BS EN ISO 10993-17:2009

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 exposure and for body surface contact to maximum dose to patient from a medical device
• Risk analysis report
• Bibliography