根据IOS11607标准在德国CSSD实施无菌屏障系统验证的实践经验

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.deAgenda§Laws and standards according to the ISO, EN and German 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/ THMIntroduction§The last revision of the IN EN ISO 11607-2 was in 2020§according to 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 packaging processes§The German Guideline is a practical approach set the ISO-Standards in CSSD§The Germa