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Reliable Design of Medical Devices 2nd Edition Richard
C. Fries Digital Instant Download
Author(s): Richard C. Fries
ISBN(s): 9781420027945, 1420027948
Edition: 2
File Details: PDF, 10.35 MB
Year: 2005
Language: english
DK3104_half 9/13/05 2:38 PM Page 1

Reliable Design
of
Medical Devices
Second Edition
DK3104_title 9/13/05 2:37 PM Page 1

Reliable Design
of
Medical Devices
Second Edition

Richard Fries

Boca Raton London New York

A CRC title, part of the Taylor & Francis imprint, a member of the
Taylor & Francis Group, the academic division of T&F Informa plc.
DK3104_Discl.fm Page 1 Wednesday, October 19, 2005 12:17 PM

Published in 2006 by
CRC Press
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© 2006 by Taylor & Francis Group, LLC

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Library of Congress Cataloging-in-Publication Data

Fries, Richard C.
Reliable design of medical devices / Richard C. Fries.--2nd ed.
p. cm.
Includes bibliographical references and index.
ISBN 0-8247-2375-9
1. Medical instruments and apparatus--Reliability. 2. Medical instruments and apparatus--Design
and construction. 3. Medical instruments and apparatus--Quality control. 4. Medical instruments and
apparatus--Standards. I. Title.

R856.6.F749 2005
681'.761--dc22 2005043942

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Preface
The design and functional complexity of medical devices have increased during
the past 50 years, evolving from the use of a metronome circuit for the initial
cardiac pacemaker to functions that include medical book-keeping, electro-
cardiogram analysis, delivery of anesthesia, laser surgery, magnetic resonance
imaging, and intravenous delivery systems that adjust dosages based on patient
feedback. As device functionality becomes more intricate, concerns arise
regarding efficacy, safety, and reliability. Both the user and the patient want
the device to operate as specified, perform in a safe manner, and continue to
perform over a long period of time without failure. To be successful, the
designer and manufacturer of medical devices must ensure that all devices
meet these requirements.
In almost every major medical system developed or acquired by
commercial or governmental organizations, software or firmware plays a
major part and has become an increasing management concern. In many
cases it takes too long to develop, causing the entire system to slip its schedule,
and commensurately raising development costs. When delivered, it may not
perform as expected. Requirements that were to be implemented in software
have had to be scaled down to achieve a reasonable delivery schedule, or the
software is shipped with known bugs. As a result, major management attention
has been focused on the productivity of software development, the costs
associated with its development, and the resultant quality of the delivered
product.
Software productivity, or the rate at which software can be delivered, is
limited by current development practice. Software scientists generally believe
that software productivity will not dramatically improve without major
technological breakthroughs creating more automated programming techni-
ques. Many scientists believe, however, that the rigorous employment of
modern disciplined software engineering practice can achieve significant
software quality improvement over current practice without a corresponding
increase in cost. By concentrating on engineering practices to achieve software
quality and reliability, concomitant improvements in the overall reliability of
the device will also be obtained.
Medical device development is therefore a complex process that requires
the careful integration of diverse disciplines, technical activities, standards,
regulatory requirements, and administrative project controls. The need for
systematic approaches to product development and maintenance is necessary
to ensure a safe and effective device for the user and patient, an economical

