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  • 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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-10-2010

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 215
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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