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.
Application du management du risque aux réseaux des technologies de l'information contenant les dispositifs médicaux — Partie 2-3: Directives pour les réseaux sans fil
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IEC/TR 80001-2-3
Edition 1.0 2012-07
TECHNICAL
REPORT
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inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-3: Guidance for wireless networks
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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
– 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 . 24
4.5.1 General . 24
4.5.2 Application clinical functionality . 24
4.5.3 Cellular networks . 24
4.5.4 Smart phone coexistence . 25
4.5.5 Wireless data security . 25
4.6 DISTRIBUTED ANTENNA SYSTEMS . 25
5 Wireless MEDICAL IT-NETWORKS: Planning and design. 26
5.1 Clinical systems and their impact on the wireless network . 26
5.1.1 Defining the clinical SLA . 26
5.1.2 Creating partnerships . 26
5.1.3 Geographical location . 26
5.1.4 Clinical use case . 27
5.2 MEDICAL DEVICE wireless capabilities . 27
5.3 MEDICAL DEVICE capabilities and networking traffic profile . 27
5.4 Network performance requirements . 27
5.5 QoS mechanisms . 28
5.6 Receiver capabilities . 28
5.7 Received signal strength and SNR versus data rates . 29
5.8 Capacity versus coverage versus AP density. 30
5.9 Deterministic versus non-deterministic wireless access protocol. 31
5.10 Planning and design summary . 31
6 Wireless MEDICAL IT-NETWORKS: Deployment and configuration . 31
6.1 RISKS versus benefit of a wireless communications system . 31
6.2 Licensed versus unlicensed spectrum . 31
6.3 Interference sources . 32
6.4 Spectrum usage and allocation . 32
6.4.1 Device coexistence . 32
6.4.2 Spectrum management . 32
6.4.3 Capacity management . 33
6.5 Wireless network configuration (802.11 specific) . 33
6.5.1 General . 33
TR 80001-2-3 © IEC:2012(E) – 3 –
6.5.2 VLAN and SSID . 33
6.5.3 Authentication and encryption . 33
6.5.4 Vendor proprietary extensions . 34
6.5.5 Cellular and proprietary networks . 34
6.5.6 Network availability. 34
6.6 VERIFICATION testing . 35
6.6.1 General . 35
6.6.2 Pre GO-LIVE VERIFICATION testing . 35
6.6.3 GO-LIVE VERIFICATION testing . 35
7 Wireless MEDICAL IT-NETWORKS: Management and support . 36
7.1 General . 36
7.2 Network and application management . 36
7.3 Policies and procedures . 36
7.4 Change control . 36
8 General RISK CONTROL measures . 37
8.1 General . 37
8.2 Determining baseline networking performance . 37
8.3 Designing for coverage signal strength . 37
8.4 Segregating traffic and data types . 38
8.5 Environmental and physical changes . 38
8.6 Maintaining a clean RF environment . 38
8.7 Capacity planning . 38
8.7.1 General . 38
8.7.2 5 GHz and DYNAMIC FREQUENCY SELECTION (DFS) . 39
8.7.3 Security measures and planning . 39
8.8 RF spectrum use . 40
8.9 Device and application classification . 40
8.10 Guest or smart phone access . 40
8.11 WLAN infrastructure configuration . 41
8.12 External partnering with both MEDICAL DEVICE and networking manufacturer. 41
8.13 Redundancy . 41
Annex A (informative) Clinical use cases and network traffic profiles . 42
Annex B (informative) Questions to consider . 44
Bibliography . 48
Figure 1 – Focus of technical report . 8
Figure 2 – HDO MEDICAL IT-NETWORK . 23
Figure 3 – Wireless WAN connectivity . 24
Figure 4 – SIGNAL TO NOISE RATIO . 29
Table A.1 – Example clinical use cases and network traffic profiles . 43
Table A.2 – Network profile parameters . 43
– 4 – TR 80001-2-3 © IEC:2012(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –
Part 2-3: Guidance for wireless networks
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 80001-2-3, which is a technical report, has been prepared by a Joint Working Group of
subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC
technical committee 62: Electrical equipment in medical practice and ISO technical committee
215: Health informatics.
