Rau lub hom phiaj ntawm daim ntawv no, cov ntsiab lus thiab cov ntsiab lus hauv qab no siv rau hauv ethylene oxide sterilization
ib feem ntawm eto gas sterilization txheej txheem thaum lub sij hawm uas ethylene oxide thiab/los yog nws
cov khoom siv tshuaj tiv thaiv desorb los ntawm cov cuab yeej kho mob kom txog rau thaum cov qib tau teev tseg
Lus Cim 1 rau kev nkag: Qhov no tuaj yeem ua tau nyob rau hauv lub sterilizer thiab / los yog nyob rau hauv ib tug cais chamber los yog chav tsev.
3.2 aeration cheeb tsam
yog ib chamber los yog ib chav uas aeration tshwm sim
3.3 Bioburden
cov pej xeem ntawm cov kab mob uas siv tau los ntawm lossis hauv cov khoom thiab / lossis cov kab mob tsis muaj menyuam
[Source: ISO/TS 11139: 2006, definition 2.2]
3.4 biological ntsuas
xeem system uas muaj cov kab mob uas muaj peev xwm muab cov lus hais tsis kam rau cov txheej txheem eto gas sterilization
3.5 Calibration
txheej txheej ntawm kev ua haujlwm uas tsim, raws li cov xwm txheej tshwj xeeb, kev sib raug zoo ntawm qhov tseem ceeb ntawm qhov ntau qhia los ntawm kev ntsuas ntsuas lossis ntsuas
system, los yog qhov tseem ceeb sawv cev los ntawm cov khoom siv ntsuas los yog cov khoom siv siv, thiab cov txiaj ntsig sib xws tau pom los ntawm cov qauv
3.6 chemical indicator
xeem system uas qhia txog kev hloov pauv hauv ib lossis ntau qhov txheej txheem ua ntej tau teev tseg
raws li kev hloov tshuaj lom neeg lossis lub cev uas tshwm sim los ntawm kev raug rau ib qho txheej txheem
[Source: ISO/TS 11139: 2006, definition 2.6]
kev kho cov khoom nyob rau hauv lub voj voog eto gas sterilization, tab sis ua ntej ethylene
oxide nkag, kom ncav cuag qhov ntsuas kub thiab txheeb ze av noo
Lus Cim 1 rau kev nkag: Qhov no ntawm lub voj voog ethylene oxide sterilization tuaj yeem nqa tawm ntawm huab cua los yog hauv lub tshuab nqus tsev.
Lus Cim 2 rau kev nkag: Saib 3.27, preconditioning
3.8 D tus nqi
D10 tus nqi
lub sij hawm los yog koob tshuaj yuav tsum ua kom tiav inactivation ntawm 90% ntawm cov pejxeem ntawm cov kab mob kuaj kab mob raws li tau teev tseg
[SOURCE: ISO/TS 11139:2006, definition 2.11] ?
Lus Cim 1 rau kev nkag: Rau lub hom phiaj ntawm International Standard no, lub D tus nqi yog lub sij hawm raug yuav tsum tau ua kom tiav 90% inactivation ntawm cov pej xeem ntawm lub xeem kab mob.
3.9 Kev txhim kho
ua ntawm elaborating ib specification
[Source: ISO/TS 11139: 2006, definition 2.13]
3.10 dew point
Qhov kub ntawm qhov saturation dej vapor siab yog sib npaug rau
ib nrab siab ntawm cov dej vapor nyob rau hauv qhov chaw
Lus Cim 1 rau kev nkag: Txhua qhov cua txias ntawm qhov chaw hauv qab qhov dej lwg yuav ua rau cov dej sib xyaw ua ke.
3.11 Tsim
txiav txim siab los ntawm kev ntsuas theoretical thiab paub meej los ntawm kev sim
[Source: ISO/TS 11139: 2006, definition 2.17]
9 ISO 11135-2014 TSI
3.12 ethylene oxide (EO) lub sijhawm txhaj tshuaj
Lub sijhawm ntawm theem pib nrog thawj qhov kev taw qhia ntawm EO (sib xyaw) rau hauv lub chamber kom tiav qhov kev txhaj tshuaj
3.13 lub sijhawm raug
lub sij hawm uas cov txheej txheem tsis tau khaws cia nyob rau hauv lawv cov kev kam rau ua
[Source: ISO/TS 11139: 2006, definition 2.18]
Lus Cim 1 rau kev nkag: Rau lub hom phiaj ntawm kev suav ntawm lub voj voog lethality, nws yog lub sij hawm ntawm ethylene oxide sterilization ntawm qhov kawg ntawm EO txhaj tshuaj thiab pib ntawm EO tshem tawm.
