ISO 10993-9:2019 pdf free

ISO 10993-9:2019 pdf free.Biological evaluation of medical devices一Framework for identification and quantification of potential degradation products
Careful consideration of the potential for intended or unintended degradation of a material is essential to the evaluation of the biological safety of a device. Part of this consideration is an assessment of the chemical characteristics and known degradation mechanisms, followed by an assessment of the need for, and design of, experimental degradation studies.
It is neither necessary nor practical to conduct degradation studies for all medical devices. Refer to Annex A to determine when degradation studies should be considered. The assessment of the need for experimental degradation studies shall include a review of the literature and/or documented clinical experience. Guidance on proper reviewing of the literature can be found in ISO 10993-1. Such an assessment can potentially result in the conclusion that no further testing is needed.
Guidance on the biological evaluation of leachables including degradation products is given in ISO 10993-1， ISO 10993-16 and ISO 10993-17. See ISO 10993-18 for guidance on the chemical characterization of materials and their leachables used in medical devices. See ISO/TS 10993-19 for guidance on the physico-chemical, morphological and topographical characterization of materials.Consideration of these standards prior to conducting degradation studies can prove helpful in distinguishing degradation products from other leachables.
NOTE Despite the difference between degradation products and other leachables, it can be possible to combine a study on degradation products with a study on other leachable components. Distinguishing between degradation products and other types of leachables might not be necessary for further biological evaluation studies. However, when a reduction of the level of leachable components is deemed necessary as a risk control measure, this information is important. Additionally, some degradation products cannot leach from the device but can still impact the properties of the device.
The degradation products produced in the study can be particulate or soluble compounds or ions.Appropriate analytical methods to characterize these products shall be used and reported in the study report. These methods shall be adequately qualified for their intended purpose. If particles are generated, they shall be characterized with regard to size, shape, surface area and other relevant characteristics.ISO 10993-9 pdf free download.