TR 80001-2-3 © IEC:2012(E) – 5 –
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/784/DTR 62A/804/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
Terms used throughout this technical report that have been defined in Clause 3 appear in
SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – TR 80001-2-3 © IEC:2012(E)
INTRODUCTION
0.1 Background
Wireless communications has been a key technology enabling the connectivity of MEDICAL
DEVICES for decades. Early examples of the use of wireless technologies and MEDICAL DEVICES
include ambulatory cardiac monitoring systems in hospitals and telemetry systems used by
paramedics over wide area wireless networks. While these solutions were based on
proprietary technology, the advent of off-the-shelf standards-based approaches has resulted
in increasingly ubiquitous wireless communications systems both indoors and outdoors.
These provide and enable compelling and varied use cases for connection between MEDICAL
DEVICES and information systems. Wireless technology has great benefits; however, as with
any technology, certain RISKS are introduced that can affect the three KEY PROPERTIES of
SAFETY, EFFECTIVENESS, and DATA AND SYSTEMS SECURITY. This document will review the
challenges associated with wireless technologies and provide guidance regarding the safe,
effective, and secure use of MEDICAL DEVICES on a wireless MEDICAL IT-NETWORK. This is done
in a framework that follows the RISK MANAGEMENT PROCESS as defined by the IEC 80001-1
standard.
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.
For the purposes of this technical report, “should” is used to indicate that amongst several
possibilities to meet a requirement, one is recommended as being particularly suitable without
mentioning or excluding others, or that a certain course of action is preferred but not
necessarily required. This term is not to be interpreted as indicating requirement.
0.2 Organization of the technical report
This technical report is divided into five main clauses, a bibliography and two annexes.
Clause 4 provides an overview of a wireless MEDICAL IT-NETWORK and reviews varying types of
wireless technologies and their applicability to healthcare. The next three clauses focus on
the high level steps involved with understanding and defining the networking performance
RISK CONTROL measures regarding the creation a
characteristics, requirements and associated
MEDICAL IT-NETWORK, namely:
a) planning and design;
b) deployment and implementation; and
c) operational management.
Clause 8 provides general RISK CONTROL measures that might be applicable to an HDO's
unique MEDICAL IT-NETWORK. Finally, a bibliography is included that lists references for further
exploration. Annex A offers a table that suggests a mapping between MEDICAL DEVICE data
types and associated networking QUALITY OF SERVICE priorities. Annex B is a checklist
questionnaire for assistance in performing a RISK ANALYSIS.
0.3 Clinical functionality and use case
One of the fundamental concepts that this technical report emphasizes is that MEDICAL DEVICES
have networking characteristics that are similar to other types of general purpose devices and
applications; yet the repercussions of not properly designing and managing the network to
ensure the SERVICE LEVEL AGREEMENT of the MEDICAL DEVICES could negatively impact clinical
functionality. This can lead to erroneous diagnostics and/or missed treatment that can
ultimately affect patient health outcome. In this technical report, clinical functionality and the
clinical use case are interchangeable; they are a reference to the means by which a clinician
TR 80001-2-3 © IEC:2012(E) – 7 –
(nurse, physician, etc.) performs their clinical duties across the wireless network, and includes
the component of patient care and SAFETY. These are components in the overall context as it
is referred to in the step-by-step technical report, IEC 80001-2-1, and this information is
required for a complete RISK ANALYSIS. A typical example is a nurse who is remotely
monitoring a patient from the nursing central station using a patient monitor at the bedside
that is wirelessly connected to the network. The clinical functionality is the remote monitoring
of a patient’s health.
0.4 Wireless guidance and RISK MANAGEMENT
The wireless link between a patient and the remote clinician is now a component of the
clinical functionality and may impact the KEY PROPERTIES of SAFETY and DATA AND SYSTEMS
SECURITY. While the benefits of wireless access are well known and documented, typically the
MEDICAL DEVICE and a clinician is more likely, or has a higher
wireless link between a
probability, of experiencing a loss of connectivity versus that of a wired connection. This is a
motivation behind the creation and focus of this technical report.
Because the definitions of HAZARD, HAZARDOUS SITUATIONS, HARM and causes are use case
specific to each HDO, this document should be used in conjunction with both the IEC 80001-1
and IEC/TR 80001-2-1 at a minimum.
RISK MANAGEMENT aspect of this technical report. The
Figure 1 provides an overview of the
column of boxes on the left of the figure is an overview (for this technical report’s purpose) of
the 10 steps of RISK MANAGEMENT as defined in the IEC/TR 80001-2-1. The center boxes show
the steps of the RISK MANAGEMENT PROCESS that this technical report is focused on. They are
the following in terms of the RISK MANAGEMENT PROCESS:
– The cause is an event that can turn a HAZARD into a HAZARDOUS SITUATION. Examples of
causes in a wireless network are RF interference, wireless network misconfiguration, or
networking device failure.
