University Of Limerick



Iowa State Course Substitution

ME Technical Elective


Course Info

International Credits: 6.0
Converted Credits: 3.5
Country: Ireland
Language: English
Course Description:
Module Code - Title: ME4306 - BIOCOMPATABILITY Year Last Offered: 2017/8 Hours Per Week Grading Type: Prerequisite Modules: Rationale and Purpose of the Module: To give a basic appreciation of the Cellular-Material Interactions that occur when a Material is used for different Biomedical Applications Syllabus: Discussion of Pathological Changes and Approaches to repair. Classification of medical device interactions and methods of assessment. Relevance of testing to medical device design strategy, regulation, validation and post market surveillance. Evolution of the regulatory environment and its implications. Learning Outcomes: Cognitive (Knowledge, Understanding, Application, Analysis, Evaluation, Synthesis) Give an overview of principal classifications of medical device tissue responses. With respect to the major classes of implantable devices, demonstrate an overview both of tissue architectures and selected relevant tissue pathologies. Describe the rationale and approach to biocompatibility testing as outlined in ISO10993 parts 1 to 20 with particular emphasis on: Identification and quantification of degradation products from polymeric, metallic and ceramic based medical devices, Chemical characterization of materials, Tests for genotoxicity, carcinogenicity and reproductive toxicity, tests for in vitro cytotoxicity local effects after implantation and Ethylene oxide sterilization residuals Describe the rationale and approach to clinical trials as outlined in ISO14155 Clinical investigation of medical devices for human subjects, parts 1 and 2 Lecture Lab Tutorial Other Private Credits 2 2 1 0 0 6 Affective (Attitudes and Values) N/A Psychomotor (Physical Skills) N/A How the Module will be Taught and what will be the Learning Experiences of the Students: Lectures, Labs and Tutorials Research Findings Incorporated in to the Syllabus (If Relevant): Linked to Research areas of CABER and MSSI Prime Texts: Santin & Phillips (2012) Biomimetic, Bioresponsive, and Bioactive Materials: An Introduction to Integrating Materials with Tissues , Wiley Dee, Pulio, Bizios (2002 ) An Introduction to Tissue-Biomaterial Interactions , Wiley Ratner, Hoffman, Schoen, Lemons (2004) Biomaterial Science 2nd ed. , Elsevier Academic Press San Diego Calif. USA Other Texts: Braybrook (1996 ) Biocompatibility assessment of medical devices and materials , Wiley Gary E. Wnek & Gary L. Bowlin. (2004) Encyclopedia of biomaterials and biomedical engineering , Marcel Dekker Inc. Programmes Semester - Year to be First Offered: Module Leader:


Evaluation Date:
November 3, 2017
John Wagner