SIST EN ISO 13940:2016
(Main)Health informatics - System of concepts to support continuity of care (ISO 13940:2015)
Health informatics - System of concepts to support continuity of care (ISO 13940:2015)
ISO 13940:2015 defines a system of concepts for different aspects of the provision of healthcare.
The core business in healthcare is the interaction between subjects of care and healthcare professionals. Such interactions occur in healthcare/clinical processes and are the justification for the process approach of ISO 13940:2015. To be able to represent both clinical content and clinical context, ISO 13940:2015 is related to a generic healthcare/clinical process model as well as comprehensive concept definitions and concept models for the clinical, management and resource aspects of healthcare services.
In practice ISO 13940:2015 covers the concept definitions needed whenever structured information in healthcare is specified as a requirement. The definitions are intended to refer to the conceptual level only and not to details of implementation. ISO 13940:2015 will cover all levels of specifications in the development of
logical reference models within the information viewpoint as a common basis for semantic interoperability on international, national or local levels,
information systems, and
information for specified types of clinical processes.
Medizinische Informatik - System von Konzepten zur Unterstützung der ununterbrochenen Pflege (ISO 13940:2015)
Informatique de santé - Système de concepts en appui de la continuité des soins (ISO 13940:2015)
ISO 13940:2015 définit un système de concepts pour différents aspects de la prestation de soins de santé.
L'activité principale du domaine des soins de santé est l'interaction entre les sujets des soins et les professionnels de santé. Ce type d'interaction a lieu dans le cadre de processus cliniques ou de soins de santé, et constitue la justification de l'approche par processus de la présente norme. Pour pouvoir représenter à la fois le contenu clinique et le contexte clinique, la présente norme s'appuie sur un modèle générique de processus cliniques ou de soins de santé, ainsi que sur des définitions et des modèles de concepts globaux pour les aspects cliniques, de gestion et de ressources des prestations de santé.
Dans la pratique, la présente norme couvre les définitions de concepts requises, chaque fois que des informations structurées en matière de soins de santé sont spécifiées en tant qu'exigence. Les définitions renvoient uniquement au niveau conceptuel, et non, aux détails de mise en ?uvre. La présente Norme couvrira tous les niveaux de spécifications dans le cadre du développement:
- de modèles de référence logiques du point de vue de l'information, servant de base commune pour l'interopérabilité sémantique aux niveaux international, national ou local;
- de systèmes d'information et
- d'informations pour certains types spécifiques de processus cliniques.
ISO 13940:2015 ne traite pas de l'exécution des processus informatiques, cliniques et de soins de santé spécifiques.
Les processus de recherche et d'éducation en soins de santé ne sont pas traités dans la présente norme.
Zdravstvena informatika - Sistem pojmov za podporo neprekinjeni oskrbi (ISO 13940:2015)
Namen tega mednarodnega standarda je opredelitev in določitev teh postopkov v zvezi s sodelovanjem med vsemi strankami na področju zdravstvene oskrbe ljudi (pri čemer so izključena druga živa bitja). Na podlagi definicije zdravja, ki jo je sprejela Svetovna zdravstvena organizacija, ta mednarodni standard vključuje tiste vidike zdravstvene oskrbe, ki temeljijo na dejavnostih drugih izvajalcev in ne zgolj zdravstvenih delavcev. Ta mednarodni standard obravnava zlasti vidike izmenjave informacij v zvezi z oskrbovancem, ki so potrebne v postopku zdravstvene oskrbe. Ta mednarodni standard vključuje več delov in med drugim obravnava naslednje teme: – izvajalci zdravstvene oskrbe in druge stranke; – organizacijska načela zdravstvene oskrbe, vključno s sodelovanjem med izvajalci; – zdravstvene težave, zdravstvena stanja in njihovo upravljanje; – časovno povezani koncepti, kot so stiki, srečanja ter epizode in obdobja oskrbe; – koncepti v zvezi s procesom, potekom dela in dejavnostmi; – koncepti v zvezi s podporo za odločanje, uporabo kliničnega znanja in kakovostjo; – koncepti v zvezi z odgovornostjo in pretoki informacij znotraj kliničnega procesa, npr. zdravstveni mandati in njihovo obveščanje; – koncepti v zvezi z upravljanjem podatkov o zdravju. Če neprekinjena zdravstvena oskrba obsega dejavnosti socialnega varstva kot del procesa okrevanja ali kot podporo temu procesu, morajo biti te dejavnosti navedene na ustreznih ravneh procesa in poteka dela. Za namene vzpostavitve skupnega konceptualnega okvirja za neprekinjeno oskrbo, ki presega nacionalne, kulturne ter strokovne omejitve, so v tem dokumentu opredeljeni vsi ti koncepti in njihove medsebojne povezave.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2016
1DGRPHãþD
SIST EN 13940-1:2008
Zdravstvena informatika - Sistem pojmov za podporo neprekinjeni oskrbi (ISO
13940:2015)
Health informatics - System of concepts to support continuity of care (ISO 13940:2015)
Medizinische Informatik - System von Konzepten zur Unterstützung der
ununterbrochenen Pflege (ISO 13940:2015)
Informatique de santé - Système de concepts en appui de la continuité des soins (ISO
13940:2015)
Ta slovenski standard je istoveten z: EN ISO 13940:2016
ICS:
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.
