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BIOE7013 - Biomedical Device Manufacture

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Title:Biomedical Device Manufacture
Long Title:Biomedical Device Manufacture
Module Code:BIOE7013
 
Duration:1 Semester
Credits: 10
NFQ Level:Intermediate
Field of Study: Biomedical Engineering
Valid From: Semester 2 - 2017/18 ( January 2018 )
Module Delivered in 2 programme(s)
Next Review Date: February 2023
Module Coordinator: DAITHI FALLON
Module Author: DAITHI FALLON
Module Description: The module is aimed at those seeking employment in the Biomedical Device Sector, or those wishing to enhance their general knowledge of the industry. The module is structured around common medical disorders which are treated by biomedical devices manufactured in Ireland. On completion, participants will be familiar with a range of disorders, the anatomy and physiology associated with these disorders, the devices used in their treatment, and the processes and environments involved in the manufacture of these devices.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the anatomy and physiology associated with a range of clinical disorders and the typical medical devices associated with the treatment of these disorders
LO2 Identify the Good Manufacturing Practices (GMP) to be implemented in a medical device manufacturing environment
LO3 Classify cleanroom requirements to meet industry standards for medical device manufacture
LO4 Describe appropriate sterilisation and packaging techniques for biomedical devices
LO5 Briefly explain the validation requirements for medical device design and manufacture
LO6 Identify the role and operation of relevant regulatory bodies within the medical device industry
Pre-requisite learning
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.

No requirements listed
Co-requisites
No Co Requisites listed
 

Module Content & Assessment

Indicative Content
Anatomy
Anatomical terminology and organisation of skeletal, muscular, nervous and cardiovascular tissues. Classification of joints by form; relationships of form to function; examples from limb joints. Muscle groups and patterns of muscle organisation; functional anatomy of the principal joints (hip, knee, ankle, shoulder, elbow, wrist).
Medical Devices
Devices used in the treatment of neurovascular, cardiovascular, orthopaedic disorders and product development history.
Manufacturing Processes and Techniques
Introduction to manufacturing processes; injection moulding, extrusion, wiredrawing; catheter coating process, embolic coil manufacturing.
Cleanroom Technology
Cleanroom classification; particle size and counting; filter design and performance, cleanroom layout, materials & standards.
Sterilisation Techniques
Ethylene oxide. Gamma sterilisation, electron beam. Saturated steam - gravity displacement, porous load, ballasted cycles. Dry heat sterilisation/depyrogenation. Microbial inactivation/endotoxin inactivation.
Packaging
Functions of packaging, packaging requirements for sterilisation, physical properties of packaging, labelling and packaging control, distribution hazards, production of packages, forming materials and methods, lidding, sealing.
Quality, Regulatory and GMP
Introduction to Manufacturing Quality and GMP, Medical Device Class (I/ II/ III), 510K products. ISO 13485 - Regulatory Documentation/submissions, Role and requirements of the FDA/IMB/Notified Bodies, introduction to 21 CFR820/Medical Devices Directive, planning for audits. Supplier Quality, Incoming quality control.
Validation
Validation protocols - Installation, operational and performance qualification. Process validation, design Qualification, validation of sterilisation system, design verification, design validation.
Assessment Breakdown%
Course Work40.00%
End of Module Formal Examination60.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Short Answer Questions Formal in-semester assessment on material covered to date 1,3,4 30.0 Week 8
Written Report Written report on site visit or industry expert speaker session 1,2,3,4,5,6 10.0 Week 10
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End of semester final examination 1,2,3,4,5,6 60.0 End-of-Semester
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The institute reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based tuition, Site visit and Laboratory visit 3.0 Every Week 3.00
Independent Learning Self directed learning 11.0 Every Week 11.00
Total Hours 14.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based tuition, Site visit and Laboratory visit 3.0 Every Week 3.00
Independent Learning Self Directed Learning 11.0 Every Week 11.00
Total Hours 14.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 3.00
 

Module Resources

Recommended Book Resources
  • R. S. Khandpur 2014, Handbook of Biomedical instrumentation, 3rd Ed., McGraw-Hill Education New York [ISBN: 9789339205430]
  • George K. Hung 2009, Principles of the Bionic Man, Volume 5 Ed., Rutger's University USA [ISBN: 9812779787]
  • Lerouge, Sophie and Simmons, Anne 2012, Sterilisation of Biomaterials and Medical Devices, 1st Ed., Woodhead Publishing [ISBN: 9781845699321]
Supplementary Book Resources
  • Joseph F. Hanlon, Robert J. Kelsey, Hallie Forcinio, Handbook of package Engineering, 3rd Ed., CRC Press [ISBN: 1566763061]
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and Technology 2 Elective
CR_EBMDM_7 Certificate in Biomedical Device Manufacture 1 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie