ANSI AAMI ISO 5840-2 pdf free download

ANSI AAMI ISO 5840-2 pdf free download.Cardiovascular implants— Cardiac valve prostheses— Part 2: Surgically implanted heart valve substitutes.
5 Fundamental requirements The manufacturer shall determine, at all stages of the product life cycle, the acceptability of the product for clinical use. 6 Device description 6.1 Intended use The manufacturer shall identify the physiological condition(s) to be treated, the intended patient population, potential adverse events, and intended claims. 6.2 Design inputs 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 6.2.2.2 Specifications shall be defined with respect to at least the following performance characteristics: — ability to allow forward flow with acceptably small mean pressure difference; — ability to prevent retrograde flow with acceptably small regurgitation; — ability to resist embolization; — ability to resist hemolysis; — ability to resist thrombus formation; — biocompatible; — compatible with in vivo diagnostic techniques; — deliverable and implantable in the target population; — ability to ensure effective fixation within the target implant site;— has an acceptable noise level; — has reproducible function; — maintains structural and functional integrity during the expected lifetime of the device; — maintains its functionality and sterility for a reasonable shelf life prior to implantation. 6.2.3 Packaging, labelling, and sterilization The surgical heart valve substitute and accessories shall meet the requirements for packaging, labelling, and sterilization contained within ISO 5840-1 :201 5, Annexes B, C, and D, respectively. 6.3 Design outputs 6.3.1 General The manufacturer shall establish (i.e. define, document, and implement) a complete specification of the surgical heart valve substitute system, which includes component and assembly-level specifications, accessories, packaging, and labelling. Annex E contains a listing of components and terms that may be used in describing various valve types. 6.4 Design transfer (manufacturing qualification) 6.4.1 The manufacturer shall generate a manufacturing flowchart identifying the manufacturing process operations and inspection steps. The input of all components and important manufacturing materials shall be indicated on the flowchart.6.4.2 As part of the risk management process, the manufacturer shall establish the control measures and process conditions necessary to ensure that the device is safe and suitable for its intended use. The risk management file shall identify and justify the verification activities necessary to demonstrate the acceptability of the process ranges chosen. 6.4.3 The manufacturer shall establish the adequacy of full-scale manufacturing by validation of the manufacturing process. The manufacturer shall document the results of the validation of all special processes and the validation of all process software. NOTE See ISO 1 3485. 6.5 Risk management The manufacturer shall define and implement a risk management program in accordance with ISO 1 4971 . Annex A contains a list of potential hazards specific to surgical heart valve substitutes that can serve as the basis for a risk analysis.ANSI AAMI ISO 5840-2 pdf download.