Download List the Criteria - Biomedical Manufacture - Past Exam and more Exams Biomedical Engineering in PDF only on Docsity!
CORK INSTITUTE OF TECHNOLOGY INSTITIÚID TEICNEOLAÍOCHTA CHORCAÍ
Semester 1 Examination 2012/
Module Title: Biomedical Manufacture
Module Code: BIOE
School: Mechanical, Electrical and Process Engineering
Programme Title: Bachelor of Engineering in Biomedical Engineering – Year 3
Programme Code: EBIOM_8_Y
External Examiner(s): Dr. Laoise McNamara, Mr. Ruairi Cullinane Internal Examiner(s): Dr. Hugh O’Donnell
Instructions: Answer Three Questions
Duration: 2 Hours
Sitting: WINTER 2012
Requirements for this examination:
Note to Candidates: Please check the Programme Title and the Module Title to ensure that you have received the correct examination paper. If in doubt please contact an Invigilator.
Q. 1 (a) Outline the principal functions of medical device packaging. (5 marks)
(b) List the criteria that packaging for sterile medical devices must meet. (5 marks)
(c) Describe, with the aid of a diagram, the pressure forming method of package production. (8 marks)
(d) Give the reasons why a pattern might be applied to a package seal. (2 marks) 20 MARKS
Q. 2 (a) Draw a schematic diagram of a typical porous load autoclave. (10 marks)
(b) Describe a typical porous load autoclave sterilisation cycle. (8 marks)
(c) In terms of sterilisation, what is meant by the term D-value? What does the following statement mean? “The value for D121°C for Bacillus Stearothermophilus =1.5 minutes.” (2 marks) 20 MARKS
Q.3 (a) Describe, using diagrams, the principal methods by which particles are captured in HEPA filters. (10 marks)
(b) Outline the design objectives that apply when designing a Cleanroom. (10 marks) 20 MARKS
Q.4 (a) Discuss the following approaches to cleaning of medical devices under the following headings? (i) Immersion/Agitation processes (ii) Ultrasonic cleaning (iii) Spray nozzle washers (12 marks)
(b) What questions should be considered when evaluating cleaning station safety? (8 marks) 20 MARKS
