|
The following eight articles on safety
testing of Electro-Medical Equipment was provided by Leo Eisner, P.E. of
Eisner Safety Consultants. Leo can be reached at
or http://www.eisnersafety.com/
|
| 1 |
Overview of the IEC60601 series of standards
- the International Standard for Electro-Medical Equipment
|
| 2 |
Why Product Safety Test Your
Electrical Medical Products? - It is important to realize that the patient is more susceptible
to shock and other hazards than a healthy person using a piece of computer
equipment. This article talks briefly about leakage currents, two-levels
of protection, and gets into detail on reasons for Certifying the product to
meet safety standards specifically to meet legal requirements.
|
| 3 |
IEC60601-1 and Your Electrical
Medical Products - Beyond user safety and legal requirements, there are two other
reasons why a manufacturer would benefit from having its product tested and
potentially certified by a Third Party (Independent) Test Agency to IEC60601-1 or equivalent National Standards. They are Litigation Risks and
Market Recognition.
|
| 4 |
Classification per
IEC60601-1 - Classification of the electrical medical product under test is
the first step in determining the test program for compliance to IEC 60601-1/EN60601-1 based standards. There are numerous requirements within
IEC60601-1 and its related standards, not all of which may apply to the
medical device under test. Therefore classifying the medical device prior to
testing will help yield a test program required for compliance to IEC60601-1/EN60601-1 based standards.
|
| 5 |
EST 101 - written by
QuadTech. This article discusses the basic of Electrical Safety Testing.
The tests discussed are Dielectric Withstand (or Hi-Pot), Leakage Current,
and Protective Earth Tests.
|
| 6 |
IEC60601-1
Leakage Current Part 1 - Part 1 of this
two-part reference on leakage current discussed the terms and
definitions associated with leakage current and the two classes that
electronic medical products are divided into per IEC60601-1.
|
| 7 |
IEC60601-1
Leakage Current Part 2 - Part 2 builds
on those basic principles and details the IEC60601-1 measurement
circuits for Earth, Touch/Chassis and Patient leakage current tests.
|
| 8 |
IEC60601-1
National Deviations - This final
installment in the IEC60601-1 Series discusses some of the national
deviations to IEC60601-1.
|
|
|
 |
A Primer for IEC 60601-1
|
|
|
|
Equipotentiality and Grounding
(PDF 118K) - Derivation of grounding resistance for equipment by .
This paper explains equipotentiality and how it provides protection against
electric shock. This paper also describes the grounding circuit for the various
power distribution systems. Finally, this paper shows the effect of the product
grounding resistance on the voltage of accessible parts, and validates the
value required by various safety standards.
|
|
Floating
Circuits – Protection against electric shock by .
|
