ANSI AAMI ISO 5840-2-2015 pdf download
ANSI AAMI ISO 5840-2-2015 pdf download.Cardiovascular implants—Cardiac valve prostheses
This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This part of ISO 5840 outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This part of ISO 5840 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis. This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This part of ISO 5840 excludes homografts.
6.2.1 Operational specifications
The manufacturer shall define the operational specifications for the device, including the principles of operation, expected device lifetime, shelf life, shipping/storage limits, and the physiological environment in which it is intended to function. The manufacturer shall carefully define all relevant dimensional parameters that will be required to accurately select the size of device to be implanted. ISO 5840-1:201 5, Table 1 and Table 2 define the expected physiological parameters of the intended adult patient population for surgical heart valve substitutes for both normal and pathological patient conditions. NOTE See the pediatric annex of ISO 5840-1 :201 5, Annex E.
6.2.2 Performance specifications
6.2.2.1 The manufacturer shall establish (i.e. define, document, and implement) the clinical performance requirements of the device and the corresponding device performance specifications for the intended use and device claims. The following list of desired clinical and device-based performance characteristics describes a safe and effective surgical heart valve substitute. NOTE For novel devices, portions of ISO 5840-3 can be applicable.
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.
