BS ISO 13926-3:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Pen systems Seals for pen-injectors for medical use
Hardcopy , PDF
English
31-03-2013
04-06-2019
Foreword
Introduction
1 Scope
2 Normative references
3 Classification
4 Shape and dimensions
5 Designation
6 Material
7 Requirements
8 Labelling
Annex A (normative) - Leakage test
Bibliography
Describes the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 10/30218554 DC. (03/2013)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13926-3:2012 | Identical |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| ISO 7885:2010 | Dentistry — Sterile injection needles for single use |
| ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness) |
| 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 11608-3:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers |
| ISO 8872:2003 | Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methods |
| 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 13926-2:2011 | Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| 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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