Test and measurement equipment, EMC pre-compliance support and electrical safety solutions for medical device manufacturers, healthcare technology developers and medical electronics organisations across Australia and New Zealand.
Medical electrical equipment must be designed and evaluated with consideration for electromagnetic disturbances, electrical safety and its intended operating environment. C-PRAV Tech helps organisations identify suitable test equipment and develop practical pre-compliance and compliance testing approaches.
Diagnostic equipment, patient monitoring systems, infusion devices, medical power supplies and other electrical medical products.
Laboratory equipment, imaging-related electronics, connected healthcare devices and embedded electronic systems.
Engineering teams developing prototypes, evaluating design changes and preparing products for EMC and electrical safety assessment.
Common standards and frameworks relevant to medical electrical equipment. The applicable edition and particular requirements must be confirmed for each device.
IEC 60601-1
Basic safety and essential performance of medical electrical equipment.
Medical electrical equipment and systems.
IEC 60601-1-2
Electromagnetic disturbances: EMC requirements and tests.
Medical electrical equipment and systems.
CISPR 11
RF disturbance characteristics and limits for industrial, scientific and medical equipment.
Applicable medical and ISM equipment, as referenced by the relevant product standard.
IEC 61000-4 series
Immunity test methods including ESD, radiated RF, EFT, surge and conducted RF.
Test methods referenced by product and generic standards.
IEC 61000-3-2
Limits for harmonic current emissions.
Applicable mains-connected equipment within the standard’s scope.
IEC 61000-3-3
Voltage changes, fluctuations and flicker limits.
Applicable equipment connected to public low-voltage systems.
IEC 62353
Recurrent testing and testing after repair of medical electrical equipment.
In-service medical electrical equipment, where applicable.
IEC 61010-1
Safety requirements for measurement, control and laboratory equipment.
Relevant laboratory and diagnostic equipment where this product safety standard applies.
Important: IEC 60601-1-2 is a medical equipment EMC collateral standard. The applicable particular standard, risk management requirements, device classification and intended use can affect the test programme. Not every medical or laboratory product is assessed under IEC 60601.
Equipment selection depends on the required test level, configuration, applicable standard edition and whether testing is for engineering pre-compliance or formal compliance assessment.
Conducted emissions
AC mains disturbance measurement
EMI receiver, LISN/artificial mains network, line impedance accessories and measurement software.
Radiated emissions
Radiated RF disturbance measurement
EMI receiver or spectrum analyser, antennas, preamplifier, cables and suitable test site.
Electrostatic discharge
IEC 61000-4-2
ESD simulator, discharge tips, calibration accessories and appropriate test setup.
Radiated RF immunity
IEC 61000-4-3
RF signal generator, power amplifier, transmitting antenna, field probe and monitoring system.
Electrical fast transient
IEC 61000-4-4
EFT/burst generator and appropriate coupling/decoupling network.
Surge immunity
IEC 61000-4-5
Surge generator, coupling/decoupling network and suitable monitoring equipment.
Conducted RF immunity
IEC 61000-4-6
RF generator, amplifier, CDN or injection clamp, and current monitoring accessories.
Power frequency magnetic field
IEC 61000-4-8
Magnetic field test system, induction coil and field measurement equipment.
Voltage dips and interruptions
IEC 61000-4-11
Voltage dip and interruption test system appropriate to the equipment rating.
Electrical safety
IEC 60601-1 and applicable clauses
Medical electrical safety analyser, leakage current measurement and dielectric strength test capability.
C-PRAV Tech works with established test equipment manufacturers to help customers identify suitable instruments and systems for medical electronics development and evaluation.
EMI receivers, spectrum analysers, signal generators, oscilloscopes, network analysers and RF measurement solutions.
EMC immunity test systems including ESD, EFT, surge and other transient test solutions, subject to model configuration.
EMC pre-compliance accessories including LISNs, current probes, near-field probes, antennas and coupling devices.
EMI receivers, LISNs, antennas, CDNs and EMC test accessories for emissions and immunity applications.
Oscilloscopes, spectrum analysers, RF generators and electronic test instruments for design and troubleshooting.
Oscilloscopes, probes and portable RF spectrum analysis solutions for electronic design, debugging and RF investigations.
C-PRAV Tech can discuss EMC pre-compliance investigations, test equipment selection and laboratory testing requirements. Formal accredited testing is subject to the laboratory’s current accreditation scope and the specific test requested.
Identify potential emissions and immunity issues earlier in the product development cycle.
Discuss suitable test and measurement equipment for medical electronics engineering and troubleshooting.
Discuss applicable standards, test configurations and the next steps towards product assessment.
C-PRAV Technology Solutions, Hallmarc Business Park, A9/2A Westall Rd, Springvale VIC 3171, Australia
Talk to C-PRAV Tech about medical EMC test equipment, electrical safety test solutions and pre-compliance support.
Australia: +61 3 9087 9383
