Adopts ISO 14630:2012 to specify general requirements for non-active surgical implants. It also specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Table of contents
Header
About this publication
Preface
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacture
9 Sterilization
9.1 General
9.2 Products supplied sterile
9.3 Sterilization by the user
9.3.1 Products supplied non-sterile
9.3.2 Re-sterilization
9.4 Sterilization residuals
10 Packaging
10.1 Protection from damage in storage and transport
