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Medical equipment electrical safety testing

Testing to IEC 60601 and IEC 62353, with a certificate for each device. A standard requirement for equipment entering healthcare institutions.

Request an electrical safety test
IEC 60601 / 62353
Testing standards.
Per device
Certificate with the measured values.
6 or 12 months
Recertification interval, depending on the device.
Included
Testing after every repair.

A requirement for equipment entry

Healthcare institutions require electrical safety testing before accepting new, demonstration or loaned equipment. We perform these tests for suppliers, manufacturers and institutions that need to keep their certificates current.

Institutions usually require current records and certificates, at an interval defined by each manufacturer (typically every six or twelve months). Testing follows IEC 62353, the standard for in-service testing and testing after repair, with the safety requirements of IEC 60601-1 as reference, and every parameter is checked against the manufacturer’s limits.

We use electrical safety analyzers, defibrillator and electrosurgical analyzers, ECG simulators, oscilloscopes and digital multimeters, plus the specific test equipment supplied by the manufacturers we are authorized for.

  • Testing to IEC 62353, with IEC 60601-1 as reference
  • Certificate and report for each device
  • Calibration to manufacturer parameters and tolerances
  • Verification of new or demonstration devices before institutional entry
  • Periodic checks to keep certificates current

Process

  1. Request

    Quantity, brand and model of the devices, and the institution receiving the certificate.

  2. Scheduling

    Location and date of the test are agreed.

  3. Testing

    To IEC 60601 and IEC 62353, with an electrical safety analyzer.

  4. Certification

    A certificate for each device with the measured values.

Frequently asked questions

How often should electrical safety testing be performed?

It depends on the device: usually every six or twelve months. It is also performed after every repair.

Do you test devices that suppliers need to deliver to an institution?

Yes. It is one of our most requested services: several institutions refer their suppliers to us to certify new or demonstration equipment.

Which standards apply?

IEC 62353 for in-service testing and testing after repair, with the safety requirements of IEC 60601-1 as reference, together with the parameters and tolerances defined by each manufacturer.

What information do you need for a quote?

The number of devices, the brand and model of each one, the institution receiving the certificate and where the devices are located.

What do you deliver?

A certificate for each device, with the measured values and the result of each test.

Does the certificate replace product certification or ANMAT registration?

No. It is an electrical safety test of the device in service: it verifies that the unit meets the applicable limits at the time of testing. Product certification and registration with ANMAT are the responsibility of the manufacturer or importer.

Other services

Request a quote

Provide the brand, model and requirement. Free diagnosis and a quote with a technical report within five business days.

Request an electrical safety test