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
10 Labelling
Annex A (normative) - Physical tests
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on Medical Devices
Bibliography