EN ISO/IEEE 11073-40101:2022

SLOVENSKI STANDARD
01-julij-2022
Zdravstvena informatika - Interoperabilnost naprav - 40101. del: Temeljno -
Kibernetska varnost - Procesi ocenjevanja ranljivosti (ISO/IEEE 11073-40101:2022)
Health informatics - Device interoperability - Part 40101: Foundational - Cybersecurity -
Processes for vulnerability assessment (ISO/IEEE 11073-40101:2022)
Informatique de santé - Interopérabilité des dispositifs - Partie 40101: Fondamentaux -
Cybersécurité - Processus pour l'évaluation de la vulnérabilité (ISO/IEEE 11073-
40101:2022)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-40101:2022
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/IEEE 11073-
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2022
ICS 35.240.80
English Version
Health informatics - Device interoperability - Part 40101:
Foundational - Cybersecurity - Processes for vulnerability
assessment (ISO/IEEE 11073-40101:2022)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Geräteinteroperabilität - Teil
- Partie 40101: Fondamentaux - Cybersécurité - 40101: Grundlagen - Cybersicherheit - Prozess zur
Processus pour l'évaluation de la vulnérabilité Schwachstellenanalyse (ISO/IEEE 11073-40101:2022)
(ISO/IEEE 11073-40101:2022)
This European Standard was approved by CEN on 13 March 2022.

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.

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Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
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United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-40101:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO/IEEE 11073-40101:2022) 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 September 2022, and conflicting national standards
shall be withdrawn at the latest by September 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN 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 standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-40101:2022 has been approved by CEN as EN ISO/IEEE 11073-
40101:2022 without any modification.

INTERNATIONAL ISO/IEEE
STANDARD 11073-40101
First edition
2022-03
Health informatics — Device
interoperability —
Part 40101:
Foundational — Cybersecurity
— Processes for vulnerability
assessment
Informatique de santé — Interopérabilité des dispositifs —
Partie 40101: Fondamentaux — Cybersécurité — Processus pour
l'évaluation de la vulnérabilité
Reference number
ISO/IEEE 11073-40101:2022(E)
© IEEE 2021
ISO/IEEE 11073-40101:2022(E)
© IEEE 2021
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Institute of Electrical and Electronics Engineers, Inc
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Website: www.ieee.org
Published in Switzerland
ii
© IEEE 2021 – All rights reserved

ISO/IEEE 11073-40101:2022(E)
Foreword
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ISO/IEEE 11073-40101 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering
in Medicine and Biology Society (as IEEE Std 11073-40101-2020) and drafted in accordance with its
editorial rules. It was adopted, under the “fast-track procedure” defined in the Partner Standards
Development Organization cooperation agreement between ISO and IEEE, by Technical Committee
ISO/TC 215, Health informatics.
A list of all parts in the ISO/IEEE 11073 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
.
complete listing of these bodies can be found at www.iso.org/members.html
© IEEE 2021 – All rights reserved iii

IEEE Std 11073-40101™-2020
Health informatics—Device interoperability
Part 40101:
Foundational—Cybersecurity—
Processes for vulnerability assessment
Developed by the
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 24 September 2020
IEEE SA Standards Board
ISO/IEEE 11073-40101:2022(E)
Abstract: For Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs), an iterative,
systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and
estimation of risk is defined by this standard. The standard presents one approach to iterative
vulnerability assessment that uses the Spoofing, Tampering, Repudiation, Information Disclosure,
Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded
Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system
decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the
remaining vulnerabilities are reduced to an acceptable level of risk.
Keywords: cybersecurity, embedded Common Vulnerability Scoring System, IEEE 11073-40101™,
medical device communication, Personal Health Devices, Point-of-Care Devices, STRIDE,
vulnerability assessment

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Open Web Application Security Project and OWASP are registered trademarks of the OWASP Foundation, Inc.
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ISO/IEEE 11073-40101:2022(E)
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