QR-7.3-55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 QR-7.3-55/C0 Verification of risk control measure and residual risk evaluation report DN：SCBTM5000-FXYS01 V1.0 QR-7.3-55/C0 Verification of risk control measure and residual risk evaluation report Verification of risk control measure and residual risk evaluation report （V1.0） 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 2014-10-25 Originated V1.0 徐浩 杨春兰 Page PAGE 7 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 11 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 control measures. Now, the device has been in pr