BS ISO 13926-3:2019

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Pen systems – Seals for pen-injectors for medical use

Published By	Publication Date	Number of Pages
BSI	2019	16

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Categories: 11.040.25 - Syringes, needles and catheters, BSI

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Description

This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use.

NOTE

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

PDF Catalog

PDF Pages	PDF Title
2	National foreword
6	Foreword
7	Introduction
9	1 Scope 2 Normative references 3 Terms and definitions
10	4 Classification 5 Shape and dimensions
11	6 Designation 7 Material 7.1 Cap 7.2 Disc 8 Requirements 8.1 General 8.2 Physical requirements 8.2.1 Hardness of the disc
12	8.2.2 Fragmentation 8.2.3 Freedom from leakage 8.2.4 Resealability 8.2.5 Resistance to ageing 8.3 Chemical requirements 8.4 Biological requirements 9 Labelling
13	Annex A (normative) Leakage test
15	Bibliography

Additional information

Status	Under Review
Pages	16
Publication Date	2019-06-04
ISBN	978 0 580 52435 6
Standard Number	BS ISO 13926-3:2019
Title	Pen systems – Seals for pen-injectors for medical use
Identical National Standard Of	ISO 13926-3
Replaces	BS ISO 13926-3:2012
Descriptors	Leak tests, Closures, Containers, Medical instruments, Performance, Medical equipment, Drug administration, Injection instruments, Elastomers, Stoppers, Classification systems, Injection guns, Dimensions, Marking, Syringes, Designations
Publisher	BSI
Committee	CH/212
ICS Codes	11.040.25 - Syringes, needles and catheters

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BS ISO 13926-3:2019

PDF Catalog

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