ANSI AAMI ISO 5840-2:2015 pdf download – Cardiovascular implants – Cardiac valve prostheses
Test specimens shall represent, as closely as possible, the finished product to be supplied for clinical use, including exposure to the maximum number of recommended sterilization cycles, process chemicals, and aging effects in accordance with all manufacturing procedures and Instructions for Use, where appropriate. Any deviations of the test specimens from the finished product shall be justified. The specimens selected for testing shall fully represent the total implant size range. Depending on the particular test, testing might not necessarily have to be completed for each discrete valve size, but shall at least be completed for the smallest, intermediate, and largest sizes. A rationale for device size selection shall be provided. For all tests, the number of samples shall be justified based on the specific intent of the test (see ISO 5840-1 :201 5, Annex F). Sampling shall ensure adequate representation of the expected variability in the manufacture of devices. Additional recommendations regarding sampling and sample conditioning are included within each test method defined herein, as appropriate. Where simulation of in vivo conditions is applicable to the test method, consideration shall be given to those operational environments given in ISO 5840-1 :201 5, Table 1 and Table 2 for the adult population. See ISO 5840-1 :2015, Annex E for guidelines regarding suggested test conditions for the pediatric population. Where applicable, testing shall be performed using a test fluid of isotonic saline, blood, or a blood-equivalent fluid whose physical properties (e.g. specific gravity, viscosity at operating temperatures) are appropriate to the test being performed. The test fluid used shall be justified. Testing shall be performed at the intended operating temperature as appropriate, Test methods for design verification testing shall be appropriately validated. Refer to applicable sections of ISO/IEC 1 7025:2005.
7.2.2.2 Biological safety
The biocompatibility of the materials and components used in surgical heart valve substitutes shall be determined in accordance with ISO 1 0993-1 . The test plan recorded in the risk management file shall comprise a biological safety evaluation program 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 1 0993-1 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 hematological 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 surgical heart valve substitutes using animal tissue or their derivatives, the risk associated with the use of these materials shall be evaluated in accordance with the ISO 22442- series.