Sisitemu
1 Ibipimo na sisitemu isanzwe kumacupa yikirahure
ingingo ya 52 y’itegeko rigenga ibiyobyabwenge muri Repubulika y’Ubushinwa igira iti: “Ibikoresho byo gupakira hamwe n’ibikoresho bifitanye isano n’imiti bigomba kuba byujuje ibisabwa kugira ngo bikoreshe imiti n’ubuziranenge bw’umutekano.”Ingingo ya 44 y’amabwiriza yo gushyira mu bikorwa itegeko rigenga ibiyobyabwenge muri Repubulika y’Ubushinwa igira iti: Ingamba z’imicungire, urutonde rw’ibicuruzwa, n’ibisabwa mu bya farumasi n’ibipimo ngenderwaho by’ibikoresho bipakira imiti n’ibikoresho byateguwe kandi bitangazwa n’ishami rishinzwe kugenzura ibiyobyabwenge mu Nama y’igihugu. .Ati: “Nkurikije ibisabwa n’amategeko n'amabwiriza yavuzwe haruguru, Ikigo cya Leta gishinzwe kurwanya ibiyobyabwenge cyateguye mu matsinda kuva mu 2002. Yashyizeho kandi itanga 113 y’ibikoresho bipakira imiti (ibikoresho) (harimo n’ibipimo byateganijwe byo kurekura 2004), harimo n’ibipimo 43 by’icupa ry’ibirahure by’imiti ibikoresho byo gupakira (ibikoresho), n'umubare w'ibipimo bingana na 38% by'ibipimo byose bipakira umudugudu.Igipimo gisanzwe gikubiyemo amacupa yimiti yububiko bwa farumasi muburyo butandukanye bwo gutera inshinge, inshinge zamazi, inshinge, ibinini, ibinini, amazi yo mu kanwa na lyofilize, inkingo, ibikomoka kumaraso nubundi buryo bwa dosiye.Sisitemu yuzuye yubuvuzi bwikirahure yubuvuzi bwashyizweho muburyo bwambere.Gutegura no kurekura ibipimo ngenderwaho, gusimbuza amacupa y’ibirahuri y’imiti n’ibikoresho, kuzamura ubwiza bw’ibicuruzwa, kwizeza ubwiza bw’imiti, kwihutisha kwishyira hamwe n’ibipimo mpuzamahanga n’isoko mpuzamahanga, kuzamura no kugenzura ubuzima bwiza , gahunda, kandi byihuse iterambere ryinganda zikora imiti yubushinwa, Ifite ibisobanuro ninshingano.
Amacupa yikirahure yimiti ni ibikoresho byo gupakira bihuye neza na farumasi.Bafite igice kinini mubijyanye nibikoresho byo gupakira imiti, kandi bafite ibintu bidasubirwaho nibyiza.Ibipimo byabo bigira ingaruka zikomeye kumiterere yububiko bwa farumasi no guteza imbere inganda.
Sisitemu y'imiti
2 Sisitemu isanzwe kumacupa yimiti yimiti
Dukurikije ibipimo ngenderwaho by’ikigo cya Leta gishinzwe kurwanya ibiyobyabwenge byo gupakira ibikoresho bigabanijwemo ibikoresho, ibintu bimwe (bitandukanye) hamwe n’urwego rumwe, hari amahame 43 y’amacupa y’ibirahure y’imiti yatanzwe kandi agomba kurekurwa.Igabanijwemo ibyiciro bitatu ukurikije ubwoko busanzwe.Hariho ibicuruzwa 23 mu cyiciro cya mbere, muri byo 18 byatanzwe, naho 5 biteganijwe ko bisohoka mu 2004;Ibipimo 17 byuburyo bwa kabiri bwibizamini, muri byo 10 byarekuwe, naho 7 biteganijwe ko bizasohoka mu 2004. Hariho amahame 3 y’ibanze yo mu cyiciro cya gatatu, 1 muri yo akaba yarasohotse, 2 azasohoka mu 2004. Hariho ubwoko 23 bwibicuruzwa mubyiciro byambere, bigabanijwe mubwoko 8 ukurikije ubwoko bwibicuruzwa, harimo "Amacupa yatewe inshinge" 3 "Amacupa yatewe inshinge" 3 "Amacupa yinjizwamo ibirahure" 3 "Amacupa yimiti yububiko" 3 "Tube Imiti ya farumasi ibintu 3 bya "Amacupa", ibintu 3 by "Amacupa yo mu kanwa agenzurwa", ibintu 3 bya "Ampoules" n ibintu 3 bya "Glass Medicinal Tubes" (Icyitonderwa: Iki gicuruzwa nigicuruzwa cyarangije igice cyo gutunganya amacupa atandukanye yo kugenzura kandi ampules).
