1、 IEC/TR 80002-1Edition 1.0 2009-09TECHNICAL REPORT Medical device software Part 1:Guidance on the application of ISO 14971 to medical device software IEC/TR 80002-1:2009(E)colourinsideLICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.TH
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8、 Customer Service Centre FAQ or contact us:Email:csciec.ch Tel.:+41 22 919 02 11 Fax:+41 22 919 03 00 LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.IEC/TR 80002-1Edition 1.0 2009-09TECHNICAL REPORT Medical device software Part 1:Gui
9、dance on the application of ISO 14971 to medical device software INTERNATIONAL ELECTROTECHNICAL COMMISSION XBICS 11.040.01 PRICE CODEISBN 2-8318-1061-9 colourinsideLICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.2 TR 80002-1 IEC:2009(
10、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 MANAG
11、EMENT 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
12、 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
13、.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
14、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 prev
15、ents incorrect software outputs from causing HARM.75H28 Figure A.1 Relationship between sequence of events,HARM and HAZARD.76H41 LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.TR 80002-1 IEC:2009(E)3 Table 1 Requirements for document
16、ation 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
