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.

Application du management du risque aux réseaux des technologies de l'information contenant les dispositifs médicaux — Partie 2-5: Titre manque

General Information

Status
Published
Publication Date
16-Dec-2014
Current Stage
6060 - International Standard published
Start Date
17-Dec-2014
Completion Date
17-Dec-2014
Ref Project

Buy Standard

Technical report
IEC/TR 80001-2-5:2014 - Application of risk management for IT-networks incorporating medical devices
English language
33 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

IEC TR 80001-2-5
Edition 1.0 2014-12
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-5: Application guidance – Guidance on distributed alarm systems
IEC TR 80001-2-5:2014-12(en)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2014 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.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org

The stand-alone application for consulting the entire The world's leading online dictionary of electronic and

bi bliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and

Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 14

documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International

iPad. Electrotechnical Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary

The advanced search enables to find IEC publications by a More than 55 000 electrotechnical terminology entries in

variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions

committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries

and withdrawn publications. have been collected from earlier publications of IEC TC 37,

77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc

details all new publications released. Available online and If you wish to give us your feedback on this publication or

also once a month by email. need further assistance, please contact the Customer Service

Centre: csc@iec.ch.
---------------------- Page: 2 ----------------------
IEC TR 80001-2-5
Edition 1.0 2014-12
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-5: Application guidance – Guidance on distributed alarm systems
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
ICS 11.040.01; 35.240.80 ISBN 978-2-8322-1969-0

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

---------------------- Page: 3 ----------------------
– 2 – IEC TR 80001-2-5:2014 © IEC 2014
CONTENTS

FOREWORD ........................................................................................................................... 4

INTRODUCTION ..................................................................................................................... 6

1 Scope .............................................................................................................................. 7

2 Normative references ...................................................................................................... 8

3 Terms and definitions ...................................................................................................... 8

4 Functions of the distribution of ALARM CONDITIONS .......................................................... 16

4.1 General ................................................................................................................. 16

4.2 SOURCES and their ALARM CONDITIONS .................................................................... 17

4.3 INTEGRATOR ........................................................................................................... 17

4.4 COMMUNICATOR ..................................................................................................... 17

4.5 MEDICAL IT-NETWORK ............................................................................................. 18

5 Types of systems for distributing ALARM CONDITIONS ....................................................... 18

5.1 General ................................................................................................................. 18

5.2 DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS ................................... 19

5.3 DISTRIBUTED ALARM SYSTEM ................................................................................... 19

5.4 DISTRIBUTED ALARM SYSTEM WITH OPERATOR CONFIRMATION ..................................... 19

6 RISK MANAGEMENT .......................................................................................................... 20

6.1 General explanation .............................................................................................. 20

6.2 Determining the RESPONSIBLE ORGANIZATION’S objective purpose ........................... 20

6.3 HAZARDS and HAZARDOUS SITUATIONS related to DIS, DAS and CDAS ........................ 21

6.4 Causes and resulting HAZARDOUS SITUATIONS ........................................................ 21

6.5 RISK CONTROL measures related to the integration of ALARM CONDITIONS ................ 23

6.5.1 Technical RISK CONTROL measures implemented in equipment ....................... 23

6.5.2 Typical RISK CONTROL measures for implementation by the RESPONSIBLE

ORGANIZATION ................................................................................................. 25

6.5.3 Organizational policies and procedures as RISK CONTROL measures for

implementation by the RESPONSIBLE ORGANIZATION ......................................... 26

Annex A (informative) Correspondence between the RISK CONTROL measures of this

technical report and IEC 60601-1-8 ....................................................................................... 28

Annex B (informative) Types of SOURCES ............................................................................. 29

B.1 MEDICAL DEVICES ................................................................................................... 29

B.2 NURSE CALL SYSTEM ............................................................................................... 30

ANNEX C (informative) Applicability of types of system for the distribution of ALARM

CONDITIONS ........................................................................................................................... 32

