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BS ISO 11040-2:2011

Current
Current

The latest, up-to-date edition.

Prefilled syringes Plunger stoppers for dental local anaesthetic cartridges
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-04-2011

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 plunger stoppers for dental local anaesthetic cartridges intended for single use only.

This part of ISO11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for dental local anaesthetic cartridges intended for single use only.

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

Committee
CH/212
DevelopmentNote
Supersedes BS 7652-2(1995). (04/2011)
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 11040-2:2011 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 2230:2002 Rubber products — Guidelines for storage
ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
ISO 9997:1999 Dental cartridge syringes
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 11499:2014 Dentistry — Single-use cartridges for local anaesthetics
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 11040-1:2015 Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges
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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Hardcopy - English
PDF - English
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