Chapter 1:

Introduction

The purpose of this document is to provide guidance in establishing and managing a medical equipment
quality assurance (QA) program and to present detailed procedures for inspection, preventive maintenance,
safety evaluation, and performance testing.
The intended audiences for this publication are those responsible for establishing and managing medical
equipment QA program, and technicians performing inspections and device testing. Readers should have a
basic technical background and some exposure to medical equipment in healthcare. The book does not pro-
vide background information on clinical or technical concepts or medical equipment principles of operation.
Medical equipment QA is part of an overall medical equipment management program for a healthcare facil-
ity or system. A complete program also includes corrective maintenance or repair, equipment control, asset
management, health care technology planning, education, and activities directed toward improving medical
device-related patient safety.
The publication is organized into four primary sections:
• A glossary of terms
• Background information on establishing and managing a program including goals, methods, device inclu-
sion and rating criteria, and standards
• General and device-specific procedures and forms for inspection, preventive maintenance, safety evalua-
tion, and performance testing
• Basic information on international testing standards
Forms, tables, diagrams, illustrations, and photos are used to aid in the understanding of the content.
This publication takes into consideration the advances in device reliability, reduced preventive mainte-
nance requirements, and internal device surveillance (self test) along with changes in standards. Due to the
ongoing efforts at global harmonization, international standards are used and referenced where applicable,
such as electrical safety testing references IEC 62353.

Acknowledgements
The publication was funded by a grant from Fluke
Electronics Corporation (FEC). A number of diagrams,
illustrations and figures were provided by FEC as was
test equipment used in many of the photographs.

2 Chapter 1: Introduction ©University of Vermont