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ÖNORM EN ISO 8871-5

Issue date: 2025 06 15

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)

This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle. NOTE            Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.

General information on ÖNORM EN ISO 8871-5

Format
Digital | 19 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 8871-5 from 2014 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 7864:2016
Titel
Sterile hypodermic needles for single use — Requirements and test methods
Ausgabedatum
2016 08 02
Art
Standard
Dokumentnummer
ISO 8362-1:2018
Titel
Injection containers and accessories — Part 1: Injection vials made of glass tubing
Ausgabedatum
2018 08 02
Art
Standard
Dokumentnummer
ISO 8362-3:2001
Titel
Injection containers and accessories — Part 3: Aluminium caps for injection vials
Ausgabedatum
2001 12 20
Art
Standard
Dokumentnummer
ISO 8362-4:2011
Titel
Injection containers and accessories — Part 4: Injection vials made of moulded glass
Ausgabedatum
2011 09 05
Art
Standard
Dokumentnummer
ISO 8362-6:2010
Titel
Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials
Ausgabedatum
2010 06 01
Art
Standard

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ÖNORM EN ISO 8871-5 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)

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