Skip to content
Please enter a keyword to search

  • PD ISO/TR 80001-2-7:2015

    Current The latest, up-to-date edition.

    Application of risk management for IT-networks incorporating medical devices. Application guidance Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-03-2015

    Publisher:  British Standards Institution

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Assessment Method
    Annex A (informative) - Assessment Method
    Annex B (informative) - Process Reference Model
    Annex C (informative) - Process Assessment Model
    Annex D (informative) - Abbreviations and Process
            Identifiers
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance to HDOs on self-assessment of their conformance against IEC 80001-1.

    Scope - (Show below) - (Hide below)

    The purpose of this part of ISO/TR80001 is to provide guidance to HDOs on self-assessment of their conformance against IEC80001-1. The purpose of this part of ISO/TR80001 is to provide guidance to HDOs on self-assessment of their conformance against IEC80001-1, provide an exemplar assessment method which can be used by HDOs in varying contexts to assess themselves against IEC80001-1, define a PRM comprising a set of processes, described in terms of process purpose and outcomes that demonstrate coverage of the requirements of IEC80001-1, and define a PAM that meets the requirements of ISO/IEC15504-2 and that supports the performance of an assessment by providing indicators for guidance on the interpretation of the process purposes and outcomes as defined in IEC80001-1 (PRM) and the process attributes as defined in ISO/IEC15504-2. This part of ISO/TR80001 does not introduce any requirements in addition to those expressed in IEC80001-1.

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

    Committee CH/62/1
    Document Type Standard
    Publisher British Standards Institution
    Status Current

    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
    ISO/IEC TR 24774:2010 Systems and software engineering Life cycle management Guidelines for process description
    ISO/IEC 15504-5:2012 Information technology Process assessment Part 5: An exemplar software life cycle process assessment model
    ISO/IEC TR 15504-6:2008 Information technology Process assessment Part 6: An exemplar system life cycle process assessment model
    ISO/IEC/IEEE 15289:2017 Systems and software engineering Content of life-cycle information items (documentation)
    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 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
    ISO/IEC 15504-2:2003 Information technology Process assessment Part 2: Performing an assessment
    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    ISO/IEC 15504-1:2004 Information technology Process assessment Part 1: Concepts and vocabulary
    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
    IEC TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective