Where can I find the official name of the standard LST EN ISO 11197 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 ISO 11197 Medical supply units.
The meaning of the LST EN ISO 11197 standard, why is it needed:
This standard applies to medical power supply units that are intended to supply electricity and medical gases to other devices.
LST EN ISO 11197 determines:
- basic safety and
- essential operational requirements;
- indicates tests of medical power blocks;
- 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 ISO 11197 standard applies to:
- medical power supplies that are used with medical equipment.
LST EN ISO 11197 standard does not apply:
- for power supplies that are not used with medical equipment.
"Sertika" testing laboratory is accredited to perform tests according to the LST EN ISO 11197 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.