chapter  14
10 Pages


Carcinogenicity studies are infrequently required for medical devices. The tables in Chapter 2 cite each of the general cases, though these do not catch all of the nuances. Under International Organization for Standardization (ISO) 10993-11, for example, the need to perform carcinogenicity tests may be triggered by

• Devices introduced in the body with greater than 30 days cumulative contact. • Devices or materials with positive genotoxicity tests. • Resorbable or biodegradable materials and devices. • Note that in those cases where carcinogenicity testing is required but no effects have

occurred in genotoxicity tests, clinical testing may be performed concurrently with carcinogenicity testing where implantation does not represent the most appropriate route of exposure, and scientically justied alternatives should be considered.