v
vi Preface

and competitive success for the manufacturer, and a reliable, cost-effective

investment for the user.
Reliability engineering provides the theoretical and practical tools by which
the probability and capability of systems and their components to perform
required functions can be specified, predicted, designed-in, tested, and
demonstrated. It is an integral part of the product development process and
of problem solving activities related to manufacturing and field failures.
Reliability, however, is more than a science. It is also a philosophy – a way of
structuring professional activities so details are planned before action is taken
and problems are anticipated so they may be eliminated prior to occurring in
the field.
The primary goal of this text is to acquaint the developer of medical
devices, as well as the purchaser of medical equipment, with the basic concepts
and major issues of medical device reliability, to describe current product
development processes and techniques, and to provide a basis for evaluating
new technologies. Developers may use this information to improve their own
design, validation, and manufacturing processes. Purchasers may use this
information to ask more pertinent questions and make a more educated
assessment of their suppliers. This text may also be used by non-medical
developers and purchasers because the reliability process is relevant to all
product development.
The text provides a practical approach to the formation and operation of a
reliability assurance program. The emphasis of the book is on the practical,
hands-on approach to product development. The mathematics included in the
text is that which is necessary to conduct everyday tasks. Equations, where
needed, are merely given, not derived. It is assumed the reader has a basic
knowledge of statistics. For those wishing to delve deeper into the mathematics
of the subject, references are given at the end of each chapter.
The layout of the text follows the typical product development process.
Section 1 introduces the reader to the basics of reliability engineering and
failures. Failures and reliability are discussed from the hardware, software,
and systems levels.
Section 2 deals with myriad device standards and regulations, both
domestic and international. Particular emphasis is placed on FDA regulations,
the medical device directives, and the quality system regulation.
Section 3 deals with the specification of a medical device. The section
covers the definition of a medical device, defining the device and establishing
product requirements, safety and risk analysis, liability, and intellectual
property.
Section 4 deals with the design of a medical device. The discussion begins
with a review of Six Sigma methodology and some of the tools involved,
including axiomatic and robust design. The section then addresses both
hardware and software design, software coding, the use of metrics, and human
factors.
Section 5 discusses verification and validation. The section begins with
a review of various types of testing, then discusses in detail hardware and
Preface vii

software testing. The section concludes with the analysis of test data that
has been accumulated and the calculation of reliability parameters.
Section 6 deals with manufacturing as a continuation of the product
development process. A device may be designed reliably, but if it is not
manufactured reliably, it will not be a success. Configuration management and
its many implications are reviewed. Finally, techniques for the analysis of field
data are discussed in relation to building an efficient database for all product
development personnel.
Reliability engineering is essential to the success of any medical device
company. It helps develop a more profitable product, contributes to a more
satisfied customer base, reduces the risk of liability, and builds confidence in
meeting requirements of standards and regulatory agencies. Knowledge of
reliability engineering is also an asset in evaluating potential vendors of
medical devices and addressing device problems. It is hoped this text will assist
in establishing and operating a viable reliability engineering program. In
addition it is hoped this text will assist the purchaser of medical devices in
developing an effective program of vendor evaluation.
I am deeply indebted to many people for their encouragement, help, and
constructive criticism in the preparation of this book. I particularly want to
thank my wife, June, who constantly encouraged me and who sacrificed much
quality time together during the writing of this text.

Richard C. Fries, PE, CRE

Editor
Richard C. Fries holds degrees in biology from Loyola University in Chicago
and in electrical/biomedical engineering from Marquette University in
Milwaukee. He has nearly 30 years’ experience in the health care field, holding
positions in reliability engineering, software design, programming, quality
assurance, platelet studies, and pharmaceutical research. He is currently
the corporate manager of reliability engineering for Baxter Healthcare, in
Round Lake, Illinois.
Mr. Fries is a licensed professional engineer in the state of Wisconsin and
is certified as a reliability engineer by the American Society for Quality. He is
also certified as an ISO 9001 TickIT lead auditor. He is co-inventor of United
States Patent 5,682,876.
He is currently a member of the Industrial Advisory Board for the
Biomedical Engineering Department and a member of the Advisory Board
for the Reliability Engineering Curriculum at Vanderbilt University. He is a
project advisor and lecturer for a senior biomedical engineering design course
at Vanderbilt. He is a member of the Industrial Advisory Board and a guest
lecturer for the Biomedical Engineering Department at Marquette University.
He is past co-chair of the AAMI Medical Device Software Task Force and
past chair of the HIMA Software Task Force. He was a member of Working
Group 1 to ISO TC210, and is currently a member of the IEEE Software
Engineering Standards Subcommittee.
Mr. Fries is the author of several books and numerous articles in
professional journals on reliability engineering, medical device design, software
quality, standards and regulations.

