BS EN ISO 10993-17:2009 Biological evaluation of medical devices. Establishment of allowable limits for leachable substances
BS EN ISO 10993-17 specifies 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.
BS EN ISO 10993-17 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. BS EN ISO 10993-17 does not address the potential for exposure from such sources.
Contents of BS EN ISO 10993-17:
Foreword
Introduction
Scope
Normative reference
Terms and definitions
General principles for establishing allowable limits
Establishment of tolerable intake (TI) for specific leachable substances
General
Exposure considerations for TI calculation
Collection and evaluation of data
Set TI for noncancer endpoints
Set TI for cancer endpoints
Establishment of tolerable contact levels (TCLs)
Risk assessment of mixtures
Calculation of tolerable exposure (TE)
General
Exposure population
Calculation of utilization factor from intended use pattern
Tolerable exposure
Feasibility evaluation
Benefit evaluation
Allowable limits
Reporting requirements
Some typical assumptions for biological parameters
Risk assessment for mixtures of leachable substances
Conversion of allowable limits for systemic e...
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