PD IEC/TR 80001-2-3:2012
Current
The latest, up-to-date edition.
Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
Hardcopy , PDF
English
10-07-2012
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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.
| Committee |
CH/62/1
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| 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 | 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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