EN ISO 15747:2019
(Main)Plastic containers for intravenous injections (ISO 15747:2018)
Plastic containers for intravenous injections (ISO 15747:2018)
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2018)
Diese Internationale Norm legt Anforderungen zur sicheren Handhabung sowie die physikalische, chemische und biologische Prüfung von Kunststoffbehältnissen für parenterale Injektionen fest.
Diese Internationale Norm gilt für Kunststoffbehältnisse für parenterale Injektionen mit einer oder mehreren Kammern und einer Gesamt-Nennfüllmenge zwischen 50 ml und 5 000 ml, wie Beutel aus Folie oder durch Spritzguss gefertigte Flaschen aus Kunststoff für Lösungen zur direkten Infusion (Injektion).
In einigen Ländern sind nationale oder regionale Arzneibücher oder sonstige staatliche Vorschriften rechts¬verbindlich und deren Anforderungen haben Vorrang gegenüber dieser Internationalen Norm.
Récipients en plastique pour injections intraveineuses (ISO 15747:2018)
Le présent document spécifie les exigences relatives à la manipulation sûre et aux essais physiques, chimiques et biologiques des récipients en plastique pour préparations parentérales.
Le présent document s'applique aux récipients en plastique pour préparations parentérales, munis d'un ou de plusieurs compartiments et ayant une capacité nominale totale comprise entre 50 ml et 5 000 ml, tels que les poches souples en feuille de polymère ou les flacons en plastique extrudé-soufflé pour l'administration directe en perfusion (injection) des solutions.
NOTE Dans certains pays, la pharmacopée nationale ou régionale ou autres réglementations gouvernementales ont force de loi et ces exigences ont priorité sur le présent document.
Plastični zbiralniki za intravenske injekcije (ISO 15747:2018)
Ta dokument določa zahteve za varno ravnanje ter fizično, kemično in biološko
preskušanje plastičnih zbiralnikov za parenteralne izdelke.
Ta dokument se uporablja za plastične zbiralnike za parenteralne izdelke z enim ali več predelki in
skupno nazivno prostornino v razponu od 50 ml do 5000 ml, kot so vrečke iz folije ali pihane
plastenke za neposredno apliciranje infuzijskih (injekcijskih) raztopin.
OPOMBA: V nekaterih državah so nacionalne ali regionalne farmakopeje in drugi vladni predpisi zakonsko
zavezujoči ter imajo te zahteve prednost pred tem dokumentom.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15747:2019
01-maj-2019
1DGRPHãþD
SIST EN ISO 15747:2012
3ODVWLþQL]ELUDOQLNL]DLQWUDYHQVNHLQMHNFLMH ,62
Plastic containers for intravenous injections (ISO 15747:2018)
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2018)
Récipients en plastique pour injections intraveineuses (ISO 15747:2018)
Ta slovenski standard je istoveten z: EN ISO 15747:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 15747:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 15747:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 15747:2019
EN ISO 15747
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 15747:2011
English Version
Plastic containers for intravenous injections (ISO
15747:2018)
Récipients en plastique pour injections intraveineuses Kunststoffbehältnisse für intravenöse Injektionen (ISO
(ISO 15747:2018) 15747:2018)
This European Standard was approved by CEN on 28 February 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15747:2019 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 15747:2019
EN ISO 15747:2019 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
2
---------------------- Page: 4 ----------------------
SIST EN ISO 15747:2019
EN ISO 15747:2019 (E)
European foreword
This document (EN ISO 15747:2019) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with CCMC.
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 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
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 15747:2011.
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 the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA”, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherw
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.