ANSI/AAMI/ISO 23500-2:2024—Hemodialysis Water Treatment
Healthy kidneys continuously filter waste products, excess fluids, and toxins from the bloodstream. When kidneys fail, hemodialysis (i.e., a life-saving treatment for kidney failure) performs…
ISO 10993-6:2026 — Implantation Effects Testing
When a medical device is implanted into the human body (whether temporarily or permanently) it triggers a biological response. The difference between safe integration and…
ISO 14155:2026— Clinical Investigation of Medical Devices
Bringing a medical device to market is not just about innovation; it is about trust. Before a device ever reaches a patient, it must undergo…
ISO 11608-1:2022—Needle-Based Injection Systems
Needle-based injection systems (NISs) are extremely common and represent the primary method for drug delivery, with at least 16 billion NISs injections administered globally each year. Therefore,…
Why Infection Prevention Certification Matters More Than Ever
The Covid-19 pandemic brought global attention to infection prevention and control (IPC), but long before the pandemic IPC professionals were shaping safer environments in hospitals,…
ISO 15223-1:2021—Medical Devices Symbols
Symbols on medical devices are crucial for patient safety, regulatory compliance, and effective communication, allowing for clear and concise information across different languages and cultures. ISO…