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Glavni meni

ISO 11608-3:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
7. 4. 2022.

Опште информације

60.60     7. 4. 2022.

ISO

ISO/TC 84

Međunarodni standard

11.040.25  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11608-3:2012

TRENUTNO

OBJAVLJEN
ISO 11608-3:2022
60.60 Standard objavljen
7. 4. 2022.

Nacionalna preuzimanja

Injekcioni sistemi sa iglom za medicinsku upotrebu – Zahtevi i metode ispitivanja – Deo 3: Kontejneri i integrisan tok tečnosti

60.60 Standard objavljen