Hariho ubwoko butatu bwibikoresho byo guhuza, harimo ibintu 8 byikirahure cya borosilike.Ikirahuri cya Borosilike kirimo α = (4 ～ 5) × 10 (-6) K (-1) (20 ～ 300 ℃) ikirahure kidafite aho kibogamiye na α = (3. 2 ~ 3. 4) × 10 (-6) K (- 1) (20 ~ 300 ° C) 3.3 Ikirahuri cya Borosilike.Ubu bwoko bwikirahure bukozwe mubirahuri mpuzamahanga bidafite aho bibogamiye, nabyo bikunze kwitwa ikirahuri cya mbere cyangwa ibikoresho byo mu rwego rwa A.Hano hari ibintu 8 byikirahure cya borosilike, naho ikirahuri gito cya borosilike ni α = (6.2 kugeza 7. 5) × 10 (-6) K (-1) (20 kugeza 300 ℃).Ubu bwoko bwibirahure nibirahuri bidasanzwe byubushinwa bidafite aho bihuriye nibipimo mpuzamahanga.Bikunze no kwitwa ibikoresho byo mu cyiciro B.Ikirahuri cya Soda-lime ibintu 7, ikirahuri cya soda-lime ni α = (7,6 kugeza 9. 0) × 10 (-6) K (-1) (20 kugeza 300 ℃), ubu bwoko bwibikoresho byibirahure muri rusange ni ibirunga, kandi hejuru ni amazi arwanya Imikorere igera kurwego rwa 2.
Hano hari amahame 17 yubwoko bwa kabiri bwuburyo bwo kugenzura.Ubu buryo bwubugenzuzi bukubiyemo ibintu bitandukanye byubugenzuzi nkimikorere nibipimo byubwoko butandukanye bwamacupa yimiti yimiti.By'umwihariko, igeragezwa ryimiterere yimiti yikirahure yongeyeho imikorere mishya yo kurwanya amazi hakurikijwe ibipimo bya ISO Kumenya kurwanya alkali na aside bitanga uburyo bwinshi, bwuzuye kandi bwa siyansi bwo kumenya uburyo bwo kumenya imiti ihamye kugirango ihuze ibicuruzwa bitandukanye bya amacupa yimiti yimiti kumiti yibintu bitandukanye nuburyo bwa dosiye.Kugenzura ireme ryamacupa yikirahure yimiti bityo ubwiza bwimiti buzagira uruhare runini.Byongeye kandi, uburyo bwo gutahura umubare wibintu byangiza byongeweho kugirango umutekano wamacupa yikirahure yimiti.Uburyo bwo gupima ibipimo byamacupa yimiti bigomba kongerwaho.Kurugero, uburyo bwikizamini cyo kurwanya alkali irwanya kwangirika kwa ampules, uburyo bwikizamini cyo kumena imbaraga, nuburyo bwo gupima uburyo bwo guhangana nigikonje gikonje byose bigira uruhare runini kumiterere no gukoresha amacupa yimiti yimiti.
Hano hari amahame 3 yibanze murwego rwa gatatu.Muri byo, "Gutondekanya hamwe nuburyo bwo gupima amacupa yubuvuzi bwikirahure" bivuga ISO 12775-1997 "Gutondekanya nuburyo bwo gupima ibirahuri mubikorwa bisanzwe binini-binini".Gutondekanya amacupa hamwe nuburyo bwo gupima bifite ibisobanuro bisobanutse byo gutandukanya ibikoresho byibirahure nizindi nganda.Ibindi bipimo bibiri byibanze bigabanya ibintu byangiza ibikoresho byikirahure, gurş, kadmium, arsenic, na antimoni, kugirango umutekano wimikorere myiza yimiti itandukanye.
