ISO 5840-1:2021 pdf – Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements.
6 Device description 6.1 General The requirements of ISO 14630 shall apply. 6.2 Intended use The manufacturer shall identify the pathological condition(s) to be treated, the intended patient population, potential adverse events, and intended claims. 6.3 Design inputs 6.3.1? 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 are 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.
6.3.2? Performance? specifications 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 specific performance specifications are provided in ISO 5840-2 and ISO 5840-3. 6.3.3 Implant procedure The heart valve 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 device specific tools and accessories that intended users 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 (all parts). 6.3.4 Packaging, labelling, and sterilization The heart valve system shall meet the requirements for packaging, labelling, and sterilization contained within Annex B, Annex C, and Annex D, respectively. The manufacturer shall provide sufficient information and guidance in the labelling to allow for appropriate preparation of the implant site, accurate selection of appropriate implant size, and reliable implantation of the heart valve substitute.
6.4 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. 6.5? Design? transfer? (manufacturing? verification/validation) The manufacturer shall generate a flowchart identifying the manufacturing process operations and inspection steps. The flowchart shall indicate the input of all components and important manufacturing materials. 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. The manufacturer shall validate any processes for production where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement. Process software shall also be validated. Results of validations shall be documented. 6.6 Risk management The manufacturer shall implement a risk management process in accordance with ISO 14971 and define and justify a risk management programme, which should be specified in the risk management plan. 7? Design? verification? and? validation 7.1 General requirements The manufacturer shall perform design verification to demonstrate that the design output of a heart valve system meets the design input. The manufacturer shall establish tests relating to hazards identified from the risk analysis.
The manufacturer shall also validate the design of the heart valve system in accordance with ISO 13485 to ensure that the device meets user needs and is suitable for the intended use. Additional requirements for design verification testing are provided in ISO 5840-2 for surgical heart valve substitutes and ISO 5840-3 for transcatheter heart valve substitutes. For novel heart valve substitutes (e.g. sutureless surgical valves), the requirements of both ISO 5840-2 and ISO 5840-3 can be relevant and shall be considered, if applicable to the specific device design and based on the results of the risk analysis. 7.2 In vitro assessment 7.2.1 General In vitro assessment shall be used to mitigate the risks identified in the risk analysis.