TS EN ISO 11135 Ethylene Oxide Sterilization Tshawb Xyuas
Daim ntawv tshuaj ntsuam xyuas kev tshaj lij no yog tsim los rau cov tuam txhab kho mob thiab cov kws tshuaj xyuas zoo los ntsuas Ethylene Oxide (EO) sterilization txheej txheem. Nws ua kom tag nrho ua raws li TS EN ISO 11135-1 thiab ISO 13485 Kev Tswj Xyuas Kev Lag Luam qauv.
1. Scope
Daim ntawv tshuaj ntsuam no muaj feem xyuam rau cov txheej txheem kom tsis muaj menyuam rau cov khoom kho mob uas ua nrog ethylene oxide. Rau sterile khoom ntawm Risk Class III, cov ntaub ntawv ntawm kev tsim thiab kev siv tau yuav tsum tau kuaj xyuas. Kev ntsuas kev ua kom tsis muaj menyuam yuav tsum tau ua raws li tsawg kawg ib cov ntaub ntawv khoom.
2. Lub luag haujlwm thiab txoj cai
Lead Auditor
Lub luag haujlwm rau kev kuaj xyuas QM system hais txog ISO 13485 thiab Council Directive 93/42/EWG. Tus kws tshuaj xyuas thawj coj saib xyuas pab pawg neeg soj ntsuam thiab xyuas kom DQS cov txheej txheem ua raws.
Cov kws tshaj lij
Lub luag haujlwm rau kev soj ntsuam cov khoom tshwj xeeb, tshwj xeeb yog tsom rau cov ntaub ntawv tsim thiab kev siv tau ntawm cov txheej txheem kom tsis muaj menyuam.
3. Mus rau qhov kev ntsuam xyuas
Lub hom phiaj yog los tshuaj xyuas qhov ua tiav ntawm TS EN ISO 11135-1. Cov txiaj ntsig yuav tsum tau tsim nyob rau hauv daim ntawv txheeb xyuas nrog rau cov ntawv txheeb xyuas no.
| Clause | Audit Question/Requirement | Kev ntsuam xyuas |
|---|---|---|
| 4. Kev Tswj Xyuas Zoo | ||
| 4.1 Cov ntaub ntawv | ||
| 4.1.1 | Puas muaj cov txheej txheem rau kev tsim, kev siv tau, kev tswj xyuas niaj hnub thiab cov khoom tso tawm los ntawm kev ua kom tsis muaj menyuam tau teev tseg? | |
| 4.1.2 | Puas yog tag nrho cov ntaub ntawv thiab cov ntaub ntawv teev tseg raws li ISO 11135-1 tshuaj xyuas, pom zoo thiab tswj hwm? | |
| 4.2 Kev Tswj Xyuas Lub Luag Haujlwm | ||
| 4.2.1 | Puas yog lub luag haujlwm thiab cov cai tau teev tseg thiab muab rau cov neeg tsim nyog? | |
| 4.2.2 | Puas muaj kev cog lus cog lus yog tias muaj ntau lub koom haum koom nrog? | |
| 4.3 Product Realization | ||
| 4.3.1-2 | Puas yog cov txheej txheem rau kev yuav khoom, kev txheeb xyuas thiab traceability tau teev tseg? | |
| 4.3.3 | Puas yog lub kaw lus rau calibration ntawm tag nrho cov cuab yeej thiab cov cuab yeej ntsuas tau teev tseg? | |
| 4.4 Kev Ntsuas, Kev Ntsuas thiab Kev Txhim Kho | ||
| 4.4 | Puas yog cov txheej txheem rau kev tswj xyuas cov khoom tsis sib haum thiab kev kho / kev tiv thaiv tau teev tseg? | |
| 5. Sterilizing Agent Characterization | ||
| 5.1 | Puas yog qhov muaj pes tsawg leeg, kev cia khoom thiab qhov ntev cia tau teev tseg rau tus neeg sawv cev EO? | |
| 5.2 | Puas yog qhov ua tau zoo ntawm microbicidal ua haujlwm yog tias tsis siv cov khoom sib xyaw ua ke? | |
| 5.3 | Kev ntsuam xyuas cov teebmeem ntawm cov khoom raws li Tshooj 7. | |
| 5.4.1 ib | Cov ntaub ntawv pov thawj txog kev cuam tshuam ib puag ncig thiab kev soj ntsuam xyuas? | |
| 5.4.2 ib | Ua raws li cov cai hauv cheeb tsam / teb chaws hais txog EO emission thiab pov tseg? | |
| 6. Cov txheej txheem thiab cov cuab yeej ua cim | ||
| 6.1.2 | Puas yog tus cwj pwm muaj xws li preconditioning, voj voog, thiab qhov cua? | |
