{"id":2332,"date":"2024-11-26T10:16:36","date_gmt":"2024-11-26T02:16:36","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2332"},"modified":"2026-02-09T09:59:05","modified_gmt":"2026-02-09T01:59:05","slug":"terms-and-definitions-of-eto-gas-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2332","title":{"rendered":"Terms and definitions of eto gas sterilization"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n

Að því er þetta skjal varðar eiga eftirfarandi hugtök og skilgreiningar við í etýlenoxíð dauðhreinsun<\/strong><\/p>\n\n\n\n

3.1 Loftun <\/a><\/strong><\/p>\n\n\n\n

\"\"<\/figure><\/div>\n\n\n\n

part of the eto gas sterilization process during which ethylene oxide and\/or its<\/p>\n\n\n\n

hvarfefni frásogast úr lækningatækinu þar til fyrirfram ákveðnu magni er náð<\/p>\n\n\n\n

Note 1 to entry: This can be performed within the sterilizer and\/or in a separate chamber or room.<\/p>\n\n\n\n

3,2 loftræstingarsvæði <\/strong><\/strong><\/p>\n\n\n\n

annað hvort hólf eða herbergi þar sem loftun á sér stað<\/p>\n\n\n\n

3.3 Líffræðileg byrði <\/strong><\/strong><\/p>\n\n\n\n

population of viable microorganisms on or in product and\/or sterile barrier system<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.2]<\/p>\n\n\n\n

3.4 líffræðilegur vísir <\/strong><\/strong><\/p>\n\n\n\n

prófunarkerfi sem inniheldur lífvænlegar örverur sem veita skilgreint viðnám gegn tilteknu dauðhreinsunarferli eto gas<\/p>\n\n\n\n

3.5 Kvörðun <\/strong><\/strong><\/p>\n\n\n\n

mengi aðgerða sem koma á, við tilteknar aðstæður, sambandið milli gilda á magni sem mælitæki eða mælingar gefa til kynna<\/p>\n\n\n\n

kerfi, eða gildum sem táknuð eru með efnismælikvarða eða viðmiðunarefni, og samsvarandi gildi framleidd með stöðlum<\/p>\n\n\n\n

3.6 efnavísir <\/strong><\/strong><\/p>\n\n\n\n

prófunarkerfi sem sýnir breytingu á einni eða fleiri fyrirfram skilgreindum ferlibreytum<\/p>\n\n\n\n

byggt á efnafræðilegri eða eðlisfræðilegri breytingu sem stafar af útsetningu fyrir ferli<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.6]<\/p>\n\n\n\n

3.7 Skilyrði <\/a><\/strong><\/p>\n\n\n\n

meðhöndlun vöru innan eto-gasfrjósemisferlisins, en fyrir etýlen<\/p>\n\n\n\n

oxíðinntöku, til að ná fyrirfram ákveðnu hitastigi og hlutfallslegum raka<\/p>\n\n\n\n

Athugasemd 1 við færslu: Þennan hluta etýlenoxíðs ófrjósemisferlis má framkvæma annað hvort við loftþrýsting eða undir lofttæmi.<\/p>\n\n\n\n

Athugasemd 2 við færslu: Sjá 3.27, forskilyrði<\/p>\n\n\n\n

3.8 <\/strong>D <\/em><\/strong><\/em><\/strong>gildi <\/strong><\/strong><\/p>\n\n\n\n

D<\/em>10 gildi <\/strong><\/strong><\/p>\n\n\n\n

tími eða skammtur sem þarf til að ná óvirkjun á 90% af þýði próförverunnar við tilgreind skilyrði<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.11] ?<\/p>\n\n\n\n

Athugasemd 1 við færslu: Að því er varðar þennan alþjóðlega staðal, D <\/em>gildi er váhrifatíminn sem þarf til að ná 90% óvirkjun á þýði prófunarlífverunnar.<\/p>\n\n\n\n

3.9 Þróun <\/strong><\/strong><\/p>\n\n\n\n

athöfn að útfæra forskrift<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.13]<\/p>\n\n\n\n

3,10 daggarmark <\/strong><\/strong><\/p>\n\n\n\n

Hitastigið þar sem mettunarvatnsgufuþrýstingurinn er jöfn<\/p>\n\n\n\n

hlutaþrýstingur vatnsgufunnar í andrúmsloftinu<\/p>\n\n\n\n

Athugasemd 1 við færslu: Öll kólnun andrúmsloftsins undir daggarmarki myndi valda vatnsþéttingu.<\/p>\n\n\n\n

