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  • NEMA HN 1 : 2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY

    Available format(s): 

    Superseded date:  14-10-2019

    Language(s): 

    Published date:  12-01-2013

    Publisher:  National Electrical Manufacturers Association

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

    FOREWORD
    CHANGES FROM PREVIOUS (2008) MDS[2] REVISION
    Section 1 - GENERAL
      1.1 Scope
      1.2 References
      1.3 Definitions
      1.4 Acronyms
    Section 2 - INSTRUCTIONS FOR OBTAINING, USING AND COMPLETING
                MDS[2] FORM
      2.1 Obtaining the MDS[2] Form (Providers)
      2.2 Using the MDS[2] Form (Providers)
      2.3 Completing the MDS[2] Form (Manufacturers)
    Section 3 - MDS[2] FORM
    Annex (Informative) - COMPARISON OF PREVIOUS (2008)
          AND CURRENT (2013) MDS[2]

    Abstract - (Show below) - (Hide below)

    Aims at assisting professionals responsible for security risk assessment processes in their management of medical device security issues.

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

    Document Type Standard
    Publisher National Electrical Manufacturers Association
    Status Superseded
    Superseded By

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

    EN 82304-1:2017 Health Software - Part 1: General requirements for product safety
    AAMI/IEC TIR80001-2-8:2016 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 80001-2-2
    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
    AAMI TIR57 : 2016 PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
    BS EN 82304-1:2017 Health Software General requirements for product safety
    PD IEC/TR 80001-2-9:2017 Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

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

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    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 80001-2-2:2012 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
    IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
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