iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ISO

ISO/TR 80001-2-6:2014

(Main)

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

ISO/TR 80001-2-6:2014 provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1. Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK.

Application de la gestion des risques pour les réseaux intégrant appareils médicaux — Partie 2-6: Application guidage — Orientation des accords de responsabilité

General Information

Status
Published
Publication Date
19-Nov-2014
ICS
11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Technical Committee
ISO/TC 215 - Health informatics
Drafting Committee
ISO/TC 215/JWG 7 - Joint ISO/TC 215 - IEC/SC 62A WG: Safe, effective and secure health software and health IT systems, including those incorporating medical devices
Current Stage
9060 - Close of review
Start Date
03-Jun-2024
Completion Date
04-Jun-2024
Ref Project

Buy Standard

ISO/TR 80001-2-6:2014 - Application of risk management for IT-networks incorporating medical devicesISO/TR 80001-2-6:2014 - Application of risk management for IT-networks incorporating medical devices
PreviousNext
Technical report
ISO/TR 80001-2-6:2014 - Application of risk management for IT-networks incorporating medical devices
English language
15 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 80001-2-6
First edition
2014-12-01

Application of risk management for
IT-networks incorporating medical
device —
Part 2-6:
Application guidance — Guidance for
responsibility agreements
Application de la gestion des risques pour les réseaux intégrant
appareils médicaux —
Partie 2-6: Application guidage — Orientation des accords de
responsabilité




Reference number
ISO/TR 80001-2-6:2014(E)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO/TR 80001-2-6:2014(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission.
Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO TR 80001-2-6:2014(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
1.1 Purpose . 1
1.2 Prerequisites . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Key aspects for RESPONSIBILITY AGREEMENTS . 5
4.1 Reasons and rationale . 5
4.2 Participants . 5
4.3 Proposed types of RESPONSIBILITY AGREEMENTS . 5
4.4 Communication control . 5
4.4.1 Bilateral versus multilateral RESPONSIBILITY AGREEMENTS . 5
4.4.2 Non-disclosure agreements . 5
4.4.3 Update of information and documentation . 6
4.5 Responsibility for establishing . 6
4.6 Methods for determination and of responsibilities . 6
4.7 Life cycle considerations. 6
5 Elements of a RESPONSIBILITY AGREEMENT . 7
Annex A (informative) RACI chart . 11
Annex B (informative) Typical documents . 12
© ISO 2014 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO TR 80001-2-6:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO,
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ISO
IEC 80001-1:2021(Main)
Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.

  • Draft
    31 pages
    English language
    sale 15% off
ISO
IEC/TR 80001-2-9:2017(Main)
Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities

IEC TR 80001-2-9:2017(E) establishes a security case framework and provides guidance to health care delivery organizations (HDO) and medical device manufacturers (MDM) for identifying, developing, interpreting, updating and maintaining security cases for networked medical devices. Use of this part of 80001 is intended to be one of the possible means to bridge the gap between MDMs and HDOs in providing adequate information to support the HDOs risk management of IT-networks. This document leverages the requirements set out in ISO/IEC 15026-2 for the development of assurance cases. It is not intended that this security case framework will replace a risk management strategy, rather, the intention is to complement risk management and in turn provide a greater level of assurance for a medical device by: - mapping specific risk management steps to each of the IEC TR 80001-2-2 security capabilities, identifying associated threats and vulnerabilities and presenting them in the format of a security case with the inclusion of a re-useable security pattern; - providing guidance for the selection of appropriate security controls to establish security capabilities and presenting them as part of the security case pattern (IEC TR 80001-2-8 provides examples of such security controls); - providing evidence to support the implementation of a security control, hence providing confidence in the establishment of each of the security capabilities. The purpose of developing the security case is to demonstrate confidence in the establishment of IEC TR 80001-2-2 security capabilities. The quality of artifacts gathered and documented during the development of the security case is agreed and documented as part of a responsibility agreement between the relevant stakeholders. This document provides guidance for one such methodology, through the use of a specific security pattern, to develop and interpret security cases in a systematic manner.

  • Technical report
    28 pages
    English language
    sale 15% off
ISO
IEC/TR 80001-2-8:2016(Main)
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(E), which is a Technical Report, provides guidance to Health Delivery Organizations (HDOs) and Medical Device Manufacturers (MDMs) for the application of the framework outlined in IEC TR 80001-2-2.

  • Technical report
    43 pages
    English language
    sale 15% off
ISO
ISO/TR 80001-2-7:2015(Main)
Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

ISO/TR 80001-2-7:2015 is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001‑1.

  • Technical report
    102 pages
    English language
    sale 15% off
ISO
IEC/TR 80001-2-5:2014(Main)
Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems

IEC TR 80001-2-5:2014(E) which is a technical report, gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. This technical report applies to the transmission of alarm conditions between sources, integrator and communicators where at least one source is a medical device and at least one communication path utilizes a medical IT-network. This technical report provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety and effectiveness. Data and systems security is an important consideration for the risk management of distributed alarm systems.

  • Technical report
    33 pages
    English language
    sale 15% off
ISO
IEC/TR 80001-2-4:2012(Main)
Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations

IEC/TR 80001-2-4:2012(E), which is a technical report, provides guidance to help a healthcare delivery organization fulfilling its obligations as a responsible organization in the application of IEC 80001-1. A healthcare delivery organization includes hospitals, doctors' offices, community care homes and clinics. Specifically, this guide helps the healthcare delivery organization assess the impact of IEC 80001-1 on the organization and establish a series of business as usual processes to manage RISK in the creation, maintenance and upkeep of its medical IT-networks. This technical report will be useful to those responsible for establishing an IEC 80001-1 compliant risk management framework within a healthcare delivery organization that is expecting to establish one or more medical IT-networks. It provides help through the key decisions and steps required to establish a risk management framework, before the organization embarks on a detailed risk assessment of an individual instance of a medical IT-network. The steps are supported by a series of decision points to steer the responsible organization through the process of understanding the medical IT-network context and identifying any organizational changes required to execute the responsibilities of top management.

  • Technical report
    18 pages
    English language
    sale 15% off
ISO
IEC/TR 80001-2-1:2012(Main)
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 80001-2-1:2012(E), which is a technical report, is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.

  • Technical report
    59 pages
    English language
    sale 15% off
ISO
IEC/TR 80001-2-2:2012(Main)
Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls

IEC/TR 80001-2-2:2012(E), which is a technical report, creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.

  • Technical report
    48 pages
    English language
    sale 15% off
ISO
IEC/TR 80001-2-3:2012(Main)
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks

IEC/TR 80001-2-3:2012(E), which is a technical report, supports the Healthcare Delivery Organizations (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a medical IT-network and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure and effective manner. The targeted audience for this technical report is the HDO IT department, biomedical and clinical engineering departments, risk managers, and the people responsible for design and operation of the wireless IT network.

  • Technical report
    41 pages
    English language
    sale 15% off
ISO
IEC 80001-1:2021(Main)
Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.

  • Draft
    31 pages
    English language
    sale 15% off