• There are no items in your cart

ISO 13926-2:2017

Current
Current

The latest, up-to-date edition.

Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

11-28-2017

ISO 13926-2:2017 specifies the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Committee
ISO/TC 76
DevelopmentNote
Supersedes ISO/DIS 13926-2. (11/2017)
DocumentType
Standard
Pages
7
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
DIN ISO 13926-2:2018-07 Identical
NEN ISO 13926-2 : 2017 Identical
BS ISO 13926-2 : 2011 Identical
BS ISO 13926-2:2017 Identical
IS/ISO 13926 : Part 2 : 2017 Identical

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 13926-3:2012 Pen systems Part 3: Seals for pen-injectors for medical use
ISO 13926-1:2004 Pen systems Part 1: Glass cylinders for pen-injectors for medical use
ISO 2230:2002 Rubber products — Guidelines for storage
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods

View more information
US$73.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.