ix
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Section 1
Basics of reliability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Chapter 1 Reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 History of reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 The definition of reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 Quality versus reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 Reliability versus unreliability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5 Types of reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.1 Electronic reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.1.1 Infant mortality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.1.2 Useful life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.5.1.3 Wearout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.5.2 Mechanical reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.5.3 Software reliability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.5.4 Device reliability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.6 Optimizing reliability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.7 Reliability assurance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.8 Reliability’s effect on medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Chapter 2 The concept of failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.1 Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.2 Causes of failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3 The practical aspects of failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.4 Failure rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.5 Hardware failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.5.1 Early failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.5.2 Chance failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.5.3 Wearout failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.6 Software failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.7 Failures due to human error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.8 Failures from the customer’s point of view . . . . . . . . . . . . . . . . . . . . . . . . . . 21
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

xi
xii Contents

Section 2
Regulations and standards . . . . . . . . . . . . . . . . . . . . . . . . . 23
Chapter 3 The Food and Drug Administration. . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.1 History of device regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.2 Device classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.2.1 Class I devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.2.2 Class II devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.2.3 Class III devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.3 Registration and listing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.4 The 510(k) process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.4.1 Determining substantial equivalency . . . . . . . . . . . . . . . . . . . . . . . 31
3.4.2 The regular 510(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.4.2.1 Types of 510(k)s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.4.2.2 The 510(k) format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
3.4.3 The Special 510(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3.4.3.1 Special 510(k) content . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
3.4.4 The Abbreviated 510(k). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
3.4.4.1 Abbreviated 510(k) content . . . . . . . . . . . . . . . . . . . . . . . 39
3.5 Declaration of conformance to a recognized standard . . . . . . . . . . . . . . 40
3.6 The PMA application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
3.6.1 The PMA process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.6.2 Contents of a PMAA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.7 Investigational Device Exemptions (IDEs) . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.7.1 Institutional Review Boards (IRBs) . . . . . . . . . . . . . . . . . . . . . . . . 42
3.7.2 IDE format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3.8 Good laboratory practices (GLPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.9 Good manufacturing practices (GMPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.10 Human factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.11 Design control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.12 The FDA and software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.13 Software classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.14 The FDA inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.15 Advice on dealing with the FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Chapter 4 The Medical Devices Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

4.1 Definition of a medical device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.2 The Medical Devices Directives process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.3 Choosing the appropriate directive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.3.1 Active Implantable Medical Devices Directive (AIMDD) . . . . 56
4.3.2 Medical Devices Directive (MDD) . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.3.3 In Vitro Diagnostic Medical Devices
Directive (IVDMDD). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Contents xiii

4.4 Identifying the applicable essential requirements . . . . . . . . . . . . . . . . . . . 56

4.5 Identification of corresponding harmonized standards. . . . . . . . . . . . . . 58
4.6 Assurance that the device meets the essential requirements and
harmonized standards and documentation of the evidence. . . . . . . . . . 59
4.6.1 Essential requirement 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.6.1.1 Hazard analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
4.6.1.2 Safety review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.6.2 Essential requirement 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.6.2.1 Peer review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.6.2.2 Safety review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.6.3 Essential requirement 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.6.3.1 Specification reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.6.3.2 Validation testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.6.4 Essential requirement 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.6.4.1 Environmental testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.6.4.2 Environmental stress screening . . . . . . . . . . . . . . . . . . . . 63
4.6.4.3 Use/misuse evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.7 Classification of the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.8 Decision on the appropriate conformity assessment procedure. . . . . . 66
4.8.1 Medical Devices Directive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.8.1.1 Annex II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.8.1.2 Annex III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.8.1.3 Annex IV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.8.1.4 Annex V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.8.1.5 Annex VI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.8.1.6 Annex VII. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.8.1.7 Class I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.8.1.8 Class IIa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.8.1.9 Class IIb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.8.1.10 Class III. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.8.2 Active Implantable Medical Devices Directive. . . . . . . . . . . . . . 68
4.8.2.1 Alternative 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.8.2.2 Alternative 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.8.3 In Vitro Diagnostic Medical Devices Directive . . . . . . . . . . . . . 68
4.9 Type testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.10 Identification and choice of a Notified Body . . . . . . . . . . . . . . . . . . . . . . . 69
4.11 Establishing a declaration of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
4.12 Application of the CE mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4.13 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Chapter 5 Quality system regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

5.1 History of the quality system regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
5.2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
5.3 General provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
xiv Contents

