ANSI/AAMI/ ISO 5840-2:2015 pdf 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.
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.