Testing Required When Applying for a CE Mark for a Medical Device Essay

Testing Required When Applying for a CE Mark for a Medical Device - Essay Example The use of a PE tube is used to hold the cement after sterilization per prescribed, typical methods contained in the standards. The cement is mixed and inserted into the tube to a level flush with the tube. The cement used in a fresh state prior to implanting is also tested for microbiological contamination. As the testing requires a tube to contain the cement for testing a like size rod of equal diameter and length and sanitized per normal procedures will be used as the control. For long term testing of in bone, which is what is required in test the effects of the cement which will be used long term in actual application, selection of the species for test and control is contained in Figure 1 below: Implantation will be done through normally accepted surgical method including shaving the insertion area and thorough antiseptic cleaning of the area and surgery to implant should be performed to minimize any trauma to the area. After insertion sutures are used to close the site and ensure tubes do not loosen or move. After surgery observation is conducted of the test species at appropriate intervals to note and record per 3.3.4 of the standard â€Å"any abnormal findings, including local, systemic and behavioural abnormalities† (p. 5). At the completion of the testing period, in this case 78 weeks the animals will be euthanized humanely in order to determine the biological response of the test area to the prolonged contact with the cement â€Å"by grading and documenting the macroscopic and histopathological test responses as a function of time† (p. 5) and comparing it with the control material (the rods) and the surrounding area. The examination will be facilitated by use of a low magnification lens of each test site material. After all of these results have been documented, the test and control tubes and rods and the surround tissue/bone shall