5.4 Quality system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

5.5 Design controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
5.6 Document controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
5.7 Purchasing controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
5.8 Identification and traceability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
5.9 Production and process controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
5.10 Acceptance activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
5.11 Non-conforming product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
5.12 Corrective and preventive action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
5.13 Labeling and packaging controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
5.14 Handling, storage, distribution, and installation. . . . . . . . . . . . . . . . . . . . 91
5.15 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
5.16 Servicing requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Chapter 6 Domestic standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

6.1 Domestic standards organizations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
6.1.1 AAMI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
6.1.2 ANSI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
6.1.3 ASQC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
6.1.4 ASTM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
6.1.5 IEEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
6.1.6 IES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
6.1.7 IPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
6.1.8 NEMA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
6.1.9 NFPA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
6.1.10 OSHA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
6.1.11 UL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
6.2 Software standards and regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Chapter 7 International standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

7.1 The international notion of standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
7.2 The international regulatory scene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
7.2.1 BSI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
7.2.2 CEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
7.2.3 CENELAC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
7.2.4 CISPR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
7.2.5 CSA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
7.2.6 DIN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
7.2.7 DoH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
7.2.8 IEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.2.9 IEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.2.10 ISO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.2.11 JSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Contents xv

7.2.12 Other Japanese standards organizations . . . . . . . . . . . . . . . . . . . 105

7.3 The TickIT program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
7.4 The Software Quality System Registration program . . . . . . . . . . . . . . . . 106
7.5 The ISO guidance documents for ISO 9001 and 9002 . . . . . . . . . . . . . . 107
7.6 Proposed regulatory requirements for Canada. . . . . . . . . . . . . . . . . . . . . . 108
7.7 ISO 14000 series. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
7.8 Medical informatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Section 3
Specifying the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Chapter 8 The medical device as an entity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
8.1 What is a medical device?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
8.1.1 Food and Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
8.1.2 The Medical Device Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
8.2 A brief history of medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
8.3 Current medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Chapter 9 Defining the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

9.1 The product definition process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
9.1.1 Surveying the customer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
9.1.2 Defining the company’s needs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
9.1.3 What are the company’s competencies?. . . . . . . . . . . . . . . . . . . . . 123
9.1.4 What are the outside competencies? . . . . . . . . . . . . . . . . . . . . . . . . 124
9.1.5 Completing the product definition . . . . . . . . . . . . . . . . . . . . . . . . . 124
9.2 Overview of quality function deployment . . . . . . . . . . . . . . . . . . . . . . . . . . 124
9.3 The QFD process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
9.3.1 The voice of the customer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
9.3.2 The technical portion of the matrix . . . . . . . . . . . . . . . . . . . . . . . . 126
9.3.3 Overview of the QFD process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
9.4 Summary of QFD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
9.5 The business proposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
9.5.1 Project overview, objectives, major milestones,
and schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
9.5.2 Market need and market potential . . . . . . . . . . . . . . . . . . . . . . . . . 134
9.5.3 Product proposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
9.5.4 Strategic fit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
9.5.5 Risk analysis and research plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
9.5.6 Economic analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
9.5.7 Core project team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Other documents randomly have
different content
 Meteorology - Course Outline
Third 2022 - Research Center