3.14 Fault
ib los yog ntau tshaj ntawm cov txheej txheem tsis pw sab nraum nws / lawv teev
kam rau ua
[Source: ISO/TS 11139: 2006, definition 2.19]
3.15 Kev khiav dej num
txheej txheem uas cov ethylene oxide tshem tawm ntawm lub load thiab chamber
los ntawm ob qho tib si kev hloov pauv ntawm huab cua lim, inert gas lossis chav thiab khiav tawm ntawm lub chamber los yog txuas mus ntxiv ntawm cov cua lim, inert 10ISO 11135-2014 roj los yog chav los ntawm lub load thiab chamber
3.16 fractional voj voog
ib lub voj voog uas lub sij hawm raug rau EO roj raug txo piv rau qhov ntawd
teev nyob rau hauv cov txheej txheem ethylene oxide sterilization
3.17 Ib nrab voj voog
ib lub voj voog uas lub sij hawm raug rau EO roj yog txo los ntawm 50% piv rau cov uas tau teev tseg hauv cov txheej txheem ethylene oxide sterilization
3.18 chaw kho mob
tsoom fwv thiab ntiav cov koom haum thiab cov koom haum devoted rau lub
kev txhawb nqa thiab kev saib xyuas kev noj qab haus huv, thiab kev tiv thaiv thiab kev kho mob ntawm
kab mob thiab kev raug mob
EXAMPLE Ib lub tsev kho mob tuaj yeem yog tsev kho mob, tsev laus, chaw kho mob txuas ntxiv, chaw kho mob dawb, chaw kho mob, chaw kho mob, lossis chaw kho hniav.
3.19 khoom kho mob
cov khoom siv kho mob, suav nrog hauv vitro Cov cuab yeej kho mob kuaj mob lossis cov khoom siv tshuaj, suav nrog biopharmaceutical(s)
11 ISO 11135-2014
[Source: ISO/TS 11139: 2006, definition 2.20]
3.20 installation kev tsim nyog
txheej txheem ntawm tau txais thiab sau cov ntaub ntawv pov thawj uas cov cuab yeej tau muab
thiab ntsia raws li nws specification
[Source: ISO/TS 11139: 2006, definition 2.22]
3.21 khoom siv kho mob
txhua yam cuab yeej, apparatus, siv, tshuab, khoom siv, cog, hauv vitro reagent los yog calibrator, software, khoom siv los yog lwm yam kab lus, npaj los ntawm cov chaw tsim tshuaj paus siv, ib leeg los yog ua ke, rau tib neeg rau ib los yog ntau tshaj ntawm lub hom phiaj tshwj xeeb ntawm
- kuaj mob, tiv thaiv, saib xyuas, kho lossis txo tus kab mob,
- kuaj mob, saib xyuas, kho, kho, lossis them nyiaj rau qhov raug mob,
- kev tshawb nrhiav, hloov lossis hloov kho lossis kev txhawb nqa ntawm lub cev lossis cov txheej txheem physiological,
- tswj kev xav,
- disinfection ntawm cov cuab yeej kho mob,
- muab cov ntaub ntawv rau kev kho mob los ntawm txoj kev hauv vitro Kev soj ntsuam ntawm cov qauv muab los ntawm tib neeg lub cev, thiab uas tsis ua tiav nws qhov tseem ceeb ntawm kev ua haujlwm hauv lossis ntawm tib neeg lub cev los ntawm kev siv tshuaj, tshuaj tiv thaiv kab mob lossis metabolic, tab sis qhov uas yuav pab tau nws txoj haujlwm los ntawm txoj kev zoo li no.
[Source: ISO 13485: 2003, txhais 3.7]
?
3.22 kab mob
Qhov chaw ntawm microscopic loj, encompassing cov kab mob, fungi, protozoa thiab kab mob
Ceeb Toom 1 rau kev nkag: Ib qho qauv tshwj xeeb yuav tsis xav tau kev ua qauv qhia ntawm
kev ua tau zoo ntawm eto gas sterilization txheej txheem hauv inactivating txhua hom
microorganisms, txheeb xyuas hauv cov ntsiab lus saum toj no, rau kev siv tau thiab / lossis
niaj hnub tswj ntawm eto gas sterilization txheej txheem.
txheej txheem ntawm tau txais thiab sau cov ntaub ntawv pov thawj uas tau teeb tsa cov khoom siv
ua haujlwm nyob rau hauv predetermined txwv thaum siv raws li nws
cov txheej txheem ua haujlwm
[Source: ISO/TS 11139: 2006, definition 2.27]
3.24 overkill mus kom ze
mus kom ze siv eto gas sterilization txheej txheem uas xa ib yam tsawg kawg nkaus ntawm 12 Spore Log
Kev txo qis (SLR) mus rau ib qho kev qhia txog kev lom neeg muaj kev tiv thaiv sib npaug los yog ntau dua li cov khoom bioburden
3.25 parametric tso tawm
tshaj tawm tias cov khoom yog tsis muaj menyuam, raws li cov ntaub ntawv qhia tau hais tias cov txheej txheem tsis tau raug xa mus nyob rau hauv qhov kev tolerances.
[Source: ISO/TS 11139: 2006, definition 2.29]
Lus Cim 1 rau kev nkag: Cov txheej txheem ntawm kev tso tawm no tsis suav nrog kev siv cov cim qhia txog roj ntsha.
txheej txheem ntawm kev tau txais thiab sau cov ntaub ntawv pov thawj tias cov cuab yeej, raws li tau teeb tsa thiab ua haujlwm raws li cov txheej txheem kev ua haujlwm, ua haujlwm tsis tu ncua raws li cov txheej txheem tau txiav txim siab ua ntej thiab yog li yields cov khoom raws li nws cov specification.
[Source: ISO/TS 11139: 2006, definition 2.30]
kev kho cov khoom, ua ntej lub voj voog eto gas sterilization, nyob rau hauv ib chav los yog chamber kom tau raws li cov kev cai rau kub thiab txheeb ze av noo.
3.28 txheej txheem sib tw ntaus ntawv
cov khoom tsim los ua kom muaj kev tiv thaiv rau eto gas sterilization txheej txheem thiab siv los ntsuas kev ua haujlwm ntawm cov txheej txheem
[Source: ISO/TS 11139: 2006, definition 2.33]
Lus Cim 1 rau kev nkag: Rau lub hom phiaj ntawm International Standard no, PCD tuaj yeem ua tau
yog cov khoom, simulated khoom los yog lwm yam khoom uas yog inoculated ncaj qha los yog
tsis ncaj. Saib 7.1.6 thiab D.7.1.6.
Lus Cim 2 rau kev nkag: Hauv Cov Txheej Txheem Thoob Ntiaj Teb no, kev sib txawv yog tsim los ntawm ib qho PCD sab hauv thiab ib qho PCD sab nraud. Ib qho PCD sab hauv yog siv los ua kom pom tias cov khoom xav tau SAL tiav. Lub PCD nyob rau hauv lub confines ntawm cov khoom los yog cov khoom shipper rooj plaub yog ib tug sab hauv PCD, whereas PCD nyob rau hauv lub shipper rooj plaub los yog nyob rau sab nrauv ntawm lub load yog ib tug sab nraud PCD. Ib qho PCD sab nraud yog ib yam khoom tsim los siv rau microbiological
kev soj ntsuam ntawm cov txheej txheem ntau lawm.
3.29 txheej txheem parameter
teev tus nqi rau tus txheej txheem sib txawv
Lus Cim 1 rau kev nkag: Cov lus qhia tshwj xeeb rau eto gas sterilization txheej txheem suav nrog
txheej txheem tsis thiab lawv kam rau ua.
[Source: ISO/TS 11139: 2006, definition 2.34]
3.30 txheej txheem variable
Cov xwm txheej hauv cov txheej txheem ethylene oxide sterilization, kev hloov pauv uas hloov cov txiaj ntsig microbicidal
EXAMPLE?Time, temperature, pressure, concentration, humidity, wavelength.
[Source: ISO/TS 11139: 2006, definition 2.35]
3.31 ua qeb
sau los ntawm cov khoom sib txawv lossis cov tsev neeg cov khoom uas tuaj yeem ua kom tsis muaj menyuam
ua ke
Lus Cim 1 rau kev nkag: Tag nrho cov khoom nyob rau hauv qeb tau txiav txim siab los nthuav qhia qhov sib npaug lossis tsawg dua kev sib tw rau cov txheej txheem ethylene oxide sterilization dua li txheej txheem kev sib tw ntaus ntawv rau pawg ntawd.
3.32 Cov khoom
tshwm sim ntawm ib tug txheej txheem
[Source: ISO 9000: 2005, txhais 3.4.2]
Lus Cim 1 rau kev nkag: Rau cov hom phiaj ntawm ethylene oxide sterilization qauv, cov khoom yog
tangible thiab tuaj yeem ua raw khoom (s), nruab nrab(s), sub-assembly(ies) thiab
cov khoom kho mob.
