AAMI TIR80001 2 4 2012
$93.55
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.
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 34 |
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’ 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/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 |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of IEC/TR 80001-2-4:2012 |
| 10 | FOREWORD |
| 12 | INTRODUCTION |
| 15 | 1 Scope 1.1 Purpose 1.2 Healthcare delivery organization 1.3 Field of application 1.4 Prerequisites |
| 16 | 2 Normative references 3 Terms and definitions |
| 21 | 4 Responsible organization 4.1 Top management responsibilities 4.2 Small responsible organization – points to consider |
| 22 | 4.3 Large responsible organization – points to consider 5 Risk management implementation steps 5.1 Overview |
| 23 | 5.2 Determine the clinical context within which the healthcare provision is made 5.3 Establish underlying risk framework |
| 24 | 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 |
| 25 | 5.4.2.2 Small responsible organization – points to consider |
| 26 | 5.4.2.3 Large responsible organization – points to consider |
| 27 | 5.4.3 Development status of medical IT-network 5.4.4 Manufacturer identification |
| 28 | 5.4.5 External IT and bio-medical engineering support 6 Responsibility agreements |
| 29 | Annex A (informative) Medical IT-network configuration examples A.1 General A.2 Isolated network configuration |
| 30 | A.3 Standalone medical IT-network |
| 31 | A.4 Collaborative medical IT- network |
| 32 | A.5 Centralized medical IT-network |
| 34 | Bibliography |
Related products
-
AAMI TIR80001 2 1 2012
AAMI/IEC TIR80001-2-1:2012 – Application of risk management for IT-networks incorporating medical device-Part 2-1: Step by…
-
AAMI TIR80001 2 2 2012
AAMI/IEC TIR80001-2-2:2012 – Application of risk management for IT-networks incorporating medical devices-Part 2-2: Guidance for…
-
AAMI TIR80001 2 3 2012
AAMI/IEC TIR80001-2-3:2012 – Application of risk management for IT-networks incorporating medical devices-Part 2-3: Guidance for…