EN ISO 13940
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2016
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13940-1:2007
English Version
Health informatics - System of concepts to support
continuity of care (ISO 13940:2015)
Informatique de santé - Système de concepts en appui Medizinische Informatik - Begriffssystem zur
de la continuité des soins (ISO 13940:2015) Unterstützung der Kontinuität der Versorgung (ISO
13940:2015)
This European Standard was approved by CEN on 19 September 2015.
CEN 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 CEN
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 CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13940:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 13940:2016) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2016, and conflicting national standards shall be
withdrawn at the latest by July 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN 13940-1:2007.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13940:2015 has been approved by CEN as EN ISO 13940:2016 without any modification.
INTERNATIONAL ISO
STANDARD 13940
First edition
2015-12-15
Health informatics — System of
concepts to support continuity of care
Informatique de santé — Système de concepts en appui de la
continuité des soins
Reference number
ISO 13940:2015(E)
©
ISO 2015
ISO 13940:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2015 – All rights reserved
ISO 13940:2015(E)
Contents Page
Foreword .vi
0 Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Healthcare . 1
3.2 Concepts and terms . 2
3.3 Actors . 2
3.4 Resources . 3
3.5 Management . 4
3.6 Process management . 5
3.7 Time . 6
3.8 Responsibility . 7
3.9 Information management . 7
4 Symbols and abbreviations . 8
5 Concepts related to healthcare actors . 9
5.1 General . 9
5.2 Healthcare actor .10
5.2.1 Subject of care .12
5.2.2 Next of kin .14
5.2.3 Healthcare provider .15
5.2.4 Healthcare third party . . .21
6 Concepts related to healthcare matters .24
6.1 General .24
6.2 Healthcare matter.25
6.3 Health issue .27
6.4 Health condition .28
6.4.1 Observed condition .29
6.4.2 Potential health condition .31
6.5 Health state .37
6.5.1 Input health state .38
6.5.2 Output health state .39
6.5.3 Health need .39
6.6 Health thread .40
6.6.1 Clinical process interest .41
6.6.2 Health problem list .42
6.6.3 Health condition evolution.42
7 Concepts related to activities .44
7.1 General .44
7.2 Healthcare activity .45
7.2.1 Healthcare provider activity .47
7.2.2 Healthcare activity directory .48
7.2.3 Self-care activity .48
7.2.4 Prescribed self-care .49
7.2.5 Healthcare third party activity .50
7.2.6 Prescribed third party activity .51
7.2.7 Healthcare activity element.51
7.2.8 Automated healthcare .60
7.2.9 Healthcare resource .61
7.2.10 Healthcare funds .63
8 Concepts related to process .65
ISO 13940:2015(E)
8.1 General .65
8.2 Healthcare process .65
8.2.1 Clinical process .66
8.2.2 Healthcare quality management .68
8.2.3 Healthcare administration .68
8.2.4 Adverse event .69
8.2.5 Adverse event management .69
8.2.6 Healthcare service .70
8.2.7 Healthcare service directory .70
9 Concepts related to healthcare planning .72
9.1 General .72
9.2 Care plan .73
9.2.1 Uniprofessional care plan .74
9.2.2 Multi-professional care plan .75
9.2.3 Core care plan .75
9.2.4 Clinical guideline.76
9.2.5 Health objective .78
9.2.6 Healthcare goal . .79
9.2.7 Healthcare activities bundle .79
9.2.8 Needed healthcare activity . .80
10 Concepts related to time .82
10.1 General .82
10.2 Health related period .82
10.2.1 Mandated period of care .83
10.2.2 Healthcare activity period .84
10.2.3 Healthcare activity delay.90
10.2.4 Clinical process episode .93
10.2.5 Health condition period .93
10.2.6 Episode of care .94
11 Concepts related to responsibilities .97
11.1 General .97
11.2 Healthcare mandate .97
11.2.1 Demand mandate .99
11.2.2 Care period mandate .100
11.2.3 Healthcare activity mandate .101
11.2.4 Continuity facilitator mandate .102
11.2.5 Mandate to export personal information .102
11.2.6 Informed consent .103
11.2.7 Dissent .104
