New ISO Updates for Medical Devices and Health Technologies
ISO (International Organization for Standardization) has published a set of new standards and updates relevant to the medical devices, health technologies and pharmaceuticals sector. These standards are essential for guaranteeing the safety, efficacy and interoperability of medical products in an increasingly demanding global regulatory environment.
The main standards published between February and March 2025 include:
ISO 18190:2025 - Defines general requirements for airway devices and related equipment essential for anesthesia and respiratory care.
ISO/TR 18965:2025 - Provides guidelines for the application of the risk management process in heart valve replacement and repair systems.
ISO/TS 6201:2025 - Introduces a customized digital framework for healthcare, facilitating the integration of digital technologies in the medical sector.
ISO/TS 6268-1:2025 - Establishes a new cybersecurity standard for telehealth environments, ensuring greater protection for sensitive data and interconnected systems.
ISO 7711-1:2021/Amd 1:2025 - Update of the general requirements for rotary diamond instruments in dentistry.
These new standards demonstrate ISO's ongoing commitment to driving innovation and safety in the healthcare sector. Compliance with these guidelines will help manufacturers and industry professionals ensure that their products meet international regulatory requirements, promoting greater patient safety and operational efficiency.