– A HAZARD associated in the context of wireless connectivity is the loss or impairment of
connectivity in a medical system. This disruption in connectivity can negatively impact the
ability of a MEDICAL DEVICE or clinical system to perform its intended function.
– A HAZARDOUS SITUATION is a circumstance in which the MEDICAL DEVICE or clinical
functionality is exposed to a HAZARD. For example, a clinician is monitoring a patient at the
nursing station (clinical functionality is remote monitoring). If RF interference causes the
wireless network to be disabled (loss of connectivity is the HAZARD), then the patient is no
longer being remotely monitored (HAZARDOUS SITUATION).
– The RISK CONTROL measures as used in this technical report are the steps taken to reduce
the probability of the occurrence of a HAZARDOUS SITUATION (referred to as P1 in
IEC/TR 80001-2-1), or the steps taken to reduce the probability of HARM once the
HAZARDOUS SITUATION has occurred (referred to as P2 in IEC/TR 80001-2-1). A P1 RISK
measure example might be RF redundancy or networking change control
CONTROL
procedures. A P2 RISK CONTROL measure example might be the sequence of actions that a
nurse would take if notified that the connectivity is lost between a patient monitor and
central station.
The majority of this technical report focuses on the design and RISK CONTROL measures
associated with wireless technologies. However, and this is another motivation for engaging
with the clinicians early in the planning phase, the role of the clinicians in mitigating against
Patient HARM should be clearly reviewed. In the example used in the bulleted steps above, the
clinician might have a documented procedure to follow during network outages; when the
network experiences loss of connectivity the clinician can follow a procedure where they need
to attend to the patient directly.
– 8 – TR 80001-2-3 © IEC:2012(E)
IEC 1299/12
Figure 1 – Focus of technical report
TR 80001-2-3 © IEC:2012(E) – 9 –
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –
Part 2-3: Guidance for wireless networks
1 Scope and object
1.1 Scope
This part of IEC 80001 supports the HDO in the RISK MANAGEMENT of MEDICAL IT-NETWORKS
that incorporate one or more wireless links. The report provides 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.
1.2 Objective
This Technical 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.
This technical report is focused on wireless technologies from an agnostic viewpoint; however,
there are particular wireless technologies that are predominant in HDOS (e.g. 802.11) and are
discussed in more detail. Where appropriate, these differences are pointed out and
discussed. In addition, while it does not focus on a single wireless technology, it is assumed
that the attached wired infrastructure is an Ethernet-based IP network.
It is not the intent of this document to propose a regimented step-by-step PROCESS for
implementing a wireless MEDICAL IT-NETWORK or mitigating the RISK associated with a
particular wireless technology. There are many reasons which conspire against such an effort
and chief among them are:
– There are many different wireless technologies available, each with their PHY, MAC and
upper layer characteristics with varying degrees of control available to the HDO.
– Many wireless technologies are in an evolving stage of development and are still subject
to frequent and significant changes.
– HDOs, depending on their needs, might utilize varying combinations of wireless
technologies to meet their particular requirements. Each technology should require its own
independent RISK ANALYSIS and RISK CONTROL measures that should be reviewed
systemically (aggregate RISKS ANALYSIS).
– Each HDO will have their own unique clinical use cases and network topologies and will
perform their own unique RISK ANALYSIS and management that will differ from other HDOs.
Instead, this technical report acknowledges a generalized or high level approach relative to a
step-by-step PROCESS review that both inherently and intentionally considers HAZARDS, the
causes leading to HAZARDOUS SITUATIONS, and RISK CONTROL measures. The general approach
that this technical report follows is the following:
a) Pose the question: does the use case of the device require wireless connectivity? This is
not a trivial question but this technical report assumes the answer is “yes”.
b) Define the clinical use-cases/functionality by bringing together the clinicians, biomedical
engineering staff and whoever else might be involved in the use and support of the
MEDICAL DEVICES.
