Testing laboratory of medical devices
Question
Our company is a manufacturer of medical devices, and we are interested in conducting tests for our products in your testing laboratory. We specifically require testing for the following medical devices: a multipurpose transcutaneous electrical stimulator and a device for dynamic electrostimulation and electromassage.
To proceed with the testing, we kindly request information regarding the accreditation of your testing laboratory in accordance with the following standards:
1.EN 60601-2-10:2015 + A1:2016 – Medical electrical equipment – Part 2-10: Particular requirements for electrical stimulators (IEC 60601-2-10:2012 + A1:2016).
2.EN 60601-1-11:2015 – Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard (IEC 60601-1-11:2015).
3.IEC 60601-1:2005/A1:2012 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
4.IEC 60601-1-2:2014 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
5.ISO 10993-1:2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
In addition, we have enclosed a general description of the devices for your reference.
If your testing laboratory possesses the necessary accreditation, we would appreciate clarification regarding the cost and timeframe for conducting the tests.
Answer
As regards your enquiry we recommend you to address directly the Slovak Institutions, for example, EVPÚ, a.s. or TSÚ s.p. that are likely to be competent to conduct testing according to mentioned standards for medical devices area.
More information about Slovak Authorized and Notified Bodies for respective areas can be found in Table: https://www.unms.sk/swift_data/source/2020/osaez/technicke_predpisy/0106_2020/Technicke%20predpisy%20z%20oblasti%20posudzovania%20zhody_01.06.2020.pdf