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ISO 5840-3-2013 pdf free download
ISO 5840-3-2013 pdf free download.Cardiovascular implants — Cardiac valve prostheses — Part 3:
Heart valve substitutes implanted by transcatheter techniques
Implants cardiovasculaires — Prothèses valvulaires — Partie 3: Valves cardiaques de substitution implantées par des techniques transca théter.
7.2.2 Material property assessment
Properties o the transcatheter heart valve sunsmuce system components e.g. support structure, valve leaflets) shall be evaluated as applicable to the specific design of the system as determined by the risk assessment. The materials requirements of ISO 14630:2012, Clause 6, shall apply. Additional testing specific to certain materials shall be performed to determine the appropriateness of the material for use in the design. For example, materials dependent on shape memory properties shall be subjected to testing in order to assess transformation properties.
126.96.36.199 Biological safety
The biocompatibility of the materials and components used in the transcatheter heart valve substitute system shall be determined in accordance with ISO 10993-1. The test plan recorded in the risk management file shall comprise a biological safety evaluation programme with a justification for the appropriateness and adequacy of the information obtained. The documentation shall include a rationale for the commission of any biological safety tests carried out to supplement information obtained from other sources and for the omission of any tests identified by ISO 10993-1 but not performed. During the hazard identification stage of a biological safety evaluation, sufficient information shall be obtained to allow the identification of toxicological hazards and the potential for effects on relevant haematological characteristics. Where an identified hazard has the potential for significant clinical effects, the toxicological risk shall be characterized through evaluation of data on, for example, mode of action, dose-response, exposure level, biochemical Interactions and toxicokinetics.
For transcatheter heart valve substitutes using animal tissue or their derivatives, the risk associated with the use of these materials shall be evaluated in accordance with ISO 22442-1, ISO 22442-2 and ISO 22442-3.
188.8.131.52 Material and mechanical property testing
The material properties of all constituent materials comprising the transcatheter heart valve substitute system and each element thereof shall be evaluated as applicable to its specific design. Scientific literature citations or previous characterization data from similar devices can be referenced; however, the applicability of the literature data to the transcatheter heart valve substitute shall be justified.
Mechanical properties shall be characterized at various stages of manufacture, as applicable: a) for the structural component raw materials, b) for the structural component in its final manufactured state, and c) for the finished device after applicable catheter loading and deployment states. Environmental conditions that might affect device or component performance or durability shall be evaluated and included in testing protocols (e.g. shelf life testing). Annex J provides potentially relevant physical, mechanical and chemical properties by material class and components.ISO 5840-3-2013 pdf free download.
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