EN 80601-2-30:2010/A1:2015
(Amendment)Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
2013-06-03 - Negative assessment
Medizinische elektrische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven Blutdruckmessgeräten
Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles de sphygmomanomètres non invasifs automatiques
Medicinska električna oprema - 2-30. del: Posebne zahteve za osnovno varnost in bistvene lastnosti avtomatiziranih neinvazivnih sfigmomanometrov - Dopolnilo A1
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 80601-2-30:2010/A1:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLDYWRPDWL]LUDQLKQHLQYD]LYQLKVILJPRPDQRPHWURY'RSROQLOR$
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphygmomanometers
Medizinische elektrische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven
Blutdruckmessgeräten
Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base
et les performances essentielles de sphygmomanomètres non invasifs automatiques
Ta slovenski standard je istoveten z: EN 80601-2-30:2010/A1:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 80601-2-30:2010/A1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 80601-2-30:2010/A1:2015
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SIST EN 80601-2-30:2010/A1:2015
EUROPEAN STANDARD EN 80601-2-30:2010/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040
English Version
Medical electrical equipment - Part 2-30: Particular requirements
for the basic safety and essential performance of automated
non-invasive sphygmomanometers
(IEC 80601-2-30:2009/A1:2013)
Appareils électromédicaux - Partie 2-30: Exigences Medizinische elektrische Geräte - Teil 2-30: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles de sphygmomanomètres non invasifs wesentlichen Leistungsmerkmale von automatisierten nicht-
automatiques invasiven Blutdruckmessgeräten
(IEC 80601-2-30:2009/A1:2013) (IEC 80601-2-30:2009/A1:2013)
This amendment A1 modifies the European Standard EN 80601-2-30:2010; it was approved by CENELEC on 2015-04-14. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 80601-2-30:2010/A1:2015 E
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SIST EN 80601-2-30:2010/A1:2015
EN 80601-2-30:2010/A1:2015
Foreword
The text of document 62D/1072/FDIS, future IEC 80601-2-30:2009/A1, prepared by
SC 62D "Electrical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted
to the IEC-CENELEC parallel vote and approved by CENELEC as EN 80601-2-30:2010/A1:2015.
The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 80601-2-30:2010.
Endorsement notice
The text of the International Standard IEC 80601-2-30:2009/A1:2013 was approved by CENELEC as
a European Standard without any modification.
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