AS ISO 14949:2003(R2014) PDF

Scope: 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

AS ISO 14949:2003(R2014) history

0000 AS ISO 14949:2003(R2014)
2003 AS ISO 14949:2003 Implants for surgery - Two-part addition-cure silicone elastomers