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SIST EN ISO 80601-2-12:2020
01-maj-2020
Nadomešča:
SIST EN ISO 80601-2-12:2011
SIST EN ISO 80601-2-12:2011/AC:2012
Medicinska električna oprema - 2-12. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev za intenzivno nego (ISO 80601-2-12:2020)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and
essential performance of critical care ventilators (ISO 80601-2-12:2020)
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die
Intensivpflege (ISO 80601-2-12:2020)
Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation
en soins intensifs (ISO 80601-2-12:2020)
Ta slovenski standard je istoveten z: EN ISO 80601-2-12:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-12:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 80601-2-12:2020
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SIST EN ISO 80601-2-12:2020
EN ISO 80601-2-12
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2020
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-12:2011
English Version
Medical electrical equipment - Part 2-12: Particular
requirements for basic safety and essential performance of
critical care ventilators (ISO 80601-2-12:2020)
Appareils électromédicaux - Partie 2-12: Exigences Medizinische elektrische Geräte - Teil 2-12: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs wesentlichen Leistungsmerkmale von
pulmonaires pour utilisation en soins intensifs (ISO Beatmungsgeräten für die Intensivpflege (ISO 80601-
80601-2-12:2020) 2-12:2020)
This European Standard was approved by CEN on 12 November 2019.
CEN 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 CEN
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 CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-12:2020 E
worldwide for CEN national Members.
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SIST EN ISO 80601-2-12:2020
EN ISO 80601-2-12:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 80601-2-12:2020
EN ISO 80601-2-12:2020 (E)
European foreword
This document (EN ISO 80601-2-12:2020) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2020, and conflicting national standards
shall be withdrawn at the latest by September 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80601-2-12:2011.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium,
...