Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Content of the outer container label
6 Content of the immediate container label
7 Content of the instructions for use
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of the EU
Directive 98/79/EC on "in vitro Diagnostic Medical
Devices"