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Examination Paper: Biomedical Manufacture (BIOE 8001) – Summer 2009, Exams of Biomedical Engineering

An examination paper from the cork institute of technology for the biomedical manufacture module (bioe 8001) in the bachelor of engineering in biomedical engineering programme. The paper consists of three sections, each with multiple-choice questions related to aqueous cleaning of medical devices, validation protocols, and hepa filters. Intended for university students and requires answering questions based on the provided instructions.

Typology: Exams

2012/2013

Uploaded on 03/29/2013

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CORK INSTITUTE OF TECHNOLOGY
INSTITIÚID TEICNEOLAÍOCHTA CHORCAÍ
Semester 2 Examinations 2008/09
Module Title: Biomedical Manufacture
Module Code: BIOE 8001
School: Mechanical and Process Engineering
Programme Title: Bachelor of Engineering in Biomedical Engineering – Award
Programme Code: EBIME_7_Y3
External Examiner(s): Dr G McGuinness, Mr M Murtagh
Internal Examiner(s): Dr H O’Donnell
Instructions: Answer Three Questions
Duration: 2 Hours
Sitting: Summer 2009
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.
pf2

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CORK INSTITUTE OF TECHNOLOGY

INSTITIÚID TEICNEOLAÍOCHTA CHORCAÍ

Semester 2 Examinations 2008/

Module Title: Biomedical Manufacture

Module Code: BIOE 8001

School: Mechanical and Process Engineering

Programme Title: Bachelor of Engineering in Biomedical Engineering – Award

Programme Code: EBIME_7_Y

External Examiner(s): Dr G McGuinness, Mr M Murtagh Internal Examiner(s): Dr H O’Donnell

Instructions: Answer Three Questions

Duration: 2 Hours

Sitting: Summer 2009

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.

1. (a) What are the disadvantages of aqueous cleaning of medical devices? (6 Marks) (b) List the safety engineering considerations that need to be addressed when evaluating cleaning station safety. (6 Marks) (c) Describe the ultrasonic method of cleaning medical devices. (8 Marks) (Total 20 Marks)

  1. (a) Describe the activities carried out and the information collated when executing the following types of validation protocols. (i) Operational Qualification (ii) Performance Qualification (12 Marks) (b) List the typical activities that may be performed when undertaking Design Validation of a medical device (8 Marks) (Total 20 Marks)
  2. (a) Draw a labelled diagram of a typical porous load autoclave. (8 Marks) (b) Describe a typical porous load autoclave sterilisation cycle. (8 Marks) (c) In terms of moist heat sterilisation, what is meant by the terms Log Reduction Value, D- Value, Sterility Assurance Level, Z-Value (4 Marks) (Total 20 Marks)
  3. (a) Describe the following types of HEPA filters: (i) Deep Pleated (ii) Mini Pleated (8 Marks) (b) Outline, using diagrams, the four principal mechanisms involved in the removal of particles in HEPA filters. (8 Marks) (c) Draw a classical efficiency curve for a HEPA filter. (4 Marks) (Total 20 Marks)