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Production Line Tests for Medical Product Safety Evaluation

From Associated Research, Inc.
 

 
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
Electric test probes are used to establish a connection between a circuit under test and the measuring instrument. Search by Specification | Learn more about Electrical Test Probes
Hipot testers are electrical safety test devices that perform a variety of electrical compliance tests. Search by Specification | Learn more about Hipot Testers
Current leakage testers measure the amount of current that leaks to ground. Search by Specification | Learn more about Current Leakage Testers
Ground bond testers are electrical safety test devices that perform electrical compliance tests. Search by Specification | Learn more about Ground Bond Testers
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)
QuadTech Inc. - Guardian 6100 Plus Safety Analyzer
The Guardian 6100 Plus Safety Analyzer joins is the industry's first medical safety analyzers with Twin-Port™ technology for simultaneous hipot and ground bond testing for dramatic time savings... (read more)
QuadTech Inc. - Guardian 6000 Plus Electrical Safety Analyzer
The Guardian 6000 Plus Electrical Safety Analyzer performs 5 major electrical safety tests (AC Hipot, DC Hipot, Insulation Resistance, Ground Bond, Open/Short) and is the industry's first tester with... (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)
Associated Research, Inc. - MedTEST system for Medical Device Safety Testing
MedTEST provides advanced test functionality while increasing efficiency for medical device manufacturers. MedTEST combines all of the most common electrical safety tests required by safety agencies... (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)
Associated Research, Inc. - Automated Hipot Testers!
HypotULTRA™ III is a fully-automated dielectric analyzer for safety agency production line testing. It features two models, the 7620 and the 7650 and will perform AC, DC Hipot and Insulation... (read more)
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)
Manufacturers of heating elements, cable harnesses, and aerospace cables must commonly perform point to point continuity tests and hipot tests as part of their routine production line tests. The... (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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