Medical devices. Application of risk management to medical devices Ingestion-build-58863 Annex P - City of

Annex P - City of Seattle

2 Dimensions and limit deviations

Die stamp and paint marking

for example when required by an application standard or by agreement between the contracting parties

Medical devices. Application of risk management to medical devices Ingestion-build-58863 Annex P - City ofBS 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