iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
IEC

IEC TR 80001-2-3:2012

(Main)

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

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.

General Information

Status
Published
Publication Date
09-Jul-2012
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Technical Committee
SC 62A - Common aspects of medical equipment, software, and systems
Drafting Committee
JWG 7 - TC 62/SC 62A/JWG 7
Current Stage
WPUB - Publication withdrawn
Start Date
05-Apr-2024
Completion Date
05-Apr-2024
Ref Project

Buy Standard

IEC TR 80001-2-3:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networksIEC TR 80001-2-3:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
PreviousNext
Technical report
IEC TR 80001-2-3:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
English language
49 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

IEC/TR 80001-2-3


Edition 1.0 2012-07




TECHNICAL



REPORT









colour

inside









Application of risk management for IT-networks incorporating medical devices –

Part 2-3: Guidance for wireless networks





































IEC/TR 80001-2-3:2012(E)

---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2012 IEC, Geneva, Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.


IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch

About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

Useful links:

IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: csc@iec.ch.

---------------------- Page: 2 ----------------------
IEC/TR 80001-2-3


Edition 1.0 2012-07




TECHNICAL



REPORT








colour

inside










Application of risk management for IT-networks incorporating medical devices –

Part 2-3: Guidance for wireless networks




























INTERNATIONAL

ELECTROTECHNICAL

COMMISSION

PRICE CODE
X


ICS 11.040.01; 35.240.80 ISBN 978-2-83220-203-6



  Warning! Make sure that you obtained this publication from an authorized distributor.

---------------------- Page: 3 ----------------------
– 2 – TR 80001-2-3 © IEC:2012(E)
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 9
1.1 Scope . 9
1.2 Objective . 9
1.3 HDO scalability . 10
2 Normative references . 10
3 Terms and definitions . 11
4 Wireless MEDICAL IT-NETWORK: An introduction . 21
4.1 Basics . 21
4.2 Enterprise MEDICAL IT-NETWORK . 22
4.3 Use of VLANs and SSIDs . 22
4.4 Wide area MEDICAL IT-NETWORK . 23
4.5 Smart phone applications .
...

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

IEC
ISO TR 80002-2:2017(Main)
Medical device software - Part 2: Validation of software for medical device quality systems

ISO/TR 80002-2:2017(E) applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
ISO/TR 80002-2:2017 applies to
- software used in the quality management system,
- software used in production and service provision, and
- software used for the monitoring and measurement of requirements.
It does not apply to
- software used as a component, part or accessory of a medical device, or
- software that is itself a medical device.

  • Technical report
    84 pages
    English language
    sale 15% off
IEC
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
    35 pages
    English language
    sale 15% off
IEC
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
IEC
IEC TR 80001-2-5:2014(Main)
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on 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
    39 pages
    English language
    sale 15% off
IEC
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

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.

  • Technical report
    15 pages
    English language
    sale 15% off
IEC
IEC TR 80001-2-4:2012(Main)
Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - 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
    24 pages
    English language
    sale 15% off
IEC
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
    66 pages
    English language
    sale 15% off
IEC
IEC 80001-1:2010(Main)
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.

  • Standard
    86 pages
    English and French language
    sale 15% off
IEC
ISO TR 80002-2:2017(Main)
Medical device software - Part 2: Validation of software for medical device quality systems

ISO/TR 80002-2:2017(E) applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
ISO/TR 80002-2:2017 applies to
- software used in the quality management system,
- software used in production and service provision, and
- software used for the monitoring and measurement of requirements.
It does not apply to
- software used as a component, part or accessory of a medical device, or
- software that is itself a medical device.

  • Technical report
    84 pages
    English language
    sale 15% off
IEC
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
    35 pages
    English language
    sale 15% off