BS ISO 13926-2:2017
Current
The latest, up-to-date edition.
Pen systems Plunger stoppers for pen-injectors for medical use
Hardcopy , PDF
English
15-12-2017
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Shape and dimensions
6 Designation
7 Material
8 Requirements
9 Labelling
Annex A (normative) - Leakage test
Bibliography
Describes the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 14/30303574 DC. (10/2015) Supersedes 17/30353012 DC. (12/2017)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document 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.
| Standards | Relationship |
| ISO 13926-2:2017 | Identical |
| ISO 13926-2:2011 | 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 |
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