As regulation becomes more demanding across the healthcare sector, the ability to validate materials through accredited testing is becoming a strategic requirement, not simply a technical step. This is particularly true for medical devices, where safety, biocompatibility and regulatory acceptance are essential conditions for market access.
AIMPLAS, the Plastics Technology Centre, has obtained a new accreditation from ENAC, the Spanish National Accreditation Body, to perform in vitro cytotoxicity testing on medical devices according to the UNE-EN ISO 10993-5 standard. The accreditation expands the centre’s capabilities in the biological evaluation of materials and reinforces its position in the field of health and consumer safety.
The new scope is particularly relevant for companies working with plastics and polymer-based solutions for the medical sector. In vitro cytotoxicity testing is one of the fundamental steps in assessing whether a material or finished device may cause adverse effects on cells. By identifying potential biological risks before products reach the market, this type of test supports safer development processes and helps companies demonstrate compliance with national and international requirements.
Biocompatibility as a market access requirement
In the medical device industry, material performance is no longer evaluated only in terms of mechanical properties, processing behaviour or durability. Biocompatibility has become a central part of product validation, especially for devices that come into direct or indirect contact with the human body.
The accreditation obtained by AIMPLAS under the UNE-EN ISO/IEC 17025:2017 standard certifies the technical competence of the laboratory and the reliability of its results. For manufacturers, this can translate into greater confidence in the testing process and smoother interactions with clients, certification bodies and regulatory authorities.
This is increasingly important in a global market where medical device companies must often navigate multiple regulatory frameworks. Accredited testing can help reduce uncertainty, shorten development timelines and support the acceptance of results in different markets.
A broader role for plastics testing centres
The new accreditation also reflects a wider transformation in the plastics sector. Technology centres are no longer only supporting material development or process optimisation. They are becoming key partners in regulatory validation, safety assessment and sustainability-related testing.
AIMPLAS already holds accreditations in areas such as food contact materials, plastic recycling and recyclability evaluation. The addition of in vitro cytotoxicity testing strengthens its portfolio in one of the most demanding application areas for plastics: healthcare.
For the medical device supply chain, this kind of capability is becoming increasingly valuable. Material suppliers, converters and manufacturers are under pressure to provide evidence-based data on safety and compliance from the earliest stages of product development. Testing is therefore becoming part of the innovation process itself, rather than a final verification step.
Why it matters for healthcare plastics
The healthcare sector continues to rely on plastics for a wide range of applications, from disposable medical devices to advanced components and functional materials. At the same time, expectations around patient safety, traceability and regulatory documentation are rising.
In this context, accredited laboratories play a critical role. They help companies move from material selection to validated product development, while reducing the risk of delays linked to incomplete or non-recognised testing.
AIMPLAS’ new ENAC accreditation underlines a broader industry trend: in medical-grade plastics, competitiveness increasingly depends on the ability to combine innovation with certified safety, regulatory readiness and reliable technical documentation.
For companies developing healthcare-related plastic products, this makes accredited testing not just a compliance requirement, but a strategic asset.
Image Credits: AIMPLAS
