ONORM EN ISO 10993-17 : 2009

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

Describes a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.