BS ISO 14949:2001
Current
The latest, up-to-date edition.
Implants for surgery. Two-part addition-cure silicone elastomers
Hardcopy , PDF
English
20-11-2001
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and conditions
4 Formulation
4.1 Composition
4.2 Raw materials assessment
5 Biocompatibility
6 Characterization and testing
6.1 Test slab preparation
6.2 Identification
6.3 Purity testing
6.4 Cure rate
6.5 Physicomechanical properties and characterization
7 Documentation
7.1 Data sheet
7.2 Certificate of analysis
Annex A (normative) Determination of substances soluble in
hexane
Annex B (normative) Determination of volatile matter
Bibliography
Describes the characteristics of and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical implants.
| Committee |
CH/150/1
|
| DevelopmentNote |
Supersedes 00/561661 DC. (12/2001)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies the characteristics of, and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical implants.
| Standards | Relationship |
| ISO 14949:2001 | Identical |
| ISO 34-1:2015 | Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces |
| ISO 6502:2016 | Rubber Guide to the use of curemeters |
| ISO 527-2:2012 | Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 14969:1999 | Quality systems Medical devices Guidance on the application of ISO 13485 and ISO 13488 |
| ISO 48:2010 | Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
| ISO 3417:2008 | Rubber Measurement of vulcanization characteristics with the oscillating disc curemeter |
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