Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Labelling and documentation requirements
6 Test methods
Annex A (informative) - Examples of analytical methods
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC 'Medical Devices'
Annex ZB (informative) - A-deviations
Bibliography