IEC TR 80001-2-8:2016

IEC TR 80001-2-8
Edition 1.0 2016-05
TECHNICAL
REPORT
Application of risk management for IT-networks incorporating medical devices –
Part 2-8: Application guidance – Guidance on standards for establishing the
security capabilities identified in IEC TR 80001-2-2
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IEC TR 80001-2-8
Edition 1.0 2016-05
TECHNICAL
REPORT
Application of risk management for IT-networks incorporating medical devices –

Part 2-8: Application guidance – Guidance on standards for establishing the

security capabilities identified in IEC TR 80001-2-2

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-3412-9

– 2 – IEC TR 80001-2-8:2016 © IEC 2016
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 9
2 Normative references. 9
3 Terms and definitions . 10
4 Guidance for establishing SECURITY CAPABILITIES . 13
4.1 General . 13
4.2 Automatic logoff – ALOF . 14
4.3 Audit controls – AUDT . 15
4.4 Authorization – AUTH . 17
4.5 Configuration of security features – CNFS . 19
4.6 Cyber security product upgrades – CSUP . 21
4.7 HEALTH DATA de-identification – DIDT . 24
4.8 Data backup and disaster recovery – DTBK . 25
4.9 Emergency access – EMRG . 27
4.10 HEALTH DATA integrity and authenticity – IGAU . 28
4.11 Malware detection/protection – MLDP . 30
4.12 Node authentication – NAUT . 32
4.13 Person authentication – PAUT . 35
4.14 Physical locks on device – PLOK . 37
4.15 Third-party components in product lifecycle roadmaps – RDMP . 39
4.16 System and application hardening – SAHD . 42
4.17 Security guides – SGUD . 44
4.18 HEALTH DATA storage confidentiality – STCF . 47
4.19 Transmission confidentiality – TXCF . 48
4.20 Transmission integrity – TXIG . 50
Bibliography . 51

Table 1 – ALOF controls . 14
Table 2 – AUDT controls . 16
Table 3 – AUTH controls . 18
Table 4 – CNFS controls . 20
Table 5 – CSUP controls . 22
Table 6 – DIDT controls . 24
Table 7 – DTBK controls . 26
Table 8 – EMRG controls . 28
Table 9 – IGAU controls . 29
Table 10 – MLDP controls . 30
Table 11 – NAUT controls . 33
Table 12 – PAUT controls . 36
Table 13 – PLOK controls . 38
Table 14 – RDMP controls . 40
Table 15 – SAHD controls . 43

Table 16 – SGUD controls. 45
Table 17 – STCF controls . 48
Table 18 – TXCF controls . 49
Table 19 – TXIG controls . 50

– 4 – IEC TR 80001-2-8:2016 © IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 2-8: Application guidance – Guidance on standards for
establishing the security capabilities identified in IEC TR 80001-2-2

FOREWORD
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data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 80001-2-8, which is a technical report, 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, and ISO technical committee 215: Health
1)
informatics.
___________
1)
This document contains original material that is © 2013, Dundalk Institute of Technology, Ireland. Permission is
granted to ISO and IEC to reproduce and circulate this material, this being without prejudice to the rights of
Dundalk Institute of Technology to exploit the original text elsewhere.

It is published as a double logo technical report.
The text of this technical report is based on the following documents of IEC:
Enquiry draft Report on voting
62A/1018/DTR 62A/1043A/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved by
14 P-members out of 31 having cast a vote.
This publication has been drafted in accordance with the ISO IEC Directives, Part 2.
Terms used throughout this technical report that have been defined in Clause 3 appear in
SMALL CAPITALS.
A list of all parts of the IEC 80001 series, published under the general title Application of risk
management for it-networks incorporating medical devices, can be found on the IEC website.
The committee has decided that t
...