– 10 – TR 80001-2-3 © IEC:2012(E)
c) Review the wireless specifications and capabilities of the MEDICAL DEVICE(S) and systems
and create baseline networking performance requirements.
d) Create the clinical SLA by mapping the networking performance requirements to the
clinical functionality. See Table A.1 for examples regarding this mapping.
e) Match the wireless networking performance requirements of the MEDICAL DEVICES and
systems to the existing capabilities of the general purpose IT-NETWORK and identify gaps
or incompatibilities. Take into consideration the wireless network configurations and
networking performance requirements of all existing or planned wireless non-MEDICAL
DEVICES.
f) Complete the RISK MANAGEMENT PROCESS, including identification and implementation of
RISK CONTROL measures relative to the KEY PROPERTIES. Many RISK CONTROL measures are
very much like ‘best design practices’, but are documented, applied, and VERIFIED as part
of the RISK MANAGEMENT PROCESS.
g) Design and configure the network(s) to match the SLAs of all devices (medical and non-
medical).
h) Perform pre-GO-LIVE network testing to VERIFY that all devices properly coexist while
maintaining their particular SLA.
i) Use operational measures to monitor and manage the live network such that SLAs are
continuously being met.
1.3 HDO scalability
The scope of this document is targeted at all HDOs regardless of network size. Large
networks might have to deal with many devices and complex application mixes using both
wired and wireless networks. They might or might not have life critical patient data traversing
the network. Other networks can be smaller in scale, simpler in the number of devices and
applications operating on the network, but also might have life critical data on the network.
The complexity of the networks and the patient SAFETY aspect of the network traffic drive the
extent of HAZARD analysis and RISK MANAGEMENT required. The patient SAFETY aspect requires
that a RISK MANAGEMENT plan be completed while the network complexity translates into the
level of complexity in the RISK CONTROL measures.
One can certainly argue that a small network (e.g. physician office) that uses wireless
technology does not need to go through the same level of RISK ANALYSIS as a hospital. For
example, there are small catheterization laboratories and small cosmetic surgery practices
that might have small scale networks, yet have patient data on the network. All HDOs have to
manage the security of their networks and evaluate their clinical functionality for patient
SAFETY implications. HDOs need to manage their network wireless technology deployments
with an appropriate and scaled attention to RISK MANAGEMENT.
While this document focuses on deployment issues for complex wireless deployments, its
guidance, appropriately applied, can be used in many different networked environments, both
large and small.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 80001-1:2010, Application of risk management for IT-networks incorporating MEDICAL
– Part 1: Roles, responsibilities and activities
DEVICES
TR 80001-2-3 © IEC:2012(E) – 11 –
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
ACCESS POINT
AP
bridge from a wireless medium to a wired medium
3.2
ACCOMPANYING DOCUMENT
document accompanying a MEDICAL DEVICE or an accessory and containing information for the
RESPONSIBLE ORGANIZATION or OPERATOR, particularly regarding SAFETY
[SOURCE: IEC 80001-1:2010, definition 2.1]
3.3
ADVANCED ENCRYPTION STANDARD
AES
a symmetric-key encryption standard
Note 1 to entry: One of its uses is for the WPA2 wireless encryption standard.
3.4
BASIC SERVICE SET IDENTIFIER
BSSID
an 802.11 term for the MAC address of an AP
3.5
BOOTSTRAP PROTOCOL
BOOTP
network protocol used by a network client to obtain an IP address from a configuration server
3.6
BROADCAST ADDRESSING
technology for delivering a message to all destinations on a network simultaneously
3.7
CHANGE PERMIT
an outcome of the RISK MANAGEMENT PROCESS consisting of a document that allows a specified
change or type of change without further RISK MANAGEMENT Activities subject to specified
constraints
[SOURCE: IEC 80001-1:2010, definition 2.3]
3.8
CHANGE-RELEASE MANAGEMENT
PROCESS that ensures that all changes to the IT-NETWORK are assessed, approved,
implemented and reviewed in a controlled manner and that changes are delivered, distributed,
and tracked, leading to release of the change in a controlled manner with appropriate input
and output with CONFIGURATION MANAGEMENT
[SOURCE: IEC 80001-1:2010, definition 2.2]
– 12 – TR 80001-2-3 © IEC:2012(E)
3.9
CONFIGURATION MANAGEMENT
PROCESS that ensures that configuration information of components and the IT-NETWORK are
defined and maintained in an accurate and controlled manner, and provides a mechanism for
identifying, controlling and tracking versions of the IT-NETWORK
[SOURCE: IEC 80001-1:2010, definition 2.4]
3.10
DATA AND SYSTEMS SECURITY
operational state of a MEDICAL IT-NETWORK in which information assets (data and systems) are
reasonably protected from degradation of confidentiality, integrity, and availability
[SOURCE: IEC 80001-1:2010, definition 2.5, modified – two notes integral to understanding
the scope of the original definition have been deleted.]
