JL-7 3-2风险评定报告体温计(2015英文模板第Ⅱ版).docxVIP

DN：SCBTM5000-FXPJ01 V1.0 Risk Assessment Report JL-A/0-7.1-03 PAGE 2 DN: SCBTM5000-FXPJ01 V1.0 Risk Assessment Report JL-A/0-7.1-03 Risk Assessment Report （V 1.0） Product/project name：ELECTRONIC THERMOMETER Model name：SCBTM5000 Project number：2014- 01-YF03 Drafted by: Date Reviewed by: Date Approved by: Date History Revision NO Revision date Revision Description Version Drafter Approver 01 14年07月 1日 Originated V1.0 徐浩 杨春兰 PAGE 17 / 19 Template：Ⅱ Contents TOC \o 1-3 \h \z \u Signification of Abbreviations 2 1 Summarize 3 1.1 Introduction of product 3 1.2 Introduction on implementation of the risk management plan 3 1.3 Risk management group 3 2 Criteria for risk evaluation 3 3 Identify medical device characteristics that could impact on safety and intended use 3 4 Risk analysis, risk evaluation and PRM 15 4.1 Energy hazards 15 4.2 Biological and chemical hazards 16 4.3 Operational hazards 17 4.4 Information hazards 19 4.5 Software hazards 20 5 Risk Management Conclusion 21 Signification of Abbreviations Abbreviations Signification RE Risk Evaluation S Severity 1 negligible；2 minor；3 Serious；4 Critical；5 Catastrophic P The probability of a harm occurring 6 Frequent; 5 Probable; 4 Occasional; 3 Remote; 2 Improbable;1 Few R Risk NO. ALOR Acceptable level of risk ACC Acceptable NACC Unacceptable ALARP As low as reasonably practicable PRM Plan of Risk control measure(s) NH New hazard generated N/A Not apply Y Yes N No 1 Summary 1.1 Introduction of product SCBTM5000 Electronic Thermometer is used for medical department or family for measuring body temperature, can be used for axillary. 1.2 Introduction on implementation of the risk management plan The project of ELECTRONIC THERMOMETER is approved on September 2014, the risk management activity including the risk management plan w