ISO 11608-3:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
Autor: ISO
Código ICS: 11.040.25


This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).This document is not applicable to the following products:—    sterile hypodermic needles;—    sterile hypodermic syringes;—    sterile single-use syringes, with or without needle, for insulin;—    containers that can be refilled multiple times;—    containers intended for dental use;—    catheters or infusion sets that are attached or assembled separately by the user.

Especificaciones de la Norma
Fecha de Publicación 07/04/2022
Título Secundario Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai — Partie 3: Conteneurs et chemins de fluide intégrés
Páginas Técnicas 27
Idioma Inglés