Ibiranga amacupa yimiti
3 Ibiranga icupa ryimiti yubuvuzi
Icupa rya farumasi yimiti ni ishami ryingenzi rya sisitemu isanzwe kubikoresho byo gupakira imiti.Kubera ko amacupa yikirahure yimiti ahura nubuvuzi, kandi amwe muramwe akeneye kubikwa igihe kirekire, ubwiza bwamacupa yikirahure yimiti bufitanye isano itaziguye nubwiza bwimiti kandi burimo ubuzima bwabantu numutekano.Kubwibyo, igipimo cyamacupa yimiti yimiti ifite ibisabwa byihariye kandi bikomeye, byavuzwe muri make kuburyo bukurikira:
Byinshi kuri gahunda kandi byuzuye, byongera guhitamo ibipimo byibicuruzwa kandi bigatsinda igihe cyibipimo byibicuruzwa
Igicuruzwa kimwe cyagaragajwe nubuziranenge bushya gishingiye ku ihame ryo gushyiraho ibipimo bitandukanye bishingiye ku bikoresho bitandukanye, byagura cyane urugero rw’ibipimo ngenderwaho, byongera uburyo bwo guhitamo no guhitamo imiti mishya n’ibiyobyabwenge bidasanzwe ku bikoresho bitandukanye by’ibirahure n'imikorere itandukanye. ibicuruzwa, hamwe nimpinduka Ibipimo mubicuruzwa rusange bisigaye inyuma yiterambere ryibicuruzwa.
Kurugero, mubwoko 8 bwibicuruzwa byamacupa yimiti yikirahure bitwikiriwe nuburyo bushya, buri gipimo cyibicuruzwa kigabanijwemo ibyiciro 3 ukurikije ibikoresho nibikorwa, icyiciro cya mbere ni ikirahuri cya borosilike, icyiciro cya kabiri ni ikirahuri cya borosilike, naho icya gatatu Icyiciro ni soda lime ikirahure.Nubwo ibicuruzwa runaka byubwoko runaka bwibintu bitarakozwe, hashyizweho ibipimo byubwoko bwibicuruzwa, bikemura ikibazo cyo gutinda mubicuruzwa bisanzwe.Ubwoko butandukanye bwibiyobyabwenge bifite amanota atandukanye, ibintu bitandukanye, imikoreshereze itandukanye nuburyo bwa dosiye bifite byinshi bihinduka kandi bihitamo byinshi mubicuruzwa bitandukanye.
Yasobanuye neza ibisobanuro byikirahuri cya borosilike nikirahure cya borosilike.Ihame mpuzamahanga ISO 4802. 1-1988 “Kurwanya Amazi Yibirahure hamwe n’ibirahure by'imbere.Igice cya 1: Kumenya no gushyira mu byiciro ukoresheje titre. ”Ikirahure) bisobanurwa nk'ikirahure kirimo 5 kugeza 13% (m / m) ya boron trioxide (B-2O-3), ariko ISO 12775 “Gutondekanya ibirahuri hamwe nuburyo bwo gupima umusaruro usanzwe” byatanzwe mu 1997 Igisobanuro cya borosilike ikirahure (harimo ikirahure kidafite aho kibogamiye) kirimo boron trioxide (B-2O-3) irenga 8% (m / m).Ukurikije amahame mpuzamahanga yo mu 1997 agenga amahame yo gutondekanya ibirahure, ibikoresho byikirahure bingana na 2% (m / m) ya B-2O-3, byakoreshejwe cyane mu nganda z’ibicupa by’imiti mu Bushinwa mu myaka myinshi, ntibigomba kwitwa ibirahuri bya borosilike cyangwa ikirahure kidafite aho kibogamiye.Ikizamini kigaragaza ko bimwe mubirahuri byamazi yikirahure hamwe nibizamini byo kurwanya amazi yimbere yibi bikoresho binanirwa kugera kurwego rwa 1 na HC1, cyangwa biri hagati yinkombe zurwego rwa 1 nurwego rwa 2. Imyitozo nayo yerekanye ko bumwe murubwo bwoko y'ibirahure bizagira kunanirwa kutabogamye cyangwa gukuramo gukoreshwa, ariko ubu bwoko bwikirahure bwakoreshejwe mubushinwa mumyaka myinshi.Ibipimo bishya bigumana ubu bwoko bwikirahure kandi bugaragaza B-2O- Ibiri muri 3 bigomba kuba byujuje ibisabwa 5-8% (m / m).Byasobanuwe neza ko ubu bwoko bwikirahure budashobora kwitwa ikirahuri cya borosilike (cyangwa ikirahure kidafite aho kibogamiye), kandi cyitwa ikirahuri cya borosilike.
