NF EN ISO 8871-5

NF EN ISO 8871-5

January 2017
Standard Cancelled

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

NOTE Functional testing with spikes is specified in ISO 8536?2 and in ISO 8536?6.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

January 2017

Number of pages

18 p.

Reference

NF EN ISO 8871-5

ICS Codes

11.040.20   Transfusion, infusion and injection equipment
83.140.99   Other rubber and plastics products

Classification index

S93-102-5

Print number

1

International kinship

ISO 8871-5:2016

European kinship

EN ISO 8871-5:2016
Sumary
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

NOTE Functional testing with spikes is specified in ISO 8536?2 and in ISO 8536?6.

Replaced standards (1)
NF EN ISO 8871-5
November 2014
Standard Cancelled
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing

ISO 8871-5:2005 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

Standard replaced by (1)
NF EN ISO 8871-5
March 2025
Standard Current
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing

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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Préparation des fermetures en élastomère pour les essais
  • Annexe A (normative) Essai de pénétrabilité
  • Annexe B (normative) Essai de fragmentation
  • Annexe C (normative) Essai d'auto-obturation et d'étanchéité à la solution colorante
  • Annexe D (normative) Essai d'étanchéité à la solution colorante
  • Bibliographie
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