Accelerated Aging Test Report of A 医疗器械产品加速老化报告模板（中英文上市公司全球市场）.pdfVIP

AcceleratedAgingTestReportof

ABC

ABC加速老化报告

受控状态

版本/Rev.：A/0

/Controlledstate

职责

职能/Position签名/Signature日期/Date

/Responsibility

编制/Editor

审核/Review

批准/Approval

Confidentiality:Thisdocumentcontainsinformationthatisconfidentialandproprietary

TableOfContents目录

1.0Purpose目的3

2.0Responsibilities职责4

3.0Reference参考4

4.0SampleInformation样品信息6

5.0EquipmentandInstrumentation设备及仪器8

6.0TestingConditions试验条件9

7.0TestingItems试验项目11

9.0TestResult测试结果18

10.0Deviation偏差22

11.0Conclusion结论23

12.0RecordsReservation文件保存23

附件X：剩余样品处置记录25

AnnexX:Residualsamplesrecord25

Confidentiality:Thisdocum

1.0Purpose目的

例1：对新产品：Thetestwillperformtodeterminethevalidityandthesterilityonthenewproduct

ABCperformancesafteracceleratedagingrefertoStandardGuideforAcceleratedAgingof

SterileBarrierSystemsforMedicalDevices,Thetestwillperformtodeterminetheshelflifeof

ABC.

本实验将根据ASTMF1980-16《无菌医疗设备包装加速老化标准指南》的要求，测定加速老化

对新产品ABC有效期及无菌的影响，并确定ABC产品的有效期。

例2：涉及变更后老化

1.1WehavecompletedtheshelflifeevaluationofABC（see“MTN-ABCRev：X”）.Theevaluation

resultsdeterminedthattheABCshelflifeisXyears.

我们已完成对ABC的有效期验证，验证结果确定ABC有效期为X年（详见“MTN-ABC版本：X）

1.2AccordingtoECR-ABC,+变更描述,thisstudywillevaluatethechangeinfluenceonproduct

performance,anddeterminetheshelflifeoftheABCwhethercanmeettheXyearsaging

requirements