Medical Equipment EN60601 Testing EMC Laboratory

JJR laboratory is accredited to conduct testing of medical devices as required by the EN 60601-1 standard.

The laboratory is already in operation, and in the coming days, our engineer, Mirko Masotti, will conduct further tests related to electrical safety.

What is the EN 60601 standard?

EN 60601 is a series of standards covering the safety, essential performance, and electromagnetic compatibility of electronic medical devices and systems. It is technically equivalent to the international standard iec 60601, consisting of over 70 separate standards.

The "Part 1" standard EN 60601-1 covers basic safety and performance applicable to all electronic medical devices, while "Part 2" or "Particular" standards cover requirements specific to particular product groups (such as EN 60601-2-22 for laser medical devices).

Compliance with EN 60601-1 Standard

EN 60601-1 applies to all electronic medical devices and electronic medical systems. The standard defines electronic medical devices as devices containing applied parts, or transmitting energy to/from patients, or detecting such energy transmission to/from patients. It also has the following criteria:

- Connected to not more than one power supply mains;

- Intended by the manufacturer for use in diagnosis, treatment, monitoring of patients, or alleviation of disease, injury, or disability.

This includes a wide range of medical devices such as:

- High-frequency surgical equipment

- Cardiac defibrillators

- Patient monitors

- Therapeutic and diagnostic ultrasound equipment

- Medical lasers

- Patient ventilators

- Infant incubators and warmers

Why choose ECM for Medical Equipment EN 60601 Compliance testing?

- We have a professional laboratory dedicated to EN 60601-1 compliance testing.

- Our laboratory is a member of the CB system, which provides globally recognized test reports and certificates.

- We can provide pre-test checks and assist in developing test plans.

- We have professional engineers overseeing the entire testing process to ensure its effectiveness.

For more information about product testing according to the EN60601-1 standard, please feel free to contact JJRLAB at your earliest convenience!