MEDICAL DEVICE ALARM SYSTEM TESTS ACCORDING TO LST EN
60601-1-8
Where can I find the official name of the standard LST EN 60601-1-8 and the valid version of the standard?
You can always find the current edition of the standard, amendments or corrections to the standard on the website of the
Lithuanian Department of Standardization.
LST EN 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance. Collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
The meaning of the LST EN 60601-1-8 standard, why is it needed:
This standard applies to electrical alarm systems for medical equipment that are designed to report various system malfunctions, hazards, etc.
LST EN 60601-1-8 determines:
- basic safety and
- essential operational requirements;
- indicates the tests of the alarm systems of medical electrical equipment and its systems;
- provides guidelines for their application.
During device testing, the following is defined:
- classification and labeling;
- electrical parameters;
- mechanical parameters.
LST EN 60601-1-8 standard applies to:
This standard applies to electrical medical equipment alarm systems/medical equipment with an alarm function:
- ventilation systems;
- dialysis machines;
- infusion pumps;
- all other electrical medical devices with an alarm function.
LST EN 60601-1-8 standard does not apply:
- for medical equipment without an alarm function;
- for equipment with an alarm function that is not classified as medical equipment.
"Sertika" testing laboratory is accredited to perform tests according to the LST EN 60601-1-8 standard.
You can find the entire current area of safety testing activities of UAB "Sertika" here: UAB "Sertika" laboratory testing area.
Do you have questions about product safety testing and/or certification?
We kindly invite you to contact us using the following contacts:
In order for us to submit a proposal for certification, the initial information required for the application is:
- technical documentation of the device;
- a precise description of the intended functions of the device;
- what standard of certification/testing do you prefer?
- 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.