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Safety assessment and global regulatory requirements for genetic toxicity evaluations of medical devices
Author(s) -
Przygoda Robert T.
Publication year - 2017
Publication title -
environmental and molecular mutagenesis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1
H-Index - 87
eISSN - 1098-2280
pISSN - 0893-6692
DOI - 10.1002/em.22102
Subject(s) - risk assessment , genotoxicity , toxicity , risk analysis (engineering) , computer science , toxicology , biochemical engineering , medicine , biology , engineering , computer security
Medical devices have the potential to leach substances which, depending on the contact category of the device, can directly contact the human body. Hence, appropriate evaluation for genetic toxicity as part of the biocompatibility risk assessment is critical. The biocompatibility risk assessment of medical devices is guided by the ISO 10993 series of standards. The recently revised ISO 10993‐3 (2014) provides guidance on evaluating the genotoxicity, carcinogenicity and reproductive toxicity potential of medical devices. The revised standard includes the use of risk assessments and chemical characterization in addition to traditional genetic toxicity tests. The ISO 10993‐3 standard provides guidance on the selection and preparation of test samples, and the selection of tests to evaluate genetic toxicity. Although conformance to ISO 10993‐3 is required by various national regulatory agencies for specific medical device categories, there are still differences in the interpretation of the requirements within the standard which may require additional testing. Environ. Mol. Mutagen. 58:375–379, 2017. © 2017 Wiley Periodicals, Inc.