SIST EN IEC 81001-5-1:2022

SLOVENSKI STANDARD
01-april-2022
Programska oprema ter varnost, učinkovitost in zaščita informacijskih sistemov v
zdravstvu - 5-1. del: Varnost - Dejavnosti življenjskega cikla izdelka (IEC 81001-5-
1:2021)
Health software and health IT systems safety, effectiveness and security - Part 5-1:
Security - Activities in the product life cycle (IEC 81001-5-1:2021)
Gesundheitssoftware und Gesundheits-IT-Systeme Sicherheit, Effektivität und Security -
Teil 5-1: Security - Aktivitäten im Produktlebenszyklus (IEC 81001-5-1:2021)
Logiciels de santé et sécurité, efficacité et sûreté des systèmes TI de santé - Partie 5-1 :
Sûreté - Activités du cycle de vie du produit (IEC 81001-5-1:2021)
Ta slovenski standard je istoveten z: EN IEC 81001-5-1:2022
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.030 Informacijska varnost IT Security
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 81001-5-1

NORME EUROPÉENNE
EUROPÄISCHE NORM February 2022
ICS 11.040.01; 35.240.80
English Version
Health software and health IT systems safety, effectiveness and
security - Part 5-1: Security - Activities in the product life cycle
(IEC 81001-5-1:2021)
Logiciels de santé et sécurité, efficacité et sûreté des Gesundheitssoftware und Gesundheits-IT-Systeme
systèmes TI de santé - Partie 5-1 : Sûreté - Activités du Sicherheit, Effektivität und Security - Teil 5-1: Security -
cycle de vie du produit Aktivitäten im Produktlebenszyklus
(IEC 81001-5-1:2021) (IEC 81001-5-1:2021)
This European Standard was approved by CENELEC on 2022-01-20. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 81001-5-1:2022 E

European foreword
The text of document 62A/1458/FDIS, future edition 1 of IEC 81001-5-1, prepared by SC 62A
"Common aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical
equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN IEC 81001-5-1:2022.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-10-20
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-01-20
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 81001-5-1:2021 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 62304:2006 NOTE Harmonized as EN 62304:2006 (not modified)
IEC 62443-3-2 NOTE Harmonized as EN IEC 62443-3-2
IEC 62443-3-3 NOTE Harmonized as EN IEC 62443-3-3
IEC 62443-4-1:2018 NOTE Harmonized as EN IEC 62443-4-1:2018 (not modified)
IEC 62443-4-2:2019 NOTE Harmonized as EN IEC 62443-4-2:2019 (not modified)
IEC 62740:2015 NOTE Harmonized as EN 62740:2015 (not modified)
IEC 82304-1:2016 NOTE Harmonized as EN 82304-1:2017 (not modified)
ISO/TS 14441 NOTE Harmonized as CEN ISO/TS 14441
ISO 14971:2019 NOTE Harmonized as EN ISO 14971:2019 (not modified) +A11:2021
ISO/IEC 27000:2018 NOTE Harmonized as EN ISO/IEC 27000:2020 (not modified)
ISO 27789 NOTE Harmonized as EN ISO 27789
ISO 27799 NOTE Harmonized as EN ISO 27799
ISO/IEC 29147 NOTE Harmonized as EN ISO/IEC 29147
ISO/IEC 30111 NOTE Harmonized as EN ISO/IEC 30111
ISO 13485:2016 NOTE Harmonized as EN ISO 13485:2016 (not modified) +A11:2021
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
IEC/TR 63069 NOTE Harmonized as CLC IEC/TR 63069
ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015 (not modified)

IEC 81001-5-1
Edition 1.0 2021-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Health software and health IT systems safety, effectiveness and security –

Part 5-1: Security – Activities in the product life cycle

Logiciels de santé et sécurité, efficacité et sûreté des systèmes TI de santé –

Partie 5-1: Sûreté – Activités du cycle de vie du produit

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 35.240.80 ISBN 978-2-8322-1053-7

