EN 60601-2-4:2011/A1:2019
(Amendment)Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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Medizinische elektrische Geräte - Teil 2-4: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Defibrillatoren
Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base et les performances essentielles des défibrillateurs cardiaques
Medicinska električna oprema - 2-4. del: Posebne zahteve za osnovno varnost in bistvene lastnosti srčnih defibrilatorjev - Dopolnilo A1 (IEC 60601-2-4:2010/A1:2018)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI SRČNIH DEFIBLIRATORJEV, v nadaljevanju ME OPREME. 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. Ta določeni standard ne velja za vsajene defibrilatorje, DEFIBLIRATORJE z daljinskim upravljanjem, zunanje transkutane srčne spodbujevalnike ali ločene samostojne srčne monitorje (ki so standardizirani z IEC 60601-2-27). Srčni monitorji, ki uporabljajo ločene elektrode ECG za spremljanje, niso v okviru uporabe tega standarda, razen če se uporabljajo izključno za zaznavo prepoznave ritma AED ali zaznave utripa za sinhronizirano kardioverzijo. Tehnologija defibrilatorskih valovnih oblik se hitro razvija. Objavljene študije navajajo, da se učinkovitost valovnih oblik razlikuje. Izbira določene valovne oblike, vključno z obliko vala, dobavljeno energijo, učinkovitostjo in varnostjo, je bila izrecno izključena iz uporabe tega standarda. Vendar so bili zaradi kritične pomembnosti terapevtske valovne oblike utemeljitvi, ki obravnava razloge za valovno obliko in njeno izbiro, dodani komentarji.
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-4:2011/A1:2019
01-december-2019
Medicinska električna oprema - 2-4. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti srčnih defibrilatorjev - Dopolnilo A1 (IEC 60601-2-
4:2010/A1:2018)
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and
essential performance of cardiac defibrillators (IEC 60601-2-4:2010/A1:2018)
Medizinische elektrische Geräte - Teil 2-4: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Defibrillatoren (IEC 60601-2-
4:2010/A1:2018)
Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base
et les performances essentielles des défibrillateurs cardiaques (IEC 60601-2-
4:2010/A1:2018)
Ta slovenski standard je istoveten z: EN 60601-2-4:2011/A1:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 60601-2-4:2011/A1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-4:2011/A1:2019
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SIST EN 60601-2-4:2011/A1:2019
EUROPEAN STANDARD EN 60601-2-4:2011/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2019
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-4: Particular requirements
for the basic safety and essential performance of cardiac
defibrillators
(IEC 60601-2-4:2010/A1:2018)
Appareils électromédicaux - Partie 2-4: Exigences Medizinische elektrische Geräte - Teil 2-4: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des défibrillateurs cardiaques wesentlichen Leistungsmerkmale von Defibrillatoren
(IEC 60601-2-4:2010/A1:2018) (IEC 60601-2-4:2010/A1:2018)
This amendment A1 modifies the European Standard EN 60601-2-4:2011; it was approved by CENELEC on 2018-04-04. 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, 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-4:2011/A1:2019 E
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SIST EN 60601-2-4:2011/A1:2019
EN 60601-2-4:2011/A1:2019 (E)
European foreword
The text of document 62D/1549/FDIS, future IEC 60601-2-4/A1, 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 60601-2-4:2011/A1:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-04-11
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-10-11
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 shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60601-2-4:2010/A1:2018 was approved by CENELEC as a
European Standard without any modification.
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SIST EN 60601-2-4:2011/A1:2019
EN 60601-2-4:2011/A1:2019 (E)
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
cons
...
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