3.11 Stofna <\/strong><\/strong><\/p>\n\n\n\n

ákvarða með fræðilegu mati og staðfesta með tilraunum<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.17]<\/p>\n\n\n\n

9ISO 11135-2014<\/p>\n\n\n\n

3.12 etýlenoxíð (EO) inndælingartími<\/strong> <\/a><\/p>\n\n\n\n

lengd stigsins sem hefst með fyrstu innleiðingu EO (blöndunnar) í hólfið þar til þeirri inndælingu er lokið<\/p>\n\n\n\n

3.13 lýsingartími <\/strong><\/strong><\/p>\n\n\n\n

tímabil þar sem ferlibreytum er haldið innan tilgreindra vikmarka<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.18]<\/p>\n\n\n\n

Athugasemd 1 við færslu: Í þeim tilgangi að reikna út dánartíðni hringrásar er það tímabil dauðhreinsunar með etýlenoxíði frá lokum EO inndælingar og upphafs EO fjarlægingar.<\/p>\n\n\n\n

3.14 Bilun <\/strong><\/strong><\/p>\n\n\n\n

one or more of the process parameters lying outside of its\/their specified<\/p>\n\n\n\n

umburðarlyndi(r)<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.19]<\/p>\n\n\n\n

3.15 Skolun <\/strong><\/strong><\/p>\n\n\n\n

aðferð þar sem etýlenoxíð er fjarlægt úr hleðslunni og hólfinu<\/p>\n\n\n\n

annaðhvort með margfaldri inntöku síaðs lofts, óvirku gasi eða gufu til skiptis og tæmingar úr hólfinu eða stöðugri leið síaðs lofts, óvirku 10ISO 11135-2014 gasi eða gufu í gegnum hleðsluna og hólfið.<\/p>\n\n\n\n

3.16 brotahringur <\/strong><\/strong><\/p>\n\n\n\n

hringrás þar sem útsetningartími fyrir EO gasi er styttur miðað við það<\/p>\n\n\n\n

tilgreint í etýlenoxíð dauðhreinsunarferlinu<\/p>\n\n\n\n

3.17 hálfur hringur <\/strong><\/strong><\/p>\n\n\n\n

hringrás þar sem útsetningartími fyrir EO gasi er styttur um 50% samanborið við það sem tilgreint er í etýlenoxíð dauðhreinsunarferlinu<\/p>\n\n\n\n

3.18 heilsugæslustöð <\/strong><\/strong><\/p>\n\n\n\n

ríkis- og einkasamtök og stofnanir sem helga sig<\/p>\n\n\n\n

efling og viðhald heilsu, og forvarnir og meðferð við<\/p>\n\n\n\n

sjúkdóma og meiðsli<\/p>\n\n\n\n

DÆMI Heilsugæslustöð getur verið sjúkrahús, hjúkrunarheimili, rýmkunaraðstaða, frístandandi skurðlækningastöð, heilsugæslustöð, læknastofa eða tannlæknastofa.<\/p>\n\n\n\n

3.19 heilbrigðisvara <\/strong><\/strong><\/p>\n\n\n\n

lækningatæki, þ.m.t in vitro <\/em>lækningatæki til greiningar eða lyf, þ.mt líflyf<\/p>\n\n\n\n

11 ISO 11135-2014<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.20]<\/p>\n\n\n\n

3.20 uppsetningarhæfi <\/a><\/strong><\/p>\n\n\n\n

ferli við að afla og skrá sönnunargögn um að búnaður hafi verið útvegaður<\/p>\n\n\n\n

og sett upp í samræmi við forskrift þess<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.22]<\/p>\n\n\n\n

3.21 lækningatæki <\/strong><\/strong><\/p>\n\n\n\n

hvaða tæki, tæki, áhöld, vél, tæki, ígræðslu, in vitro <\/em>hvarfefni eða kvörðunartæki, hugbúnaður, efni eða tengdur hlutur, sem framleiðandi ætlar að nota, einn eða í samsetningu, fyrir menn í einum eða fleiri af þeim sérstöku tilgangi sem<\/p>\n\n\n\n

\u2014 diagnosis, prevention, monitoring, treatment or alleviation of disease,<\/p>\n\n\n\n

\u2014 diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,<\/p>\n\n\n\n

\u2014 investigation, replacement or modification or support of the anatomy or of a physiological process,<\/p>\n\n\n\n

