SAFETY TESTING ACCORDING TO LST EN 60601-2-24 - INFUSION PUMPS AND CONTROLS
Where can I find the official name of the standard LST EN 60601-2-24 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 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers.
The meaning of the LST EN 60601-2-24 standard, why is it needed:
This standard applies to infusion pumps and volumetric infusion controllers, which are intended for the dosing and delivery of liquid substances to the human body.
LST EN 60601-2-24 determines:
- basic safety and
- essential operational requirements;
- indicates tests of infusion pumps;
- provides guidelines for their application.
During device testing, the following is defined:
- classification and labeling;
- electrical parameters;
- mechanical parameters.
LST EN 60601-2-24 standard applies to:
- for enteral feeding pumps;
- infusion pumps;
- for ambulatory infusion pumps,
- for syringe or tank pumps,
- for volumetric infusion controllers
- for volumetric infusion pumps, etc.
LST EN 60601-2-24 standard does not apply:
- for circulatory devices;
- for implantable devices;
- for devices intended for urodynamics diagnostics;
- for devices performing diagnostics and testing for the treatment of male impotence, etc.
"Sertika" testing laboratory is accredited to perform tests according to the LST EN 60601-2-24 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:
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.