Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General principles
6 Characterization procedure
7 Chemical characterization parameters and methods
8 Reporting of data obtained
Annex A (normative) - Flowchart summarizing the stepwise
generation of chemical characterization data for
use in toxicological risk assessment
Annex B (informative) - Information sources for chemical
characterization
Annex C (informative) - Principles for judging toxicological
equivalency
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
National Annex NA (informative) - Bibliography