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SIST EN ISO 12417-1:2015
01-december-2015
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Cardiovascular implants and extracorporeal systems - Vascular device-drug combination
products - Part 1: General requirements (ISO 12417-1:2015)
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre
Medizinprodukt/Arzneimittel-Kombinationsprodukte - Teil 1: Allgemeine Anforderungen
(ISO 12417-1:2015)
Implants cardiovasculaires et circuits extra-corporels - Produits de combinaison
médicament-dispositif vasculaire - Partie 1: Exigences générales (ISO 12417-1:2015)
Ta slovenski standard je istoveten z: EN ISO 12417-1:2015
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 12417-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 12417-1:2015
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SIST EN ISO 12417-1:2015
EN ISO 12417-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Cardiovascular implants and extracorporeal systems -
Vascular device-drug combination products - Part 1:
General requirements (ISO 12417-1:2015)
Implants cardiovasculaires et circuits extra-corporels - Kardiovaskuläre Implantate und extrakorporale
Produits de combinaison médicament-dispositif Systeme - Vaskuläre Medizinprodukt/Arzneimittel-
vasculaire - Partie 1: Exigences générales (ISO 12417- Kombinationsprodukte - Teil 1: Allgemeine
1:2015) Anforderungen (ISO 12417-1:2015)
This European Standard was approved by CEN on 8 August 2015.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12417-1:2015 E
worldwide for CEN national Members.
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SIST EN ISO 12417-1:2015
EN ISO 12417-1:2015 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4
2
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SIST EN ISO 12417-1:2015
EN ISO 12417-1:2015 (E)
European foreword
This document (EN ISO 12417-1:2015) has been prepared by Technical Committee ISO/TC 150
“Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical
implants” the secretariat of which is held by DIN.
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 April 2016, and conflicting national standards shall be
withdrawn at the latest by April 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organ
...