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PD IEC/TR 80001-2-3:2012

Current
Current

The latest, up-to-date edition.

Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-07-2012

Publisher

British Standards Institution

FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
4 Wireless MEDICAL IT-NETWORK: An introduction
5 Wireless MEDICAL IT-NETWORKS: Planning and design
6 Wireless MEDICAL IT-NETWORKS: Deployment and
  configuration
7 Wireless MEDICAL IT-NETWORKS: Management and
  support
8 General RISK CONTROL measures
Annex A (informative) - Clinical use cases and
        network traffic profiles
Annex B (informative) - Questions to consider
Bibliography

Gives technical background concerning wireless technology and examples of HAZARDS to be considered when wireless technology is used in MEDICAL IT-NETWORKS and suggests RISK CONTROL measures to reduce the probability of UNINTENDED CONSEQUENCES.

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.

Committee
CH/62/1
DocumentType
Standard
Pages
54
PublisherName
British Standards Institution
Status
Current

Standards Relationship
IEC TR 80001-2-3:2012 Identical

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO/IEC 15408-2:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 2: Security functional components
ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
IEEE/ANSI C63.18-2014 REDLINE American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
ISO/IEC 27002:2013 Information technology Security techniques Code of practice for information security controls
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
AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
ISO 14971:2007 Medical devices Application of risk management to medical devices
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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Hardcopy - English
PDF - English
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