ANSI/AAMI/ ISO 5840-1:2015 pdf download – Cardiovascular implants— Cardiac valve prostheses— Part 1: General requirements.
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.
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. The manufacturer shall validate the design of the heart valve system. 7.2 In vitro assessment Reference the following Annexes for in vitro assessments: — Annex F: Statistical procedures when using in vitro performance criteria; — Annex G: Examples and definitions of some physical and material properties of heart valve systems; — Annex H: Examples of standards applicable to testing of materials and components of heart valve systems; — Annex I: Raw and post-conditioning mechanical properties for support structure materials; — Annex J: Corrosion assessment; Specific requirements for in vitro assessments are provided in ISO 5840-2 and ISO 5840-3. 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.