根据IOS 11607标准在德国CSSD实施无菌屏障系统验证的实践经验.pdf

1、Practical experience in implementing the validation of sterile barrier systems according to ISO 11607-2:2020 at CSSD in GermanyRainer Stens Board Member of the German Association for Hospital Sterile Sciences(DGSV e.V.)www.dgsv-ev.deAgendaAgenda Laws and standards according to the ISO,EN and German

2、Rules Why validation?Overview in packaging of sterile medical products Who must validate?Who is allowed to validate?Validation Plan IQ OQ PQ Validation Report Routine Controls Experiences/Lessons Learned/THMIntroductionIntroduction The last revision of the IN EN ISO 11607-2 was in 2020 according to

3、the new European harmonised Medical Device Regulation(MDR)which was activated in 2017 MDR Annex I Chapter II/11.5 says“Products labelled sterile shall be processed,manufactured,packaged and sterilized using appropriate validatedprocesses.”this results in a legal requirement for the validation of pac

4、kaging processes The German Guideline is a practical approach set the ISO-Standards in CSSD The German Medical Devices operator ordinance forms the framework for the obligation to validateWhy this Lecture/Why this Topic?Why this Lecture/Why this Topic?The last autumn the German Board of the DGSVe.V.

5、invited Mrs.Cinthia Vera Fuentes to their annual Kongress to give a Lecture about the Chilean education system for reprocessing As a re-invitation the German Board asked,how they can support important Topics in South-America as bestWhy this Lecture/Why this Topic?Why this Lecture/Why this Topic?KLS

6、MartinMiele/Steelco/BelimedMMMRichard WolfVP Stericlinwww.dgsv-ev.deScan me To make this lecture“ready to use”in your countries,we translated the Guideline in cooperation with Mrs.Westermann from MHP-Verlag and Mr.Pilasiin English and Spanish language.You can get the printed brochure at the booths o