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Production Line Tests for Medical Product Safety Evaluation
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Production Line Tests for Medical Product Safety Evaluation
 
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Production Line Tests for Medical Product Safety Evaluation
From globalspec.com
In order to ensure the electrical safety of any medical device, there are several tests that must be performed on each device before it can be shipped. In most cases these tests are required in order to comply with safety agency regulations. This article deals with two of the most widely performed production line safety tests commonly required on medical devices. The first and most prevalent test is the Dielectric Voltage Withstand Test, commonly known as a “hipot” test. Hipot testing is the deliberate application of high voltage between current carrying and non-current carrying components of the equipment under test (EUT). This test is designated to stress the insulation far beyond what it will encounter in normal use. If the insulation can withstand the higher voltage for a given period of time, it is assumed that it will be able to adequately protect medical personnel and patients from electrical hazards at normal operating voltage. This is the origin of the term “voltage withstand.”
 


Products & Services
Hipot testers are electrical safety test devices that perform a variety of electrical compliance tests.
High voltage relays are used to transfer power for high voltage and high frequency applications. They are heavily insulated and consist of strong materials to increase contact life.
Mechanical testing equipment covers devices used for adhesion, compression, drop (shock), tensile, vibration and fatigue testing.
Wire harness testers evaluate continuity, resistance, isolation, and other performance factors for multi-strand wire harnesses.
Megohmmeters generate high voltage, low current signals for testing the breakdown strength of electrical insulation. They are called megohmmeters because the insulating resistance of a properly designed product is expressed in mega ohms (MOmega: Ohms ).
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Product Announcements
Vitrek Corporation - Hipot-Insulation Resistance-Ground Bond Testers
The GPT/GPI-800 Electrical Safety Testers (EST) are Hipot Testers designed for AC/DC Withstanding Voltage testing and Insulation Resistance (IR) testing to provide electrical safety compliance testing... (read more)
Associated Research, Inc. - Electrical Safety Testers
The OMNIA series are UL and TUV listed fully automated multi-function electrical safety compliance analyzers for safety agency production line testing. The OMNIA series features 4-in-1, 5-in-1 and... (read more)
Associated Research, Inc. - Production Hipot Testers with RS-232 Interface
Hypot® III is a mid range family of Hipot testers that feature an RS-232 interface, enhanced graphic LCD. Hypot III consists of three models the 3705, the 3765, and the 3770. Models will perform AC,... (read more)
Associated Research, Inc. - Ground Bond Testers
The HYAMP III family are manual Ground Bond testers that feature an enhanced graphic LCD. They consist of a 30 Amp, 40 Amp, and 60 Amp models. All models can be used stand alone or interconnected to... (read more)
Slaughter Company - Hipot Testers with Safety Agency Listing
Slaughter's 2900 series of Hipot testers are C-UL-US and TÜV-GS safety agency listed. These low cost testers feature the latest technology including microprocessor control, electronic ramp and dwell... (read more)
Slaughter Company - 6-in-1 Electrical safety tester - Model 6330
The 6330 is a 6-in-1 multi-function electrical safety tester that will perform six common electrical safety tests all in a single instrument. The 6330 features the following test modes: AC Hipot, DC... (read more)
Slaughter Company - AC/DC Hipot with IR Tester
The 2900 Series is their newest line of UL & TUV safety agency listed Hipot testers. (read more)
Baker Instrument Company, an SKF Group Company - AWAIV Surge/HiPot/Resistance Tester
The AWA predictive maintenance solution from Baker offers a great deal of flexibility in providing fault recognition in one convenient instrument. (read more)
Associated Research, Inc. - 500VA Hipot & Ground Bond Tester
HypotMAXT, model 7704 provides 500 VA AC Hipot, 6 kV DC Hipot, Insulation Resistance and Ground Bond tests in a single DUT connection. The 7704 can be used as a bench-top instrument or as a PC... (read more)
QuadTech Inc. - 277/299 Medical Device Safety Analyzers
The QuadTech Medical Device Safety Analyzers, available in two convenient models: the portable 277 and the bench top 299, provide an integrated safety testing solution for medical device testing in... (read more)
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Topics of Interest
An electrical safety analyzer is a device that has been designed to conduct a wide variety of electrical safety analyzation tests and in a sense analyzes the device under test in order to determine if... (Read More)
The Hipot or Dielectric Withstand test is routinely specified as both a “Type” test and a “Routine Production Line” test on electrical products. This is a voltage test that is designed to stress the... (Read More)
In an industry comprised of workers with varying electronics knowledge, a Hipot test can seem a daunting task for some. Indeed, many test operators and quality assurance supervisors, having never been... (Read More)
Compliance testing is the process of verifying that a given device meets the requirements regulating it. Regulatory compliance testing on typical electronic devices includes testing in a variety of... (Read More)
Line Leakage tests are commonly specified as a part of many product safety standards. This test is most often specified as engineering “type test” but may also be specified “routine production line... (Read More)
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Technical Articles
Production Line Tests for Medical Product Safety Evaluation (.pdf) - Electrical Testing Equipment
Chocolate Temper Measurement - Temperature Sensing
V-Cone Flow Meter Solves Nuclear Underwater Measurement Problem - Test and Measurement
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See more product announcements for Hipot Testers
V685 Cable/Harness Hipot Tester

V685 Cable/Harness Hipot Tester
Vitrek Corporation


Hipot and Insulation Resistance Tester

Hipot and Insulation Resistance Tester
Kikusui America, Inc.


V4 Electrical Safety Analyzer

V4 Electrical Safety Analyzer
Vitrek Corporation


11 See more product announcements for Hipot Testers



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