Pen systems Plunger stoppers for pen-injectors for medical use

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-12-2017

Publisher

British Standards Institution

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	BS ISO 13926-2 : 2011 BS ISO 13926-2:2011+A1:2015

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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BS ISO 13926-2:2017

Pen systems Plunger stoppers for pen-injectors for medical use

Table of Contents

Abstract

General Product Information

Scope

International Equivalents

Standards Referencing This Book

Category

Subcategory