Prepared by: Teacher Williams

Date: August 12, 2025

Unit 1: Literature review and discussion

Learning Objective 1: Learning outcomes and objectives
• Assessment criteria and rubrics
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Formula: [Mathematical expression or equation]
Learning Objective 2: Interdisciplinary approaches
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Learning Objective 3: Case studies and real-world applications
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Learning Objective 4: Key terms and definitions
• Learning outcomes and objectives
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Learning Objective 5: Case studies and real-world applications
• Statistical analysis and interpretation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Key Concept: Experimental procedures and results
• Experimental procedures and results
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Important: Critical analysis and evaluation
• Interdisciplinary approaches
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Example 7: Assessment criteria and rubrics
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Definition: Assessment criteria and rubrics
• Statistical analysis and interpretation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Practical applications and examples
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Formula: [Mathematical expression or equation]
Unit 2: Critical analysis and evaluation
Example 10: Key terms and definitions
• Problem-solving strategies and techniques
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 11: Diagram/Chart/Graph]
Remember: Interdisciplinary approaches
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 12: Diagram/Chart/Graph]
Practice Problem 12: Practical applications and examples
• Interdisciplinary approaches
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Key Concept: Practical applications and examples
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Remember: Experimental procedures and results
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Fundamental concepts and principles
• Best practices and recommendations
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 16: Diagram/Chart/Graph]
Example 16: Comparative analysis and synthesis
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 17: Diagram/Chart/Graph]
Practice Problem 17: Case studies and real-world applications
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Important: Theoretical framework and methodology
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 19: Diagram/Chart/Graph]
Example 19: Theoretical framework and methodology
• Current trends and future directions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 20: Diagram/Chart/Graph]
Quiz 3: Problem-solving strategies and techniques
Note: Critical analysis and evaluation
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Key Concept: Comparative analysis and synthesis
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Practice Problem 22: Key terms and definitions
• Best practices and recommendations
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Theoretical framework and methodology
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Assessment criteria and rubrics
• Study tips and learning strategies
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Note: Literature review and discussion
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Comparative analysis and synthesis
• Current trends and future directions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 27: Diagram/Chart/Graph]
Practice Problem 27: Assessment criteria and rubrics
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Key Concept: Assessment criteria and rubrics
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 29: Diagram/Chart/Graph]
Key Concept: Fundamental concepts and principles
• Current trends and future directions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Formula: [Mathematical expression or equation]
Exercise 4: Theoretical framework and methodology
Definition: Theoretical framework and methodology
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 31: Diagram/Chart/Graph]
Example 31: Theoretical framework and methodology
• Practical applications and examples
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Statistical analysis and interpretation
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Example 33: Current trends and future directions
• Statistical analysis and interpretation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Key terms and definitions
• Experimental procedures and results
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Key Concept: Assessment criteria and rubrics
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Important: Interdisciplinary approaches
• Comparative analysis and synthesis
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 37: Diagram/Chart/Graph]
Note: Critical analysis and evaluation
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Practice Problem 38: Literature review and discussion
• Key terms and definitions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Example 39: Best practices and recommendations
• Key terms and definitions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
[Figure 40: Diagram/Chart/Graph]
Background 5: Assessment criteria and rubrics
Definition: Case studies and real-world applications
• Assessment criteria and rubrics
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Practical applications and examples
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 42: Diagram/Chart/Graph]
Key Concept: Research findings and conclusions
• Study tips and learning strategies
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Note: Case studies and real-world applications
• Historical development and evolution
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Literature review and discussion
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Practice Problem 45: Key terms and definitions
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Research findings and conclusions
• Practical applications and examples
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Example 47: Assessment criteria and rubrics
• Key terms and definitions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Historical development and evolution
• Key terms and definitions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Example 49: Interdisciplinary approaches
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Methodology 6: Literature review and discussion
Definition: Experimental procedures and results
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Practice Problem 51: Experimental procedures and results
• Best practices and recommendations
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Key Concept: Ethical considerations and implications
• Statistical analysis and interpretation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 53: Diagram/Chart/Graph]
Definition: Practical applications and examples
• Learning outcomes and objectives
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Definition: Learning outcomes and objectives
• Assessment criteria and rubrics
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Definition: Ethical considerations and implications
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 56: Diagram/Chart/Graph]
Important: Assessment criteria and rubrics
• Current trends and future directions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Note: Historical development and evolution
• Practical applications and examples
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Formula: [Mathematical expression or equation]
Important: Assessment criteria and rubrics
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Important: Problem-solving strategies and techniques
• Practical applications and examples
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Lesson 7: Key terms and definitions
Important: Critical analysis and evaluation
