1、 IEC/TR 80002-1 Edition 1.0 2009-09 TECHNICAL REPORT Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software IEC/TR 80002-1:2009(E) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless ot
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8、2 11 Fax: +41 22 919 03 00 IEC/TR 80002-1 Edition 1.0 2009-09 TECHNICAL REPORT Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software INTERNATIONAL ELECTROTECHNICAL COMMISSION XB ICS 11.040.01 PRICE CODE ISBN 2-8318-1061-9colour inside 2 TR 80002-1 IEC:20
9、09(E) CONTENTS FOREWORD.4 INTRODUCTION.6 1 General 7 1.1 Scope7 1.2 Normative references 7 2 Terms and definitions .8 3 General requirements for RISK MANAGEMENT8 3.1 RISK MANAGEMENT PROCESS .8 3.2 Management responsibilities .11 3.3 Qualification of personnel13 3.4 RISK MANAGEMENT plan 14 3.5 RISK M
10、ANAGEMENT FILE .16 4 RISK ANALYSIS .17 4.1 RISK ANALYSIS PROCESS17 4.2 INTENDED USE and identification of characteristics related to the SAFETY of the MEDICAL DEVICE18 4.3 Identification of HAZARDS .20 4.4 Estimation of the RISK(S) for each HAZARDOUS SITUATION22 5 RISK EVALUATION .25 6 RISK CONTROL
11、.26 6.1 RISK reduction .26 6.2 RISK CONTROL option analysis26 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 CONTROL37 7 Evaluation of overall residual risk acc
12、eptability.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 managem
13、ent grid57 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 CONTR
14、OL measure which prevents incorrect software outputs from causing HARM . 75H28 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 requirem
15、ents .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 a
16、ssurance that RISK CONTROL methods are likely to perform as intended52 Table C.1 Potential software-related pitfalls to avoid53 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 applicatio
17、n 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 q
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26、 IEC Publications. 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 s
27、ubject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. 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
28、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 technic
29、al 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/639
30、A/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 w
31、ith 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.
32、 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
33、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. I
34、MPORTANT The “colour inside” logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this publication using a colour printer. 6 TR 80002-1 IEC:2009(E) INTRODUCTION Soft
35、ware is often an integral part of MEDICAL DEVICE technology. Establishing the SAFETY and effectiveness of a MEDICAL DEVICE containing software requires knowledge of what the software is intended to do and demonstration that the implementation of the software fulfils those intentions without causing
36、any unacceptable RISKS. It is important to understand that software is not itself a HAZARD, but software may contribute to HAZARDOUS SITUATIONS. Software should always be considered in a SYSTEM perspective and software RISK MANAGEMENT cannot be performed in isolation from the SYSTEM. Complex softwar
37、e designs can permit complex sequences of events which may contribute to HAZARDOUS SITUATIONS. Much of the TASK of software RISK MANAGEMENT consists of identifying those sequences of events that can lead to a HAZARDOUS SITUATION and identifying points in the sequences of events at which the sequence
38、 can be interrupted, preventing HARM or reducing its probability. Software sequences of events which contribute to HAZARDOUS SITUATIONS may fall into two categories: a) sequences of events representing unforeseen software responses to inputs (errors in specification of the software); b) sequences of
39、 events arising from incorrect coding (errors in implementation of the software). These categories are specific to software, arising from the difficulty of correctly specifying and implementing a complex SYSTEM and the difficulty of completely verifying a complex SYSTEM. Since it is very difficult t
40、o estimate the probability of software ANOMALIES that could contribute to HAZARDOUS SITUATIONS, and since software does not fail randomly in use due to wear and tear, the focus of software aspects of RISK ANALYSIS should be on identification of potential software functionality and ANOMALIES that cou
41、ld result in HAZARDOUS SITUATIONS not on estimating probability. RISKS arising from software ANOMALIES need most often to be evaluated on the SEVERITY of the HARM alone. RISK MANAGEMENT is always a challenge and becomes even more challenging when software is involved. The following clauses contain a
42、dditional details regarding the specifics of software and provide guidance for understanding ISO 14971:2007 in a software perspective. Organization of the technical report This technical report is organized to follow the structure of ISO 14971:2007 and guidance is provided for each RISK MANAGEMENT a
43、ctivity in relation to software. There is some intentional REDUNDANCY in the information provided due to the iterative nature of RISK MANAGEMENT activities in the software LIFE-CYCLE. TR 80002-1 IEC:2009(E) 7 MEDICAL DEVICE SOFTWARE Part 1: Guidance on the application of ISO 14971 to medical device
44、software 1 General 1.1 Scope This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software Software li
45、fe cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. This technical report is aimed at RISK MANAGEMENT practitioners who need to perform RISK MANAGEMENT when software is included in the MEDICAL DEVICE/SYSTEM, and at software engineers who
46、 need to understand how to fulfil the requirements for RISK MANAGEMENT addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing MEDICAL DEVICE RISK MANAGEMENT. IEC 62304:2006, makes a normative reference to ISO 149
47、71 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on MEDICAL DEVICES, this technical report may be used to implement a SAFETY RISK MANAGEMENT PROCESS for all softwa
48、re in the healthcare environment independent of whether it is classified as a MEDICAL DEVICE. This technical report does not address: areas already covered by existing or planned standards, e.g. alarms, usability engineering, networking, etc.; production or quality management system software; or sof
49、tware development tools. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities. For the purposes of this technical report, “should” is used to indicate that amongst several possibilities to meet a requirement, one is recommended as being particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required. This term is not to be
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