StudentShare
Contact Us
Sign In / Sign Up for FREE
Search
Go to advanced search...

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

Comments (0) Cite this document
Summary
Per BS EN 30993-6:1995 testing of my polymeric cement is required to assess the ”local effects of an implant material on living tissues, at both the macroscopic and microscopic level” (p. 3) in the long-term application. This is necessary to determine if the unique property…
Download full paperFile format: .doc, available for editing
GRAB THE BEST PAPER92.6% of users find it useful
Testing Required When Applying for a CE Mark for a Medical Device
Read TextPreview

Extract of sample "Testing Required When Applying for a CE Mark for a Medical Device"

Download file to see previous pages 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 “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 “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 ...Download file to see next pagesRead More
Cite this document
  • APA
  • MLA
  • CHICAGO
(“Testing Required When Applying for a CE Mark for a Medical Device Essay”, n.d.)
Testing Required When Applying for a CE Mark for a Medical Device Essay. Retrieved from https://studentshare.org/miscellaneous/1536598-testing-required-when-applying-for-a-ce-mark-for-a-medical-device
(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. https://studentshare.org/miscellaneous/1536598-testing-required-when-applying-for-a-ce-mark-for-a-medical-device.
“Testing Required When Applying for a CE Mark for a Medical Device Essay”, n.d. https://studentshare.org/miscellaneous/1536598-testing-required-when-applying-for-a-ce-mark-for-a-medical-device.
  • Cited: 0 times
Comments (0)
Click to create a comment or rate a document

CHECK THESE SAMPLES OF Testing Required When Applying for a CE Mark for a Medical Device

Key Factors of Leadership Required In the Management of Change

Leadership is associated with larger-than-life characteristics. It is most important for complex organizations operating in changing environments. One needs to analyze the basic motivations for change because it includes human beings. Timothy Galpin (1996) describes the human elements of change, covering an organization-wide area.
Healthcare organizations need constant maneuvering into the future and change. John (1990) states, “Leadership is an ability to influence followers that involves the use of power and the acceptance of the leader by the followers. This ability to influence followers is related to the followers’ need satisfaction.”

Gregory & Ricky (1989) have defined leadership as &ldq...
16 Pages(4000 words)Case Study

The Google Story by Mark Malseed

The Google Story is more than just the history of a successful company; it is a story about two college kids with a vision that held to their principles to become the rulers of the dot-com mountain.
Investors were overwhelmed by opportunities and under-impressed by a lack of results. The financial markets had gained a lukewarm attitude about these gee-whiz technologies and some had developed a "healthy skepticism for fancy PowerPoint presentations that wowed others" (46). Still, Google not only persisted they grew at a phenomenal rate. They shunned advertising and investors from the beginning and went head to head with technical giants such as Microsoft, AltaVista, and Yahoo. Eventually, the technology got too expensive for t...
6 Pages(1500 words)Article

Medical Physiology

D. Smooth muscle cells: Though smooth muscle cells are recruited by day 3 or 4 of the wound along with fibroblasts, myofibroblasts, pericytes, and smooth muscle cells, their main role is fibroplasia, synthesis of connective tissue matrix, tissue remodeling, wound contraction, and wound strength. They do not produce cytokines and chemoattractants (Sephel, 72). Hence this is not the correct answer.
A 68-year-old man with prostate cancer and bone metastases presents with shaking chills and fever. The peripheral WBC count is 1,000/uL (normal = 4,000-11,000/uL). Which of the following terms best describes this hematologic finding?
A. Leukocytosis: This is not the correct answer because leukocytosis means an increase in WBC co...
14 Pages(3500 words)Case Study

Chomsky: Language Acquisition Device

Skinner and many others. From their theories and arguments (Avram) Noam Chomsky, an American linguist and educator, as well as political activist, came up with his own views and theories which rejected, accepted and added depth in the study of language revolutionizing linguistics.
Today, English is known to be the universal language. To be at par with the rest of the world and to be able to compete and join the bandwagon of technology and business, even professionals of different nationalities study language without so much of a difficulty.
The paper consists of discussions on Chomsky’s view on Language Development focusing more on what is called the “universal grammar” comparing it with the theories of...
6 Pages(1500 words)Assignment