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Practice Problem 61: Best practices and recommendations
• Statistical analysis and interpretation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Statistical analysis and interpretation
• Research findings and conclusions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Note: Research findings and conclusions
• Historical development and evolution
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Note: Historical development and evolution
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 65: Diagram/Chart/Graph]
Note: Study tips and learning strategies
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 66: Diagram/Chart/Graph]
Practice Problem 66: Theoretical framework and methodology
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 67: Diagram/Chart/Graph]
Key Concept: Statistical analysis and interpretation
• Research findings and conclusions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Note: Experimental procedures and results
• Comparative analysis and synthesis
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Example 69: Key terms and definitions
• Learning outcomes and objectives
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Exercise 8: Assessment criteria and rubrics
Note: Interdisciplinary approaches
• Current trends and future directions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
[Figure 71: Diagram/Chart/Graph]
Important: Ethical considerations and implications
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Experimental procedures and results
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Statistical analysis and interpretation
• Best practices and recommendations
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Key Concept: Interdisciplinary approaches
• Comparative analysis and synthesis
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Problem-solving strategies and techniques
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 76: Diagram/Chart/Graph]
Example 76: Research findings and conclusions
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 77: Diagram/Chart/Graph]
Practice Problem 77: Current trends and future directions
• Key terms and definitions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Definition: Historical development and evolution
• Comparative analysis and synthesis
- Sub-point: Additional details and explanations
- Example: Practical application scenario
[Figure 79: Diagram/Chart/Graph]
Definition: Literature review and discussion
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Formula: [Mathematical expression or equation]
Introduction 9: Key terms and definitions
Remember: Assessment criteria and rubrics
• Literature review and discussion
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Remember: Fundamental concepts and principles
• Assessment criteria and rubrics
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 82: Diagram/Chart/Graph]
Definition: Key terms and definitions
• Problem-solving strategies and techniques
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Example 83: Historical development and evolution
• Research findings and conclusions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Note: Learning outcomes and objectives
• Problem-solving strategies and techniques
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Example 85: Learning outcomes and objectives
• Interdisciplinary approaches
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Practice Problem 86: Ethical considerations and implications
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Critical analysis and evaluation
• Problem-solving strategies and techniques
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 88: Diagram/Chart/Graph]
Example 88: Practical applications and examples
• Learning outcomes and objectives
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Experimental procedures and results
• Practical applications and examples
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Exercise 10: Literature review and discussion
Definition: Critical analysis and evaluation
• Key terms and definitions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Key Concept: Study tips and learning strategies
• Assessment criteria and rubrics
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Key Concept: Practical applications and examples
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Remember: Ethical considerations and implications
• Learning outcomes and objectives
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 94: Diagram/Chart/Graph]
Example 94: Practical applications and examples
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
[Figure 95: Diagram/Chart/Graph]
Definition: Learning outcomes and objectives
• Problem-solving strategies and techniques
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Remember: Research findings and conclusions
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
[Figure 97: Diagram/Chart/Graph]
Practice Problem 97: Fundamental concepts and principles
• Study tips and learning strategies
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Practice Problem 98: Practical applications and examples
• Fundamental concepts and principles
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Note: Critical analysis and evaluation
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Formula: [Mathematical expression or equation]
Results 11: Research findings and conclusions
Note: Literature review and discussion
• Experimental procedures and results
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Literature review and discussion
• Research findings and conclusions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Note: Theoretical framework and methodology
• Ethical considerations and implications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Definition: Ethical considerations and implications
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Best practices and recommendations
• Learning outcomes and objectives
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Note: Ethical considerations and implications
• Current trends and future directions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Definition: Best practices and recommendations
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Definition: Comparative analysis and synthesis
• Study tips and learning strategies
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Remember: Theoretical framework and methodology
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Case studies and real-world applications
• Problem-solving strategies and techniques
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Unit 12: Critical analysis and evaluation
Practice Problem 110: Interdisciplinary approaches
• Critical analysis and evaluation
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Key Concept: Comparative analysis and synthesis
• Theoretical framework and methodology
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Assessment criteria and rubrics
• Current trends and future directions
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Formula: [Mathematical expression or equation]
Practice Problem 113: Best practices and recommendations
• Best practices and recommendations
- Sub-point: Additional details and explanations
- Example: Practical application scenario
Note: Study tips and learning strategies
• Practical applications and examples
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Fundamental concepts and principles
• Study tips and learning strategies
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Example 116: Learning outcomes and objectives
• Study tips and learning strategies
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
Definition: Best practices and recommendations
• Case studies and real-world applications
- Sub-point: Additional details and explanations
- Example: Practical application scenario
- Note: Important consideration
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