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Tecnalia. Inspiring Business

Tecnalia. Inspiring Business

We help manufacturers evaluate the biocompatibility and biocide efficacy of their products

2020.06.04

We have extensive experience in the evaluation of the biocompatibility of biomedical devices in line with ISO 10993 and in diverse microbiological tests

We perform the necessary tests for companies to certify their medical devices by means of the CE Marking and sell them in compliance with the regulations.

In the specific scope of products to combat COVID-19, surgical masks are a representative item. Unlike other Personal Protection Equipment (PPE), these are considered to be medical devices: they must fulfil the strict regulations to obtain the CE Marking that indicates conformity to be placed on the market.

In addition to biocompatibility evaluation in line with ISO 10993, we also carry out the Microbial Cleaning test (determination of the population of micro-organisms), set out, along with Biocompatibility, in UNE EN14126:2004  Medical Face Masks - Requirements and Test Methods.

TECNALIA has extensive experience in microbiological testing; covering the evaluation of biofilm on surfaces and/or characterisation of antimicrobial efficacy (ISO 22196, ASTM E2149) against common micro-organisms in infections produced in medical devices; determination of bioburden and sterility (ISO 11737) in medical devices, as well as the evaluation of bactericidal efficacy in disinfectants (UNE EN 1040).

We also perform tests for the evaluation of the efficacy of film preservatives in a coating against fungi and algaein line with Standards EN 15457 and EN 15458, as well as the evaluation of possible fungal growth in numerous materials in line with Standards ISO 846, MIL STD 810 and DO-160.

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Parque Científico y Tecnológico de Gipuzkoa. Mikeletegi Pasealekua, 2. E-20009 Donostia - San Sebastián. Gipuzkoa (Spain). Tel.: 902.760.000 - International Calls: (+34) 946.430.850


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