EN ISO 7886-3:2020
(Main)Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.
This document does not specify the design of the auto-disable syringe feature.
This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2020)
Dieses Dokument legt Eigenschaften und Leistungsmerkmale für sterile Einmalspritzen mit einem Selbstblockierungsbauteil fest, die für die Abgabe einer fixen Impfdosis unmittelbar nach ihrem Befüllen vorgesehen sind. Die Spritzen können aus Kunststoff, Gummi oder anderen Werkstoffen gefertigt, und mit oder ohne Kanüle und Kanülenschutzvorrichtung gefertigt sein.
Dieses Dokument legt nicht die Gestaltung des Selbstblockierungsbauteils einer Spritze fest.
Dieses Dokument gilt nicht für Insulinspritzen (behandelt in ISO 8537), Spritzen für Druckinfusionsapparate (behandelt in ISO 7886 2), Spritzen mit Vorrichtung zur Verhinderung der Wiederverwendung (behandelt in ISO 7886 4) oder zur Vorfüllung ausgelegte Spritzen (behandelt in der Normenreihe ISO 11040). Es behandelt nicht die Verträglichkeit mit Injektionsflüssigkeiten bzw. Impfstoffen.
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes pour vaccination à dose fixe (ISO 7886-3:2020)
Le présent document spécifie les propriétés et les performances des seringues hypodermiques stériles, non réutilisables, dotées d'un système autobloquant, prévues pour délivrer une dose fixe de vaccin immédiatement après remplissage. Les seringues peuvent être en plastique, en caoutchouc et en d'autres matériaux et peuvent être avec ou sans aiguille et avec ou sans dispositifs de protection contre les piqûres d'aiguilles.
Le présent document ne spécifie pas la conception du système autobloquant.
Le présent document n'est pas applicable aux seringues à insuline (couvertes par l'ISO 8537), aux seringues pour pousse-seringues électriques (couvertes par l'ISO 7886‑2), aux seringues avec dispositif empêchant la réutilisation (couvertes par l'ISO 7886‑4) ou aux seringues conçues pour être préremplies (couvertes par la série ISO 11040). Il n'aborde pas le problème de la compatibilité avec les liquides injectables et les vaccins.
Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno določen odmerek imunizacije s sistemom za samouničenje (ISO 7886-3:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2020
Nadomešča:
SIST EN ISO 7886-3:2010
Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno
določen odmerek imunizacije s sistemom za samouničenje (ISO 7886-3:2020)
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose
immunization (ISO 7886-3:2020)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2020)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination à dose fixe (ISO 7886-3:2020)
Ta slovenski standard je istoveten z: EN ISO 7886-3:2020
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 7886-3
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-3:2009
English Version
Sterile hypodermic syringes for single use - Part 3: Auto-
disabled syringes for fixed-dose immunization (ISO 7886-
3:2020)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 3: Seringues autobloquantes pour vaccination à 3: Selbstblockierende Spritzen für die Injektion mit
dose fixe (ISO 7886-3:2020) fixer Impfstoffdosis (ISO 7886-3:2020)
This European Standard was approved by CEN on 24 April 2020.
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 7886-3:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 7886-3:2020) 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 November 2020, and conflicting national standards
shall be withdrawn at the latest by November 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 7886-3:2009.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
Endorsement notice
The text of ISO 7886-3:2020 has been approved by CEN as EN ISO 7886-3:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 7886-3
Second edition
2020-05
Sterile hypodermic syringes for
single use —
Part 3:
Auto-disabled syringes for fixed-dose
immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe
Reference number
ISO 7886-3:2020(E)
©
ISO 2020
ISO 7886-3:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2020 – All rights reserved
ISO 7886-3:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 2
5 General requirements . 3
6 Extraneous matter . 4
6.1 General . 4
6.2 Limits for acidity or alkalinity . 4
6.3 Limits for extractable metals . 4
7 Lubricant . 4
8 Tolerance on nominal capacity . 4
9 Graduated scale . 5
9.1 Scale . 5
9.2 Position of scale . 5
10 Barrel . 5
10.1 Dimensions . 5
10.2 Barrel flanges . 5
11 Plunger stopper/plunger assembly. 5
11.1 Design . 5
11.2 Fit of the plunger stopper/plunger in the barrel . 6
11.3 Fiducial line . 6
12 Needle . 6
12.1 General . 6
12.2 Integrated needle . 6
12.3 Non-integrated needle . 6
12.4 Sharps protection features . 6
13 Performance . 7
13.1 General . 7
13.2 Dead space . 7
13.3 Freedom from air and liquid leakage . 7
13.4 Auto-disable syringe feature . 7
13.5 Performance after shipping . 7
14 Packaging . 8
14.1 Unit packaging providing sterile barrier . 8
14.2 Multiple unit pack. 8
14.3 User packaging . 8
15 Information supplied by the manufacturer . 8
15.1 General . 8
15.2 Syringes . 8
15.3 Unit packaging providing sterile barr
...
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