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ANSI/AAMI/IEC 80001-1:2010

Current
Current

The latest, up-to-date edition.

APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-01-2010

Publisher

Association for the Advancement of Medical Instrumentation

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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Hardcopy - English
PDF - English - DRM
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