| 6.1.3 | Lub voj voog puas suav nrog kev tshem tawm cua, EO ntxiv, kev saib xyuas, thiab yaug? | |
| 6.1.4 ib | Puas yog (ua ntej) kev kho mob tau ua raws li kev tswj cov av noo thiab kub? | |
| 6.1.5-6 | Puas yog cov txheej txheem sib txawv (temp, humidity, EO conc, lub sij hawm) teev nrog kam rau ua? | |
| 6.2.1-2 | Cov cuab yeej tshwj xeeb tau sau tseg nrog rau cov lus piav qhia ntawm txhua qhov ntsuas ntsuas? | |
| 6.2.3 | Cov ntaub ntawv pov thawj ntawm kev sib tham nrog cov lus qhia tshwj xeeb (ISO 9000-3)? | |
| 6.2.4 ib | Puas tswj kev ua haujlwm tsis ua haujlwm TSIS cuam tshuam rau kev kaw haujlwm? | |
| 7. Khoom txhais | ||
| 7.1.1-2 | Kev nqis tes ua rau cov khoom tshiab / hloov pauv lossis thauj khoom teeb tsa? Cov ntaub ntawv sib npaug? | |
| 7.1.3-5 | Permeation / tshem tawm ntawm EO nyob rau hauv qhov nyuaj tshaj plaws kom tsis muaj menyuam pov thawj? | |
| 7.2.1-5 | Kev nyab xeeb khoom: cuam tshuam ntawm ntau yam kev ua kom tsis muaj menyuam, kev nyab xeeb lom neeg (ISO 10993), thiab EO residues? | |
| 7.3.1-2 | Bioburden kwv yees (ISO 11737-1) thiab kev ntsuam xyuas kev ua haujlwm huv (ISO 17664) | |
| 8. Txheej txheem txhais | ||
| 8.1-4 | Sterilization txheej txheem teev thiab txhawb nqa los ntawm IQ/PQ cov ntaub ntawv? | |
| 8.5-7 | Microbial efficiency txiav txim siab (Annex A/B)? Cov ntsuas BI ua raws li ISO 11138? | |
| 8.8-9 | Kev ntsuas tshuaj lom neeg (ISO 11140) thiab kuaj tsis muaj menyuam (ISO 11737-2) ua raws? | |
| 9. Kev lees paub (IQ, OQ, PQ) | ||
| 9.1 Installation Qualification (IQ) | ||
| 9.1.1-6 | Cov cuab yeej ua raws li, cov txheej txheem thev naus laus zis, thiab qhov chaw teeb tsa tshwj xeeb tsim? | |
| 9.2 Kev Tsim Nyog Ua Haujlwm (OQ) | ||
| 9.2.1-2 | Cov ntaub ntawv pov thawj ntawm cov cuab yeej muaj peev xwm ua tau nyob rau hauv qhov kam rau ua; calibration paub tseeb? | |
| 9.3 Kev Tsim Nyog Ua Haujlwm (PQ) | ||
| 9.3.1-3 | Cov pov thawj ua haujlwm zoo ib yam, microbiological PQ, thiab lub cev PQ (3 khiav sib law liag)? | |
| 9.4 ib | Cov kev hloov pauv rau kev thauj khoom configuration ntsuas rau SAL cuam tshuam? | |
| 9.5.1-6 | Kev txheeb xyuas cov ntaub ntawv pov thawj thiab kev pom zoo; parametric tso tawm cov txheej txheem teev tseg? | |
| 10. Kev saib xyuas thiab kev tswj xyuas niaj hnub | ||
| 10.1 | Saib xyuas qhov kub thiab txias, siab, av noo, EO concentration, thiab roj ncig? | |
| 10.2 | Parametric tso tawm: 2-point ntsuas kub thiab ncaj qha EO tsom xam? | |
| 11. Cov khoom tso tawm los ntawm Sterilization | ||
| 11.1 | Cov ntaub ntawv pov thawj rau kev ua raws (cov ntaub ntawv cov ntaub ntawv vs specification)? | |
| 11.2 | Kev tuav cov khoom tsis sib haum (ISO 13485) yog qhov hloov pauv lossis BI ua tsis tiav? | |
| 12. Txhim kho cov txheej txheem ua tau zoo | ||
| 12.1-2 | Lub sijhawm ua haujlwm pov thawj thiab tiv thaiv kev npaj kho? | |
| 12.3.1-8 | Cov txheej txheem rov ntsuas dua (ib xyoos rau kev tso tawm parametric); BI kev kuaj xyuas qhov tsim nyog? | |
| 12.4.1-3 | Kev soj ntsuam ntawm cov kev hloov pauv (cov khoom siv / khoom / tus neeg sawv cev) thiab qhov kev lees paub qhov tseeb? | |
Tsis lees paub: Daim ntawv txheeb xyuas no yog ib qho kev qhia. Ib txwm xa mus rau ISO 11135: 2014 tus qauv rau kev tswj hwm kev xa tawm.