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
5.1 General
5.2 Exposure considerations for TI calculation
5.3 Collection and evaluation of data
5.4 Set TI for noncancer endpoints
5.5 Set TI for cancer endpoints
5.6 Establishment of tolerable contact levels (TCLs)
5.7 Risk assessment of mixtures
6 Calculation of tolerable exposure (TE)
6.1 General
6.2 Exposure population
6.3 Calculation of utilization factor from intended
use pattern
6.4 Tolerable exposure
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