\u2014 control of conception,<\/p>\n\n\n\n

\u2014 disinfection of medical devices,<\/p>\n\n\n\n

\u2014 providing information for medical purposes by means of in vitro <\/em>athugun á sýnum úr mannslíkamanum og nær ekki megináformi í eða á mannslíkamann með lyfjafræðilegum, ónæmisfræðilegum eða efnaskiptaaðferðum, en sem hægt er að aðstoða við virkni þess með slíkum aðferðum.<\/p>\n\n\n\n

[HEIM: ISO 13485:2003, skilgreining 3.7]<\/p>\n\n\n\n

?<\/p>\n\n\n\n

3.22 örvera <\/strong><\/strong><\/p>\n\n\n\n

eining af smásjá stærð, sem nær yfir bakteríur, sveppi, frumdýr og vírusa<\/p>\n\n\n\n

Athugasemd 1 við færslu: Sérstakur staðall gæti ekki krafist sönnunar á<\/p>\n\n\n\n

skilvirkni eto gas dauðhreinsunarferlisins við að óvirkja allar gerðir af<\/p>\n\n\n\n

microorganisms, identified in the definition above, for validation and\/or<\/p>\n\n\n\n

reglubundið eftirlit með dauðhreinsunarferli eto gass.<\/p>\n\n\n\n

3.23 rekstrarhæfi <\/a><\/strong><\/p>\n\n\n\n

ferli við að afla og skrá sönnunargögn um að búnaður hafi verið settur upp<\/p>\n\n\n\n

starfar innan fyrirfram ákveðinna marka þegar það er notað í samræmi við það<\/p>\n\n\n\n

verklagsreglur<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.27]<\/p>\n\n\n\n

3.24 ofur nálgun<\/strong><\/strong><\/p>\n\n\n\n

nálgun með því að nota eto gas dauðhreinsunarferli sem skilar að lágmarki 12 spora Log<\/p>\n\n\n\n

Lækkun (SLR) til líffræðilegs vísis sem hefur viðnám sem er jafnt eða hærra en lífbyrði vörunnar<\/p>\n\n\n\n

3.25 breytulausn <\/strong><\/strong><\/p>\n\n\n\n

yfirlýsing um að vara sé dauðhreinsuð, byggð á skrám sem sýna fram á að ferlisbreytur hafi verið afhentar innan tilgreindra vikmarka<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.29]<\/p>\n\n\n\n

Athugasemd 1 við færslu: Þessi aðferð við losun ferli felur ekki í sér notkun líffræðilegra vísbendinga.<\/p>\n\n\n\n

3.26 frammistöðuhæfi <\/a><\/strong><\/p>\n\n\n\n

ferli til að afla og skrá sönnunargögn um að búnaðurinn, eins og hann er settur upp og starfræktur í samræmi við verklagsreglur, virki stöðugt í samræmi við fyrirfram ákveðnar viðmiðanir og skili þar með vöru sem uppfyllir forskriftir hans<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.30]<\/p>\n\n\n\n

3.27 Forskilyrðing <\/a><\/strong><\/p>\n\n\n\n

meðhöndlun vöru, fyrir eto-gasfrjósemisferli, í herbergi eða hólfi til að ná tilgreindum skilyrðum fyrir hitastig og rakastig<\/p>\n\n\n\n

3.28 ferli áskorunartæki <\/strong><\/strong><\/p>\n\n\n\n

hlutur sem er hannaður til að mynda skilgreint viðnám gegn dauðhreinsunarferli aeto gass og notað til að meta árangur ferlisins<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.33]<\/p>\n\n\n\n

Athugasemd 1 við færslu: Að því er varðar þennan alþjóðlega staðal getur PCD<\/p>\n\n\n\n

verið vara, hermdarvara eða annað tæki sem er sáð beint eða<\/p>\n\n\n\n

óbeint. Sjá 7.1.6 og D.7.1.6.<\/p>\n\n\n\n

Athugasemd 2 við færslu: Í þessum alþjóðlega staðli er gerður greinarmunur á innri PCD og ytri PCD. Innri PCD er notað til að sýna fram á að tilskilinni vöru SAL sé náð. PCD sem staðsett er innan marka vöru- eða vöruflutningshylkisins er innri PCD, en PCD sem staðsett er á milli sendandahylkja eða á ytra yfirborði farmsins er ytri PCD. Ytri PCD er hlutur hannaður til að nota til örverufræðilegra<\/p>\n\n\n\n

eftirlit með venjubundnum framleiðslulotum.<\/p>\n\n\n\n

3.29 ferlibreytu <\/strong><\/strong><\/p>\n\n\n\n

tilgreint gildi fyrir ferlibreytu<\/p>\n\n\n\n

Athugasemd 1 við færslu: Forskriftin fyrir dauðhreinsunarferli eto gas inniheldur<\/p>\n\n\n\n

ferlibreytur og vikmörk þeirra.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.34]<\/p>\n\n\n\n

