EN ISO 14630-2012 pdf free download.Non-active surgical implants – General requirements (ISO 14630:2012). 7 Design evaluation 7.1 General Implants shall be evaluated to demonstrate that the intended performance (see Clause 4) is achieved The extent to which the intended performance has been achieved shall be determined and documented. Safety and intended performance shall be demonstrated by pre-clinical evaluation, clinical evaluation and post-market surveillance, including appropriate risk management at all stages of the life cycle of the implant, in accordance with the requirements of ISO 14971. 7.2 Pre-clinical evaluation Implants shall undergo pre-clinical evaluation based on a) the relevant scientific literature relating to the safety, performance, design characteristics, and intended use of the implant, b) analysis of available predictive and outcome data from sources such as national and other registries, and c) analysis of data obtained from testing, including bench-testing and, when available, data from validated techniques for evaluating implant safety and intended performance. The extent of pre-clinical evaluation shall take account of existing data in relation to similar implants or design features. Pre-clinical testing of implants should simulate conditions of intended use. Test methods and related limits for specific types of implants shall be defined and justified by the manufacturer and shall include, as appropriate. in vitro handling tests to verify the intended interaction between the implant and the instrumentation and, if applicable, between interconnecting implants. In instances when implantation and, where appropriate, removal cannot be evaluated by direct comparison with existing devices, cadaveric evaluation should be performed where possible. If static and/or dynamic loading tests are relevant for the evaluation of the implant, either accepted test standards, when available, or customized test models taking into account the characteristics of the implant shall be applied. Because of the wide variance of implants and their features, testing standards might not exist or may be modified as needed. Where appropriate. biophysical or modelling research may be used to demonstrate that the intended performance of the implant is achieved, Tests should take into account anticipated loading and/or environmental conditions. Where appropriate, test specimens should represent as closely as possible the implants to be implanted. Test methods and limits for particular implants can be described in related standards, such as those listed in the bibliography.EN ISO 14630 pdf download.
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