– 2 – IEC 81001-5-1:2021 © IEC 2021
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
0.1 Structure . 7
0.2 Field of application . 8
0.3 Conformance . 8
1 Scope . 10
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 18
4.1 Quality management . 18
4.1.1 Quality management system . 18
4.1.2 Identification of responsibilities . 18
4.1.3 Identification of applicability . 18
4.1.4 SECURITY expertise . 18
4.1.5 SOFTWARE ITEMS from third-party suppliers. 19
4.1.6 Continuous improvement . 19
4.1.7 Disclosing SECURITY-related issues . 19
4.1.8 Periodic review of SECURITY defect management . 19
4.1.9 ACCOMPANYING DOCUMENTATION review . 20
4.2 SECURITY RISK MANAGEMENT . 20
4.3 SOFTWARE ITEM classification relating to risk transfer. 20
5 Software development PROCESS . 21
5.1 Software development planning . 21
5.1.1 ACTIVITIES in the LIFE CYCLE PROCESS . 21
5.1.2 Development environment SECURITY . 21
5.1.3 Secure coding standards . 21
5.2 HEALTH SOFTWARE requirements analysis . 21
5.2.1 HEALTH SOFTWARE SECURITY requirements . 21
5.2.2 SECURITY requirements review . 22
5.2.3 SECURITY risks for REQUIRED SOFTWARE . 22
5.3 Software architectural design . 22
5.3.1 DEFENSE-IN-DEPTH ARCHITECTURE/design . 22
5.3.2 Secure design best practices . 22
5.3.3 SECURITY architectural design review . 23
5.4 Software design . 23
5.4.1 Software design best practices . 23
5.4.2 Secure design . 23
5.4.3 Secure HEALTH SOFTWARE interfaces . 23
5.4.4 Detailed design VERIFICATION for SECURITY . 24
5.5 Software unit implementation and VERIFICATION . 24
5.5.1 Secure coding standards . 24
5.5.2 SECURITY implementation review . 24
5.6 Software integration testing . 25
5.7 Software system testing . 25
5.7.1 SECURITY requirements testing . 25
5.7.2 THREAT mitigation testing . 25

IEC 81001-5-1:2021 © IEC 2021 – 3 –
5.7.3 VULNERABILITY testing . 25
5.7.4 Penetration testing . 26
5.7.5 Managing conflicts of interest between testers and developers . 26
5.8 Software release . 26
5.8.1 Resolve findings prior to release . 26
5.8.2 Release documentation . 27
5.8.3 File INTEGRITY . 27
5.8.4 Controls for private keys . 27
5.8.5 Assessing and addressing SECURITY-related issues . 27
5.8.6 ACTIVITY completion . 27
5.8.7 SECURE decommissioning guidelines for HEALTH SOFTWARE . 27
6 SOFTWARE MAINTENANCE PROCESS . 28
6.1 Establish SOFTWARE MAINTENANCE plan . 28
6.1.1 Timely delivery of SECURITY updates . 28
6.2 Problem and modification analysis . 28
6.2.1 Monitoring public incident reports . 28
6.2.2 SECURITY update VERIFICATION . 28
6.3 Modification implementation . 29
6.3.1 SUPPORTED SOFTWARE SECURITY update documentation . 29
6.3.2 MAINTAINED SOFTWARE SECURITY update delivery . 29
6.3.3 MAINTAINED SOFTWARE SECURITY update INTEGRITY . 29
7 SECURITY RISK MANAGEMENT PROCESS . 29
7.1 RISK MANAGEMENT context . 29
7.1.1 General . 29
7.1.2 PRODUCT SECURITY CONTEXT . 29
7.2 Identification of VULNERABILITIES, THREATS and associated adverse impacts . 30
7.3 Estimation and evaluation of SECURITY risk. 31
7.4 Controlling SECURITY risks . 31
7.5 Monitoring the effectiveness of RISK CONTROLS . 31
8 Software CONFIGURATION MANAGEMENT PROCESS . 32
9 Software problem resolution PROCESS . 32
9.1 Overview. 32
9.2 Receiving notifications about VULNERABILITIES . 32
9.3 Reviewing VULNERABILITIES . 32
9.4 Analysing VULNERABILITIES. 33
9.5 Addressing SECURITY-related issues . 33
Annex A (informative) Rationale . 35
A.1 Relationship to IEC 62443 . 35
A.2 Relationship to IEC 62304 . 36
A.3 Risk transfer . 37
A.3.1 Overview . 37
A.3.2 MAINTAINED SOFTWARE . 37
A.3.3 SUPPORTED SOFTWARE . 37
A.3.4 REQUIRED SOFTWARE . 37
A.4 Secure coding best practices . 38
Annex B (informative) Guidance on implementation of SECURITY LIFE CYCLE ACTIVITIES . 39
B.1 Overview. 39
B.2 Related work . 39

