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