Annex D (informative) Scalability of types of system for the distribution of ALARM

CONDITIONS ........................................................................................................................... 35

Bibliography .......................................................................................................................... 37

Index of defined terms used in this technical report ............................................................... 38

Figure 1 – Focus of this technical report ................................................................................. 6

Figure 2 – Functions of a MEDICAL IT-NETWORK incorporating SOURCES, an INTEGRATOR

and COMMUNICATORS to distribute ALARM CONDITIONS ................................................................ 7

Figure C.1 – Cascading structure of system for the distribution of ALARM CONDITIONS ........... 32

Figure C.2 – Example for INTEGRATOR of a PATIENT monitor with central monitoring

station to distribute ALARM CONDITIONS in a physically isolated IT-NETWORK in a CDAS ............ 33

---------------------- Page: 4 ----------------------
IEC TR 80001-2-5:2014 © IEC 2014 – 3 –
Figure C.3 – Example for INTEGRATOR of a PATIENT monitor to distribute ALARM

CONDITIONS in a NURSE CALL SYSTEM, and via a PBX with handsets ........................................ 34

Figure D.1 – Example hospital-wide DISTRIBUTED ALARM SYSTEM ............................................ 36

Table 1 – General comparison of system properties for ALARM CONDITION integration ........... 18

Table A.1 – Correspondence of the technical RISK CONTROL measures of this technical

report for a CDAS and IEC 60601-1-8 for a DAS ...................................................................... 28

---------------------- Page: 5 ----------------------
– 4 – IEC TR 80001-2-5:2014 © IEC 2014
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –
Part 2-5: Application guidance –
Guidance on distributed alarm systems
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

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 80001-2-5, 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.
---------------------- Page: 6 ----------------------
IEC TR 80001-2-5:2014 © IEC 2014 – 5 –
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/943/DTR 62A/955/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.

A list of all parts of the IEC 80001 series, published under the general title Application of risk

management for it-networks incorporating medical devices , can be found on the IEC website.

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC website 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.
---------------------- Page: 7 ----------------------
– 6 – IEC TR 80001-2-5:2014 © IEC 2014
INTRODUCTION

An increasing number of MEDICAL DEVICES are designed to exchange information electronically

with other equipment, including other MEDICAL DEVICES. Such information is frequently

exchanged through an information technology network (IT-NETWORK) that also transfers data

of a more general nature. IEC 80001-1:2010 addresses RISK MANAGEMENT of IT-NETWORKS

incorporating MEDICAL DEVICES.

ALARM SIGNALS are frequently used to indicate unsatisfactory physiological PATIENT states,

unsatisfactory functional states of the MEDICAL DEVICE or other parts of system to distribute

ALARM CONDITIONS, or to warn the OPERATOR of HAZARDS to the PATIENT or OPERATOR. The

ALARM CONDITIONS that cause these ALARM SIGNALS are often transmitted across the MEDICAL

IT-NETWORK, creating a system to distribute ALARM CONDITIONS.

A system to distribute ALARM CONDITIONS provides 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 technical report is consistent with other guidance documents of this series [1][2][3][4][5] .

IEC
Figure 1 – Focus of this technical report
_____________
Numbers in square brackets refer to the Bibliography.
---------------------- Page: 8 ----------------------
IEC TR 80001-2-5:2014 © IEC 2014 – 7 –
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –
Part 2-5: Application guidance –
Guidance on distributed alarm systems
1 Scope

This part of IEC 80001, 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. Figure 2 illustrates the

functions of a MEDICAL IT-NETWORK incorporating SOURCES, an INTEGRATOR and
COMMUNICATORS to distribute ALARM CONDITIONS.
IEC

NOTE This is a functional diagram and does not imply that these functions are in separate components. It is

possible for functionality to be provided in one or more components.
Figure 2 – Functions of a MEDICAL IT-NETWORK incorporating SOURCES,
an INTEGRATOR and COMMUNICATORS to distribute ALARM CONDITIONS
---------------------- Page: 9 ----------------------
– 8 – IEC TR 80001-2-5:2014 © IEC 2014

