IEC TR 60601-4-5:2021

Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications

IEC TR 60601-4-5:2021 provides detailed technical specifications for SECURITY features of MEDICAL DEVICES used in MEDICAL IT-NETWORKS. MEDICAL DEVICES dealt with in this document include MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS and MEDICAL DEVICE SOFTWARE. MEDICAL DEVICE SOFTWARE, although not in the scope of IEC 60601 (all parts), can also make use of this document. Based on the seven foundational requirements described in the state-of-the-art document IEC TS 62443 1 1:2009, this document provides specifications for different MEDICAL DEVICE capability SECURITY LEVELS (SL C). The specified SECURITY capabilities of a MEDICAL DEVICE can be used by various members of the medical community to integrate the device correctly into defined SECURITY ZONES and CONDUITS of a MEDICAL IT-NETWORK with an appropriate MEDICAL IT NETWORK's target SECURITY LEVEL (SL T).
This document is applicable to MEDICAL DEVICES with external data interface(s), for example when connected to a MEDICAL IT-NETWORK or when a human interface is used for processing – e.g. entering, capturing or viewing – CONFIDENTIAL DATA.
This document does not apply to other software used on a MEDICAL IT-NETWORK which does not meet the definition of MEDICAL DEVICE SOFTWARE.
This document does not apply to in-vitro diagnostic devices (IVD).

General Information

• Status: Published
• Publication Date: 17-Jan-2021
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: MT 35 - TC 62/SC 62A/MT 35
• Current Stage: PPUB - Publication issued
• Start Date: 21-Jan-2021
• Completion Date: 18-Jan-2021

Standards Content (Sample)

IEC TR 60601-4-5 ®
Edition 1.0 2021-01
TECHNICAL
REPORT
colour
inside
Medical electrical equipment –
Part 4-5: Guidance and interpretation – Safety-related technical security
specifications
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IEC TR 60601-4-5 ®
Edition 1.0 2021-01
TECHNICAL
REPORT
colour
inside
Medical electrical equipment –

Part 4-5: Guidance and interpretation – Safety-related technical security

specifications
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-9227-3

– 2 – IEC TR 60601-4-5:2021 © IEC 2021
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 Common SECURITY constraints . 15
4.1 Overview. 15
4.2 * Support of ESSENTIAL FUNCTION . 15
4.3 COMPENSATING COUNTERMEASURES . 16
4.4 LEAST PRIVILEGE . 17
4.5 Data minimization . 17
4.6 * Overarching constraints . 17
4.6.1 Constraints referenced by the MEDICAL DEVICE specifications . 17
4.6.2 Hardware SECURITY . 17
4.6.3 * Specific SECURITY features for MEDICAL DEVICES . 18
5 SECURITY LEVELS for the different foundational requirements . 18
5.1 * Application of SECURITY LEVELS . 18
5.2 Modified specifications for SECURITY LEVELS . 18
6 Technical description . 19
7 Mapping of requirements to capability security levels (SL-C) . 21
Annex A (informative) General guidance and rationale . 26
A.1 The approach of this document: Type testable MEDICAL DEVICE IT SECURITY
properties . 26
A.2 Typical network connections of MEDICAL DEVICES covered in this document . 32
A.3 Inclusion of ME SYSTEMS . 33
A.4 Correlation to existing regulations, standards and technical specifications . 34
A.5 Concept of ZONES and CONDUITS with specified target SECURITY LEVELS
(SL-T) within an IT-NETWORK as specified by IEC 62443 (all parts) [3] . 37
A.6 Documentation of capability SECURITY LEVEL (SL-C) of a MEDICAL DEVICE . 37
A.7 Conceptual elements of IEC 62443 (all parts) [3] used for this document . 38
A.8 Correlation with IEC TR 80001-2-2 [9] . 48
Bibliography . 50

Figure 1 – ESSENTIAL FUNCTION . 16
Figure A.1 – Illustration with SECURITY LEVELS . 27
Figure A.2 – Capability – Target – Achieved . 28
Figure A.3 – Wireless point-to-point connection between a portable device (e.g.
PATIENT programmer) and an implant . 32
Figure A.4 – Connection between a PATIENT's portable device and a doctor's computer . 32
Figure A.5 – Connection between a MEDICAL DEVICE and a doctor's computer . 32
Figure A.6 – IT-NETWORK in a hospital . 33
Figure A.7 – Selection of IT SECURITY related documents . 35
Figure A.8 – Example of what a complex IT-NETWORK can consist of . 37
Figure A.9 – Comparison of objectives between industrial automation and control
systems and general IT-NETWORKS . 39

Table 1 – Mapping of single requirements to capability security levels (SL-C) . 22
Table A.1 – Exemplary criteria for the selection of appropriate target SECURITY LEVEL
SL-T in typical INTENDED USE environments . 31
Table A.2 – Exemplary vector of capability SECURITY LEVEL SL-C . 38

– 4 – IEC TR 60601-4-5:2021 © IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 4-5: Guidance and interpretation –
Safety-related technical security specifications

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC TR 60601-4-5 has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, of IEC technical committee 62: Electrical equipment in
medical practice. It is a Technical Report.
The text of this Technical Report is based on the following documents:
Draft TR Report on voting
62A/1402/DTR 62A/1417A/RVDTR
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Technical Report is English.

This document has been drafted in accordance with the 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:
– TERMS DEFINED IN CLAUSE 3: SMALL CAPITALS;
– COMPLIANCE STATEMENTS IN CLAUSE 4 AND CLAUSE 5: ITALICS.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex A.
A list of all parts in the IEC 60601 series, published under the general title Medical electrical
equipment, 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 "http://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.
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– 6 – IEC TR 60601-4-5:2021 © IEC 2021
INTRODUCTION
This document provides IT SECURITY specifications for MEDICAL ELECTRICAL EQUIPMENT (ME
EQUIPMENT) AND MEDICAL ELECTRICAL SYSTEMS (ME SYSTEMS) connectable to MEDICAL
IT-NETWORKS as network components. MEDICAL DEVICE SOFTWARE, although not in the scope of
IEC 60601 (all parts), can also make use of this document. The intent of this document is to
specify SECURITY capabilities that enable a MEDICAL DE
...