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 ExampleThe 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 inserting is also seeed 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 form 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 belowImplantation 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 tra uma 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 any abnormal findings, including local, systemic and behavioural abnormalities (p. 5). At the uttermost 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 drawn-out contact with the cement 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 inquiry 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