
Annex AA (informative) Particular guidance and rationale . 25
Bibliography . 34
Index of defined terms used in this document . 36
Figure 201.101 – Layout of TEST DEVICES . 10
Figure 201.102 – TEST DEVICE . 11
Figure AA.1 – Illustration of the main requirements of this document . 25
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 12
IEC 60601-2-21:2020 © IEC 2020 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers
FOREWORD
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