– 4 – IEC 81001-5-1:2021 © IEC 2021
B.3 THREAT / RISK ANALYSIS . 39
B.4 THREAT and RISK MANAGEMENT . 40
B.5 Software development planning . 40
B.5.1 Development . 40
B.5.2 HEALTH SOFTWARE requirements analysis . 41
B.5.3 Software architectural design . 41
B.5.4 Software unit implementation and VERIFICATION . 41
B.5.5 Secure implementation . 42
B.5.6 Not used . 42
B.5.7 Software system testing . 42
Annex C (informative) THREAT MODELLING . 44
C.1 General . 44
C.2 ATTACK-defense trees . 44
C.3 CAPEC / OWASP / SANS . 44
C.4 CWSS . 44
C.5 DREAD . 45
C.6 List known potential VULNERABILITIES . 45
C.7 OCTAVE . 45
C.8 STRIDE . 45
C.9 Trike . 45
C.10 VAST . 45
Annex D (informative) Relation to practices in IEC 62443-4-1:2018 . 46
D.1 IEC 81001-5-1 to IEC 62443-4-1:2018 . 46
D.2 IEC 62443-4-1:2018 to IEC 81001-5-1 . 47
Annex E (informative) Documents specified in IEC 62443-4-1 . 48
E.1 Overview. 48
E.2 Release documentation. 48
E.2.1 PRODUCT documentation . 48
E.2.2 HEALTH SOFTWARE DEFENSE-IN-DEPTH documentation . 49
E.2.3 DEFENSE-IN-DEPTH measures expected in the environment . 49
E.2.4 SECURITY hardening guidelines . 49
E.2.5 SECURITY update information . 50
E.3 Documents for decommissioning HEALTH SOFTWARE . 50
Annex F (normative) TRANSITIONAL HEALTH SOFTWARE . 51
F.1 Overview. 51
F.2 Development assessment and gap closure activities . 51
F.3 Rationale for use of TRANSITIONAL HEALTH SOFTWARE . 52
F.4 Post-release ACTIVITIES . 52
Annex G (normative) Object identifiers . 53
Bibliography . 54

Figure 1 – HEALTH SOFTWARE field of application . 8
Figure 2 – HEALTH SOFTWARE LIFE CYCLE PROCESSES . 10

Table A.1 – Required level of independence of testers from developers . 36
Table G.1 – Object identifiers for conformance concepts of this document . 53

IEC 81001-5-1:2021 © IEC 2021 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
HEALTH SOFTWARE AND HEALTH IT SYSTEMS SAFETY,
EFFECTIVENESS AND SECURITY –
Part 5-1: Security –
Activities in the product life cycle

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,
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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.
International Standard IEC 81001-5-1 has been prepared by a Joint Working Group of IEC
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.
It is published as a double logo standard.
The text of this document is based on the following documents:
Draft Report on voting
62A/1458/FDIS 62A/1466/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
– 6 – IEC 81001-5-1:2021 © IEC 2021
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
In this document, the following print types are used:
– requirements and definitions: roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
A list of all parts in the IEC 81001 series, published under the general title Health software and
health IT systems safety, effectiveness and security, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The "colour inside" logo on the cover page of this document 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.

