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AAMI ISO 10993-3 pdf free download

AAMI ISO 10993-3 pdf free download.Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1, Iso 10993-12, and the following apply.
3.1 carcinogenicity test: Test to determine the tumorigenic potential of medical devices, materials, and/or extracts using either single or multiple exposures over a major portion of the life span of the test animal.
NOTE—These tests may be designed to examine both chronic toxicity and tumorigenicity in a single experimental study. When chronic toxicity and carcinogenicity are evaluated within a single study, care in study design with emphasis on dose selection should be exercised. This will help to ensure that premature mortality from chronic/cumulative toxicity does not compromise the statistical evaluation of animals that survive until scheduled study termination (i.e. normal life-span).
3.2 energy-depositing medical device: Device intended to exert its therapeutic or diagnostic effect by the delivery of electromagnetic radiation, ionizing radiation, or ultrasound.
NOTE—This does not include medical devices that deliver simple electrical current, such as electrocautery medical devices, pacemakers, or functional electrical stimulators.
3.3 genotoxicity test: Test using mammalian or non-mammalian cells, bacteria, yeasts, or fungi to determine whether gene mutations, changes in chromosome structure, or other DNA or gene changes are caused by the test samples.
NOTE—These tests can include whole animals.
3.4 maximum tolerated dose (MTD): Maximum dose that a test animal can tolerate without any adverse
physical effects.
3.5 reproductive and developmental toxicity test: Test to evaluate the potential effects of test samples on
reproductive function, embryonic morphology (teratogenicity), and prenatal and early postnatal development.
4 Genotoxicity tests
4.1 General
Before a decision to perform a genotoxicity test is made, ISO 10993-1 and the chemical characterization of materials (ISO 10993-18) shall be taken into account. The rationale for a test program, taking into consideration all relevant factors, shall be documented.
ISO 10993-1 indicates circumstances where the potential for genotoxicity is a relevant hazard for consideration in an overall biological safety evaluation (see ISO 10993-1:1997, Table 1). Testing for genotoxicity, however, is not necessary for medical devices, and components thereof, made only from materials known to show no genotoxicity. Testing for genotoxicity is indicated where a review of the composition of the materials reveals the possible presence in the final medical device of compounds that might interact with genetic material, or when the chemical composition of the medical device is unknown. In such circumstances, the genotoxic potential of suspect chemical components should be assessed, bearing in mind the potential for synergy, in preference to carrying out genotoxicity tests on the material or medical device as a whole.
When the genotoxicity of a medical device has to be experimentally assessed, a series of in vitro tests shall be used. This series shall include either two tests if 4.2.1.2 is performed, which uses the mouse lymphoma assay incorporating colony number and size determination, or three tests if 4.2.1.1 is performed. When tests are performed, at least two tests, investigating different endpoints, shall use mammalian cells.AAMI ISO 10993-3 pdf download.

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