Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Packaging
Annex A (normative) - Physical tests
Annex ZA (informative) - Relationship between
this International Standard and the
Essential Requirements of EU Directive
93/42/EEC on Medical Devices
Bibliography