| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 12<\/td>\n | 1 Scope <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4 Symbols (and abbreviated terms) 5 Overarching themes 5.1 General <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.2 Socio-Technical Ecosystem <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.3 System of systems 5.4 Lifecycle of a health IT system <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.5 Roles and responsibilities <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.6 Communication <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 5.7 Interdependence of safety, effectiveness and security 6 Foundational elements 6.1 General <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6.2 Governance (Internal organization focus) 6.2.1 Organization leadership, culture and competence 6.2.1.1 Statement 6.2.1.2 Rationale <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 6.2.1.3 Key concepts and Principles <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 6.2.1.4 Approach 6.2.2 Quality management and effectiveness 6.2.2.1 Statement 6.2.2.2 Rationale 6.2.2.3 Key concepts and Principles <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 6.2.2.3.4 Key tenets of an effective quality management program include: 6.2.2.4 Approach 6.2.3 Information Governance 6.2.3.1 Statement 6.2.3.2 Rationale <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 6.2.3.3 Key concepts and Principles 6.2.3.4 Approach <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 6.2.4 Human factors 6.2.4.1 Statement 6.2.4.2 Rationale 6.2.4.3 Key concepts and Principles <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 6.2.4.4 Approach <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 6.3 Knowledge transfer (Cross organization collaboration) 6.3.1 Risk management 6.3.1.1 Statement 6.3.1.2 Rationale 6.3.1.3 Key concepts <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 6.3.1.4 Approach 6.3.2 Safety Management 6.3.2.1 Statement <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 6.3.2.2 Rationale 6.3.2.3 Key concepts 6.3.2.4 Approach <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 6.3.3 Security Management 6.3.3.1 Statement 6.3.3.2 Rationale 6.3.3.3 Key concepts <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 6.3.3.4 Approach <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 6.3.4 Privacy Management 6.3.4.1 Statement 6.3.4.2 Rationale 6.3.4.3 Key concepts and principles <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 6.3.4.4 Approach <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Annex A (informative) Overview of clinical assurance case <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Annex B (informative) Overview of clinical assurance case report <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Annex C (informative) The clinical assurance report template <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | Annex D (informative) Use of clinical assurance cases across the lifecycle <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Annex E (informative) Example assurance case <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | 1. IEC 60027 (all parts), Letter symbols to be used in electrical technology 2. IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical devices \u2014 Part 1: Roles, responsibilities and activities 3. IEC\/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices \u2014 Part 2-2: Guidance for the communication of medical device security needs, risks and controls 4. IEC\/TR 80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices \u2014 Part 2-3: Guidance for wireless networks 5. ISO\/IEC Guide 51:2014, Safety aspects \u2014 Guidelines for their inclusion in standards 6. ISO\/IEC Guide 63:20XX, Guide to the development and inclusion of aspects of safety in International Standards for medical devices 7. ISO 31 (all parts), Quantities and units 8. ISO 690, Documentation \u2014 Bibliographic references \u2014 Content, form and structure 9. ISO 690-2, Information and documentation \u2014 Bibliographic references \u2014 Part 2: Electronic documents or parts thereof 10. ISO 128-30, Technical drawings \u2014 General principles of presentation \u2014 Part 30: Basic conventions for views 11. ISO 128-34, Technical drawings \u2014 General principles of presentation \u2014 Part 34: Views on mechanical engineering drawings 12. ISO 128-40, Technical drawings \u2014 General principles of presentation \u2014 Part 40: Basic conventions for cuts and sections 13. ISO 128-44, Technical drawings \u2014 General principles of presentation \u2014 Part 44: Sections on mechanical engineering drawings 14. ISO 1000, SI units and recommendations for the use of their multiples and of certain other units 15. ISO 10241, International terminology standards \u2014 Preparation and layout 16. ISO 9000:2015, Quality management systems \u2014 Fundamentals and vocabulary 17. ISO\/IEC TR 10000-1, Information technology \u2014 Framework and taxonomy of International Standardized Profiles \u2014 Part 1: General principles and documentation framework 18. ISO 14971:2007, Medical devices \u2014 Application of risk management to medical devices 19. ISO 14971:20XX, Medical devices \u2014 Application of risk management to medical devices 20. ISO\/IEC 20000-1:2005, Information technology — Service management — Part 1: Specification <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | 21. ISO 27799:2016, Health informatics — Information security management in health using ISO\/IEC 27002 22. ISO 31000,2018, Risk management 23. ISB 0160, F. Brindley, J. Fox, S. White, Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems – Implementation Guidance, UK National Health Service: 2013 (Available at: http:\/\/webarchive.nationalarchives.gov.uk\/… <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" BS ISO 81001-1. Health software and health IT systems safety, effectiveness and security – Part 1. Foundational principles, concepts, and terms<\/b><\/p>\n |