{"id":4587,"date":"2020-10-20T15:57:26","date_gmt":"2020-10-20T15:57:26","guid":{"rendered":"https:\/\/www.niutec.ch\/testing-of-medical-devices\/biokompatibilitaet\/"},"modified":"2023-01-17T07:44:42","modified_gmt":"2023-01-17T07:44:42","slug":"biocompatibility","status":"publish","type":"page","link":"https:\/\/www.niutec.ch\/en\/medical-technology\/biocompatibility\/","title":{"rendered":"Biocompatibility"},"content":{"rendered":"[vc_row][vc_column width=”1\/4″][\/vc_column][vc_column width=”3\/4″][gt3_spacing height=”40px” responsive_es=”true” height_tablet=”20″ height_mobile=”20″][vc_column_text]\n

Biocompatibility of medical devices
\nand materials according to ISO 10993<\/h2>\n[\/vc_column_text][gt3_spacing height=”40px” responsive_es=”true” height_tablet=”20″ height_mobile=”20″][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/4″][vc_column_text]\n

Please do not hesitate
\n<\/strong>to contact us<\/strong><\/h5>\n[\/vc_column_text][gt3_spacing height=”25px”][vc_column_text]\n

Andreas Thurnheer<\/span><\/h4>\n[\/vc_column_text][gt3_spacing height=”10px”][vc_text_separator title=”Business Unit Manager” title_align=”separator_align_right” align=”align_left” el_width=”30″ text_separator_custom_color=”yes”][gt3_spacing height=”25px”][vc_column_text]Tel. +41 (0)52 262 21 81
\nE-Mail: andreas.thurnheer@niutec.ch[\/vc_column_text][vc_single_image image=”4899″ img_size=”medium”][\/vc_column][vc_column width=”1\/2″][vc_row_inner][vc_column_inner][vc_column_text]Niutec AG carries out chemical characterisation using recognised Methods. We test materials, medical devices and packging materials.<\/p>\n

Contact our specialists to discuss the procedure tailored to your product.[\/vc_column_text][vc_empty_space height=”40px”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”1\/4″][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1581513658950{background-color: #ededed !important;}”][vc_column width=”1\/4″][\/vc_column][vc_column width=”1\/2″][vc_column_text]The main reason for assessing the biocompatibility of a medical device or material is to protect the patient from possible biological risks.<\/p>\n

For this reason, medical devices are usually subject to biocompatibility testing to investigate interactions with the patient’s tissues, cells or body fluids.<\/p>\n

The biocompatibility testing of medical devices and materials is governed by the ISO 10993 series of standards. The test procedures specified in ISO 10993 provide detail on requirements and test methods. The test procedures offer a model that can be used to plan the appropriate steps for biological assessment and biocompatibility testing.<\/p>\n

The specific tests required depends on the type of medical device, the material, the intended use and the nature and duration of contact with the human body. The standard distinguishes between in vitro, in vivo and chemical or physical tests.<\/p>\n

The following parts of the standard are commonly referred to when assessing the biological effects of medical devices or materials on the human body by means of chemical characterisation:[\/vc_column_text][gt3_spacing height=”25px”][vc_column_text]\n

Sample preparation and refernce materials ( ISO 10993-12)<\/h2>\n[\/vc_column_text][vc_column_text]\n