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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

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.

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.

Committee
CH/150/1
DevelopmentNote
Supersedes 00/561661 DC. (12/2001)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Current
Supersedes

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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