New Course Proposal
ENSC 378-3 Medical Device
Development and Standards
Jim Cavers,
Engineering Science, Bruno Jaggi, BCIT
Course Number: ENSC 378-2
Course Title: Medical Device Development and Standards
Credit Hours: 2 Vector: 1-2-0 (lecture-tutorial-lab)
Course Description:
Standards play a critical role in biomedical
engineering, and they affect design even at early stages. This course introduces students to a
systematic approach in medical device design/development, istandards
and regulations. The course emphasizes engineering/design methodology. It consists of three modules. The first module provides an overview and
compares medical device regulations and standards applicable in
Prerequisite: ENSC 372-4 Biomedical Instrumentation, ENSC 340-4
Engineering Science Project
Recommended: ENSC 330-4 Engineering Materials
Corequisite: None
Special Instructions: This course mirrors the BCIT course BMET 7102
Medical Device Development and Standards.
It will be taught by a senior member of BCIT’s
Biomedical Electronics Technology program for the foreseeable future.
Course(s) to be dropped if this course is approved:
None.
Will this be a required or elective course in the
curriculum; probable enrolment when offered?
This is a
required course for all biomedical engineering students. Probable enrolment 30.
Indicate Semester and Year this course would be first
offered and planned frequency of offering thereafter.
First offering Fall 2008. Semesterly
thereafter.
Which of your present CFL faculty have the expertise to
offer this course? Will the course be taught by sessional
or limited term faculty?
No current CFL faculty have the expertise.
It will be taught by Bruno Jaggi, a senior
instructor at BCIT.
Are there any proposed student fees associated with this
course other than tuition fees?
No.
Is this course considered a ‘duplicate’ of any current or
prior course under the University's duplicate course policy? Specify, as
appropriate.
No.
Note: Senate has approved (S.93-11) that no new course
should be approved by Senate until funding has been committed for necessary
library materials. Each new course proposal must be accompanied by a library
report and, if appropriate, confirmation that funding arrangements have been
addressed.
Provide details on how existing instructional resources
will be redistributed to accommodate this new course. For instance, will
another course be eliminated or will the frequency of offering of other courses
be reduced; are there changes in pedagogical style or class sizes that allow
for this additional course offering.
We do not have to redistribute anything, since it
will be taught in foreseeable future by BCIT.
However, that institution has already put this course on the Web,
including distribution of all materials and the course coordination. It is well set up for distance learning –
even across
Does the course require specialized space or equipment not
readily available in the department or university, and if so, how will these
resources be provided?
No.
Does this course require computing resources (e.g.
hardware, software, network wiring, use of computer
laboratory space) and if so, describe how they will be provided.
No.
Introduces
students to a systematic approach in medical device design/development,
standards and regulations. The course emphasizes engineering/design
methodology. Objectives:
Outline
It consists of three modules. The first module provides an overview and
compares medical device regulations and standards applicable in
Topics
1.Course Objective
2.Course Outline
3.Overview of Medical Device Development
4.Basis and Types of Regulation &
Standards
5. Classification
6. Canadian Health Product and
Food Branch Regulation, Medical Device Bureau
7.US Food and Drug Regulation, Center
for Devices and Radiological Health
8.European Medical Device Directives
9.Basics of ISO13485/88
10. Rationale of Design Control
11. Elements of Design Control
12. Example of a Medical Device
Development
DESIGN INPUT:
13. Product Definition and Device
Requirement Specification
14. Architectural Design
DESIGN OUTPUT:
15. Hardware Detailed Design
16. Software Detailed Design
VERIFICATION AND VALIDATION
17.Test
Plan
18.Test
Report
HAZARD ANALYSIS:
19.Hazard
Analysis and mitigation
MEDICAL ELECTRICAL EQUIPMENT
(IEC60601-1):
20.Overview
, Definitions and Rationale
21.General
Requirements
MEDICAL ELECTROMAGNETIC COMPATIBILITY
(IEC60601-1-2):
22.Scope,
Definition
23.Emission
Radiated and Conducted CISPR11
24.Susceptibility
Radiated and Conducted IEC801
10 substantial
assignments, no final examination.
Projects
None.
Laboratories
None.
Handbook of Medical Device Design: Richard C. Fries, Marcel Dekker,
New York 2000, ISBN: 0-8247-0399-5
Product Development Planning for Health Care Products Regulated by the
FDA: Elaine
Whitmore, ASQC Quality Press,
The FDA and Worldwide Quality System Requirements Guidebook for
Medical Devices:
Kimberly A. Trautman, ASQC Quality Press,
Canadian Medical Devices
Regulations: Department of Health, Extract Canadian
Gazette, Part I, May 27th, 1998.
US Code of Federal Regulations
2001: Title 21 – Food and Drugs, Chapter I – Subchapter H Medical Devices.
Medical Electrical Equipment –
Part 1 General Requirements for Safety: IEC 60601-1, 3rd edition 2000.
Medical Electrical Equipment – Part
1 General Requirements for Safety Section 1.2 Collateral Standard:
Electromagnetic Compatibility: IEC
60601-1-2, 1993.
Expanded Description
The full outline of BMET 7102 and selected assignments from its module 2.