EN ISO 7886-1:2018
(Main)Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen Gebrauch (ISO 7886-1:2017, korrigierte Fassung 2019-08)
Dieses Dokument legt Anforderungen an und Prüfverfahren für die Verifizierung der Auslegung leerer steriler Einmalspritzen für medizinische Zwecke aus Kunststoff und anderen Werkstoffen mit oder ohne Kanüle fest, die für das Ansaugen und die Injektion von Flüssigkeiten nach dem Füllen durch die Endanwender vorgesehen sind. Dieses Dokument enthält keine Anforderungen an die Losfreigabe. Die Spritzen sind vorwiegend für die Anwendung beim Menschen vorgesehen.
Die in diesem Dokument festgelegten sterilen Spritzen sind für den Einsatz unmittelbar nach dem Füllen vorgesehen und sind nicht dafür vorgesehen, über einen längeren Zeitraum mit dem Arzneimittel gefüllt zu sein.
Ausgenommen sind Insulinspritzen (siehe ISO 8537), Einmalspritzen aus Glas, Spritzen für Druckinfusionsapparate, durch den Hersteller vorgefüllte Spritzen sowie Spritzen, die für die Lagerung nach dem Füllen vorgesehen sind (z. B. Beilagespritzen, die vom Apotheker gefüllt werden).
Spritzen für medizinische Zwecke ohne Kanüle nach diesem Dokument sind für den Einsatz mit Spritzen für medizinische Zwecke nach ISO 7864 vorgesehen.
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation manuelle (ISO 7886-1:2017, Version corrigée 2019-08)
ISO 7886-1:2017 fixe les exigences et les méthodes d'essai relatives à la vérification de la conception des seringues hypodermiques stériles non réutilisables vides, avec ou sans aiguille, constituées de matières plastiques ou d'autres matières et destinées à l'aspiration et à l'injection de liquides après remplissage par les utilisateurs finaux. Le présent document ne spécifie pas d'exigences applicables à la libération des lots. Les seringues sont destinées en premier lieu à l'Homme.
Les seringues stériles spécifiées dans le présent document sont prévues pour être utilisées immédiatement après leur remplissage et ne sont pas destinées à contenir le médicament pendant de longues périodes.
Il exclut les seringues utilisables avec de l'insuline (voir l'ISO 8537), les seringues non réutilisables en verre, les seringues pour pousse-seringues mus par un moteur, les seringues pré-remplies par le fabricant et les seringues prévues pour être conservées après leur remplissage (par exemple dans un kit prévu pour être rempli par un pharmacien).
Les seringues hypodermiques sans aiguille spécifiées dans le présent document sont destinées à être utilisées avec les aiguilles hypodermiques indiquées dans l'ISO 7864.
Sterilne podkožne injekcijske brizge za enkratno uporabo - 1. del: Injekcijske brizge za ročno injiciranje (ISO 7886-1:2017, popravljena verzija 2019-08)
Ta dokument določa zahteve in preskusne metode za preverjanje zasnove praznih sterilnih podkožnih injekcijskih brizg z iglo ali brez nje, izdelanih iz plastike ali drugih materialov, ki so namenjene za aspiracijo in injiciranje tekočin, s katerimi jih napolni končni uporabnik. Ta dokument ne podaja zahtev za izdajo serij. Injekcijske brizge so namenjene predvsem za uporabo pri ljudeh.
Sterilne injekcijske brizge, ki so določene v tem dokumentu, so namenjene za uporabo takoj po polnjenju in ne smejo vsebovati zdravila dalj časa.
V tem dokumentu niso zajete injekcijske brizge za inzulin (glej standard ISO 8537), steklene injekcijske brizge za enkratno uporabo, injekcijske brizge za uporabo z injekcijskimi črpalkami, injekcijske brizge, ki jih predhodno napolni proizvajalec, in injekcijske brizge, ki so namenjene za shranjevanje po polnjenju (npr. v kompletu, ki ga napolni farmacevt).
Podkožne injekcijske brizge brez igle, ki so navedene v tem dokumentu, so namenjene za uporabo s podkožnimi
iglami, ki so navedene v standardu ISO 7864.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7886-1:2018
01-junij-2018
1DGRPHãþD
SIST EN ISO 7886-1:2000
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO ,QMHNFLMVNH
EUL]JH]DURþQRLQMLFLUDQMH ,62
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-
1:2017)
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen
Gebrauch (ISO 7886-1:2017)
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation
manuelle (ISO 7886-1:2017)
Ta slovenski standard je istoveten z: EN ISO 7886-1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 7886-1:2018
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SIST EN ISO 7886-1:2018
EN ISO 7886-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-1:1997
English Version
Sterile hypodermic syringes for single use - Part 1:
Syringes for manual use (ISO 7886-1:2017)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 1: Seringues pour utilisation manuelle (ISO 1: Spritzen zum manuellen Gebrauch (ISO 7886-
7886-1:2017) 1:2017)
This European Standard was approved by CEN on 28 February 2017.
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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-1:2018 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Contents Page
European foreword . 3
Endorsement notice . 4
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 7886-1:2018
EN ISO 7886-1:2018 (E)
European foreword
This document (EN ISO 7886-1:2017) has been prepared by Technical Committee ISO/TC 84 " Devices
for administration of medicinal products and catheters " in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” 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 September 2018, and conflicting national standards
shall be withdrawn at the latest by September 2018.
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 7886-1:1997.
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.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (inclu
...
SLOVENSKI STANDARD
SIST EN ISO 7886-1:2018
01-junij-2018
Nadomešča:
SIST EN ISO 7886-1:2000
Sterilne podkožne injekcijske brizge za enkratno uporabo - 1. del: Injekcijske
brizge za ročno injiciranje (ISO 7886-1:2017, popravljena verzija 2019-08)
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-
1:2017, Corrected version 2019-08)
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen
Gebrauch (ISO 7886-1:2017, korrigierte Fassung 2019-08)
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation
manuelle (ISO 7886-1:2017, Version corrigée 2019-08)
Ta slovenski standard je istoveten z: EN ISO 7886-1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 7886-1:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-1:1997
English Version
Sterile hypodermic syringes for single use - Part 1:
Syringes for manual use (ISO 7886-1:2017, Corrected
version 2019-08)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 1: Seringues pour utilisation manuelle (ISO 1: Spritzen zum manuellen Gebrauch (ISO 7886-
7886-1:2017, Version corrigée 2019-08) 1:2017)
This European Standard was approved by CEN on 28 February 2017.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 09 October 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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-1:2018 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (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 7886-1:2018
EN ISO 7886-1:2018 (E)
European foreword
This document (EN ISO 7886-1:2017) has been prepared by Technical Committee ISO/TC 84 " Devices
for administration of medicinal products and catheters " in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” 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 September 2018, and conflicting national standards
shall be withdrawn at the latest by September 2018.
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 7886-1:1997.
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.
The following referenced documents are indispensable for the appli
...
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