BS EN 80001-1:2011
$189.07
Application of risk management for IT-networks incorporating medical devices – Roles, responsibilities and activities
| Published By | Publication Date | Number of Pages |
| BSI | 2011 | 46 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | English CONTENTS |
| 7 | INTRODUCTION |
| 10 | 1 Scope 2 Terms and definitions |
| 15 | 3 Roles and responsibilities 3.1 General 3.2 Responsible organization |
| 16 | 3.3 Top management responsibilities |
| 17 | 3.4 Medical it-network risk manager Figures Figure 1 – Illustration of top management responsibilities |
| 18 | 3.5 Medical device manufacturer(s) |
| 19 | 3.6 Providers of other information technology |
| 20 | 4 Life cycle risk management in medical IT-networks 4.1 Overview |
| 21 | 4.2 Responsible organization risk management Figure 2 – Overview of life cycle of medical it-networks including risk management |
| 22 | 4.3 Medical it-network risk management planning and documentation |
| 25 | 4.4 Medical it-network risk management |
| 28 | 4.5 Change-release management and Configuration management |
| 30 | 4.6 Live network risk management |
| 31 | 5 Document control 5.1 Document control procedure 5.2 Medical it-network risk management file |
| 32 | Annex A (informative) Rationale |
| 34 | Tables Table A.1 – Relationship between ISO 14971 and IEC 80001-1 |
| 36 | Annex B (informative) Overview of risk management relationships Figure B.1 – Overview of roles and relationships |
| 37 | Annex C (informative) Guidance on field of application Table C.1 – IT-network scenarios that can be encountered in a clinical environment |
| 39 | Annex D (informative) Relationship with ISO/IEC 20000-2:2005, Information technology – Service management – Part 2: Code of practice |
| 40 | Figure D.1 – Service management processes |
| 41 | Table D.1 – Relationship between IEC 80001-1 and ISO/IEC 20000-1:2005 or ISO/IEC 20000-2:2005 |
| 43 | Bibliography |