3.33 khoom tsev neeg
pab pawg ntawm cov khoom muaj cov yam ntxwv uas tso cai rau lawv kom tsis muaj menyuam
siv cov txheej txheem teev tseg
3.34 khoom ntim ntim
txhais qhov chaw nyob rau hauv lub usable chamber ntim occupied los ntawm cov khoom
3.35 paub txog kab lis kev cai sau
tso cai tso nyiaj raws li Budapest Treaty rau Lub International
Kev lees paub ntawm Cov Nyiaj Txiag ntawm
Microorganisms rau Lub Hom Phiaj ntawm Patent thiab Kev Cai
[Source: ISO/TS 11139: 2006, definition 2.38]
3.36 siv cov kab mob
microbial strain tau txais los ntawm kev lees paub kab lis kev cai sau
3.37 Kev tsim nyog
repetition ntawm ib feem ntawm validation rau lub hom phiaj ntawm kev lees paub qhov kev lees txais txuas ntxiv ntawm cov txheej txheem teev tseg
3.38 reusable kho mob cuab yeej
cov cuab yeej kho mob tsim los yog npaj los ntawm cov chaw tsim khoom raws li tsim nyog
reprocessing thiab rov siv dua
Lus Cim 1 rau kev nkag: Qhov no tsis yog ib qho khoom siv kho mob uas raug xaiv los yog npaj
los ntawm cov chaw tsim khoom siv rau ib leeg xwb.
3.39 Kev pabcuam
cov khoom siv los ntawm ib qho chaw sab nraud, xav tau rau kev ua haujlwm raug ntawm cov khoom siv
EXAMPLE Hluav taws xob, dej, compressed cua, ntws.
[Source: ISO/TS 11139: 2006, definition 2.41]
3.40 ib leeg-siv cov cuab yeej kho mob
cov cuab yeej kho mob tsim los yog npaj los ntawm cov chaw tsim khoom siv rau ib zaug xwb
3.41 Ib
qhia kom meej nyob rau hauv ib daim ntawv pom zoo
3.42 Spore-log-txo log ntawm thawj cov neeg spore, N0, rho tawm lub cav ntawm cov neeg zaum kawg, Nu
[Source: ISO 14161: 2009, txhais 3.19]
Lus Cim 1 rau kev nkag: Piav txog qhov txo qis ntawm cov spores ntawm a
biological indicator los yog inoculated yam uas tsim los ntawm raug mus rau teev
tej yam kev mob.
Rau Direct Enumeration:
SLR = log N0 log ? Nu
qhov twg
N0 yog thawj cov pejxeem;
Nkoj yog cov neeg zaum kawg.
Rau Fraction Negative:
SLR = log N0 - log [ln(q/n)]
qhov twg
N0 yog thawj cov pejxeem;
q yog tus naj npawb ntawm cov qauv replicate kuaj;
n yog tus naj npawb ntawm cov qauv tsis zoo rau kev loj hlob.
Yog tias tsis muaj cov neeg muaj sia nyob, qhov tseeb SLR tsis tuaj yeem suav. SLR tuaj yeem ua tau
tshaj tawm tias "ntau dua" log N0 yog siv ib lub cev muaj sia nyob.
3.43 Sterile
dawb los ntawm cov kab mob siv tau
[Source: ISO/TS 11139: 2006, definition 2.43]
3.44 sterile barrier system
Yam tsawg kawg nkaus pob uas tiv thaiv ingress ntawm cov kab mob thiab tso cai rau aseptic
kev nthuav qhia ntawm cov khoom ntawm qhov chaw siv
[Source: ISO/TS 11139: 2006, definition 2.44]
3.45 Nws
lub xeev yog dawb los ntawm cov kab mob siv tau
Lus Cim 1 rau kev nkag: Hauv kev xyaum, tsis muaj cov lus qhia meej txog qhov tsis muaj kab mob tuaj yeem ua pov thawj.
Lus Cim 2 rau kev nkag: Saib 3.47, ua kom tsis muaj menyuam.
[Source: ISO/TS 11139: 2006, definition 2.45]
3.46 sterility assurance qib
Qhov tshwm sim ntawm ib qho kab mob uas muaj peev xwm tshwm sim ntawm ib yam khoom tom qab
ua kom tsis muaj menyuam
Lus Cim 1 rau kev nkag: Lub sij hawm SAL siv tus nqi ntau, feem ntau 10-6 lossis 10-3. Thaum siv tus nqi ntau npaum li no rau kev ua kom tsis muaj menyuam, SAL ntawm 10-6 muaj tus nqi qis dua tab sis muab kev ruaj ntseg ntau dua li SAL ntawm 10-3.