The following is a typical chain of events. An event is detected by a SOURCE that initiates an

ALARM CONDITION. The SOURCE sends the ALARM CONDITION to the INTEGRATOR. Based on the

RESPONSIBLE ORGANIZATION-established assignment protocol, the INTEGRATOR directs the

ALARM CONDITION to the assigned COMMUNICATOR. The COMMUNICATOR generates the

appropriate ALARM SIGNALS. The INTEGRATOR now waits for an OPERATOR response from the

COMMUNICATOR or for the SOURCE to indicate that the ALARM CONDITION no longer exists.

If the COMMUNICATOR is capable of accepting a response and the OPERATOR responds, the

OPERATOR indicates that it either accepts or rejects responsibility for the ALARM CONDITION. If

the OPERATOR rejects the responsibility, the INTEGRATOR redirects the ALARM CONDITION to a

different COMMUNICATOR (i.e. a different OPERATOR) and might also escalate the priority of the

ALARM CONDITION. Eventually an OPERATOR accepts responsibility for the ALARM CONDITION.

When an OPERATOR has taken appropriate action, the ALARM CONDITION subsequently ends.

Alternately, the ALARM CONDITION could end without OPERATOR action in which case when the

SOURCE notifies the INTEGRATOR that the ALARM CONDITION is no longer present, the

INTEGRATOR instructs the COMMUNICATOR to stop generating ALARM SIGNALS. Should an ALARM

CONDITION remain uncorrected for an extended period of time, the ALARM SYSTEM should cause

the ESCALATION of the ALARM CONDITION, notify additional OPERATORS, etc.

EXAMPLE A pulse oximeter detects a low SpO level in the PATIENT, initiates an ALARM CONDITION and sends that

ALARM CONDITION to the INTEGRATOR via a MEDICAL IT-NETWORK. The INTEGRATOR then directs that ALARM CONDITION

to the COMMUNICATOR that is mapped to the clinical OPERATOR assigned to the PATIENT via a MEDICAL IT-NETWORK.

OPERATOR A responds by rejecting responsibility for the ALARM CONDITION. The COMMUNICATOR sends this response

information back to the INTEGRATOR, which then redirects the ALARM CONDITION to the COMMUNICATOR of clinical

OPERATOR B. OPERATOR B then accepts responsibility for the ALARM CONDITION. The COMMUNICATOR sends this

response information back to the INTEGRATOR, which then sends it back to the SOURCE causing an ALARM SIGNAL

inactivation state (e.g. AUDIO PAUSED) to be generated. OPERATOR B adjusts the oxygen concentration in the gas

going to the PATIENT and the ALARM CONDITION ceases (e.g. the event ends).
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.

NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent

(in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography on page 37.

IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical

devices – Part 1: Roles, responsibilities and activities
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE An index of defined terms is found beginning on page 38.
3.1
ALARM CONDITION

state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS

SITUATION exists for which OPERATOR awareness or response is required

Note 1 to entry: An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.

Note 2 to entry: An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.

[SOURCE: IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, 3.1]
---------------------- Page: 10 ----------------------
IEC TR 80001-2-5:2014 © IEC 2014 – 9 –
3.2
ALARM SETTINGS
ALARM SYSTEM configuration, including but not limited to:
– ALARM LIMITS;
– the characteristics of any ALARM SIGNAL inactivation states; and

– the values of variables or parameters that determine the function of the ALARM SYSTEM