Koresha neza ISO.Ibipimo bishya bihuye n’ibipimo mpuzamahanga.Ibipimo bishya byerekeza ku bipimo bya ISO hamwe n’ibipimo nganda na farumasi yo muri Amerika, Ubudage, Ubuyapani n’ibindi bihugu byateye imbere, kandi bigahuza imiterere nyayo y’inganda zikoreshwa mu icupa ry’imiti mu Bushinwa bivuye mu bice bibiri by’ubwoko bw’ibirahure n'ibikoresho by'ibirahure. Kugera ku rwego mpuzamahanga.
Ubwoko bw'ibirahure: Hariho ubwoko 4 bw'ikirahure muburyo bushya, harimo ubwoko 2 bwikirahure cya borosilike, harimo ikirahuri cya borosilike 3.3 [α = (3. 3 ± 0. 1) × 10 (-6) K (-1)] Kandi 5.0 0 ikirahure kidafite aho kibogamiye [α = (4 kugeza 5) × 10 (-6) K (-1)], ikirahuri cya borosilike nkeya [α = (6.2 kugeza 7. 5) × 10 (-6) K (-1) ] Ubwoko 1, ikirahuri cya soda-lime [α = (7.6 ~ 9. 0) × 10 (-6) K (-1)] ubwoko 1, nuko hariho ubwoko 4 bwikirahure kubintu.
Kuberako ikirahuri cya soda kirimo umubare munini wubuvuzi butabogamye mubikorwa no kubishyira mubikorwa, bigabanijwe mubwoko 5 ukurikije ibicuruzwa.Ubwoko 4 bwibirahuri hamwe nubwoko 5 bwibicuruzwa byibirahure birimo ibipimo mpuzamahanga, Pharmacopoeia yo muri Amerika hamwe nuducupa tw’ibirahure by’ubuvuzi by’Ubushinwa.Byongeye kandi, mubicuruzwa 8 bikubiye mubisanzwe, ampules yonyine niyo yashyizeho ibipimo 2, "amarashi ya borosilicate ibirahuri" na "amarashi yo mu bwoko bwa borosilike," n'ubwoko bumwe gusa bwa α = (4 kugeza 5) × 10 (-6) K (-1) yikirahuri cya borosilike 5.0 idafite α = (3. 3 ± 0. 1) × 10 (-6) K (-1) ya 3. 3 ikirahuri cya borosilike Ni ukubera ko nta bicuruzwa nkibi ku isi , hamwe no koroshya ikirahuri cya 3.3 borosilike ni ndende, bigatuma bigorana gufunga ampule.Mubyukuri, amahame mpuzamahanga afite gusa 5.0 ya borosilique yikirahure, kandi nta 3.3 ya borosilike yikirahure ampoule na soda-lime ikirahure.Kubijyanye n’Ubushinwa budasanzwe bwa borosilike y’ibirahure, ampules 5.0 ya borosilike yikirahure ntirashiraho igihe cyihariye cy’umusaruro munini uhagaze neza mu Bushinwa kubera impamvu zitandukanye, kandi ushobora gukoreshwa gusa nkibicuruzwa byinzibacyuho.Mu kurangiza, ikirahuri gito cya borosilike kiracyari gito.Ampoule, tezimbere 5.0 borosilicate ibirahuri ampule kugirango ugere kubufatanye bwuzuye nibipimo mpuzamahanga nibicuruzwa byihuse.
