AS ISO 14949-2003

1 - AS ISO 14949-2003 IMPLANTS FOR SURGERY-TWO-PART ADDITION-CURE SILICONE ELASTOMERS
4 - PREFACE
6 - CONTENTS
7 - INTRODUCTION
9 - 1 Scope
9 - 2 Normative references
9 - 3 Terms and definitions
9 - 3.1 catalyst
10 - 3.2 crosslinking agent
10 - 3.3 filler reinforcing agent
10 - 3.4 inhibitor
10 - 3.5 lot batch
10 - 3.6 manufacturer
10 - 3.7 raw materials
10 - 3.8 silicone elastomer
11 - 3.9 silicone polymer
11 - 3.10 supplier
11 - 3.11 treating agent
12 - 3.12 two-part addition-cure silicone elastomer
12 - 4 Formulation
12 - 4.1 Composition
12 - 4.2 Raw materials assessment
13 - 5 Biocompatibility
13 - 6 Characterization and testing
13 - 6.1 Test slab preparation
13 - 6.2 Identification
13 - 6.3 Purity testing
13 - 6.3.1 Metal contamination
14 - 6.3.2 Particulate contamination
14 - 6.3.3 Cytotoxicity
14 - 6.3.4 Substances soluble in hexane
14 - 6.3.5 Determination of volatile matter
14 - 6.4 Cure rate
15 - 6.5 Physicomechanical properties and characterization
15 - 7 Documentation
15 - 7.1 Data sheet
15 - 7.2 Certificate of analysis
16 - Annex A - Determination of substances soluble in hexane
16 - A.1 Objective
16 - A.2 Principle
16 - A.3 Sample preparation
16 - A. 4 Reagents
17 - ISO 14949:2001(E)
17 - 9
17 - A. 4.1 n-Hexane
17 - A. 4.2 Isopropanol,
17 - A.5 Apparatus and glassware
17 - A.6 Experimental precautions
18 - A.7 Procedure
18 - A.8 Calculation
19 - A.9 Specification
20 - Annex B - Determination of volatile matter
20 - B.1 Objective
20 - B.2 Principle
20 - B.3 Sample preparation
20 - B.4 Reagent
20 - B.5 Apparatus and glassware
20 - B.6 Experimental precautions
21 - B.7 Procedure
21 - B.8 Calculation
21 - B.9 Specification
22 - Bibliography

Identically Adopts ISO 14949 2001 which specifies the characteristics of, and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for the use in the manutufutre 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.

First published as AS ISO 14949-2003.