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BS ISO 13926-3:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Pen systems Seals for pen-injectors for medical use
Available format(s)

Hardcopy , PDF

Superseded date

06-04-2019

Language(s)

English

Published date

03-31-2013

Publisher

British Standards Institution

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Superseded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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PDF - English
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