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...
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...
Pharmaceutical and medical device manufacturers and materials suppliers must ensure their products are not shedding harmful particles. Unexpected particulate findings during production are a risk that all manufacturers face. Sudden, unexpected findings of particulate...
Are you a pharmaceutical manufacturer? Do you know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by the various regulatory agencies? SAXOCON has the expertise and services necessary to help you to...
