IEC 81001-5-1

IEC 81001-5-1 is a modification of the IEC 62443-4-1 standard tailored to medical devices. The standard is intended for producers of “medical software”, which encompasses both medical devices and other software used in healthcare. It defines life cycle requirements for the development and maintenance of medical software with the goal of ensuring security and protection, as well as a balance between the key properties of medical software. Certification according to this standard is highly beneficial for producers of medical devices due to its very strong connection to new MDR legislation.