AAMI ISO 10993-1:2018 pdf download – Biological evaluation of medical devices
4.4 The biological evaluation shall commence with categorization of medical devices (see Clause 6). Assessment of the information already available then enables a gap analysis to facilitate the selection of appropriate tests. The rigour necessary in the biological evaluation is principally determined by the nature, degree, frequency and duration of the exposure and the hazards identified for the medical device or material. Testing is usually not necessary when sufficient information is already available to perform a risk assessment of the material and/or the medical device (see Annex C). For example, biological testing is usually not necessary, if material characterization (e.g. physical and chemical) demonstrates equivalence to a previously assessed medical device or material with established safety (see ISO 10993-18 and ISO/TR 10993-19). The interpretation of the data shall take into account the chemical composition of the materials, including the conditions of exposure as well as the nature, degree, frequency and duration of exposure of the body to the medical device or its constituents.
4.5 All known possible biological hazards shall be taken into account for every material and final product, but this does not imply that testing for all possible hazards will be necessary or practical (see Clauses 5 and 6). Test results cannot guarantee freedom from potential biological hazards, thus biological investigations shall be followed by careful observations for unexpected adverse reactions or events in humans during clinical use of the medical device. The range of possible biological hazards is wide and can include short-term effects such as acute toxicity, irritation to the skin, eye and mucosal surfaces, haemolysis and thrombogenicity, as well as long-term or specific toxic effects such as subchronic and chronic toxic effects, sensitization resulting in allergy, genotoxicity, carcinogenicity (tumorigenicity) and effects on reproduction or development, including teratogenicity.
4.6 If testing is needed, selection of any in vitro or in vivo tests (see Annex A) shall be based on intended use. In vitro test methods, which are appropriately validated, reasonably and practically available, reliable and reproducible, shall be considered for use in preference to in vivo tests (see ISO 10993-2). Whenever in vivo tests are indicated by findings of the initial risk assessment, use of appropriate in vitro screening, if available, shall be considered before in vivo tests are commenced. A rationale for the testing strategy, as well as for test selection, shall be provided. Test data, complete to the extent that an independent analysis could be made, shall be evaluated by competent, informed professionals, and shall be retained.
4.11 This document shall not be used to mandate re-testing of historical products assessed previously using the appropriate edition of this document at the time of the assessment. Nevertheless, compliance to this new edition shall be shown, by providing a justification for omission of further testing. Where recommendations for endpoint assessment per Annex A are different from prior published versions of this document, a history of safe clinical use can be used to document why additional testing on a commercially-marketed medical device is not needed. However, if any of the changes described in Clause 4.9 occur, an evaluation of the biologic risks related to the change shall be performed using the current version of this standard.