Imikorere y'ibirahure: Coefficient yo kwagura ubushyuhe α yerekanwe muburyo bushya, ikirahuri cya borosilike 3.3 hamwe nikirahure cya borosilike 5.0 bihuye rwose nubuziranenge mpuzamahanga.Ikirahuri gito cya borosilike cyihariye mu Bushinwa, kandi nta bikoresho nk'ibi biri mu rwego mpuzamahanga.Ikirahuri cya soda-lime ISO iteganya α = (8 ～ 10) × 10 (-6) K (-1), naho igipimo gishya giteganya α = (7.6–9. 0) × 10 (-6) K (-1) , Ibipimo birakomeye gato kurenza ibipimo mpuzamahanga.Mubipimo bishya, imiterere yimiti yikirahuri cya borosilike 3.3, ikirahuri cya borosilike 5.0 hamwe nikirahuri cya soda-lime kuri 121 ° C bihuye nibipimo mpuzamahanga.Byongeye kandi, ibisabwa mubigize imiti ya boride oxyde (B-2O-3) mubwoko butatu bwibirahure bihuye neza nubuziranenge mpuzamahanga.
Imikorere y'ibirahuri: Imikorere y'ibicuruzwa iteganijwe mu gipimo gishya, kurwanya amazi yo hejuru imbere, kurwanya ubushyuhe bw’umuriro, hamwe n’ibipimo byerekana umuvuduko w’imbere bihuye n’ibipimo mpuzamahanga.Ihangayikishwa ryimbere ryurwego rwa ISO riteganya ko ampule ari 50nm / mm, ibindi bicuruzwa ni 40nm / mm, naho igipimo gishya giteganya ko ampule ari 40nm / mm, bityo igipimo cyimbere cyimbere cya ampule kiri hejuru gato ugereranije na ISO.
Gusaba icupa ryubuvuzi
Gukoresha amacupa yimiti yimiti
Ibicuruzwa bitandukanye nibikoresho bitandukanye bigize sisitemu isanzwe yo gutambuka, itanga ishingiro rihagije hamwe nibisabwa mubikoresho bya siyanse, byumvikana kandi bibereye mubirahuri byubwoko butandukanye bwimiti.Guhitamo no gukoresha imiti itandukanye yimiti muburyo butandukanye, imiterere itandukanye hamwe n amanota atandukanye kumacupa yikirahure yimiti igomba gukurikiza amahame akurikira:
Imiti ihamye
Amahame meza kandi akwiye yimiti ihamye
Ikirahuri gikoreshwa mu gufata imiti y'ubwoko bwose kigomba kuba gihuye neza nibiyobyabwenge, nukuvuga, mugukora, kubika no gukoresha ibiyobyabwenge, imiti yimiti yikirahure ntigomba kuba idahungabana, nibintu bimwe hagati ntibigomba kubaho.Guhindagurika cyangwa kudakora neza imiti iterwa na reaction ya chimique.Kurugero, ibikoresho byibirahuri bikozwe mubirahuri bya borosilike bigomba gutoranywa kumiti yo murwego rwohejuru nko gutegura amaraso ninkingo, hamwe nubwoko butandukanye bwa acide ikomeye hamwe nogutegura amazi ya alkali, cyane cyane imyiteguro yo gutera amazi ya alkaline, nayo igomba gukorwa mubirahuri bya borosilike .Ampules nkeya ya borosilike ikoreshwa cyane mubushinwa ntabwo ikwiriye kubamo imyiteguro yo gutera amazi.Ibikoresho nkibi byibirahure bigomba guhinduka buhoro buhoro mubikoresho byibirahure 5.0 kugirango bihuze nibipimo mpuzamahanga byihuse kugirango barebe ko imiti irimo idakoreshwa.Off-chip, ntabwo ihindagurika, kandi ntabwo yangirika.
