We help you deal with medical textile biocompatibility, from application to material selection and sourcing.
Biocompatibility services for medical wearables & textiles
What is biocompatible textile and why it matters
Biocompatibility services for medical wearables & textiles became more relevant when recently the latest Medical Device Regulations were implemented. As described in ISO 10993, biocompatibility means the ‘Ability to be in contact with a living system without producing an adverse effect’.
This sounds obvious and simple, especially for medical devices using textile on the skin. However, finding the correct textiles is harder than it looks. As the tests for biocompatibility go far beyond the OEKOTEX standards, and even most underwear materials do not pass the tests…
Elitac Wearables textile biocompatibility services
At Elitac Wearables, we help companies in their journey of development and compliance of their medical wearable devices and textiles with MDR and ISO 10993 biocompatibility regulations.
Our textile biocompatibility service includes custom research, tailored test plans and pre‑validation for sweat exposure, galvanic corrosion, mechanical abrasion, washability, and more—helping clients catch potential skin-safety issues before clinical or consumer use.
We can help you with
- Design and development of medical textile wearables, following biocompatibility rules.
- Reviewing your already developed product, and advise on textile biocompatibility risks and alternatives.
- Source and replace your medical textile part, by making use of our extensive network of biocompatible textile suppliers.
- Guide or arrange medical wearable textile biocompatibility testing.
We work within ISO 13485 quality management systems to control how we produce medical wearables—and use ISO 10993 for testing and demonstrating that the materials are safe to touch skin.
Our expertise in biocompatible selection and certification
We already successfully helped several clients to reach their biompatibility needs, by making use of
- Our already certified product examples.
- Our pre-certified textile samples by our trusted suppliers.
- Access to custom textile suppliers, able to give you the exact material specs. you need.
Want to read more about Biocompatibility for medical wearables & textiles? Read or blog here.
Contact us
If you have any questions about biocompatible textiles or need help selecting the best textile for your project, contact us today: