IEC 80001-1:2021

FINAL
INTERNATIONAL IEC/FDIS
DRAFT
STANDARD 80001-1
ISO/TC 215
Safety, effectiveness and security
Secretariat: ANSI
in the implementation and use
Voting begins on:
2021-02-12 of connected medical devices or
connected health software —
Voting terminates on:
2021-04-09
Part 1:
Application of risk management
Member bodies are requested to consult relevant national interests in IEC/SC
62A before casting their ballot to the e-Balloting application.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC/FDIS 80001-1:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. IEC 2021

IEC/FDIS 80001-1:2021(E)
ii © IEC 2021 – All rights reserved

– 2 – IEC FDIS 80001-1 © IEC 2021
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 9
4 Principles . 11
5 Framework . 12
5.1 General . 12
5.2 Leadership and commitment . 12
5.3 Integrating RISK MANAGEMENT . 12
5.4 Design/planning . 12
5.4.1 General . 12
5.4.2 RISK MANAGEMENT FILE . 13
5.4.3 Understanding the organization and the SOCIOTECHNICAL ECOSYSTEM . 13
5.4.4 Articulating RISK MANAGEMENT commitment . 14
5.4.5 Assigning organizational roles, authorities, responsibilities and
accountabilities . 14
5.4.6 Allocating resources . 15
5.4.7 Establishing communication and consultation . 15
5.5 Implementation . 15
5.6 Evaluation . 16
5.7 Improvement . 16
6 RISK MANAGEMENT PROCESS . 16
6.1 Generic requirements. 16
6.1.1 General . 16
6.1.2 RISK ANALYSIS . 17
6.1.3 RISK EVALUATION . 19
6.1.4 RISK CONTROL . 19
6.2 Lifecycle specific requirements . 22
6.2.1 General . 22
6.2.2 Acquisition . 22
6.2.3 Installation, customization and configuration . 22
6.2.4 Integration, data migration, transition and validation . 23
6.2.5 Implementation, workflow optimization and training . 23
6.2.6 Operation and maintenance . 23
6.2.7 Decommission . 25
Annex A (informative) IEC 80001-1 requirements mapping table . 26
Annex B (informative) Guidance for accompanying document Information . 33
B.1 Foreword . 33
B.2 Information system categorization . 34
B.3 Overview. 34
B.4 Reference documents . 34
B.5 System level description . 34
B.5.1 Environment description . 34
B.5.2 Network ports, protocols and services . 35

IEC FDIS 80001-1 © IEC 2021 – 3 –
B.5.3 Purpose of connection to the health IT infrastructure . 35
B.5.4 Networking requirements . 35
B.5.5 Required IT-network services . 35
B.5.6 Data flows and protocols . 35
B.6 Security and user access . 36
B.6.1 General . 36
B.6.2 Malware / antivirus / whitelisting . 36
B.6.3 Security exclusions . 36
B.6.4 System access . 36
B.7 RISK MANAGEMENT . 38
Bibliography . 39

Figure 1 – Lifecycle framework addressing safety, effectiveness and security of health

IT software and health IT systems. 8
Figure 2 – RISK MANAGEMENT PROCESS . 13

Table A.1 – IEC 80001-1 requirements table . 26
Table B.1 – Organization name and location . 33
Table B.2 – Cybersecurity device characterization level . 34
Table B.3 – Ports, protocols and services . 35
Table B.4 – Information system name and title . 36
Table B.5 – Roles and privileges . 37

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY, EFFECTIVENESS AND SECURITY IN THE IMPLEMENTATION
AND USE OF CONNECTED MEDICAL DEVICES
OR CONNECTED HEALTH SOFTWARE –

Part 1: Application of risk management

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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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 80001-1 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 of ISO Technical
Committee 215: Health informatics.
It is published as a double logo standard.
This second edition cancels and replaces the first edition published in 2010. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;

IEC FDIS 80001-1 © IEC 2021 – 5 –
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles
that support preservation of the KEY PROPERTIES during the implementation and use of
connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
The text of this document is based on the following documents:
FDIS Report on voting
62A/XX/FDIS 62A/XX/RVD
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
• requirements and definitions: roman type;
• test specifications: italic 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 THIS DOCUMENT OR AS NOTED ARE PRINTED IN SMALL CAPITALS.
In referring to the structure of this document, the term
• “clause” means one of the five numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 5 includes subclauses 5.1, 5.2, etc.);
• “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2 and 5.3 are all
subclauses of Clause 5).
References to clauses within this document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used i
...