Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Implantable materials
5 Technical file
5.1 Contents
5.2 Chemical composition
5.3 Physical properties
5.4 Intended applications, precautions, warnings and
instructions
5.5 Preclinical and clinical evaluation
5.6 Manufacture
5.7 Materials of animal origin
5.8 Sterilization
5.9 Packaging
5.10 Additional information supplied by the manufacturer
Bibliography