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91 L X_M0 91 �y AXM{M p jC'(TAi Doc. No. HYST/QR2-25-06 <br />X u ll 7 j,`�7��� Version No.: 0/B <br />mJn n1,rn:x��.iznnon Certification of EO Sterilization ±'& g1A Effective date: 1 2021-04-05 <br />Report no.:2022090221 <br />9P customer <br />Yiwu Limem tattoo equipment co., Ltd <br />/"-nA-'8#j, Product name <br />Specification <br />?t5 Batch <br />ttl Quantity <br />9( �3'CM,+- tattoo cartridge needle <br />700 box <br />E0822 <br />7 4t� <br />XC SA, Sterilization mode <br />Lrt EO gas <br />X_MOA 5' Sterilizer no. <br />HYST/ST-05 <br />j Sterilization date <br />2022-08-24 <br />Sterilization batch <br />2022082405A <br />�y Sterilization parameters <br />Unit <br />R* Requirements <br />_t -FM Actual <br />Validated <br />Min. <br />Max. <br />Min. Max. <br />Loading tem. prior to preconditioning <br />T <br />>_10.0 <br />10.0 <br />/ <br />30.3 <br />fftgfia Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />46.4 <br />49.6 <br />�1J �LaMfk Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />47.7 <br />57.3 <br />fft3EFIT' Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />trt1�7 Transfertime <br />Minute <br />5_60 <br />/ <br />60 <br />/ <br />R -W` Initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-24.5 <br />Evacuation rate <br />kPa/min <br />554.0 <br />/ <br />4.0 <br />2.5 <br />Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />'�f:T[JE)75ck Leak test pressure rise OP <br />kPa <br />51.0 <br />/ <br />1.0 <br />0.8 <br />z `EWHARfl1 (;-A ZM) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EO e-%v7it'� EO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.4 <br />k_ffiPJJ_2 EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />19.9 <br />EO Pressure rising after EO injection AP <br />kPa <br />'531.0 <br />31.0 <br />/ <br />S:-23.7 <br />E:12.7 <br />A P:36.4 <br />EO Afk EO concentration commence of exposure (theorical) <br />mg/I <br />600 <br />400 <br />800 <br />593 <br />TCMRIA Exposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />52.0 <br />54.4 <br />TcMagf Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />50.8 <br />61.9 <br />XMI5401 Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />AA�A_2�1 Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-14.9 <br />V-%1 J Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 <br />4.9 <br />-A"Q: W Number of repetition <br />Times <br />>:4.0 <br />4 <br />/ <br />4 <br />iWUT 1 Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />156 <br />BI TGM K pA BI test of sterility <br />< A Conformity; ❑ T 4 4 non -conformity. <br />Wii Conclusion: <br />XM-, f.�AWn BI )MAI VR o ISO 11135:2014 *P4AikN*, 1'`aa SAL(10.6)T4YI�i1-E-> TMLMq=k!1F1A4To <br />Above all, sterilization process and BI sterility testing are meeting with EN ISO 11135:2014 and validated requirements, and Sterile Assurance <br />Level (SAL) of 10-6 is achieved and products can be released from sterilization process. <br />4,$111 Prepator: A" <br />til$ Approval(QA): <br />EM Dat�i' Z <br />Zhejiang Huanyi Steri(itatiooTechnology Co., Ltd. (stamp) <br />ffi:Rid:�k QI.IAI Iry RFrnRD 1/2 <br />