1、 IEC/TR 80001-2-1 Edition 1.0 2012-07 TECHNICAL REPORT Application of risk management for IT-networks incorporating medical devices Part 2-1:Step-by-step risk management of medical IT-networks Practical applications and examples IEC/TR 80001-2-1:2012(E)colourinsideCopyrighted material licensed to BR
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10、ution is permitted.Uncontrolled when printed.IEC/TR 80001-2-1 Edition 1.0 2012-07 TECHNICAL REPORT Application of risk management for IT-networks incorporating medical devices Part 2-1:Step-by-step risk management of medical IT-networks Practical applications and examples INTERNATIONAL ELECTROTECHNI
11、CAL COMMISSION XB ICS 11.040.01;35.240.80 PRICE CODE ISBN 978-2-83220-201-2 Warning!Make sure that you obtained this publication from an authorized distributor.colourinsideCopyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,downloaded on Nov-28-2014 by James Madison.No furth
12、er reproduction or distribution is permitted.Uncontrolled when printed.2 TR 80001-2-1 IEC:2012(E)CONTENTS FOREWORD.5 INTRODUCTION.7 1 Scope.8 2 Normative references.8 3 Terms and definitions.8 4 Prerequisites.14 5 Study of terms used in RISK MANAGEMENT.14 5.1 Overview.14 5.2 HAZARDS.15 5.3 HAZARDOUS
13、 SITUATIONS.15 5.4 Foreseeable sequences of events and causes.16 5.5 UNINTENDED CONSEQUENCE.16 5.6 RISK CONTROL measures(mitigations).17 5.7 Degrees of RISK.17 5.8 Checking wording.18 6 The steps.18 6.1 Overview of the steps.18 6.2 A basic example using the 10 steps.19 6.2.1 General.19 6.2.2 Initial
14、 RISK Steps 1 5(Figure 2).19 6.2.3 RISK CONTROL and final RISK Steps 6 10(Figure 3).20 7 IEC 80001-1:2010,Clause 4.4:Step by step.23 7.1 General.23 7.2 Application of Subclause 4.4.1:Document all RISK MANAGEMENT elements.23 7.3 Note about RISK EVALUATION.23 7.4 The 10-step PROCESS.23 7.4.1 STEP 1:Id
15、entify HAZARDs and HAZARDOUS SITUATIONS.23 7.4.2 STEP 2:Identify causes and resulting HAZARDOUS SITUATIONS.24 7.4.3 STEP 3:Determine UNINTENDED CONSEQUENCES and estimate the potential severities.25 7.4.4 STEP 4:Estimate the probability of UNINTENDED CONSEQUENCE.25 7.4.5 STEP 5:Evaluate RISK.26 7.4.6
16、 STEP 6:Identify and document proposed RISK CONTROL measures and re-evaluate RISK(return to Step 3).27 7.4.7 STEP 7:Implement RISK CONTROL measures.28 7.4.8 STEP 8:Verify RISK CONTROL measures.29 7.4.9 STEP 9:Evaluate any new RISKS arising from RISK CONTROL.30 7.5 The steps and their relationship to IEC 80001-1 and ISO 14971.30 8 Practical examples.31 8.1 General.31 8.2 Example 1:Wireless PATIENT monitoring during PATIENT transport.32 8.2.1 Full description of context.32 8.2.2 Description of
