ISO/TS 20405:2018 PDF

ISO/TS 20405:2018 Referenced Document

IEC 62304:2006 Medical device software - Software life cycle processes
IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC 82304-1:2016 Health software - Part 1: General requirements for product safety
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 31000:2018 Risk management - Guidelines
ISO GUIDE 73:2009 Risk management - Vocabulary
ISO/IEC 27005:2011 Information technology - Security techniques - Information security risk management
ISO/IEC 27035-1:2016 Information technology - Security techniques - Information security incident management - Part 1: Principles of incident management
ISO/IEC 27035-2:2016 Information technology - Security techniques - Information security incident management - Part 2: Guidelines to plan and prepare for incident response
ISO/IEC GUIDE 51:2014 Safety aspects - Guidelines for their inclusion in standards
ISO/TR 17791:2013 Health informatics.Guidance on standards for enabling safety in health software
ISO/TR 27809:2007 Health informatics - Measures for ensuring patient safety of health software
ISO/TS 25238:2007 Health informatics - Classification of safety risks from health software

2018 ISO/TS 20405:2018 Health informatics - Framework of event data and reporting definitions for the safety of health software