ANSI/AAMI/IEC 80001-1:2010
Current
The latest, up-to-date edition.
APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
Hardcopy , PDF
English
01-10-2010
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 80001-1:2010
FOREWORD
INTRODUCTION
1 Scope
2 Terms and definitions
3 Roles and responsibilities
4 Life cycle RISK MANAGEMENT in MEDICAL IT-NETWORKS
5 Document control
Annex A (informative) - Rationale
Annex B (informative) - Overview of RISK MANAGEMENT
relationships
Annex C (informative) - Guidance on field of application
Annex D (informative) - Relationship with ISO/IEC 20000-2:2005
Information technology - Service
management - Part 2: Code of practice
Bibliography
Describes general requirements for the application of risk management of IT-networks incorporating medical devices that achieve essential properties such as safety, effectiveness, data & system security and interoperability.
| Committee |
ISO/TC 215
|
| DocumentType |
Standard
|
| ISBN |
1-57020-400-4
|
| Pages |
52
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| IEC 80001-1:2010 | Identical |
| AAMI TIR57 : 2016 | PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| ANSI/AAMI EQ56:2013 | RECOMMENDED PRACTICES FOR A MEDICAL EQUIPMENT MANAGEMENT PROGRAM |
| AAMI TIR69 : 2017 | RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS |
| ISO 16484-2:2004 | Building automation and control systems (BACS) — Part 2: Hardware |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 31000:2009 | Risk management — Principles and guidelines |
| ISO/IEC 20000-1:2011 | Information technology — Service management — Part 1: Service management system requirements |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/IEC 20000-2:2012 | Information technology — Service management — Part 2: Guidance on the application of service management systems |
| ISO/IEC 15026-2:2011 | Systems and software engineering — Systems and software assurance — Part 2: Assurance case |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| IEC 61907:2009 | Communication network dependability engineering |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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