Kubitera ifu rusange, gutegura umunwa no gushiramo binini, gukoresha ikirahuri cya borosilike nkeya cyangwa ikirahuri cya soda-lime itabogamye irashobora kuba yujuje ibyangombwa bisabwa kugirango imiti ihamye.Urwego rwo kwangirika kwimiti kumirahuri muri rusange ni amazi aruta ibinini kandi alkaline iruta aside, cyane cyane inshinge zikomeye zatewe mumazi ya alkaline zifite imiti myinshi ikenerwa mumacupa yimiti yimiti.
Kurwanya ubushyuhe bwumuriro
Kurwanya neza ubushyuhe bwihuse
Mu gukora imiti itandukanye yibiyobyabwenge, gukanika ubushyuhe bwo hejuru, gukonjesha cyangwa gukonjesha ubushyuhe buke bikenerwa mugikorwa cyo kubyaza umusaruro, bisaba ko icyombo cyikirahure gifite ubushobozi bwiza kandi bukwiye bwo guhangana nimpinduka zitunguranye zubushyuhe butaturika .Kurwanya ikirahuri kumihindagurikire yubushyuhe bwihuse bifitanye isano na coefficient yo kwaguka kwinshi.Hasi coefficente yo kwagura ubushyuhe, niko irwanya imbaraga zubushyuhe.Kurugero, imyiteguro myinshi yinkingo zo murwego rwohejuru, imyiteguro yibinyabuzima hamwe nimyiteguro ya lyofilize igomba gukoresha muri rusange ibirahuri bya borosilike 3.3 cyangwa ikirahuri cya borosilike 5.0.Iyo ubwinshi bwikirahure gito cya borosilike ikorerwa mubushinwa bigira ihinduka ryihuse mubitandukaniro ryubushyuhe, akenshi usanga biturika no guta amacupa.Ikirahuri cya borosilike ya 3.3 mu Bushinwa gifite iterambere ryinshi, iki kirahure kibereye cyane cyane imyiteguro ya lyofilize, kubera ko irwanya ihinduka ritunguranye ry’ubushyuhe iruta ikirahuri cya borosilike 5.0.
Imbaraga za mashini
Imbaraga nziza kandi zikwiye
Ibiyobyabwenge muburyo butandukanye bigomba kwihanganira urwego runaka rwo kurwanya imashini mugihe cyo gukora no gutwara.Imbaraga zumukanishi wamacupa yikirahure yimiti nibikoresho ntabwo bifitanye isano gusa nuburyo icupa, ingano ya geometrike, gutunganya amashyuza, nibindi, ahubwo nimbaraga zubukorikori bwibikoresho byikirahure.Ku rugero runaka, imbaraga za mashini yikirahuri cya borosilike iruta iy'ikirahuri cya soda-lime.
Gutanga no gushyira mu bikorwa ibipimo bishya by’amacupa y’ibirahure y’imiti birakenewe kugira ngo hashyizweho uburyo bunoze kandi bw’ubumenyi bwa siyansi, kwihutisha umuvuduko wo kwishyira hamwe n’ibipimo mpuzamahanga ndetse n’amasoko mpuzamahanga, no kuzamura ireme ry’ibikoresho bipakira imiti, byemeza ubuziranenge bw’imiti, guteza imbere iterambere ryinganda nubucuruzi mpuzamahanga.Azagira uruhare rwiza.Birumvikana ko, kimwe na sisitemu isanzwe y'ibikoresho byo gupakira imiti, haracyari ibibazo byinshi bigomba kurushaho kunozwa, kunozwa, no gutunganywa muri sisitemu ibanza y’amacupa y’ibirahure y’imiti, cyane cyane kugira ngo ihuze n’iterambere ryihuse ry’inganda zimiti. no guhuriza hamwe isoko mpuzamahanga.Ikirego.Gutegura, ibiyikubiyemo n'ibipimo ngenderwaho, hamwe n’uburyo amahame mpuzamahanga yemejwe kandi ajyanye n’isoko mpuzamahanga byose bisaba guhinduka no kongerwaho mugihe cyo gusubiramo.
Icupa ry'ikirahure n'ibipimo byo gupima tank:
Uburyo bwo kwipimisha kubibazo byibirahure: ASTM C 148-2000 (2006).
Igihe cyo kohereza: Ukuboza-06-2019