IEC 81001-5-1:2021 © IEC 2021 – 7 –
INTRODUCTION
0.1 Structure
PROCESS standards for HEALTH SOFTWARE provide a specification of ACTIVITIES that will be
performed by the MANUFACTURER – including software incorporated in medical devices –as a
part of a development LIFE CYCLE. The normative clauses of this document are intended to
provide minimum best practices for a secure software LIFE CYCLE. Local legislation and
regulation are considered.
PROCESS requirements (Clause 4 through Clause 9) have been derived from the
IEC 62443-4-1[11] PRODUCT LIFE CYCLE management. Implementations of these specifications
can extend existing PROCESSES at the MANUFACTURER’s organization – notably existing
PROCESSES conforming to IEC 62304[8]. This document can therefore support conformance to
IEC 62443-4-1[11].
Normative clauses of this document specify ACTIVITIES that are the responsibility of the
MANUFACTURER. The HEALTH SOFTWARE LIFE CYCLE can be part of an incorporating PRODUCT
project. Some ACTIVITIES specified in this document depend on input and support from the
PRODUCT LIFE CYCLE (for example to define specific criteria). Examples include:
• RISK MANAGEMENT;
• requirements;
• testing;
• post-release (after first placing HEALTH SOFTWARE on the market).
In cases where ACTIVITIES for HEALTH SOFTWARE need support from PROCESSES at the PRODUCT
level, Clause 4 through Clause 9 of this document specify respective requirements beyond the
HEALTH SOFTWARE LIFE CYCLE.
PROCESSES, but
Similar to IEC 62304[8], this document does not prescribe a specific system of
Clause 4 through Clause 9 of this document specify ACTIVITIES that are performed during the
HEALTH SOFTWARE LIFE CYCLE.
Clause 4 specifies that MANUFACTURERS develop and maintain HEALTH SOFTWARE within a quality
management system (see 4.1) and a RISK MANAGEMENT SYSTEM (4.2).
Clause 5 through Clause 8 specify ACTIVITIES and resulting output as part of the software LIFE
PROCESS implemented by the MANUFACTURER. These specifications are arranged in the
CYCLE
ordering of IEC 62304[8].
Clause 9 specifies ACTIVITIES and resulting output as part of the problem resolution PROCESS
implemented by the MANUFACTURER.
The scope of this document is limited to HEALTH SOFTWARE and its connectivity to its INTENDED
ENVIRONMENT OF USE, based on IEC 62304[8], but with emphasis on CYBERSECURITY.
For expression of provisions in this document,
– “can” is used to describe a possibility or capability; and
– “must” is used to express an external constraint.
___________
Numbers in square brackets refer to the Bibliography.

– 8 – IEC 81001-5-1:2021 © IEC 2021
NOTE HEALTH SOFTWARE can be placed on the market as software, as part of a medical device, as part of hardware
specifically intended for health use, as a medical device (SaMD), or as a PRODUCT for other health use. (See
Figure 2).
0.2 Field of application
This document applies to the development and maintenance of HEALTH SOFTWARE by a
MANUFACTURER, but recognizes the critical importance of bi-lateral communication with
organizations (e.g. HEALTHCARE DELIVERY ORGANIZATIONS, HDOS) who have SECURITY
responsibilities for the HEALTH SOFTWARE and the systems it is incorporated into, once the
software has been developed and released. The ISO/IEC 81001-5 series of standards (for
which this is part -1), is therefore being designed to include future parts addressing SECURITY
that apply to the implementation, operations and use phases of the LIFE CYCLE for organizations
such as HDOs.
A medical device software is a subset of HEALTH SOFTWARE. A practical Venn diagram of HEALTH
SOFTWARE types is shown in Figure 1. Therefore, this document applies to:
– software as part of a medical device;
– software as part of hardware specifically intended for health use;
– software as a medical device (SaMD); and
– software-only PRODUCT for other health use.
NOTE In this document, the scope of software considered part of the LIFE CYCLE ACTIVITIES for secure HEALTH
SOFTWARE is larger and includes more software (drivers, platforms, operating systems) than for SAFETY, because for
SECURITY the focus will be on any use including foreseeable unauthorized access rather than just the INTENDED USE.

[SOURCE: IEC 82304-1[18]]
Figure 1 – HEALTH SOFTWARE field of application
0.3 Conformance
Conformance with this document focuses on the implementation of requirements regarding
PROCESSES, ACTIVITIES, and TASKS – and can be claimed in one of two alternative ways:
• for HEALTH SOFTWARE by implementing requirements in Clause 4 through Clause 9 of this
document,
TRANSITIONAL HEALTH SOFTWARE by only implementing the PROCESSES, ACTIVITIES, and
• for
TASKS identified in Annex F.
IEC 81001-5-1:2021 © IEC 2021 – 9 –
This document is designed to assist in the implementation of the PROCESSES required by
IEC 62443-4-1, however, conformance to this document is not necessarily a sufficient condition
for conformance to IEC 62443-4-1[11]. More guidance on coverage can be found in Annex D.
MANUFACTURERS can implement the specifications for Annex E in order to achieve conformance
of documentation to IEC 62443-4-1[11].
Clause 4 through Clause 9 of this document require establishing one or more PROCESSES that
include identified ACTIVITIES. Per these normative parts of this document, the LIFE CYCLE
PROCESSES implement these ACTIVITIES. None of the requirements in this document requires to
implement these ACTIVITIES as one single PROCESS or as separate PROCESSES. The ACTIVITIES
specified in this document will typically be part of an existing LIFE CYCLE PROCESS.