3.30 ferlibreytu <\/strong><\/strong><\/p>\n\n\n\n

ástand innan etýlenoxíðs ófrjósemisferlis, breytingar sem breyta örverueyðandi virkni<\/p>\n\n\n\n

DÆMI?Tími, hitastig, þrýstingur, styrkur, raki, bylgjulengd.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.35]<\/p>\n\n\n\n

3.31 vinnsluflokkur <\/strong><\/strong><\/p>\n\n\n\n

safn mismunandi vöru eða vöruflokka sem hægt er að dauðhreinsa<\/p>\n\n\n\n

saman<\/p>\n\n\n\n

Athugasemd 1 við færslu: Allar vörur innan flokksins hafa verið staðráðnar í að vera jafn eða minni áskorun fyrir etýlenoxíð dauðhreinsunarferlið en vinnsluáskorunarbúnaðurinn fyrir þann hóp.<\/p>\n\n\n\n

3.32 Vara <\/strong><\/strong><\/p>\n\n\n\n

afleiðing af ferli<\/p>\n\n\n\n

[Heimild: ISO 9000:2005, skilgreining 3.4.2]<\/p>\n\n\n\n

Athugasemd 1 við færslu: Að því er varðar dauðhreinsunarstaðla fyrir etýlenoxíð er vara<\/p>\n\n\n\n

áþreifanlegt og getur verið hráefni(r), milliefni(r), undirsamstæðu(r) og<\/p>\n\n\n\n

heilsuvörur.<\/p>\n\n\n\n

3.33 vöruflokkur <\/strong><\/strong><\/p>\n\n\n\n

vöruflokkur sem hefur eiginleika sem gera þeim kleift að dauðhreinsa<\/p>\n\n\n\n

með skilgreindum ferliskilyrðum<\/p>\n\n\n\n

3.34 vöruhleðslumagn<\/strong><\/strong><\/p>\n\n\n\n

skilgreint rými innan nothæfs hólfsrúmmáls sem er upptekið af vöru<\/p>\n\n\n\n

3.35 viðurkennt menningarsafn <\/strong><\/strong><\/p>\n\n\n\n

vörsluvald samkvæmt Búdapest sáttmálanum um Alþjóða<\/em><\/p>\n\n\n\n

Viðurkenning á innborgun á<\/em><\/p>\n\n\n\n

Örverur vegna einkaleyfa og reglugerðar<\/em><\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.38]<\/p>\n\n\n\n

3.36 viðmiðunarörvera <\/strong><\/p>\n\n\n\n

örverustofn fengin úr viðurkenndu ræktunarsafni<\/p>\n\n\n\n

3.37 Endurhæfi <\/strong><\/p>\n\n\n\n

endurtekning á hluta fullgildingar í þeim tilgangi að staðfesta áframhaldandi samþykkt tiltekins ferlis<\/p>\n\n\n\n

3.38 margnota lækningatæki <\/strong><\/strong><\/p>\n\n\n\n

lækningatæki sem framleiðandi tilgreinir eða ætlar að henta fyrir<\/p>\n\n\n\n

endurvinnslu og endurnotkun<\/p>\n\n\n\n

Athugasemd 1 við færslu: Þetta er ekki lækningatæki sem er tilgreint eða ætlað<\/p>\n\n\n\n

frá framleiðanda eingöngu einnota.<\/p>\n\n\n\n

3.39 Þjónusta <\/strong><\/strong><\/p>\n\n\n\n

aðföng frá utanaðkomandi aðilum, sem þarf til að búnaður virki rétt<\/p>\n\n\n\n

DÆMI Rafmagn, vatn, þjappað loft, frárennsli.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.41]<\/p>\n\n\n\n

3.40 einnota lækningatæki <\/strong><\/p>\n\n\n\n

lækningatæki sem framleiðandi tilgreinir eða ætlaði eingöngu til notkunar í eitt skipti<\/p>\n\n\n\n

