Objavljen
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.
POVUČEN
ISO 11608-3:2012
OBJAVLJEN
ISO 11608-3:2022
60.60
Standard objavljen
7. 4. 2022.
Injekcioni sistemi sa iglom za medicinsku upotrebu – Zahtevi i metode ispitivanja – Deo 3: Kontejneri i integrisan tok tečnosti
60.60 Standard objavljen