Should the U.S Navy Be Required to Standardize the Flight Operations Quality Assurance

This factor points to the increased role of data regarding operations and quality of the flights. It requires methods for detecting errors and capturing error contexts, as well as methods for reducing errors and mitigating their effects. In the maintenance of flight safety data Flight Operational Quality Assurance (FOQA) programs are of special mention. “FOQA programs use flight data collected during a carrier’s normal line operations to reduce costs and enhance safety by identifying a variety of ‘exceedances’- deviations of important flight parameters from normal operating ranges. FOQA programs typically use commercial Ground Data Replay and Analysis Systems (GDRASs) to detect specified deviations, generat...
6 Pages(1500 words)Term Paper

Negative Advertisement When It Works

Keeping aside honesty and ethics rich politicians invest huge amount of money to launch election campaign to win the favor of the public. Empirical evidences suggest that this strategy quite often works but by no means can we ignore the negative impact of such campaign. In general, propaganda concerns set of messages aimed at influencing the opinions or behavior of large numbers of people. Instead of impartially providing information, propaganda in its most basic sense presents information in order to influence its audience. The most effective propaganda is often completely truthful, but some propaganda presents facts selectively to encourage a particular synthesis, or gives loaded messages in order to produce an emotional rather...
9 Pages(2250 words)Case Study

Medical Radiographic Technique for Dealing with the Pediatric Patients

This poses a challenge in pediatric radiographic investigations. Obtaining quality radiographs on pediatric patients can be a challenge. Minimizing radiation dose in pediatric imaging is a crucial issue that has been emphasized and reemphasized in recent years1.
Diagnostic radiation overexposure can cause radiation skin reactions and acute radiation sickness. It can also lead to systemic reactions that may lead to disturbances of normal functional processes, such as, radiation pneumonitis. It is known to have carcinogenic effects and genetic effects2. However, it is also to be considered that the dose required to produce genetic or carcinogenic effects are virtually precluded by modern radiographic apparatus and special techn...
13 Pages(3250 words)Assignment

Analysis of Mark Twains The War Prayer

As a satirist and journalist, Mark Twain wrote some of the most influential works in American literary history. His work has influenced the stereotype of American life. Within his words are the images that typify the 19th-century experience with the whitewashed fences, the steamboats on the Mississippi, and the raft on the river, rolling lazily along on a hot summer day. However, within this writing one can find a deeper truth about the greater American experience of all its inhabitants. While creating a warm and charming atmosphere, Twain commented on racial discrimination and the false ‘superiority’ that the policies of the American government. 

As it is popularly known in this time, the name Mark Twa...
12 Pages(3000 words)Book Report/Review

The Management, Leadership and Teamwork Competencies Required by a Small Business Owner

On the other hand organizational leadership is defined as the ability based on the specific skill of an individual to lead his/her subordinates in a manner that pre-planned organizational goals could be achieved within the defined time-frame.

According to Burns (1978) and Bass (1985), transformational leadership has a set of category constructs such as values, morals, farsightedness, long term goals, principles, acute awareness about the dividing line between causes and symptoms, mission statements, strategic perspectives, and human resources. Similarly, they identify a set of category constructs in the transactional leadership also. For instance concentration on the task at hand, short term goals and tactics, confusion co...
6 Pages(1500 words)Coursework

The Legalization of Medical Cannabis

The federal government, through the 2009’s Controlled Substances Act, makes the use of marijuana a criminal offense. However, various states, such as Arizona, Colorado, and California, have legalized the use of cannabis for therapeutic purposes. This paper presents an argument that marijuana should be made legal for its therapeutic uses.
The legalization of medical cannabis is justified because of the positive therapeutic effects of the drug. Proponents of the legalization of medical cannabis argue that if marijuana is made illegal, patients will not be able to access and use it for the relief of their symptoms (Gwynne 29). Marijuana has been reported to be a safe drug for the treatment of various conditions. The drug a...
6 Pages(1500 words)Case Study
sponsored ads
We use cookies to create the best experience for you. Keep on browsing if you are OK with that, or find out how to manage cookies.

Let us find you another Essay on topic Testing Required When Applying for a CE Mark for a Medical Device for FREE!

Contact Us