3.41 Tilgreinið <\/strong><\/strong><\/p>\n\n\n\n

kveða nánar á um í samþykktu skjali<\/p>\n\n\n\n

3.42 Spore-log-reduction <\/strong>skrá yfir upphafsgróstofn, N<\/em>0, að frádregnum skrá yfir lokafjölda, N<\/em>u<\/p>\n\n\n\n

[HEIM: ISO 14161:2009, skilgreining 3.19]<\/p>\n\n\n\n

Athugasemd 1 við færslu: Lýsir fækkun gróa á a<\/p>\n\n\n\n

líffræðilegur vísir eða sáð hlutur framleiddur með útsetningu fyrir tilgreindum<\/p>\n\n\n\n

skilyrði.<\/p>\n\n\n\n

Fyrir beina upptalningu:<\/p>\n\n\n\n

SLR = log N<\/em>0 log ? N<\/em>u<\/p>\n\n\n\n

hvar<\/p>\n\n\n\n

N<\/em>0 er upphafsþýði;<\/p>\n\n\n\n

N<\/em>u er endanlegur íbúafjöldi.<\/p>\n\n\n\n

Fyrir brot neikvæð:<\/p>\n\n\n\n

SLR = log N<\/em>0 \u2013 log [ln (q<\/em>\/n<\/em>)]<\/p>\n\n\n\n

hvar<\/p>\n\n\n\n

N<\/em>0 er upphafsþýði;<\/p>\n\n\n\n

q <\/em>er fjöldi endurtekinna sýna sem prófuð eru;<\/p>\n\n\n\n

n <\/em>er fjöldi sýna neikvæð fyrir vöxt.<\/p>\n\n\n\n

Ef það eru engir eftirlifendur er ekki hægt að reikna út hið sanna SLR. SLR getur verið<\/p>\n\n\n\n

reported as \u201cgreater than\u201d log N<\/em>0 ef ein lífvera er notuð.<\/p>\n\n\n\n

3.43 Dauðhreinsuð <\/strong><\/strong><\/p>\n\n\n\n

laus við lífvænlegar örverur<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.43]<\/p>\n\n\n\n

3.44 dauðhreinsað hindrunarkerfi<\/strong><\/strong><\/p>\n\n\n\n

lágmarks pakki sem kemur í veg fyrir innkomu örvera og gerir smitgát kleift<\/p>\n\n\n\n

framsetningu vörunnar á notkunarstað<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.44]<\/p>\n\n\n\n

3.45 Ófrjósemi<\/strong><\/p>\n\n\n\n

ástand þess að vera laus við lífvænlegar örverur<\/p>\n\n\n\n

Athugasemd 1 við færslu: Í reynd er ekki hægt að sanna slíka algera fullyrðingu um fjarveru örvera.<\/p>\n\n\n\n

Athugasemd 2 við færslu: Sjá 3.47, ófrjósemisaðgerð.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.45]<\/p>\n\n\n\n

3.46 ófrjósemistryggingarstig <\/strong><\/strong><\/p>\n\n\n\n

líkur á að ein lífvænleg örvera komi fyrir á hlut eftir<\/p>\n\n\n\n

ófrjósemisaðgerð<\/p>\n\n\n\n

Athugasemd 1 við færslu: Hugtakið SAL tekur magnbundið gildi, venjulega 10-6 eða 10-3. Þegar þetta magngildi er notað til að tryggja ófrjósemi, hefur SAL upp á 10-6 lægra gildi en veitir meiri fullvissu um ófrjósemi en SAL upp á 10-3.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.46]<\/p>\n\n\n\n

3.47 Ófrjósemisaðgerð <\/a><\/strong><\/p>\n\n\n\n

fullgilt ferli notað til að gera vöruna lausa við lífvænlegar örverur<\/p>\n\n\n\n

Athugasemd 1 við færslu: Í dauðhreinsunarferli, eðli örvera<\/p>\n\n\n\n

óvirkjun er veldisvísis og því er hægt að tjá lifun örveru á einstökum hlut með tilliti til líkinda. Á meðan þetta<\/p>\n\n\n\n

Hægt er að lækka líkur í mjög lága tölu, þær er aldrei hægt að lækka í núll. ISO 11135-2014<\/p>\n\n\n\n

Athugasemd 2 við færslu: Sjá 3.46, ófrjósemistryggingarstig.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.47]<\/p>\n\n\n\n

