ISO 10993-3:2014 pdf download.Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
— existing information relevant to the genotoxicity, carcinogenlcity and reproductive toxicity evaluation of the medical device,
— the extent of previous use of comparable materials in relevant applications,
— consideration of residuals from the final finished device with respect to how well they are characterized and their potential biological activity e.g. structure-activity relationships, or previous demonstration of relevant outcomes).
— exposure route,
— patient population,
— extent and duration of localized (at the site of implantation or use) and systemic exposure.
— the anticipated impact of test results (or lack of testing) on risk management udgements. and
— changes in the type or amount of residuals that the patient will be exposed to. either through an increase in device exposure, or an increase in devices size when compared to an equivalent device.
Commonly used risk assessment tools (e.g. TTC) may be helpful in evaluating these factors.
Where an analysis olthe composition of device materials reveals the presence of chemical constituents that are of concern but for which inadequate toxicity data are available, consideration shall be given to testing individual chemical. Individual chemicals shall be tested in preference to compounded materials or extracts, where this would improve the risk estimate. Where testing ala device material is indicated testing shall be conducted on the final product (including sterilization if applicable). or representatives from the final products, or materials processed in the same manner as the final product (including sterilization if applicable). The decision to test, and the nature of the test sample. shall be justified and documented.
TestIng may he warranted for additional states of the device such as. wear debris generated from the device or materials that cure En situ (e.g. cements, adhesives and pre-polyrner mixtures) unless toxicological risk assessment determines no cause for concern from additional device/material states. Far guidance on in situ curing devices see ISO 10993-12.
— the extent of previous use of comparable materials in relevant applications,
— consideration of residuals from the final finished device with respect to how well they are characterized and their potential biological activity e.g. structure-activity relationships, or previous demonstration of relevant outcomes).
— exposure route,
— patient population,
— extent and duration of localized (at the site of implantation or use) and systemic exposure.
— the anticipated impact of test results (or lack of testing) on risk management udgements. and
— changes in the type or amount of residuals that the patient will be exposed to. either through an increase in device exposure, or an increase in devices size when compared to an equivalent device.
Commonly used risk assessment tools (e.g. TTC) may be helpful in evaluating these factors.
Where an analysis olthe composition of device materials reveals the presence of chemical constituents that are of concern but for which inadequate toxicity data are available, consideration shall be given to testing individual chemical. Individual chemicals shall be tested in preference to compounded materials or extracts, where this would improve the risk estimate. Where testing ala device material is indicated testing shall be conducted on the final product (including sterilization if applicable). or representatives from the final products, or materials processed in the same manner as the final product (including sterilization if applicable). The decision to test, and the nature of the test sample. shall be justified and documented.
TestIng may he warranted for additional states of the device such as. wear debris generated from the device or materials that cure En situ (e.g. cements, adhesives and pre-polyrner mixtures) unless toxicological risk assessment determines no cause for concern from additional device/material states. Far guidance on in situ curing devices see ISO 10993-12.
