Instek Medical Device Safety Testers

Instek Medical Device Safety Testers

Medical Device Safety Testers are a class of Electrical Safety Testing and Surge Testing Equipment designed to test Medical Devices for operator and patient use. They include Hipots, Ground Bond Testers, and Leakage Current Testers, and multifunction instruments that can perform more than one test. Medical Device Safety Testers are used by equipment manufacturers, those doing repairs, and others to meet specific medical device safety standards.

Learn more about the tests and test methods in our Safety Tester Buyer's Guide and checkout this Medical Device Safety Tester department for our wide selection of models.

Electrical Safety Test Methods for Equipment

There are global standards to test for electrical safety of medical devices. For example, IEC 60990 Standard discusses the safety involving the flow of leakage or touch current through the human body. The effect of electric current on a human body can be extremely dangerous. It provides measuring methods for the four body responses:
JIS T 0601-1 is the Japanese modification of the existing IEC 60601-1 Safety Standard. IEC 60601-1 is the accepted standard for safety testing of all medical equipment. Both consider safety to be the primary concern.

Here are more standards to consider. Note: It is a partial list. Also, if a test instrument we offer does not specifically list a particular test method, that does not necessarily mean it cannot be used. Since there are so many test methods, the litereture may not enumerate them all. Please contact us with the specific method and we can research it for you.

ANSI / AAMI EC11	Diagnostic Electrocardiographic Devices	U.S.
ANSI / AAMI EC13	Cardiac Monitors, Heart Rate Meters, and Alarms	U.S.
ANSI / AAMI EC53	ECG Cables and Leadwires	U.S.
DIN VDE 0701-0702	0701 Repair, Modification, and Inspection of Electrical Equipment. 0702 Periodic Testing of Electrical Equipment	German
IEC 60601-1	Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance	Europe
IEC 60601-2	Medical Electrical Equipment - Part 2: Particular Requirements for the Basic Safety and Essential Performance of Gamma Beam Therapy Equipment	Europe
IEC 60990	Methods of Measurement of Touch Current and Protective Conductor Current	Europe
IEC 61010-1	Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use	Europe
IEC 62052-11	Electricity Metering Equipment (AC) - General Requirements, Tests, and Test Conditions	Europe
IEC 62353	Medical Electrical Equipment - Recurrent Test and Test After Repair of Medical Electrical Equipment	Europe
JIS T 0601-1	Electrical Safety Standard for Medical Devices	Japan