AS/NZS 2817:1997

1 - AS/NZS 2817:1997 IMPLANTS FOR SURGERY-CARE AND HANDLING OF ORTHOPAEDIC IMPLANTS
4 - PREFACE
5 - CONTENTS
7 - 0 Introduction
7 - 1 Scope and field of application
7 - 2 Definition
7 - 3 General guidance
7 - 3.1 On receipt
7 - 3.1.1 General
7 - 3.1.2 Sterile implants
7 - 3.1.3 Non-sterile implants
7 - 3.1.4 Useability of implants
7 - 3.2 Transport
7 - 3.3 Stock records
7 - 3.3.1 General
7 - 3.3.2 Unique numbers
8 - 3.3.3 Records to be compiled
8 - 3.4 Storage
8 - 3.4.1 General
8 - 3.4.2 Storage conditions
8 - 3.5 Stock rotation
8 - 3.6 Cleaning and sterilization of non-sterile implants
8 - 3.7 Appearance
8 - 3.8 Contouring and modifying implants
8 - 3.9 Re-use
8 - 4 Additional guidance on polymeric implants and materials
8 - 4.1 Sterilization
8 - 4.2 Acrylic bone cement
9 - 4.3 Silicone implants
9 - 5 Additional guidance on ceramic components
9 - 5.1 Sterilization and handling
9 - 5.2 Dropping of ceramic components
9 - 5.3 Manufacturer’s instructions
9 - 6 Additional guidance on implants or components of implants with rough surfaces or surfaces with intrinsic porosity
9 - 6.1 Sterile implants
9 - 6.2 Subsequent cleaning of implants
9 - 6.3 Non-sterile implants
9 - 7 Bibliography
10 - APPENDIX ZZ - AMENDMENTS TO ISO 8828 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND

Sets out procedures for handling orthopaedic implants from receipt at the health care facility until they are implanted or discarded. It is technically equivalent to and reproduced from ISO 8828:1988.

This International Standard gives guidance on the recommended procedures for handling orthopaedic implants (such as currently used metal, ceramic or polymeric implants, and also including acrylic resin and other bone cements) from receipt at the hospital until they are implanted or discarded.NOTE - The guidance does not apply to the implant manufacturer.

First published as AS 2817-1985.
Jointly revised and designated AS/NZS 2817:1997.