IEC 80001-1:2010

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.

Application de la gestion des risques aux réseaux des technologies de l'information contenant les dispositifs médicaux - Partie 1: Fonctions, responsabilités et activités

La CEI 80001-1:2010 Etant donné que les dispositifs médicaux sont incorporés dans des réseaux TI afin d'en tirer des bénéfices (par exemple, l'interopérabilité), définit les fonctions, responsabilités et activités nécessaires à la gestion des risques des réseaux TI comportant des dispositifs médicaux afin de traiter la sécurité, l'efficacité et la sécurité des données et du système (les propriétés clés). La présente norme internationale ne spécifie pas les niveaux de risques acceptables. La CEI 80001-1:2010 s'applique dès lors qu'un dispositif médical a été acquis par un organisme responsable et qu'il est envisagé de l'incorporer dans un réseau IT. Elle s'applique tout au long du cycle de vie des réseaux TI comportant des dispositifs médicaux. La CEI 80001-1:2010 s'applique lorsqu'il n'existe aucun fabricant de dispositifs médicaux se portant responsable de la définition des propriétés clés du réseau TI comportant un dispositif médical. La CEI 80001-1:2010 s'applique aux organismes responsables, aux fabricants de dispositifs médicaux et aux fournisseurs d'autres technologies de l'information pour les besoins de la gestion des risques d'un réseau IT incorporant des dispositifs médicaux tels que spécifiés par l'organisme responsable. Elle ne s'applique pas aux applications d'utilisation personnelle où le patient, l'opérateur et l'organisme responsable ne désignent qu'une seule et même personne.

General Information

• Status: Published
• Publication Date: 26-Oct-2010
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 7 - TC 62/SC 62A/JWG 7
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 21-Sep-2021

Relations

• Revised: IEC 80001-1:2021 - Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 80001-1
Edition 1.0 2010-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 1: Roles, responsibilities and activities

Application de la gestion des risques aux réseaux des technologies de
l’information contenant des dispositifs médicaux –
Partie 1: Fonctions, responsabilités et activités

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IEC 80001-1
Edition 1.0 2010-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 1: Roles, responsibilities and activities

Application de la gestion des risques aux réseaux des technologies de
l’information contenant des dispositifs médicaux –
Partie 1: Fonctions, responsabilités et activités

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.01; 35.240.80 ISBN 978-2-88912-221-9

– 2 – 80001-1 © IEC:2010
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.9
2 Terms and definitions .9
3 Roles and responsibilities.14
3.1 General .14
3.2 RESPONSIBLE ORGANIZATION .14
3.3 TOP MANAGEMENT responsibilities .15
3.4 MEDICAL IT-NETWORK RISK MANAGER .16
3.5 MEDICAL DEVICE manufacturer(s).17
3.6 Providers of other information technology.18
4 Life cycle RISK MANAGEMENT in MEDICAL IT-NETWORKS.19
4.1 Overview .19
4.2 RESPONSIBLE ORGANIZATION RISK MANAGEMENT.20
4.2.1 POLICY FOR RISK MANAGEMENT for incorporating MEDICAL DEVICES.20
4.2.2 RISK MANAGEMENT PROCESS.21
4.3 MEDICAL IT-NETWORK RISK MANAGEMENT planning and documentation .21
4.3.1 Overview .21
4.3.2 RISK-relevant asset description.22
4.3.3 MEDICAL IT-NETWORK documentation .22
4.3.4 RESPONSIBILITY AGREEMENT .22
4.3.5 RISK MANAGEMENT plan for the MEDICAL IT-NETWORK .24
4.4 MEDICAL IT-NETWORK RISK MANAGEMENT.24
4.4.1 Overview .24
4.4.2 RISK ANALYSIS .24
4.4.3 RISK EVALUATION .25
4.4.4 RISK CONTROL .25
4.4.5 RESIDUAL RISK evaluation and reporting .26
4.5 CHANGE-RELEASE MANAGEMENT and CONFIGURATION MANAGEMENT .27
4.5.1 CHANGE-RELEASE MANAGEMENT PROCESS.27
4.5.2 Decision on how to apply RISK MANAGEMENT.27
4.5.3 Go-live .29
4.6 Live network RISK MANAGEMENT.29
4.6.1 Monitoring .29
4.6.2 EVENT MANAGEMENT .29
5 Document control .30
5.1 Document control procedure.30
5.2 MEDICAL IT-NETWORK RISK MANAGEMENT FILE.30
Annex A (informative) Rationale.31
Annex B (informative) Overview of RISK MANAGEMENT relationships .35
Annex C (informative) Guidance on field of application .36
Annex D (informative) Relationship with ISO/IEC 20000-2:2005 Information technology
– Service management – Part 2: Code of practice.38
Bibliography.42

80001-1 © IEC:2010 – 3 –
Figure 1 – Illustration of TOP MANAGEMENT responsibilities.16
Figure 2 – Overview of life cycle of MEDICAL IT-NETWORKS including RISK MANAGEMENT .20
Figure B.1 – Overview of roles and relationships .35
Figure D.1 – Service management processes .39

Table A.1 – Relationship between ISO 14971 and IEC 80001-1 .33
Table C.1 – IT-NETWORK scenarios that can be encountered in a clinical environment.36
Table D.1 – Relationship between IEC 80001-1 and ISO/IEC 20000-1:2005 or
ISO/IEC 20000-2:2005.40

– 4 – 80001-1 © IEC:2010
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 1: Roles, responsibilities and activities

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