IEC standards drive safety and innovation in medical devices
As technology advances and the use of connected medical devices increases, so does the concern for the safety, reliability, and performance of these devices, especially in hospital, home care, and diagnostic environments. The International Electrotechnical Commission (IEC) has developed essential technical standards to ensure these products meet the highest safety and quality requirements at every stage of use.
Among the recent highlights are standards such as IEC 60601-1-11, focused on the safety of medical devices used in home settings, and IEC TR 60601-4-5, which addresses the cybersecurity of connected devices — a growing concern given increasing exposure to digital threats. Standards like IEC 60601-2-37, for ultrasound equipment, and IEC 60601-2-46, for surgical tables, also reinforce the importance of standardization in supporting the development of reliable and effective technologies.
These standards are available in formats that facilitate their understanding and application, such as Commented versions (CMV), Redline versions (RLV), and Consolidated versions (CSV), offering improvements for manufacturers, healthcare professionals, and conformity assessors. International standardization is a key pillar of quality infrastructure, allowing medical technologies to advance with safety, interoperability, and global acceptance.
To learn more about IEC standards for medical devices and healthcare systems, visit: https://lnkd.in/dvZ7DrKD.