[Source: ISO/TS 11139: 2006, definition 2.46]
Cov txheej txheem validated siv los ua cov khoom tsis muaj cov kab mob siv tau
Lus Cim 1 rau kev nkag: Hauv kev ua kom tsis muaj menyuam, qhov xwm txheej ntawm microbial
inactivation yog exponential thiab yog li kev ciaj sia ntawm cov kab mob ntawm ib tus neeg tuaj yeem raug nthuav tawm raws li qhov tshwm sim. Thaum no
Qhov tshwm sim tuaj yeem raug txo kom tsawg heev, nws tsis tuaj yeem txo mus rau xoom. TS EN ISO 11135-2014
Lus Cim 2 rau kev nkag: Saib 3.46, qib kev ruaj ntseg sterility.
[Source: ISO/TS 11139: 2006, definition 2.47]
Kev kho mob hauv chav kaw, uas suav nrog kev tshem tawm cua, cua txias (yog siv), txhaj tshuaj ethylene oxide, roj inert (yog siv), raug ethylene oxide, tshem tawm ethylene oxide thiab yaug (yog siv), thiab cua / inert gas nkag
3.49 sterilization load
cov khoom yuav, los yog uas tau, sterilized ua ke siv ib tug muab
txheej txheem sterilization
[Source: ISO/TS 11139: 2006, definition 2.48]
3.50 sterilization txheej txheem
series ntawm kev ua lossis kev ua haujlwm xav tau kom ua tiav cov kev cai tshwj xeeb rau kev tsis muaj menyuam
[Source: ISO/TS 11139: 2006, definition 2.49]
Nco tseg 1 rau kev nkag: Cov kev ua haujlwm lossis kev ua haujlwm no suav nrog kev kho ua ntej
(yog tias tsim nyog), raug rau cov ethylene oxide raws li cov kev cai thiab cov kev kho mob tom qab tsim nyog yuav tsum tau tshem tawm ntawm ethylene oxide thiab nws cov by-products. Nws tsis suav nrog kev tu, tshuaj tua kab mob lossis kev ntim khoom ua ntej ua kom tsis muaj menyuam.
3.51 sterilization kws tshwj xeeb
tus neeg muaj kev paub txog kev siv tshuab kom tsis muaj menyuam thiab nws cov teebmeem rau cov khoom siv thiab cov kab mob
3.52 sterilizing tus neeg sawv cev
ination ntawm cov koom haum muaj kev ua kom txaus microbicidal kom ua kom tsis muaj menyuam nyob rau hauv cov xwm txheej tau hais tseg
[Source: ISO/TS 11139: 2006, definition 2.50]
3.53 survivor nkhaus
graphical sawv cev ntawm inactivation ntawm cov pej xeem ntawm cov kab mob nrog nce kis mus rau ib tug microbicidal tus neeg sawv cev raws li tau teev tseg.
[Source: ISO/TS 11139: 2006, definition 2.51]
3.54 test rau sterility
kev lag luam uas tau teev tseg hauv Pharmacopoeia ua rau cov khoom tom qab raug rau kev ua kom tsis muaj menyuam
[Source: ISO/TS 11139: 2006, definition 2.53]
3.55 test of sterility
kev lag luam ua ib feem ntawm kev txhim kho, kev siv tau, lossis
requalification los txiav txim seb muaj los yog tsis muaj cov kab mob uas siv tau rau ntawm cov khoom lossis feem ntawm qhov ntawd
[Source: ISO/TS 11139: 2006, definition 2.54]
3.56 usable chamber ntim
txhais qhov chaw nyob rau hauv lub sterilizer chamber, uas yog tsis txwv los ntawm taag los yog mobile qhov chaw thiab uas yog muaj los txais lub sterilization load
Lus Cim 1 rau kev nkag: Lub ntim tso cai rau cov roj ncig ncig ntawm lub load sab hauv
lub chamber tsis suav nrog qhov chaw siv tau.
Cov txheej txheem sau tseg kom tau txais, sau thiab txhais cov txiaj ntsig xav tau los tsim kom muaj cov txheej txheem yuav ua kom cov khoom lag luam ua raws li cov lus qhia tshwj xeeb
[Source: ISO/TS 11139: 2006, definition 2.55]
3.58 cov ntaub ntawv nkauj xwb
cov khoom uas tsis tau siv yav tas los, los yog raug rau kev ua lwm yam tshaj li rau nws thawj ntau lawm
Yog tias koj xav paub ntau ntxiv txog Ethylene Oxide Sterilization
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