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BS ISO 14949:2001

BS ISO 14949:2001

Current

Current

The latest, up-to-date edition.

Implants for surgery. Two-part addition-cure silicone elastomers

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

20-11-2001

Publisher

British Standards Institution

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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