Standards Worldwide
Standards Worldwide
Phone +49 30 58885700-07

Standard [CURRENT]

DIN EN ISO 8871-5:2017-03

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016); German version EN ISO 8871-5:2016

German title
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2016); Deutsche Fassung EN ISO 8871-5:2016
Publication date
2017-03
Original language
German
Pages
18

from 77.90 EUR VAT included

from 72.80 EUR VAT excluded

Format and language options

PDF download
  • 77.90 EUR

  • 93.50 EUR

  • 97.50 EUR

Shipment (3-5 working days)
  • 94.00 EUR

  • 117.80 EUR

Monitor with the Standards Ticker

This option is only available after login.
Easily subscribe: Save time and money now!

You can also subscribe to this document - together with other important standards in your industry. This makes your work easier and pays for itself after a short time.

Sparschwein_data
Subscription advantages
Sparschwein Vorteil 1_data

Important standards for your industry, regularly updated

Sparschwein Vorteil 2_data

Much cheaper than buying individually

Sparschwein Vorteil 3_data

Useful functions: Filters, version comparison and more

Publication date
2017-03
Original language
German
Pages
18
DOI
https://dx.doi.org/10.31030/2466018

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice

All transactions are encrypted

Overview

Elastomeric or rubber closures for pharmaceutical use are used in combination with vials and many times in conjunction with piercing devices. There are three functional parameters which are important to the piercing process. These are penetrability, fragmentation and self-sealing. The three functional tests described in this part of ISO 8871 can be used as a reference method for testing elastomeric closures that are pierced using injection needles made from metal. In addition, the aqueous solution tightness test can be used to verify the effectiveness of the sealing of a specific closure/vial combination. This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

Content
ICS
11.040.20
DOI
https://dx.doi.org/10.31030/2466018
Replacement amendments

This document replaces DIN EN ISO 8871-5:2014-10 .

Cooperation at DIN

Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...