IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 5<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 1 Scope 2 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 3 Roles and responsibilities 3.1 General 3.2 Responsible organization <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 3.3 Top management responsibilities <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 3.4 Medical it-network risk manager Figures Figure 1\u00a0\u2013 Illustration of top management responsibilities <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 3.5 Medical device manufacturer(s) <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 3.6 Providers of other information technology <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 4 Life cycle risk management in medical IT-networks 4.1 Overview <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4.2 Responsible organization risk management Figure 2\u00a0\u2013 Overview of life cycle of medical it-networks including risk management <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 4.3 Medical it-network risk management planning and documentation <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 4.4 Medical it-network risk management <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 4.5 Change-release management and Configuration management <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 4.6 Live network risk management <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 5 Document control 5.1 Document control procedure 5.2 Medical it-network risk management file <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Annex A (informative) Rationale <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Tables Table A.1 \u2013 Relationship between ISO\u00a014971 and IEC\u00a080001-1 <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Annex B (informative) Overview of risk management relationships Figure B.1\u00a0\u2013 Overview of roles and relationships <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex C (informative) Guidance on field of application Table\u00a0C.1\u00a0\u2013 IT-network scenarios that can be encountered in a clinical environment <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Annex D (informative) Relationship with ISO\/IEC 20000-2:2005, Information technology \u2013 Service management \u2013 Part 2: Code of practice <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Figure D.1\u00a0\u2013 Service management processes <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Table D.1 \u2013 Relationship between IEC 80001-1 and ISO\/IEC 20000-1:2005 or ISO\/IEC 20000-2:2005 <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Application of risk management for IT-networks incorporating medical devices – Roles, responsibilities and activities<\/b><\/p>\n |