Nicht aktive Medizinprodukte

Since May 2021, the Medical Device Regulation (MDR) has replaced the previous vertical directives on "Active Implantable Medical Devices" (AIMD) and "Medical Devices" (MDD). At the same time, the directive on "in vitro diagnostic medical devices" (IVD) was replaced by the corresponding EU regulation. The regulations represent the next step in the harmonisation of the European directive and standards landscape, which provides for the replacement of vertical standards by horizontal standards that are applicable not only to individual products, but to all medical devices. The DIN-EN-ISO standards on non-active medical devices contained in this volume deal with the following areas: -Biological evaluation of medical devices-Clinical testing-Risk analysis-Sterilisation of medical devices or health care products-Symbols on and labelling of medical devices (incl. instructions for use)-Packaging materialsThe current 4th. The current 4th edition of the DIN Pocketbook 268 offers all users the documents on the topics mentioned in a cost-effective alternative to the complete loose-leaf collection "Medical Devices in Europe".The book is aimed at:Manufacturing companies, development companies, quality management, sellers, test centres and experts.