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

DN：SCBTM5000-FXPJ01 V1.0 Risk Assessment Report QR-7.3-54/C0 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 19 / 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 14 4.1 Energy hazards 14 4.2 Biological and chemical hazards 15 4.3 Operational hazards 16 4.4 Information hazards 17 4.5 Software hazards 错误!未定义书签。 5 Risk Management Conclusion 19 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 managemen