UNI 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
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
Bibliography

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