ISO 10993-1 is the foundational standard for the biological evaluation of medical devices within a risk management process. It specifies the general principles for assessing the biological safety of medical devices that come into contact with the body. The latest...
We are pleased to share that a new edition of ISO 10993-1, the cornerstone standard for the biological evaluation of medical devices, has reached the Final Draft International Standard (FDIS) stage. This means the updated version — ISO/FDIS 10993-1:2025 — is now out...
Technically Unavoidable Particles (TUPs) are always present in excipients. Concern regarding their presence has increased dramatically in recent years due to several US FDA warning letters to pharmaceutical companies, highlighting adverse findings during inspections....
SAXOCON provides microscopic particle count testing in accordance with Method 2 in USP-NF (788). Testing is conducted in our Class N2 clean workspace according to our internal protocols to guarantee the precise identification and measurement of particles that satisfy...
Last fall, the European Chemicals Agency (ECHA) won a decisive judgement at the European Court of Justice. This judgement allows the ECHA to classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT),...
Medical device manufacturers must ensure the biosafety of their medical implant products to comply with relevant regulations. Medical implants have intimate contact with the human body for durations lasting a few hours to permanently. As such, they are subject to...
