预热灭菌方案房及验证.pdfVIP

目录

TableofContents

1.目的Purpose………………………..3

2.范围Scope……………3

3.相关文件Reference………………...3

4.职责Responsibility…………………..3

5.程序Procedure………………………4

附件Listofattachments

Attachment1:Thetemperaturesensorsplacementofinnerwalltemperatureuniformity

test………………6

Attachment2:Thetemperaturesensorsplacementofspacetemperatureuniformity

test………………7

1.目的Purpose

根据EN550和GB18279-2000标准及EN1422-1997(《医疗器械的灭菌――环氧乙烷灭菌的验证及

日常控制》及《灭菌的医疗目的-环氧乙烷-要求及测试方法，NEQ》)的要求，对环氧乙烷灭菌预热房进

行有效性的安装确认及操作鉴定(验证)，以保证满足医疗器械无菌的要求。

AccordingtoEN550andthestandardofGB18279-2005,EN1422-1997(Medicaldevices–

ValidationandroutineofcontrolofethyleneoxidesterilizationandEN1422:1997,Sterilizationfor

medicalpurpose—Ethyleneoxidesterilizers–Requirementsandtestmethods,NEQ)requirements,will

dotheeffectiveIQandOQofEOsterilizationpreconditioningchamber,tomakesuretheequipment

canmeetone-offmedicaldevicerequirementsduringactualrunning.

2.范围Scope

本方案仅适用于ETO部门的环氧乙烷灭菌预热房的安装及操作的鉴定。

TheprotocolonlyappliestoEOsterilizationpreconditioningroominstallationandoperational

qualificationofETOdepartment.

3.相关文件Reference

a)EN550/GB18279-2000:医疗器械――环氧乙烷灭菌的验证及常规控制

EN550/GB18279-2000:Medicaldevices–Validationandroutineofcon