11.2.8 Consent competence.104
11.2.9 Authorization by law .105
11.2.10 Healthcare commitment .105
11.2.11 Subject of care desire .106
11.3 Demand for care.106
11.3.1 Demand for initial contact .108
11.3.2 Referral .108
11.3.3 Request .109
11.3.4 Reason for demand for care .110
12 Concepts related to information management .111
12.1 General .111
12.2 Health record .111
12.2.1 Professional health record .113
12.2.2 Personal health record . .114
12.2.3 Health record component .114
12.2.4 Electronic health record component .115
12.3 Sharable data repository .116
iv © ISO 2015 – All rights reserved
ISO 13940:2015(E)
12.4 Summarized healthcare information repository .117
12.5 Health record extract .117
12.5.1 Electronic health record extract .118
12.5.2 Electronic patient summary.119
12.5.3 Clinical Report .120
12.5.4 Health concern .123
12.5.5 Healthcare information request .124
12.6 Certificat e related to a healthcare matter .125
13 Conformance .126
Annex A (informative) Framework for the normative concepts in this International Standard .127
Bibliography .142
ISO 13940:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
vi © ISO 2015 – All rights reserved
ISO 13940:2015(E)
0 Introduction
0.1 General
The purpose of this International Standard is to define the generic concepts needed to achieve
continuity of care. Continuity of care is an important aspect of quality and safety in healthcare and
semantic interoperability is a basic requirement for continuity of care. The concepts that are needed for
these should represent both the content and context of the healthcare services.
Healthcare is provided through activities in healthcare and clinical processes. These types of processes
reflect the interaction between a subject of care and healthcare professionals. A clinical process
provides continuity from the subject of care’s perspective. To complete the concepts representing
continuity of care, a number of basic premises for management, resource handling and administration
are also needed.
The system of concepts for continuity of care defined in this International Standard is based upon
the clinical perspective with the clinical process as focus, it defines its component concepts and
their descriptive terms regarding all types of healthcare and especially considering patient-centred
continuity of care. This International Standard will establish a common conceptual framework across
national, cultural and professional barriers.
0.2 Aims for this International Standard
The general aim for this International Standard is to provide a comprehensive, conceptual basis for
content and context in healthcare services. It should be the foundation for interoperability at all levels
in healthcare organizations and for development of information systems in healthcare.
The concepts aim to support the continuity of care in healthcare with clinical processes as the focus,
enabling the use of healthcare information for other purposes such as secondary use for follow-up
and knowledge management. The core business in healthcare is the interaction between subjects of
care and healthcare professionals, such interactions occur in healthcare and clinical processes and are
the justification for the process approach of this International Standard. To be able to represent both
clinical content and clinical context, this International Standard is based upon the clinical perspective
and has focus upon the clinical process as a main concept for achieving continuity of care.
To be able to support continuity of care, the standard also aims to include comprehensive concept
definitions and concept relations for the clinical, management and resource aspects of healthcare.
In practice this International Standard aims to be used whenever requirements for information in
healthcare are specified. This will cover all levels of specifications in the development of,
• enterprise models as a common basis for interoperability on international, national or local levels,
• information systems, and
• structured information for specified types of clinical processes.
