There are a host of questions surrounding updates to ISO 10993-1, an international standard that sets the general principles for the biological evaluation of medical devices. Last month, ...

What changed: The FDA’s updated guidance clarifies how manufacturers should use ISO 10993-1 in premarket submissions, including risk-based approaches and considerations for devices with intact skin ...

Dongguan Ruixiang Precision Silicone Products Co., Ltd. (Ruixiang Silicone) has released a platinum-cured medical-grade silicone tubing series manufactured at an FDA-registered facility and carrying ...

Biological evaluation for all medical devices is conducted using guidance provided in ISO 10993-1, the overarching standard for this process. It is the document that gives the general framework for ...

The primary aim of ISO 10993 is establishing a set of standards that safeguard and protect patients from biological risks associated with the use of medical devices. The standards address testing ...

Ashland Global Holdings Inc. ASH recently launched a new water-based pressure sensitive adhesive (PSA) platform, which is entirely compliant with the International Organization for Standardization ...

In this interview, AZoM talks to Kevin Rowland, Laboratory Manager at Jordi Labs, about the ISO 10993-18 guidance document describing best practices for performing chemical characterization. Jordi ...

Over the last 15 years, ISO 10993-18 has become a notable resource for professionals at each stage in the supply chain and manufacturing of medical devices, assisting them in the evaluation of ...

"We have had strong interest in our newest meliflex XT grades not only from Europe, but also from USA and Asia", says Jesper Laursen, Business Director. "Materials are now also explored for various ...

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