Medical Electronics Test Equipment and ATE

Medical Electronics

There are a number of global standards that serve as the ruling body on how medical products will be tested. IEC60601-1 is mainly intended for product development where safety considerations must be taken into account early in the design phase of a product, however much of it applies to production line testing to ensure manufacturer are shipping safe products. Vital areas of medical device electrical safety testing include hipot test or dielectric breakdown, leakage current, insulation resistance and ground bond testing.

Ensuring The Safety Of Medical Electronics

Vital areas of electrical safety testing for medical products include leakage current, dielectric breakdown, insulation resistance and ground bond testing. To better understand the differences in these tests and others, this article examines the purpose and techniques for each test then offers a detailed discussion on ensuring the safety of medical electronics.

Automated Test Solutions

Chroma’s Sentinel Systems are fully customizable automated test solutions designed specifically for medical device electronics, including R&D and production testing, in order to meet global compliance requirements. Sentinel Systems can provide complete Electrical Safety Testing to IEC60601-1 and IEC 60601-2-49 (Multifunctional Patient Monitoring Equipment).

Sentinel I Medical Test System

19032 Hipot Analyzer + CaptivATE Automation Software

Automated Medical Device Safety Testing to IEC/EN/UL/CSA 60601-1. Test Hipot, Ground Bond, Insulation Resistance, Patient Leakage, Earth Line Leakage, Enclosure Leakage and Patient Auxiliary Leakage. CaptivATE Software provides data logging of electrical tests with an easy to use programmable interface. The Sentinel I System accommodates Class I, Class II and internally powered medical devices with the following specifications:

Mains Power up to 4400VA, 0-300Vac
1 B-Type Patient Connection

Sentinel II Medical Test System

19032 Hipot Analyzer + CaptivATE + Programmable AC Power

Automated Medical Device Safety Testing to IEC/EN/UL/CSA 60601-1. Sentinel II saves time by scanning patient connections for leakage current without powering down the medical device. The Sentinel II System can be configured to accommodate Class I, Class II, mains and internally powered medical devices with the following configurations:

Mains Power supply up to 4000VA, 0~300VAC @ 15~1kHZ
Up to 1 B-Type Patient Connection

Sentinel III Medical Test System

19032 Hipot Analyzer + CaptivATE + 1500VA or 800VA AC Source + Matrix 8000 Scanning System

Automated Medical Device Safety Testing to IEC/EN/UL/CSA 60601-1 and IEC60601-2-49 (Multifunctional Patient Monitoring Equipment). Sentinel III also scans patient connections for leakage current without powering down the medical device. The Sentinel III System can accommodate Class I, Class II, mains and internally powered medical devices with the following configurations:

Mains power input up to 4000VA, 0~300Vac @ 15~1kHz
Up to 16 B, BF, or CF patient connections
4 signal inputs/signal outputs
Other custom configurations available

Sentinel Series: IEC60601 Medical Device Automated Test Systems with IQ/OQ Test Protocol Documents

Sentinel systems are available in 3 efficient configurations with or without an AC power source to fit a wide variety applications from 1 to multiple patient connections. All systems include tests for ground bond, AC and DC Hipot, insulation resistance, and leakage measurements.

CaptivATE Automation Software

CaptivATE provides an off-the-shelf test platform for automating hipot, leakage current, and functional tests. By automating the loading of test setups, sharing test setups plantwide, and combining safety and functional tests into one system, CaptivATE increases efficiency and productivity. For medical devices, software supports IEC60601-1 test requirements, digitally stores product test certificates, and provides IQOQ protocol documentation.

Hipot Testing

Hipot testing or dielectric strength testing determines the suitability of the dielectric or insulation barrier between hazardous and non-hazardous parts. The IEC60601-1 standard and its supporting standards specify the voltage to be applied to the device under test (DUT) and the acceptance criteria, usually: ‘no breakdown or repeated flashover shall occur’.

Guardian Electrical Safety Analyzer

Chroma 19032

Twinport function reduces the safety test time and can eliminate potential bottlenecks in the production line

Add to bench

Guardian Hipot Tester AC/DC/IR/SCAN

Chroma 19050

Advanced digital hipot testers with load and line regulations that help ensure measurement integrity, and Multi-step capability allows users to perform multiple tests in sequence

Add to bench

Guardian Multi-Channel Hipot Tester

Chroma 19020

Measure the hipot leakage current of all channels at the same time and conduct tests on up to 100 DUTs simultaneously

Add to bench

Sentry Hipot Tester AC/DC/IR

Chroma 19070

Compact, lightweight and low cost safety testers for electronic components

Add to bench

Leakage Current Test

Leakage current is the residual flow of current after HIGH voltage (greater than normal operating voltage) has been applied to the device under test (DUT). This is the current measured in a hipot test. Line leakage current is that measured at 110% of highest rated operating voltage and highest rated frequency. The device under test is turned on and the line leakage is measured across a circuit that simulates the impedance of the human body. There are four types of leakage current: Earth, Touch/Chassis (Enclosure), Patient (Applied Part) and Patient Auxiliary.

4 Types of Leakage Current:

Earth leakage

is that line leakage current measured when the ground connector is open, a circuit that simulates the impedance of the human body is inserted and the voltage is measured across it.

Touch/Chassis (Enclosure) leakage

is that line leakage current measured by connecting the circuit that simulates the impedance of the human body to any exposed part of the chassis of the DUT. This simulates someone touching the enclosure/chassis of the DUT.

Patient (Applied Part) leakage

is that line leakage measured from or between applied parts of the DUT such as the current that might flow from patient leads and sensors on a medical device.

Patient Auxiliary leakage

is that line leakage current flowing in the patient in NORMAL use between applied parts of the DUT and not intended to produce a physiological effect.