Note 1 to entry: Some algorithmically-determined ALARM SETTINGS can require time to be determined or re-

determined.
[SOURCE: IEC 60601-1-8:2006, 3.8]
3.3
ALARM SIGNAL

type of signal generated by the ALARM SYSTEM or COMMUNICATOR to indicate the presence (or

occurrence) of an ALARM CONDITION
[SOURCE: IEC 60601-1-8:2006, 3.9, modified – added 'or COMMUNICATOR'.]
3.4
ALARM SIGNAL GENERATION DELAY

time from the onset of an ALARM CONDITION to the generation of its ALARM SIGNAL(S)

[SOURCE: IEC 60601-1-8:2006, 3.10]
3.5
ALARM SYSTEM

parts of a MEDICAL DEVICE that detect ALARM CONDITIONS and, as appropriate, generate ALARM

SIGNALS
[SOURCE: IEC 60601-1-8:2006, 3.11, modified – The term MEDICAL DEVICE replaces
'ME EQUIPMENT or a ME SYSTEM'.]
3.6
COMMUNICATOR
COM
function that generates ALARM SIGNALS to notify an OPERATOR
Note 1 to entry: A COM can receive an OPERATOR response.
Note 2 to entry: An OPERATOR response is not limited to direct OPERATOR action.
3.7
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

Note 1 to entry: Security, when mentioned in this standard, should be taken to include DATA AND SYSTEMS

SECURITY.

Note 2 to entry: DATA AND SYSTEMS SECURITY is assured through a framework of policy, guidance, infrastructure,

and services designed to protect information assets and the systems that acquire, transmit, store, and use

information in pursuit of the organization’s mission.

Note 3 to entry: For the purposes of this technical report, 'reasonably' should be interpreted to mean necessarily.

[SOURCE: IEC 80001-1:2010, 2.5, modified – a third note to entry has been added.]

---------------------- Page: 11 ----------------------
– 10 – IEC TR 80001-2-5:2014 © IEC 2014
3.8
DISTRIBUTED ALARM SYSTEM
DAS

ALARM SYSTEM that involves more than one MEDICAL DEVICE intended for delivery of ALARM

CONDITIONS with technical confirmation

Note 1 to entry: The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.

Note 2 to entry: A DISTRIBUTED ALARM SYSTEM is intended to notify OPERATORS of the existence of an ALARM

CONDITION.

Note 3 to entry: The requirements for a DAS are described in IEC 60601-1-8:2005 and

IEC 60601-1-8:2005/AMD1:2012, 6.11.2.2.1.

Note 4 to entry: For the purposes of this technical report, technical confirmation means that each element of a

DISTRIBUTED ALARM SYSTEM confirms or guarantees the successful delivery of the ALARM CONDITION to the next

element or appropriate TECHNICAL ALARM CONDITIONS are created as described in IEC 60601-1-8:2006 and

IEC 60601-1-8:2006/AMD1:2012, 6.11.2.2.1.

[SOURCE: IEC 60601-1-8:2006, 3.17, modified – Replaced ‘item of equipment of a ME

SYSTEM’ with ‘MEDICAL DEVICE’, added ‘intended for delivery of ALARM CONDITIONS with technical

confirmation’ and added notes to entry 2, 3 and 4.]
3.9
DISTRIBUTED ALARM SYSTEM WITH OPERATOR CONFIRMATION
CDAS

DISTRIBUTED ALARM SYSTEM that includes the capability to receive an OPERATOR response

3.10
DISTRIBUTED INFORMATION SYSTEM
DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS
DIS

system that involves at least one MEDICAL DEVICE that is intended to provide information about

ALARM CONDITIONS but does not guarantee delivery of that information

Note 1 to entry: A DIS is not intended to notify OPERATORS of the existence of an ALARM CONDITION as a RISK

CONTROL measure. A DIS is intended to provide information about an ALARM CONDITION to an OPERATOR that has

otherwise been made aware of the existence of the ALARM CONDITION by an ALARM SYSTEM.

Note 2 to entry: This is in terms of IEC 60601-1-8:2005 and IEC 60601-1-8:2005/AMD1:2012, 6.11.2.2.2, a

‘DISTRIBUTED ALARM SYSTEM not intended for confirmed delivery of ALARM CONDITIONS’.