– 10 – IEC 81001-5-1:2021 © IEC 2021
HEALTH SOFTWARE AND HEALTH IT SYSTEMS SAFETY,
EFFECTIVENESS AND SECURITY –
Part 5-1: Security –
Activities in the product life cycle

1 Scope
This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH
SOFTWARE needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for
HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this
document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE
PROCESSES. An informal overview of activities for HEALTH SOFTWARE is shown in Figure 2.

[derived from IEC 62304:2006[8], Figure 2]
Figure 2 – HEALTH SOFTWARE LIFE CYCLE PROCESSES
The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain
ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the
SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves.
It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness
and SECURITY as discussed in ISO 81001-1[17].
This document excludes specification of ACCOMPANYING DOCUMENTATION contents.
2 Normative references
There are no normative references in this document.

IEC 81001-5-1:2021 © IEC 2021 – 11 –
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at www.electropedia.org/
• ISO Online browsing platform: available at www.iso.org/obp
3.1
ACCOMPANYING DOCUMENTATION
documentation intended to be used for a HEALTH SOFTWARE or a HEALTH IT SYSTEM or an
accessory, containing information for the responsible organization or operator
3.2
ACTIVITY
TASKS
set of one or more interrelated or interacting
[SOURCE: IEC 62304:2006[8], 3.1]
3.3
ARCHITECTURE
fundamental concepts or properties of a system in its environment, embodied in its elements,
relationships, and in the principles of its design and evolution
[SOURCE: ISO/IEC/IEEE 24765:2017, 3.216, definition1]
3.4
ASSET
physical or digital entity that has value to an individual, an organization or a government
Note 1 to entry: As per the definition for ASSET this can include the following:
a) data and information;
b) HEALTH SOFTWARE and software needed for its operation;
c) hardware components such as computers, mobile devices, servers, databases, and networks;
d) services, including SECURITY, software development, IT operations and externally provided services such as data
centres, internet and software-as-a-service and cloud solutions;
e) people, and their qualifications, skills and experience;
f) technical procedures and documentation to manage and support the HEALTH IT INFRASTRUCTURE;
g) HEALTH IT SYSTEMS that are configured and implemented to address organizational objectives by leveraging the
ASSETS; and
h) intangibles, such as reputation and image.
[SOURCE: ISO 81001-1:2021[17] 3.3.2, modified – Addition of a new Note 1 to entry.]
3.5
ATTACK
attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make
unauthorized use of an ASSET
[SOURCE: ISO/IEC 27000:2018, 3.2]

– 12 – IEC 81001-5-1:2021 © IEC 2021
3.6
ATTACK SURFACE
physical and functional interfaces of a system that can be accessed and, therefore, potentially
exploited by an attacker
[SOURCE: IEC 62443-4-1:2018[11], 3.1.7]
3.7
AVAILABILITY
property of being accessible and usable on demand by an authorized entity
[SOURCE: ISO/IEC 27000:2018, 3.7]
3.8
CONFIDENTIALITY
property that information is not made available or disclosed to unauthorized individuals, entities,
or PROCESSES
[SOURCE: ISO/IEC 27000:2018, 3.10]
3.9
CONFIGURATION ITEM
entity that can be uniquely identified at a given reference point
[SOURCE: IEC 62304:2006[8], 3.5]
3.10
CONFIGURATION MANAGEMENT
PROCESS ensuring consistency of CONFIGURATION ITEMS by using mechanisms for identifying,
controlling and tracking versions of CONFIGURATION ITEMS
3.11
DEFENSE-IN-DEPTH
approach to defend the system against any particular ATTACK using several independent
methods
Note 1 to entry: DEFENSE-IN-DEPTH implies layers of SECURITY and detection, even on single systems, and provides
the following features:
• is based on the idea that any one layer of protection, can and probably will be defeated;
• attackers are faced with breaking through or bypassing each layer without being detected;
• a flaw in one layer can be mitigated by capabilities in other layers;
• system SECURITY becomes a set of layers within the overall network SECURITY; and
• each layer is autonomous and not rely on the same functionality nor have the same failure modes as the other
layers.
[SOURCE: IEC 62443-4-1:2018[11], 3.1.15]
3.12
EXPLOIT (noun)
defined way to breach the SECURITY of information systems through some VULNERABILITY
[SOURCE: ISO/IEC 27039:2015, 2.9]

