医疗器械质量体系QR-QP-23-01The literature search report

1、 DOCPROPERTY 文件编号 * MERGEFORMAT 错误！未知的文档属性名称（ DOCPROPERTY 版本 * MERGEFORMAT 错误！未知的文档属性名称）第 Document name:The literature search report Written: Auditor: Approved: Date:Date:Date:Revision RecordVer.Revision descriptionRevisorDateTable of Contents TOC o 1-3 h z HYPERLINK l _Toc326159185 Table of Content

2、s PAGEREF _Toc326159185 h 2 HYPERLINK l _Toc326159186 Chapter1 Summary PAGEREF _Toc326159186 h 3 HYPERLINK l _Toc326159187 Chapter2 Scope of the literature search PAGEREF _Toc326159187 h 4 HYPERLINK l _Toc326159188 Chapter3 Methods of the literature search PAGEREF _Toc326159188 h 5 HYPERLINK l _Toc3

3、26159189 3.1Date of search PAGEREF _Toc326159189 h 5 HYPERLINK l _Toc326159190 3.2Name of person(s) undertaking the literature search: PAGEREF _Toc326159190 h 5 HYPERLINK l _Toc326159191 3.3Period covered by search PAGEREF _Toc326159191 h 5 HYPERLINK l _Toc326159192 3.4Literature sources used to ide

4、ntify data PAGEREF _Toc326159192 h 5 HYPERLINK l _Toc326159193 3.5Database search details PAGEREF _Toc326159193 h 5 HYPERLINK l _Toc326159194 3.6Selection criteria used to choose articles PAGEREF _Toc326159194 h 5 HYPERLINK l _Toc326159195 3.7Have same or similar principles and structural features P

5、AGEREF _Toc326159195 h 5 HYPERLINK l _Toc326159196 Chapter4 Outputs of the literature search PAGEREF _Toc326159196 h 6 HYPERLINK l _Toc326159197 4.1Attach copy of literature citations retrieved from each database search PAGEREF _Toc326159197 h 6 HYPERLINK l _Toc326159198 4.2Data selection process PA

6、GEREF _Toc326159198 h 7SummaryEC Certificate Registration No.Legal ManufacturerProduct groupUMDNS NumberProduct Name(s)& modelClassification RuleClassProcedure for CertificationNotified BodyScope of the literature searchAccording to the XXX Intended use,the scope of the literature search is as follo

7、ws:Methods of the literature searchDate of search Name of person(s) undertaking the literature search: Period covered by searchLiterature sources used to identify dataDatabase search detailsSelection criteria used to choose articlesHave same or similar principles and structural featuresHave same or

8、similar performance.Have same or similar intended use and intended purpose.Used for the same or similar clinical condition or purpose, used at the same site in the body, used in similar population.Outputs of the literature searchAttach copy of literature citations retrieved from each database search

9、 The related clinical literatures identified through the evaluation of the products of the other companies which are registeredNumberName of literatureSourceData selection processFlow chart of data selection process Potentially relevant literature identified through the search 搜索到的可能与待评估的医疗设备相关的文献 L

10、iterature excluded, with reasons Literature retrieved for more detailed assessment assessment Literature excluded from clinical evaluation, with reasons evaluation, with reasons Literature with relevant useable data included in the clinical evaluation, by outcome: Device performance and safety.Associated tables showin