BS ISO 11040-3:2012
Current
The latest, up-to-date edition.
Prefilled syringes Seals for dental local anaesthetic cartridges
Hardcopy , PDF
English
29-02-2012
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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 seals for dental local anaesthetic cartridges intended for single use only.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 10/30216808 DC. (02/2012)
|
| 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 seals 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 significantly affected by the nature and performance of the primary packaging.
| Standards | Relationship |
| ISO 11040-3:2012 | Identical |
| ISO 11040-2:2011 | Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges |
| 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 2230:2002 | Rubber products — Guidelines for storage |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 3302-1:2014 | Rubber — Tolerances for products — Part 1: Dimensional tolerances |
| ISO 9997:1999 | Dental cartridge syringes |
| 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 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 3302-2:2008 | Rubber Tolerances for products Part 2: Geometrical tolerances |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| 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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