BS ISO 11040-2:2011
Current
The latest, up-to-date edition.
Prefilled syringes Plunger stoppers for dental local anaesthetic cartridges
Hardcopy , PDF
English
04-30-2011
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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.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes BS 7652-2(1995). (04/2011)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| 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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