3.11
EFFECTIVENESS

ability to produce the intended result for the PATIENT and the RESPONSIBLE ORGANIZATION

[SOURCE: IEC 80001-1:2010, 2.6]
3.12
ESCALATION

PROCESS by which an ALARM SYSTEM increases the priority of an ALARM CONDITION or increases

the sense of urgency of an ALARM SIGNAL
[SOURCE: IEC 60601-1-8:2006, 3.18]
3.13
FALSE NEGATIVE ALARM CONDITION

absence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the

equipment or the ALARM SYSTEM

Note 1 to entry: An ALARM CONDITION can be rejected or missed because of spurious information produced by the

PATIENT, the PATIENT-equipment interface, other equipment or the ALARM SYSTEM itself.

---------------------- Page: 12 ----------------------
IEC TR 80001-2-5:2014 © IEC 2014 – 11 –

[SOURCE: IEC 60601-1-8:2006, 3.20, modified – replaced last ‘equipment’ with ‘ALARM

SYSTEM’ in the note to entry.]
3.14
FALSE POSITIVE ALARM CONDITION

presence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT,

ALARM SYSTEM
the equipment or the

Note 1 to entry: A FALSE POSITIVE ALARM CONDITION can be caused by spurious information produced by the

PATIENT, the PATIENT-equipment interface, other equipment or the ALARM SYSTEM itself.

[SOURCE: IEC 60601-1-8:2006, 3.21]
3.15
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 SYSTEM SECURITY
[SOURCE: IEC 80001-1:2010, 2.8]
3.16
HAZARD
potential source of HARM
[SOURCE: IEC 80001-1:2010, 2.9]
3.17
HAZARDOUS SITUATION

circumstance in which people, property, or the environment are exposed to one or more

HAZARD(S)
[SOURCE: ISO 14971: 2007, 2.4]
3.18
HIGH PRIORITY
indicating that immediate OPERATOR response is required
Note 1 to entry: The priority is assigned through RISK ANALYSIS.
[SOURCE: IEC 60601-1-8:2006, 3.22]
3.19
INTEGRATOR
INT
SOURCES and COMMUNICATORS or to other
function that handles communication between
INTEGRATORS

Note 1 to entry: An INTEGRATOR can direct or redirect an ALARM CONDITION to another OPERATOR.

Note 2 to entry: An INTEGRATOR can send the acceptance of responsibility from a COMMUNICATOR to a SOURCE.

3.20
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, 2.10]
---------------------- Page: 13 ----------------------
– 12 – IEC TR 80001-2-5:2014 © IEC 2014
3.21
IT-NETWORK
INFORMATION TECHNOLOGY NETWORK

a system or systems composed of communicating nodes and transmission links to provide

physically linked or wireless transmission between two or more specified communication

nodes
Note 1 to entry: Adapted from IEC 61907:2009, definition 3.1.1.

Note 2 to entry: The scope of the MEDICAL IT-NETWORK in this standard is defined by the RESPONSIBLE

ORGANIZATION based on where the MEDICAL DEVICES in the MEDICAL IT-NETWORK are located and the defined use of

the network. It can contain IT infrastructure, home health and non-clinical contexts. See also 80001-1:2010, 4.3.3.

[SOURCE: IEC 80001-1:2010, 2.12]
3.22
KEY PROPERTIES

three risk managed characteristics (SAFETY, EFFECTIVENESS, and DATA AND SYSTEMS SECURITY)

of MEDICAL IT-NETWORKS
[SOURCE: IEC 80001-1:2010, 2.13]
3.23
LOW PRIORITY
indicating that OPERATOR awareness is required
Note 1 to entry: The priority is assigned through RISK ANALYSIS.
[SOURCE: IEC 60601-1-8:2006, 3.27]
3.24
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,
...

Questions, Comments and Discussion

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