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
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

ISO 10993-17:2002 specifies 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. ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.