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EN ISO 7886-1:2018

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)

Edition date: 2018-03-28
In Force
Available languages: French, English
Summary: 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.

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.

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.
ICS: 11.040.25-Syringes, needles and catheters
CTN: CEN/TC 205 - 6186

Standards Cancellations

Es anulada por prEN ISO 7886-1

Otras Relaciones

Acuerdo de Viena ISO 7886-1:2017

Reemplazo Normas

Reemplaza a EN ISO 7886-1:1997

The book in the author's words

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