This helps a RESPONSIBLE ORGANIZATION through the key decisions and steps required to establish a RISK MANAGEMENT framework, before the organization embarks on a detailed RISK ASSESSMENT of an individual instance of a MEDICAL IT-NETWORK. This Technical Report is addressed to all Healthcare Delivery Organizations. A Healthcare Delivery Organization includes hospitals, doctors\u2019 offices, community care homes and clinics. It identifies a series of decision points to steer the RESPONSIBLE ORGANIZATION through the process of understanding the MEDICAL IT-NETWORK context and identifying any organizational changes required before undertaking the RISK MANAGEMENT PROCESS identified in IEC 80001-1.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/IEC TIR80001-2-4:2012, Application of risk management for IT-networks incorporating medical devices \u2014 Part 2-4: General implementation guidance for healthcare delivery organizations <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | AAMI Technical Information Report ANSI Technical Report <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Background of ANSI\/AAMI adoption of IEC\/TR 80001-2-4:2012 <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 1 Scope 1.1 Purpose 1.2 Healthcare delivery organization 1.3 Field of application 1.4 Prerequisites <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4 Responsible organization 4.1 Top management responsibilities 4.2 Small responsible organization \u2013 points to consider <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 4.3 Large responsible organization \u2013 points to consider 5 Risk management implementation steps 5.1 Overview <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.2 Determine the clinical context within which the healthcare provision is made 5.3 Establish underlying risk framework <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.4 Determining and understanding a medical IT-network 5.4.1 Performing a risk assessment 5.4.2 Medical IT-network configuration 5.4.2.1 Understanding of the components of the medical IT-network <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.4.2.2 Small responsible organization \u2013 points to consider <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.4.2.3 Large responsible organization \u2013 points to consider <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.4.3 Development status of medical IT-network 5.4.4 Manufacturer identification <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 5.4.5 External IT and bio-medical engineering support 6 Responsibility agreements <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Annex A (informative) Medical IT-network configuration examples A.1 General A.2 Isolated network configuration <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | A.3 Standalone medical IT-network <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | A.4 Collaborative medical IT- network <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | A.5 Centralized medical IT-network <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI\/IEC TIR80001-2-4:2012 – Application of risk management for IT-networks incorporating medical devices-Part 2-4: General implementation guidance for healthcare delivery organizations.<\/b><\/p>\n |