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  • AAMI TIR57 : 2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-05-2020

    Language(s):  English

    Published date:  01-01-2016

    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
    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 General guidance for performing security risk management
    4 Security risk analysis
    5 Security risk evaluation
    6 Risk control
    7 Evaluation of overall residual security risk acceptability
    8 Security risk management report
    9 Production and post-production information
    Annex A (informative) - Security engineering principles and
            nomenclature
    Annex B (informative) - Security risk assessment
    Annex C (informative) - Generating cybersecurity requirements
    Annex D (informative) - Questions that can be used to identify
            medical device security characteristics
    Annex E (informative) - Security risk examples applied to a
            medical device
    Annex F (informative) - A comparison of terminology between key
            referenced standards
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    ANSI/AAMI/IEC 80001-1:2010 APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
    ISO/IEC 29147:2014 Information technology Security techniques Vulnerability disclosure
    NEMA HN 1 : 2013 MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
    IEC TS 62443-1-1:2009 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
    IEC TR 62443-3-1:2009 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
    CFR 45(PTS1-199) : OCT 2017 PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
    IEC TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
    IEC 62443-2-1:2010 Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
    FIPS PUB 140-2 : 0 SECURITY REQUIREMENTS FOR CRYPTOGRAPHIC MODULES
    AAMI IEC TIR 80001-2-2 : 2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS
    AAMI IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO/IEC 27005:2011 Information technology Security techniques Information security risk management
    FIPS PUB 185 : 0 ESCROWED ENCRYPTION STANDARD (EES)
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO/IEC 30111:2013 Information technology Security techniques Vulnerability handling processes
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