3.11
DIGITAL ENHANCED CORDLESS TELECOMMUNICATIONS
DECT
digital communication standard which is primarily used for creating cordless phone system
3.12
DISTRIBUTED ANTENNA SYSTEM
DAS
antenna system that collects wireless signals and routes them to centralized locations
3.13
DYNAMIC FREQUENCY SELECTION
DFS
mechanism for dynamically selecting frequencies to avoid interference sources – usually used
in conjunction with the mechanism 802.11a based systems use to avoid frequencies used by
radar systems
3.14
DYNAMIC HOST CONFIGURATION PROTOCOL
DHCP
method to allocate IP addresses to client devices upon request by the client
3.15
EFFECTIVENESS
ability to produce the intended result for the patient and the RESPONSIBLE ORGANIZATION
[SOURCE: IEC 80001-1:2010, definition 2.6]
3.16
ELECTRONIC MEDICAL RECORD
EMR
computerized medical record created in an HDO
3.17
ENCODER/DECODER
CODEC
module that can encode data and decode data
TR 80001-2-3 © IEC:2012(E) – 13 –
3.18
EVENT MANAGEMENT
PROCESS that ensures that all events that can or might negatively impact the operation of the
IT-NETWORK are captured, assessed, and managed in a controlled manner
[SOURCE: IEC 80001-1:2010, definition 2.7]
3.19
EXTENDED SERVICE SET IDENTIFIER
ESSID
term that describes a logical grouping of multiple BSSIDs
Note 1 to entry: This term is sometimes used in place of SSID.
3.20
EXTENSIBLE AUTHENTICATION PROTOCOL
EAP
authentication framework frequently used in wireless networks and point-to-point connections
Note 1 to entry: It is defined in RFC 3748 and was updated by RFC 5247.
3.21
EXTENSIBLE AUTHENTICATION PROTOCOL – TRANSPORT LAYER SECURITY
EAP-TLS
specific authentication method using the EAP authentication framework (RFC 5216)
3.22
GO-LIVE
point at which a system transitions from the installation phase to the active use phase
3.23
HARM
physical injury or damage to the health of people, or damage to property or the environment,
or reduction in EFFECTIVENESS, or breach of DATA AND SYSTEMS SECURITY
[SOURCE: IEC 80001-1:2010, definition 2.8]
3.24
HAZARD
potential source of HARM
[SOURCE: IEC 80001-1:2010, definition 2.9]
3.25
HAZARDOUS SITUATION
circumstance in which people, property, or the environment are exposed to one or more
HAZARD (s)
[SOURCE: ISO 14971:2007, definition 2.4]
3.26
HEALTH DATA
PRIVATE DATA that indicates physical or mental health
Note 1 to entry: This generically defines PRIVATE DATA and it subset, HEALTH DATA, within this document to permit
users of this document to adapt it easily to different privacy compliance laws and regulations. For example, in
Europe, the requirements might be taken and references changed to “Personal Data” and “Sensitive Data”; in the
USA, HEALTH DATA might be changed to “Protected Health Information (PHI)” while making adjustments to text as
necessary.
[SOURCE: IEC 80001-2-2:2012, definition 3.7]
– 14 – TR 80001-2-3 © IEC:2012(E)
3.27
HEALTHCARE DELIVERY ORGANIZATION
HDO
facility or enterprise such as a clinic or hospital that provides healthcare services
3.28
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT
HIPAA
legislation enacted in the USA that among its provisions requires the protection of protected
HEALTH DATA
3.29
INDUSTRIAL, SCIENTIFIC AND MEDICAL BAND
ISM BAND
radio bands that were originally reserved internationally for the use of RADIO FREQUENCY (RF)
energy for industrial, scientific and medical purposes
3.30
INFORMATION TECHNOLOGY
IT
technology (computer systems, networks, software) used to PROCESS, store, acquire and
distribute information
3.31
INFORMATION TECHNOLOGY NETWORK
IT-NETWORK
system or systems composed of communicating nodes and transmission links to provide
physically linked or wireless transmission between two or more specified communication
nodes
[SOURCE: IEC 80001-1:2010, definition 2.12, modified – the two notes to the original
definition have not been retained.]
