Aimplas, the Plastics Technology Centre, has obtained a new accreditation from the Spanish accreditation body ENAC to perform in vitro cytotoxicity testing for medical devices. The scope of the accreditation covers testing carried out in accordance with the UNE-EN ISO 10993-5 standard, used in the biological evaluation of materials that come into contact with the body. This expands the centre's capabilities in the technical validation of materials and products intended for the medical sector, which is subject to growing regulatory and quality requirements. In a global medical device market that continues to expand, confirmation of material biocompatibility, risk reduction, and demonstration of product reliability throughout the entire life cycle are becoming important conditions for market access. In this context, accredited biomedical testing is gaining importance as a tool supporting the competitiveness of manufacturers and suppliers.
The new accreditation complements the existing capabilities of Aimplas laboratories in areas related to consumer safety and sustainability. According to the centre, this includes, among other things, testing of materials intended for food contact and the assessment of plastics recycling and recyclability. The accreditation obtained on May 8 under the demanding UNE-EN ISO/IEC 17025:2017 system confirms the laboratory's technical competence and the reliability of its test results. In practice, this strengthens Aimplas' position as a technical partner for companies operating in the healthcare sector.
Importance of in vitro cytotoxicity testing
In vitro cytotoxicity testing is one of the fundamental elements of the biological evaluation of materials used in medical devices. Its purpose is to detect potential adverse effects on cells before a product is placed on the market. With the newly accredited method, Aimplas can offer companies a tool that supports the development of safe medical devices, risk reduction, and compliance with national and international regulatory requirements.
ENAC accreditation also increases the formal value of the results generated by the laboratory, as it ensures their official recognition and may facilitate acceptance of the results in international markets. For companies in the medical sector, this means the possibility of streamlining certification processes, shortening product development times, and increasing confidence among both customers and regulatory authorities.
Expansion of services for the healthcare sector
Obtaining the accreditation is part of Aimplas' efforts to develop technical capabilities, innovation, and knowledge transfer. The centre identifies these areas as the basis for supporting a safer, more sustainable, and more competitive industry. Expanding the service portfolio to include in vitro cytotoxicity testing strengthens the institute's position in areas related to health, consumer safety, and advanced materials, while also increasing its presence in one of the most demanding application sectors for plastics.
