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ISO 14971:2019 Risk Management for Medical Devices. • Introduction. • Terms & Definitions. • ISO 14971:2019 Overview of structure and contents. STANDARD. ISO. 14971. Third edition. 2019-12. Reference number. ISO 14971:2019(E) Permission can be requested from either ISO at the address.The risk management process as described in BS. EN ISO 14971 [1] is discussed in detail and the main changes in the third edition are indicated and explained. Annex B (informative) Risk management process for medical devices. Annex C (informative) Fundamental risk concepts. Bibliography.. ISO 2019 All rights reserved. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing BS-EN-ISO-14971-2019 - Free download as PDF File (.pdf) or read online for free. Risk Analysis.