IEC TR 80002-1:2009

IEC/TR 80002-1
Edition 1.0 2009-09
TECHNICAL
REPORT
colour
inside
Medical device software –
Part 1: Guidance on the application of ISO 14971 to medical device software

IEC/TR 80002-1:2009(E)
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IEC/TR 80002-1
Edition 1.0 2009-09
TECHNICAL
REPORT
colour
inside
Medical device software –
Part 1: Guidance on the application of ISO 14971 to medical device software

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XB
ICS 11.040.01 ISBN 978-2-88910-779-7

– 2 – TR 80002-1 © IEC:2009(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 General .7
1.1 Scope.7
1.2 Normative references .7
2 Terms and definitions .8
3 General requirements for RISK MANAGEMENT.8
3.1 RISK MANAGEMENT PROCESS .8
3.2 Management responsibilities .11
3.3 Qualification of personnel.13
3.4 RISK MANAGEMENT plan .14
3.5 RISK MANAGEMENT FILE .16
4 RISK ANALYSIS .17
4.1 RISK ANALYSIS PROCESS.17
4.2 INTENDED USE and identification of characteristics related to the SAFETY of the
MEDICAL DEVICE .18
4.3 Identification of HAZARDS .20
4.4 Estimation of the RISK(S) for each HAZARDOUS SITUATION .22
5 RISK EVALUATION .25
6 RISK CONTROL .26
6.1 RISK reduction .26
6.2 RISK CONTROL option analysis .26
6.3 Implementation of RISK CONTROL measure(s) .35
6.4 RESIDUAL RISK EVALUATION .36
6.5 RISK/benefit analysis .36
6.6 RISKS arising from RISK CONTROL measures .37
6.7 Completeness of RISK CONTROL.37
7 Evaluation of overall residual risk acceptability.38
8 Risk management report.38
9 Production and POST-PRODUCTION information.39
Annex A (informative)  Discussion of definitions.41
Annex B (informative) Examples of software causes .43
Annex C (informative) Potential software-related pitfalls .53
Annex D (informative) Life-cycle/risk management grid.57
Annex E (informative) SAFETY cases .70H60
34HBibliography.71H61
35HIndex .72H62
36HIndex of defined terms .73H63

Figure 1 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION and HARM – from ISO 14971:2007 Annex E .74H24
Figure 2 – FTA showing RISK CONTROL measure which prevents incorrect software
HARM .75H28
outputs from causing
Figure A.1 – Relationship between sequence of events, HARM and HAZARD .76H41

TR 80002-1 © IEC:2009(E) – 3 –

Table 1 – Requirements for documentation to be included in the RISK MANAGEMENT FILE
in addition to ISO 14971:2007 requirements .17
Table A.1 – Relationship between HAZARDS, foreseeable sequences of events,
HAZARDOUS SITUATIONS and the HARM that can occur .42
Table B.1 – Examples of causes by software function area .43
Table B.2 – Examples of software causes that can introduce side-effects .48
Table B.3 – Methods to facilitate assurance that RISK CONTROL methods are likely to
perform as intended.52
Table C.1 – Potential software-related pitfalls to avoid.53
Table D.1 – LIFE-CYCLE/RISK MANAGEMENT grid .57

– 4 – TR 80002-1 © IEC:2009(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICE SOFTWARE –
Part 1: Guidance on the application of ISO 14971
to medical device software
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 80002-1, which is a technical report, 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 ISO technical
committee 210: Quality management and corresponding general aspects for MEDICAL DEVICES.

TR 80002-1 © IEC:2009(E) – 5 –
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/639A/DTR 62A/664/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 technical report has been approved
by 16 P-members out of 17 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this technical report the following print types are used:
• requirements and definitions: in roman 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 USED THROUGHOUT THIS TECHNICAL REPORT THAT HAVE BEEN DEFINED IN CLAUSE 2 AND
ALSO GIVEN IN THE INDEX: IN SMALL CAPITALS.
A list of all parts of the IEC 80002 series, published under the general title Medical device
software, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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– 6 – TR 80002-1 © IEC:2009(E)
INTRODUCTION
Software is often an integral part of MEDICAL DEVICE technology. Establishing the SAFETY and
effectiveness of a MEDICAL DEVICE containing software requires knowle
...