Foreword
Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 General principles for establishing allowable limits
5 Establishment of tolerable intake (TI) for specific
leachable substances
6 Calculation of tolerable exposure (TE)
7 Feasibility evaluation
8 Benefit evaluation
9 Allowable limits
10 Reporting requirements
Annex A (informative) - Some typical assumptions for
biological parameters
Annex B (informative) - Risk assessment for mixtures
of leachable substances
Annex C (informative) - Conversion of allowable limits
for systemic exposure and for body surface
contact to maximum dose to patient from a
medical device
Annex D (informative) - Risk analysis report
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