Medical Device EMC Test Preparation Checklist

Define the device and requirements

• Provide the product name, model, variants, intended use and target markets.
• Identify the intended electromagnetic environment: professional healthcare, home healthcare or a special environment.
• Specify the required IEC 60601-1-2 edition and applicable collateral or particular requirements. For IVD equipment, identify the applicable IEC 61326 requirements.
• List requested emissions, immunity and proximity-field evaluations; agree method availability and accreditation coverage with the laboratory.

Define performance and acceptance criteria

• Supply the manufacturer’s essential-performance statement and the relevant device-specific risk information.
• Provide observable, measurable immunity pass/fail criteria, including limits and any permitted recovery behaviour.
• Identify the operating modes and functions to monitor, including outputs, alarms, measurements, control and communications as applicable.
• Provide a monitoring procedure and suitable simulators or loads; agree how results will be recorded without disturbing the EMC measurement.

Prepare a representative configuration

• Provide production-representative samples and identify hardware, software and firmware versions.
• List accessories, applied parts, sensors, power supplies, chargers, batteries, cables and interconnected equipment needed for the tested system.
• Document cable types, lengths, routing and port functions; explain proposed representative or worst-case configurations.
• Explain model-family differences and identify the configurations proposed for testing.

Make the sample ready to operate

• Include setup instructions, safe handling information, operating procedures and the tools or access needed to run the sample.
• Provide agreed non-clinical test loads, simulators and consumables; establish how any patient-related functions will be simulated.
• Confirm supply voltage, frequency, current, battery endurance and charging arrangements.
• Describe wireless functions, antennas and simultaneous-transmission modes; provide existing module approvals where relevant.

Agree logistics and documentation

• Send sample dimensions, mass, handling requirements and a photo or configuration drawing.
• Confirm sample quantities, spares, accessories, shipping arrangements and the requested schedule.
• Provide the technical contact who can resolve setup questions and any required remote-support arrangements.
• Agree report identifiers, tested configurations, requested documentation and treatment of deviations before formal testing.

Before You Book

Stancer’s A2LA scope (certificate 7352.01) lists IEC 60601-1-2, BS EN/EN 60601-1-2, CISPR 11 and relevant IEC 61000 methods. It also lists IEC 61326-2-6. Required editions, additional methods and the final test matrix are confirmed for each project.

The manufacturer remains responsible for intended use, risk evaluation and essential-performance definitions. This is a preparation aid, not a complete compliance matrix or evidence of medical-device approval.

Review our accreditation information and medical device EMC testing service. Send your product details to our technical team.