Standards Worldwide
Standards Worldwide
Phone +49 30 58885700-07

Standard [WITHDRAWN]

DIN ISO 13926-2:2012-09

Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use (ISO 13926-2:2011)

German title
Pen Systeme - Teil 2: Kolbenstopfen für Pen-Injektoren zur medizinischen Verwendung (ISO 13926-2:2011)
Publication date
2012-09
Original language
German
Pages
12

from 56.60 EUR VAT included

from 52.90 EUR VAT excluded

Format and language options

PDF download 1
  • 56.60 EUR

  • 70.70 EUR

Shipment (3-5 working days) 1
  • 68.30 EUR

  • 85.70 EUR

Monitor with the Standards Ticker

1

 Attention: Document withdrawn!

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
2012-09
Original language
German
Pages
12

Quick delivery via download or delivery service

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

All transactions are encrypted

Overview

The standard specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for pen-injectors for medical use. The performance requirements include freedom from leakage as well as initiating and sustaining forces. The standard contains a test method for verification that there is no leakage between the cylinder and the plunger stopper. The standard contains the second edition of ISO 13926-2:2011-04 which shall be adopted without any modifications as a DIN ISO standard. With respect to DIN ISO 13926-2:2000-10, the requirements for plunger stoppers and seals have been divided. In the future, seals will be dealt with in a Part 3 of the standard series DIN ISO 13926 (publication in preparation). Other modifications include an adaptation to the standard series DIN EN ISO 8871, Elastomeric parts for parenterals and for devices for pharmaceutical use, modifications regarding the dimensions of plunger stoppers as well as revisions of the requirements for material, freedom from leakage, initiating and sustaining forces. Requirements for the resistance to ageing have been incorporated. Standard ISO 13926-2 has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" with the participation of German experts. The responsible committee is Working Committee NA 063-02-15 AA "Elastomere Pharmapackmittel und zugehörige Komponenten" ("Elastomeric pharmaceutical packagings and associated components") at the Medical Standards Committee (NAMed).

Content
ICS
11.040.25
Replacement amendments

This document replaces DIN ISO 13926-2:2000-10 .

This document has been replaced by: DIN ISO 13926-2:2018-07 .

Cooperation at DIN

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