ISO 7405:2018 pdf free

ISO 7405:2018 pdf free.Dentistry一Evaluation of biocompatibility of medical devices used in dentistry
Each medical device used in dentistry shall be subjected to a structured biological evaluation programme within a risk management process (see ISO 10993-1). Guidance on the implementation of this programme in ISO 14971 and ISO 10993-1 shall be used.
The biological evaluation programme shall include the review of data sets concerning the biological properties of each medical device used in dentistry. When this part of the biological evaluation programme indicates that one or more data sets are incomplete and that further testing is necessary,the tests shall be selected from the methods described in the ISO 10993 series of standards or in this document, or in both. If tests that are not included in these International Standards are selected, a statement shall be made that indicates that the tests described in these International Standards have been considered and shall include a justification for the selection of other tests.
For combination products the final product shall be evaluated according to this document in conjunction with any applicable standards.
According to the categorization of the device, tests shall be considered for use as summarized in Table A.1. This table indicates which types of test method shall be considered, but not that they are necessarily required to be carried out. A decision not to carry out a type of test identified in Table A.1 shall be justified in the test report on each device. The types of test listed are regarded as a framework for the evaluation of the biocompatibility of medical devices used in dentistry. For most types of test,particular methods are identified, although for some devices it is recognized that alternative methods not included in the International Standards listed can be more appropriate.
Material characterization of the medical device or component (see Table A.1) is a crucial first step in the biological evaluation. Material characterization, if performed, shall be conducted in accordance with ISO 10993-18 and ISO/TS 10993-19. For nanomaterials, see ISO/TR 10993-22.For convenience, the types of biological tests have been listed in three groups.ISO 7405 pdf free.