Table of Contents

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

Abstract

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.

RECONFIRMATION NOTICE
Technical Committee HE-012 has reviewed the content of this publication and in
accordance with Standards Australia procedures for reconfirmation, it has been determined
that the publication is still valid and does not require change.
Certain documents referenced in the publication may have been amended since the original
date of publication. Users are advised to ensure that they are using the latest versions of
such documents as appropriate, unless advised otherwise in this Reconfirmation Notice.
Approved for reconfirmation in accordance with Standards Australia procedures for
reconfirmation on 29 April 2014.
The following are represented on Technical Committee HE-012:
Australian College of Operating Room Nurses
Australian Dental Association
Australian Society for Biomaterials
Medical Technology Association of Australia
Neurosurgical Society of Australasia
Royal Australasian College of Surgeons
Royal Perth Hospital
Therapeutic Goods Administration

Scope

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Reconfirmed 30/05/2014. This standard has been reconfirmed in Australia in 2014 and remains current in New Zealand. Reconfirmation Notice 30/05/2014
Pages
ISBN
Committee	HE-012
Supersedes	DR 03120 CP