JL-7.3-3风险控制措施验证及剩余风险评价报告体温计(20130926英文模板第Ⅱ版)(1).doc

DN ：SCBTM5000-FXYS01 V1.0 JL-A/0-7.1-05 Verification of risk control measure and residual risk evaluation report DN：SCBTM5000-FXYS01 V1.0 JL-A/0-7.1-05 Verification of risk control measure and residual risk evaluation report Verification of risk control measure and residual risk evaluation report （V1.1） 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 2014-10-25 Originated V1.0 徐浩 杨春兰 02 2015-5-28 Upgrade Test Report No. V1. 赵春雷 杨春兰 Page PAGE 9 of 7 Template：Ⅱ Page PAGE 1 of 9 Template：Ⅱ Contents TOC \o 1-3 \h \z \u Signification of Abbreviations 2 1 Review 3 1.1 Introduction of product 3 1.2 Introduction on implementation of the risk management plan 3 1.3 Risk management team 3 2 Criteria of risk evaluation 3 3 Validation of risk control measures and residual risk assessment 4 4 Residual risk evaluation and conclusion 9 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 Review 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 According to the risk management plan, risk management group has been finished the risk analysis, evaluation, and take the