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ANSI AAMI ISO 5840-1 pdf free download

ANSI AAMI ISO 5840-1 pdf free download.Cardiovascular implants— Cardiac valve prostheses— Part 1: General requirements.
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, intended device delivery approach/process, 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. Table 1 and Table 2 define the expected physiological parameters of the intended adult patient population for heart valve substitutes for both normal and pathological patient conditions. Refer to Annex E for in vitro test guidelines for pediatric devices. 6.2.2 Performance specifications The manufacturer shall establish (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 specific performance specifications are provided in ISO 5840-2 and ISO 5840-3. 6.2.3 Implant procedure The entire system shall provide intended users the ability to safely and effectively perform all required pre-operative, intra-operative, and post-operative procedural tasks and achieve all desired objectives. This shall include all other device specific tools and accessories that intended users will use to complete the procedure. NOTE For guidance on how to determine and establish design attributes pertaining to the use of the system to conduct the implant procedure, see IEC 62366.6.3 Design outputs The manufacturer shall establish (i.e. define, document, and implement) a complete specification of the heart valve system including component and assembly-level specifications, delivery system (if applicable), accessories, packaging, and labelling. In addition to the physical components of the heart valve system, the implant procedure itself should be considered an important element of safe and effective heart valve therapy.7 Design verification testing and analysis/design validation 7.1 General requirements The manufacturer shall perform verification testing to demonstrate that the device specifications result in a heart valve system that meets the design specifications (design output meets design input). The manufacturer shall establish tests relating to hazards identified from the risk analysis. The protocols shall identify the test purpose, setup, equipment (specifications, calibration, etc.), test conditions (with a justification of appropriateness to anticipated in vivo operating conditions for the device), acceptance criteria, and sample quantities tested.7.3 Preclinical in vivo evaluation A preclinical in vivo test program shall be conducted in order to address the heart valve system, placement, imaging characteristics, and safety and performance. The preclinical program design should be based on risk management assessment. The specific preclinical requirements are provided in ISO 5840-2 and ISO 5840-3. 7.4 Clinical investigations For new heart valve designs, a clinical investigation shall be carried out in accordance with the ISO 5840-series. For modification of an existing valve, a clinical investigation shall be considered based on the results of a risk assessment that evaluates the modification. The clinical investigation shall be conducted in accordance with ISO 1 41 55.ANSI AAMI ISO 5840-1 pdf download.

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