| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 84<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 88<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 90<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 93<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 94<\/td>\n | Figure 1 \u2013 Lifecycle framework addressing safety, effectiveness and securityof health software and health IT systems <\/td>\n<\/tr>\n | ||||||
| 95<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 96<\/td>\n | 4 Principles <\/td>\n<\/tr>\n | ||||||
| 97<\/td>\n | 5 Framework 5.1 General 5.2 Leadership and commitment 5.3 Integrating risk management <\/td>\n<\/tr>\n | ||||||
| 98<\/td>\n | 5.4 Design\/planning 5.4.1 General Figure 2 \u2013 Risk management process <\/td>\n<\/tr>\n | ||||||
| 99<\/td>\n | 5.4.2 RISK MANAGEMENT FILE 5.4.3 Understanding the organization and the sociotechnical ecosystem 5.4.4 Articulating risk management commitment 5.4.5 Assigning organizational roles, authorities, responsibilities and accountabilities <\/td>\n<\/tr>\n | ||||||
| 100<\/td>\n | 5.4.6 Allocating resources 5.4.7 Establishing communication and consultation <\/td>\n<\/tr>\n | ||||||
| 101<\/td>\n | 5.5 Implementation 5.6 Evaluation 5.7 Improvement 6 RISK MANAGEMENT PROCESS 6.1 Generic requirements 6.1.1 General <\/td>\n<\/tr>\n | ||||||
| 102<\/td>\n | 6.1.2 RISK ANALYSIS <\/td>\n<\/tr>\n | ||||||
| 104<\/td>\n | 6.1.3 RISK EVALUATION <\/td>\n<\/tr>\n | ||||||
| 105<\/td>\n | 6.1.4 RISK CONTROL <\/td>\n<\/tr>\n | ||||||
| 107<\/td>\n | 6.2 Lifecycle specific requirements 6.2.1 General 6.2.2 Acquisition <\/td>\n<\/tr>\n | ||||||
| 108<\/td>\n | 6.2.3 Installation, customization and configuration 6.2.4 Integration, data migration, transition and validation 6.2.5 Implementation, workflow optimization and training <\/td>\n<\/tr>\n | ||||||
| 109<\/td>\n | 6.2.6 Operation and maintenance <\/td>\n<\/tr>\n | ||||||
| 110<\/td>\n | 6.2.7 Decommission <\/td>\n<\/tr>\n | ||||||
| 111<\/td>\n | Annex A (informative)IEC 80001-1 requirements mapping table Tables Table A.1 \u2013 IEC 80001-1 requirements table <\/td>\n<\/tr>\n | ||||||
| 117<\/td>\n | Annex B (informative)Guidance for accompanying document Information B.1 Foreword Table B.1 \u2013 Organization name and location <\/td>\n<\/tr>\n | ||||||
| 118<\/td>\n | B.2 Information system categorization B.3 Overview B.4 Reference documents B.5 System level description B.5.1 Environment description Table B.2 \u2013 Cybersecurity device characterization level <\/td>\n<\/tr>\n | ||||||
| 119<\/td>\n | B.5.2 Network ports, protocols and services B.5.3 Purpose of connection to the health IT infrastructure B.5.4 Networking requirements B.5.5 Required IT-network services B.5.6 Data flows and protocols Table B.3 \u2013 Ports, protocols and services <\/td>\n<\/tr>\n | ||||||
| 120<\/td>\n | B.6 Security and user access B.6.1 General B.6.2 Malware \/ antivirus \/ allow-list B.6.3 Security exclusions B.6.4 System access Table B.4 \u2013 Information system name and title <\/td>\n<\/tr>\n | ||||||
| 121<\/td>\n | Table B.5 \u2013 Roles and privileges <\/td>\n<\/tr>\n | ||||||
| 122<\/td>\n | B.7 RISK MANAGEMENT <\/td>\n<\/tr>\n | ||||||
| 123<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Application of risk management for IT-networks incorporating medical devices – Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software<\/b><\/p>\n |