0.3 About the concept of health
This International Standard is based on the World Health Organization’s (WHO) declaration of health
from 1948: “. a state of complete physical, mental and social well-being and not merely the absence
of disease or infirmity”. In 1986 WHO made two amendments to the above definition: “resource for
everyday life, not the objective of living” and “health is a positive concept emphasizing social and
personal resources, as well as physical capacities”.
In the International Classification of Functioning, Disability and Health (ICF) of WHO, the concept of
health is categorized in a more specified way. The theoretical model in ICF identifies health components;
body function, body structure, activity and participation, personal and environmental factors
respectively. This International Standard applies the ICF model of health based on the health declaration.
ISO 13940:2015(E)
In this International Standard, the word “health” is not used as an isolated term designating any
concept within the scope of the standard. The word “health” is merely used as prefix in several terms.
The meaning of this prefix is that the concept represented by the term has to do with the subject of
care’s health state or health condition, often in relation to a healthcare/clinical process.
0.4 Healthcare versus social care
Healthcare as well as social care has the objective to influence, restore and maintain health in the WHO
sense. All kinds of activities that have the potential to influence any one of the five components of health
mentioned in the ICF model can be a part of such care. There is an evident overlap between healthcare
activities and social care activities. This International Standard is focused upon the part of healthcare
that (in most cultures) does not include social care. The role of the subject of care is defined with
respect to healthcare and the terms chosen are from this sector. However, many of the concepts are
relevant for the social care sector and through the cooperation of the different domains of healthcare
this International Standard should also be applicable for social care.
0.5 Intended users for this International Standard
All parties interested in the interoperability issues in health care are intended users of this health
informatics standard. This includes, but is not limited to, healthcare professionals and teams, subjects
of care, healthcare managers, healthcare funding organizations and all types of healthcare providers
and community care teams.
This system of concepts is relevant across all healthcare information and the development and use of
healthcare information systems. It can also be used for business analysis as a basis for organizational
decisions and more widely in developments that are not inherently tied to the use of information systems.
0.6 Architecture of this system of concepts
To cover continuity of care, concepts are needed from all of these basic process aspects:
• Healthcare/clinical processes
• Management
• Support
This system of concepts is based upon the clinical perspective of healthcare, this being the
healthcare/clinical processes. All other areas of work in healthcare both relate to and interact with
the healthcare/clinical processes. As such, the management aspects of healthcare are identified in the
process management areas and similarly the resource support areas are correspondingly identified
as outcomes of the support processes. This architecture with the areas around the healthcare/clinical
process is described in Figure 1.
viii © ISO 2015 – All rights reserved
ISO 13940:2015(E)
Figure 1 — Architecture of the concept areas
0.7 Description and display of concepts
In this International Standard the concepts are grouped into separate clauses. The relationships between
the enterprise/information areas that need to be covered are used to structure this International
Standard. Each of the concepts are defined and described systematically and their relations are shown
in UML models.
Descriptions are framed within tables, following the same pattern, and information is systematically
provided for all the concepts presented in Clauses 5 to 12. Some categories will intentionally be left
blank as these are not relevant to a given concept.
Examples are provided wherever they are considered relevant and necessary. However and in
general, examples for superordinate concepts are to be sought at the level of the corresponding
subordinate concepts.
ISO 13940:2015(E)
In order to help the reader understand the relationships between these concepts more easily, diagrams
have been included based on UML conventions. For each one of the concepts described in Clauses 5 to
12, a partial view of the general subclause and comprehensive diagram is provided, showing only its
direct relationships with other concepts belonging to the relevant aspect of the system of concepts.
At the beginning of Clauses 5 to 12 there are diagrams that provide partial views of the concepts that
are to follow and focus upon the topic addressed in the corresponding clause. For clarity of reading,
• concepts shown in white with a solid border are defined in the same clause or subclause,
• concepts defined in other clauses or subclauses are shown in grey with a solid border,
• concepts not defined in this International Standard are shown in grey with a dashed border,
• for the concepts shown in white, all relationships are included,
• relationships between concepts shown in grey are not included,
• italic characters are used in the headings for concepts that are purely abstract and therefore
supported only through their specializations.
