Medical devices. Application of risk management to medical devices Ingestion-build-58863 Contents of PD ISO/TR 12773-2:

Contents of PD ISO/TR 12773-2: contain:

2 Dimensions and limit deviations

Organizations considering

including authentication

BS EN 755-4:2008 supersedes BS EN 755-4:1995

Medical devices. Application of risk management to medical devices Ingestion-build-58863 Contents of PD ISO/TR 12773-2:BS EN ISO 14971: 2009 Application of risk management to medical devices What is it? BS EN ISO 14971 is the latest international risk management standard for the manufacture of medical devices. It outlines ways to identify, evaluate, control and monitor risks associated with medical device manufacturing, including in vitro diagnostic (IVD) devices. The standard applies to the medical device lifecycle, covering risks to the patient and operator as well