3.32
INTENDED USE
INTENDED PURPOSE
use for which a product, PROCESS or service is intended according to the specifications,
instructions and information provided by the manufacturer
[SOURCE: IEC 80001-1:2010, definition 2.10]
3.33
INTENSIVE CARE UNIT
ICU
area of the hospital where a PATIENT will be monitored closely for a critical medical condition
3.34
INTERNET GROUP MULTICAST PROTOCOL
IGMP
communications protocol used by hosts and adjacent routers on IP networks to establish
MULTICAST group memberships
3.35
INTEROPERABILITY
a property permitting diverse systems or components to work together for a specified purpose
[SOURCE: IEC 80001-1:2010, definition 2.11]
TR 80001-2-3 © IEC:2012(E) – 15 –
3.36
INTRUSION DETECTION SYSTEM
IDS
system that monitors the wireless environment and detects unauthorized uses such as “rogue”
ACCESS POINTS, viruses, worms, etc.
3.37
INTRUSION PROTECTION SYSTEM
IPS
system that includes an IDS and actively attempts to block system intrusions
3.38
KEY PROPERTIES
three RISK managed characteristics (SAFETY, EFFECTIVENESS, and DATA AND SYSTEMS SECURITY)
of MEDICAL IT-NETWORKS
[SOURCE: IEC 80001-1:2010, definition 2.13]
3.39
LOCAL AREA NETWORK
LAN
computer network covering a small physical area, such as a home or office, or small group of
buildings, such as a school or an airport
Note 1 to entry: In 802.3 parlance, a LAN is a set of devices that share a BROADCAST domain.
3.40
MEDIA ACCESS CONTROL
MAC
part of the Link Layer in the Open System Interconnection Reference Model
3.41
MEDICAL DEVICE
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or
calibrator, software, material or other similar or related article:
a) intended by the manufacturer to be used, alone or in combination, for human beings
for one or more of the specific purpose(s) of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
– investigation, replacement, modification, or support of the anatomy or of a
physiological PROCESS,
– supporting or sustaining life,
– control of conception,
– disinfection of MEDICAL DEVICES,
– providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body; and
b) which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
intended function by such means.
Note 1 to entry: The definition of a device for in vitro examination includes, for example, reagents, calibrators,
sample collection and storage devices, control materials, and related instruments or apparatus. The information
provided by such an in vitro diagnostic device may be for diagnostic, monitoring or compatibility purposes. In some
jurisdictions, some in vitro diagnostic devices, including reagents and the like, may be covered by separate
regulations.
– 16 – TR 80001-2-3 © IEC:2012(E)
Note 2 to entry: Products which may be considered to be MEDICAL DEVICES in some jurisdictions but for which
there is not yet a harmonized approach, are:
– aids for disabled/handicapped people;
– devices for the treatment/diagnosis of diseases and injuries in animals;
– accessories for MEDICAL DEVICES (see Note 3 to entry);
– disinfection substances;
– devices incorporating animal and human tissues which may meet the requirements of the above definition but
are subject to different controls.
Note 3 to entry: Accessories intended specifically by manufacturers to be used together with a ‘parent’ MEDICAL
DEVICE to enable that MEDICAL DEVICE to achieve its intended purpose should be subject to the same GHTF
procedures as apply to the MEDICAL DEVICE itself. For example, an accessory will be classified as though it is a
MEDICAL DEVICE in its own right. This may result in the accessory having a different classification than the ‘parent’
device.
Note 4 to entry: Components to MEDICAL DEVICES are generally controlled through the manufacturer’s quality
management system and the conformity assessment procedures for the device. In some jurisdictions, components
are included in the definition of a ‘MEDICAL DEVICE’.
[SOURCE: IEC 80001-1:2010, definition 2.14]
3.42
MEDICAL DEVICE MANUFACTURER
MDM
manufacturer of MEDICAL DEVICES
3.43
MEDICAL DEVICE SOFTWARE
software system that has been developed for the purpose of being incorporated into the
MEDICAL DEVICE or that is intended for use as a MEDICAL DEVICE in its own right
[SOURCE: IEC 80001-1:2010, definition 2.15]
3.44
MEDICAL IT-NETWORK
an IT-NETWORK that incorporates at least one MEDICAL DEVICE
[SOURCE: IEC 80001-1:2010, definition 2.16]
3.45
MEDICAL IT-NETWORK RISK MANAGER
person accountable for RISK MANAGEMENT of a MEDICAL IT-NETWORK
[SOURCE: IEC 80001-1:2010, definition 2.17]
3.46
MULTIPLE-IN MULTIPLE-OUT
MIMO
use of multiple antennas at both the transmitter and receiver to improve communication
performance
3.47
MULTICAST ADDRESSING
technology for delivering a message to a group of destinations on a network simultaneously
3.48
OPERATOR
person handling equipment
[SOU
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