Medical Equipment Acceptance Testing: A Step-by-Step Guide

Prepare before the equipment arrives

Acceptance starts with the purchase order and specification. Agree in writing which tests will be performed, who attends, which instruments are used and what pass criteria apply. Ask the supplier for its installation and commissioning procedure and for the factory test records if available.

Make sure the site is ready; the points are in our installation checklist. Nominate an acceptance team: a biomedical engineer, a clinical user and a supplier engineer, with procurement involved when contract terms are affected.

Incoming inspection

On delivery, check packaging for damage, and compare contents against the packing list and the order: model, serial number, accessories, cables, consumables, software versions and documents. Record any shortfall or damage with photos and notify the supplier within the period set in the contract.

Assign an asset number, label the device and enter it in the register, ideally in a maintenance management system. Verify that the device carries the manufacturer's labelling and, where applicable, the conformity marking.

Commissioning and performance tests

Commissioning is the installation, set-up and first operation by the supplier's engineer. It is followed by tests that show the device meets its specification. These vary by device but generally include functional checks of every mode, alarms and safety interlocks, calibration against reference instruments, and, for imaging or radiation equipment, image quality and dose checks by the qualified person.

Use the manufacturer's service manual and your specification as the test basis. Keep numerical results, not only 'pass', so that future tests can be compared. This same baseline helps during preventive maintenance.

Electrical safety testing

Before clinical use, test electrical safety: protective earth resistance, leakage currents and insulation as applicable. The product standard is IEC 60601-1, and routine in-service testing often follows IEC 62353. Read our explanation of IEC 60601 and electrical safety testing for detail.

Record the instrument used, its calibration status, the readings and the limits. A device that fails any safety test must not be released to users until the cause is corrected and the test is repeated.

Training sign-off and handover documents

Training is part of acceptance. Ensure operators and cleaning or reprocessing staff are trained and sign an attendance sheet, and that biomedical engineers receive service training where it is offered. Provide quick reference cards at the point of use.

The handover pack should include the signed acceptance certificate, instructions for use and service manuals, test records, warranty terms and start date, spare parts list, software licences, registration or conformity documents, and the contact path for support. Payment milestones should depend on acceptance, not only on delivery.

Support from Beckfinity

Beckfinity's engineers carry out installation, commissioning and user training for the equipment we supply, and provide documentation for your acceptance file. Ask us for the acceptance procedure for your device before delivery.