Medical devices. Application of risk management to medical devices Ingestion-build-276583 Risk and safety labelling according

Risk and safety labelling according to the EU Directives

Need for a high level of assurance

If the degree of compactability is less than 1

Bolt and nut assemblies conforming to this document may include washer(s) according to BS EN 14399-6 or to BS EN 14399-5 (under the nut only)

Medical devices. Application of risk management to medical devices Ingestion-build-276583 Risk and safety labelling accordingBS 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