School of Digital HealthWhat is the relationship between DCB0129/DCB0160 and ISO 14971?
ISO 14971:2019 is the international standard for risk management of medical devices. DCB0129 and DCB0160 were designed to be compatible with ISO 14971 but are tailored specifically to the NHS context. They extend beyond the scope of devices classified under Medical Devices Regulations — applying to all health IT that could impact patient health, not just regulated medical devices. This broader scope is considered UK best practice.