The purpose of using concept models in this International Standard is to highlight the relationships
between concepts. Attributes do not belong to the field of concept modelling. Attributes can be added in
the course of implementation and still be conformant to this International Standard.
x © ISO 2015 – All rights reserved
INTERNATIONAL STANDARD ISO 13940:2015(E)
Health informatics — System of concepts to support
continuity of care
1 Scope
This International standard defines a system of concepts for different aspects of the provision of
healthcare.
The core business in healthcare is the interaction between subjects of care and healthcare professionals.
Such interactions occur in healthcare/clinical processes and are the justification for the process
approach of this International Standard. To be able to represent both clinical content and clinical
context, this International Standard is related to a generic healthcare/clinical process model as well
as comprehensive concept definitions and concept models for the clinical, management and resource
aspects of healthcare services.
In practice this International Standard covers the concept definitions needed whenever structured
information in healthcare is specified as a requirement. The definitions are intended to refer to the
conceptual level only and not to details of implementation. This International Standard will cover all
levels of specifications in the development of
• logical reference models within the information viewpoint as a common basis for semantic
interoperability on international, national or local levels,
• information systems, and
• information for specified types of clinical processes.
How to perform specific healthcare/clinical/informatics processes is not covered by this
International Standard.
Healthcare research processes and healthcare educational processes are not covered in this
International Standard.
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.
ISO 9000, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.
3.1 Healthcare
3.1.1
healthcare
care activities, services, management or supplies related to the health of an individual
Note 1 to entry: This includes more than performing procedures for subjects of care. It includes, for example, the
management of information about patients, health status and relations within the healthcare delivery framework
and may also include the management of clinical knowledge.
ISO 13940:2015(E)
[SOURCE: ISO/TR 18307:2001, 3.70, modified]
3.1.2
continuity of care
efficient, effective, ethical care delivered through interaction, integration, co-ordination and sharing of
information (3.9.5) between different healthcare actors over time
Note 1 to entry: “Healthcare actors” is defined in 5.2.1.
3.2 Concepts and terms
3.2.1
concept
unit of knowledge created by a unique combination of characteristics
[SOURCE: ISO 1087-1:2000, 3.2.1]
3.2.2
system of concepts
DEPRECATED: concept system
set of concepts (3.2.1) structured according to the relations among them
[SOURCE: ISO 1087-1:2000, 3.2.11]
3.2.3
deprecated term
term rejected by an authoritative body
[SOURCE: ISO 1087-1:2000, 3.4.17]
3.3 Actors
3.3.1
organization
unique framework of authority within which a person (3.3.4) or persons act, or are designated to act
towards some purpose
[SOURCE: ISO/IEC 6523-1:1998, 3.1]
Note 1 to entry: Groupings or subdivisions of organizations may also be considered as organizations where there
is need to identify them in this way for purposes of information interchange.
Note 2 to entry: In this International Standard, this definition applies to any kind of organizations, whatever
their legal status.
3.3.2
organizational pattern
relationships between the various parts of an organization (3.3.1)
3.3.3
party
person or group performing a role (3.3.5) in relation to the business of a specific community or domain
[SOURCE: ISO 8459:2009, 2.33]
3.3.4
person
human being regarded as an individual
2 © ISO 2015 – All rights reserved
ISO 13940:2015(E)
3.3.5
role
function or position
[SOURCE: ISO/HL7 21731:2006]
3.3.6
person role
role (3.3.5) of a person (3.3.4)
3.3.7
organization role
role (3.3.5) of an organization (3.3.1)
3.4 Resources
3.4.1
resource
asset that is utilized or consumed during the execution of a process (3.6.1)
Note 1 to entry: Includes diverse entities such as funding, personnel, facilities, capital equipment, tools, and
utilities such as power, water, fuel and communication infrastructures.
Note 2 to entry: Resources include those that are reusable, renewable or consumable.
EXAMPLE Time, personnel, human skills and knowledge, equipment, services, supplies, facilities,
technology, data, money
[SOURCE: ISO/IEC/IEEE 15288:2015, 4.1.38, modified]
3.4.2
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article, 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,
...
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