Electrical Equipment Safety Testing for Medical Devices

Where can I find the official name of the standard LST EN 60601-1 and the valid version of the standard?

LST EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

The meaning of the LST EN 60601-1 standard, why is it needed:

This standard applies to all electrical medical equipment and their modules, which are intended for treatment, examination, diagnosis, rehabilitation.

LST EN 60601-1 determines:

• basic safety and
• essential operational requirements;
• indicates electrical medical equipment tests;
• provides guidelines for their application.

During device testing, the following is defined:

• classification and labeling;
• electrical parameters;
• mechanical parameters.

Depending on the structure of the device, the principle of operation, additional standards may be applied.

LST EN 60601-1 standard applies to:

• thermometers, colposcopes, bioimpedance measurement systems;
• gamma imaging systems, foot scanners, endoscopic cameras, ultrasound scanners;
• infusion pumps, feeding pumps, syringe pumps;
• psoriasis treatment devices, incubators, air disinfection systems;
• cardiographs, heart rate monitors;
• and for all other electrical medical equipment.

LST EN 60601-1 standard does not apply:

• for in vitro diagnostic devices not covered by the definition of an electrical medical device, the IEC 61010 series of standards apply.
• for implantable medical devices described in IEC 14708-1.

"Sertika" testing laboratory is accredited to perform tests according to the LST EN 60601-1 standard.

You can find the entire current area of safety testing activities of UAB "Sertika" here: UAB "Sertika" laboratory accreditation scope.

Do you have questions about product safety testing and/or certification?

We kindly invite you to contact us using the following contacts:

• phone: +37067224664;
• e-mail/remote chat: lab@sertika.lt;
• address: Mituvos str. 2-251.

In order for us to submit a proposal for certification, the initial information required for the application is:

1. technical documentation of the device;
2. a precise description of the intended functions of the device;
3. what standard of certification/testing do you prefer?
4. how long and when do you want SERTIKA conformity assessment results?

If you are considering product testing or certification, you may benefit from:

How to prepare for product certification and testing - preparation of documents and product prototype for the legalization procedure.
What requirements must be met when placing a product on the European market? - typical steps that a product manufacturer must take before placing the product on the EU market.