DIN EN ISO 5840-1:2015-12

There is, as yet, no heart valve substitute which can be regarded as ideal. This International Standard has been prepared by a group well aware of the issues associated with heart valve substitutes and their development. In several areas, the provisions of this International Standard have deliberately not been specified in order to encourage development and innovation. It specifies the types of tests, test methods, and/or requirements for test apparatus and requires documentation of test methods and results. The areas with which this International Standard is concerned are those which will ensure that associated risks to the patient and other users of the device have been adequately mitigated, facilitate quality assurance, aid the clinician in choosing a heart valve substitute, and ensure that the device will be presented at the operating table in convenient form. Emphasis has been placed on specifying types of in vitro testing, on preclinical in vivo and clinical evaluations, on reporting of all in vitro, preclinical in vivo, and clinical evaluations, and on the labelling and packaging of the device. Such a process involving in vitro, preclinical in vivo, and clinical evaluations is intended to clarify the required procedures prior to market release and to enable prompt identification and management of any subsequent problems. With regard to in vitro testing and reporting, apart from basic material testing for mechanical, physical, chemical, and biocompatibility characteristics, this International Standard also covers important hydrodynamic and durability characteristics of heart valve substitutes. This standard does not specify exact test methods for hydrodynamic and durability testing, but it offers guidelines for the test apparatus. This International Standard is incomplete in several areas. It is intended to be revised, updated, and/or amended as knowledge and techniques in heart valve substitute technology improve. The committee responsible for this document is NA 027-02-17-01 UA "Herz- und Gefäßimplantate" ("Cardiovascular implants") at DIN.