3.48 ófrjósemisaðgerð <\/a><\/strong><\/p>\n\n\n\n

treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air\/inert gas admission<\/p>\n\n\n\n

3,49 dauðhreinsunarálag <\/strong><\/strong><\/p>\n\n\n\n

vara sem á að vera, eða hefur verið, sótthreinsuð saman með því að nota tiltekið<\/p>\n\n\n\n

dauðhreinsunarferli<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.48]<\/p>\n\n\n\n

3.50 dauðhreinsunarferli <\/a><\/strong><\/p>\n\n\n\n

röð aðgerða eða aðgerða sem þarf til að ná tilgreindum kröfum um ófrjósemi<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.49]<\/p>\n\n\n\n

Athugasemd 1 við færslu: Þessi röð aðgerða eða aðgerða felur í sér forskilyrðingu<\/p>\n\n\n\n

(ef nauðsyn krefur), útsetning fyrir etýlenoxíði við skilgreind skilyrði og hvers kyns nauðsynlegri eftirmeðferð sem þarf til að fjarlægja etýlenoxíð og aukaafurðir þess. Það felur ekki í sér neinar hreinsunar-, sótthreinsunar- eða pökkunaraðgerðir sem eru á undan dauðhreinsunarferlinu.<\/p>\n\n\n\n

3.51 ófrjósemisaðgerðir <\/strong><\/strong><\/p>\n\n\n\n

einstaklingur með tæknilega þekkingu á dauðhreinsunartækni sem notuð er og áhrif hennar á efni og örverur<\/p>\n\n\n\n

3.52 dauðhreinsunarefni <\/strong><\/strong><\/p>\n\n\n\n

myndun einingar sem hafa nægilega örverueyðandi virkni til að ná ófrjósemi við skilgreind skilyrði<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.50]<\/p>\n\n\n\n

3,53 survivor ferill <\/strong><\/p>\n\n\n\n

myndræn framsetning á óvirkjun á hópi örvera með vaxandi útsetningu fyrir örverueyðandi efni við tilgreindar aðstæður<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.51]<\/p>\n\n\n\n

3,54 próf fyrir ófrjósemi <\/strong><\/strong><\/p>\n\n\n\n

tæknileg aðgerð sem er skilgreind í lyfjaskrá sem framkvæmd er á vöru eftir útsetningu fyrir dauðhreinsunarferli<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.53]<\/p>\n\n\n\n

3,55 próf á ófrjósemi <\/strong><\/strong><\/p>\n\n\n\n

tæknileg aðgerð framkvæmd sem hluti af þróun, löggildingu eða<\/p>\n\n\n\n

endurhæfi til að ákvarða tilvist eða fjarveru lífvænlegra örvera á vöru eða hlutum hennar<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.54]<\/p>\n\n\n\n

3,56 nothæft hólfarúmmál <\/strong><\/strong><\/p>\n\n\n\n

skilgreint rými innan dauðhreinsunarhólfsins, sem er ekki takmarkað af föstum eða hreyfanlegum hlutum og sem er tiltækt til að taka við dauðhreinsunarálaginu<\/p>\n\n\n\n

Athugasemd 1 við færslu: Rúmmálið sem leyfir gasflæði í kringum farminn inni<\/p>\n\n\n\n

hólfið er ekki innifalið sem nothæft rými.<\/p>\n\n\n\n

3.57 Löggilding <\/a><\/strong><\/p>\n\n\n\n

skjalfest verklag til að fá, skrá og túlka þær niðurstöður sem þarf til að staðfesta að ferli muni stöðugt skila vöru sem uppfyllir fyrirfram ákveðnar forskriftir<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.55]<\/p>\n\n\n\n

3,58 jómfrúarefni <\/strong><\/p>\n\n\n\n

efni sem ekki hefur áður verið notað eða farið í aðra vinnslu en til upphaflegrar framleiðslu<\/p>\n\n\n\n

EF ÞÚ VILT VITA MEIRA Um etýlenoxíð ófrjósemisaðgerð<\/h2>\n\n\n\n

Sími:+8619975258603<\/a><\/p>\n\n\n\n

Netfang:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Staðbundin staður: Herbergi 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, Kína<\/p>\n\n\n\n

Vefsíða:hzbocon.com<\/a> zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Í þessu skjali eiga eftirfarandi hugtök og skilgreiningar við í dauðhreinsun með etýlenoxíði 3.1 Loftun hluti af 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