DIN EN 80001-1 - DRAFT PDF

Published Date: 02/01/2023

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (IEC 80001-1:2021); German version EN IEC 80001-1:2021

Published Date: 09/01/2018

Draft Document - Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management (IEC 62A/1244/CD:2018); Text in German and English

Published Date: 11/01/2011

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010); German version EN 80001-1:2011

Published Date: 10/01/2009

Draft Document - Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 62A/668/CDV:2009); German version FprEN 80001-1:2009

Published Date: 10/01/1999

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003; German version EN 46003:1999

Published Date: 03/01/2022

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

Published Date: 01/01/2005

Membrane filter elements - Part 3: Testing for specific liquid flow rate

Published Date: 03/26/2009