ISO 10993-1:2018 pdf free

ISO 10993-1:2018 pdf free.Biological evaluation of medical devices
Evaluation can include both a review of relevant existing preclinical and clinical data and actual testing. Such an evaluation might result in the conclusion that no testing is needed if the material has a demonstrable safe history of use in a specified role and physical form that is equivalent to that of the medical device under design. The type of information that can be useful to demonstrate equivalence is included in Annex B. 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).
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.
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.
In certain circumstances, such as for specific medical devices, or biological endpoint assessments, if a non-standardized, non-validated test is necessary, additional information regarding the rationale for the study design and data interpretation should be provided.ISO 10993-1 pdf free download.