作业指导书辐照灭菌方案确认及再确认程序指引含产品生物负载测试报告表,产品无菌检查报告表.pdf

XXX有限公司文件编号Page1of14

XX

名称:辐照灭菌方案确认及再确认程

工作指引

序指引

1适用范围Scope

适用于外发进行辐照灭菌产品方案的制定,确认,验证程序.

2参考文件Normativereference

2.1ISO11137-1Sterilizationofhealthcareproducts—Radiationpart1:

Requirementsfordevelopment,validationandroutinecontrolofsterilization

processformedicaldevices;

2.2ISO11137-2Sterilizationofhealthcareproducts—Radiation—Part2:

Establishingthesterilizationdose;

2.3ISO11737-1Sterilizationofmedicaldevices—Microbiologicalmethods—Part1:

Determinationofapopulationofmicroorganismsonproducts;

2.4ISO11737-2Sterilizationofmedicaldevices—Microbiologicalmethods—Part2:

Testsofsterilityperformedinthevalidationofasterilizationprocess;

2.5ISO13485Medicaldevices—Qualitymanagementsystems—Requirementsfor

regulatorypurposes;

3定义Definitions

3.1IQ:设备安装验证Installationqualification

3.2OQ:设备运行验证Operationqualification

3.3PQ:设备性能验证Performancequalification

3.4SAL:无菌保证水平sterilityassurancelevel

3.5我司:XX医疗XXCo.,LTD.

制定:XX确認:日期:5-Mar-20修定版次:3

XXX有限公司文件编号Page2of14

XX

名称:辐照灭菌方案确认及再确认程

工作指引

序指引

4职责Responsibility

4.1我司:

4.1.1Implementradiationprocessagreement.

4.1.2Establishingthesterilizationdose;

4.1.3Developingproductfamilies;

4.1.4Establishingthemaximumacceptabledose;