IEC 81001-5-1:2021 © IEC 2021 – 13 –
3.13
HEALTH IT INFRASTRUCTURE
combined set of IT ASSETS available to the individual or organization for developing, configuring,
integrating, maintaining, and using IT services and supporting health, patient care and other
organizational objectives
[SOURCE: ISO 81001-1:2021[17], 3.3.7, modified – Deletion of the Note 1 to entry.]
3.14
HEALTH IT SYSTEM
a combination of interacting health information elements (including HEALTH SOFTWARE, medical
devices, IT hardware, interfaces, data, procedures and documentation) that is configured and
implemented to support and enable an individual or organization’s specific health objectives
[SOURCE: ISO 81001-1:2021[17], 3.3.8, modified – Addition of "(including HEALTH SOFTWARE,
medical devices, IT hardware, interfaces, data, procedures and documentation)".]
3.15
HEALTH SOFTWARE
software intended to be used specifically for managing, maintaining, or improving health of
individual persons, or the delivery of care, or which has been developed for the purpose of
being incorporated into a medical device
Note 1 to entry: HEALTH SOFTWARE fully includes what is considered software as a medical device.
[SOURCE: ISO 81001-1:2021[17], 3.3.9]
3.16
HEALTHCARE DELIVERY ORGANIZATION
HDO
facility or enterprise such as a clinic or hospital that provides healthcare services
[SOURCE: ISO 81001-1:2021[17], 3.1.4]
3.17
INTEGRITY
property of accuracy and completeness
[SOURCE: ISO/IEC 27000:2018, 3.36]
3.18
INTENDED ENVIRONMENT OF USE
conditions and setting in which users interact with the HEALTH SOFTWARE – as specified by the
MANUFACTURER
3.19
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
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted
with, user profile, INTENDED ENVIRONMENT OF USE, and operating principle are typical elements of the INTENDED USE.
[SOURCE: ISO 81001-1:2021[17], 3.2.7, modified – In Note 1 to entry, replacement of "USE
ENVIRONMENT" with "INTENDED ENVIRONMENT OF USE".]

– 14 – IEC 81001-5-1:2021 © IEC 2021
3.20
LIFE CYCLE
series of all phases in the life of a PRODUCT or system, from the initial conception to final
decommissioning and disposal
[SOURCE: ISO 81001-1:2021[17], 3.3.12]
3.21
MAINTAINED SOFTWARE
SOFTWARE ITEM for which the MANUFACTURER will assume the risk related to SECURITY
Note 1 to entry: See also A.3.
3.22
MANUFACTURER
organization with responsibility for design or manufacture of a PRODUCT
Note 1 to entry: Responsibility extends to supporting ACTIVITIES during operations.
Note 2 to entry: There is only one MANUFACTURER, but technical responsibility can be with multiple entities along
the supply chain, with service providers, or with entities at different stages in the LIFE CYCLE.
Note 3 to entry: Independent of the MANUFACTURER’s responsibility, any specific legal accountability is defined by
contracts and legislation.
[SOURCE: ISO 81001-1:2021[17], 3.1.7– Addition of the notes to entry.]
3.23
PROCESS
set of interrelated or interacting ACTIVITIES that use inputs to deliver an intended result
(outcome)
[SOURCE: ISO 81001-1:2021[17], 3.2.10, modified – Added “(outcome)” after “result”.]
3.24
PRODUCT
output of an organization that can be produced without any transaction taking place between
the organization and the customer
Note 1 to entry: Production of a PRODUCT is achieved without any transaction necessarily taking place between
provider and customer, but can often involve this service element upon its delivery to the customer.
Note 2 to entry: The dominant element of a PRODUCT is that it is generally tangible.
[SOURCE: ISO 81001-1:2021[17], 3.3.15]
3.25
REQUIRED SOFTWARE
SOFTWARE ITEM for which the MANUFACTURER will consider SECURITY-related risks known before
release of the HEALTH SOFTWARE
Note 1 to entry: This includes SUPPORTED SOFTWARE. See A.3.
3.26
RESIDUAL RISK
risk remaining after RISK CONTROL measures have been implemented
[SOURCE: ISO 81001-1:2021[17], 3.4.9]

IEC 81001-5-1:2021 © IEC 2021 – 15 –
3.27
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