Adopts ISO 8828:2014 to specify the recommended procedures for handling orthopaedic implants from receipt at the hospital until they are implanted or discarded. Applies to implants (such as currently used metal, ceramic, or polymeric implants) and also to acrylic resin and other bone cements.
Table of contents
Header
About this publication
Preface
Introduction
1 Scope
2 Terms and definitions
3 General guidance
3.1 Manufacturer’s instructions
3.2 On receipt
3.2.1 General
3.2.2 Products supplied sterile
3.2.3 Non-sterile implants
3.2.4 Usability of implants
3.3 Transport
3.4 Stock records
3.4.1 General
3.4.2 Lot or batch code or serial number
3.4.3 Records to be compiled
3.5 Storage
3.5.1 General
3.5.2 Storage conditions
3.6 Stock rotation
3.7 Cleaning and sterilization of non-sterile implants
3.7.1
3.7.2
3.7.3
3.7.4
3.7.5
3.7.6
3.8 Appearance
3.9 Contouring and modifying implants
3.9.1
3.9.2
3.9.3
3.10 Re-use
4 Additional guidance on polymeric implants and materials
4.1 Sterilization
4.2 Acrylic bone cement
4.3 Silicone implants
4.4 Biodegradable implants
5 Additional guidance on ceramic components
5.1 Sterilization and handling
5.2 Dropping of ceramic components
5.3 Manufacturer’s instructions
6 Additional guidance on implants or components of implants with rough surfaces or surfaces with intrinsic porosity
