{"id":4110,"date":"2025-05-26T17:13:43","date_gmt":"2025-05-26T09:13:43","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4110"},"modified":"2025-05-27T08:28:34","modified_gmt":"2025-05-27T00:28:34","slug":"iso-11040-4","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/sl\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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ISO 11040-4<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Napolnjene injekcijske brizge
Del 4: Stekleni sodi za injiciranje in sterilizirane sestavljene brizge, pripravljene za polnjenje<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tZahtevajte ponudbo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Standardni povzetek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Namen preskusa tesnosti brizge je preveriti odpornost sistemov za zapiranje brizg proti pu\u0161\u010danju teko\u010dine<\/strong> pod dolo\u010denimi pogoji tlaka. V skladu z Priloga G2 k standardu ISO 11040-4<\/em>, test simulira notranji nadtlak (obi\u010dajno 110 kPa), ki se lahko pojavi pri polnjenju ali prevozu brizg.<\/p>\n

S tem testom se ocenjujeta oba \u0161\u010ditniki za igle<\/strong> in pokrov\u010dki za konice<\/strong>, kar zagotavlja, da so zapirala varna in ne pu\u0161\u010dajo pod obremenitvijo.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Tak\u0161na ocena je bistvenega pomena za farmacevtsko kontrolo kakovosti, prepre\u010devanje kontaminacije in zagotavljanje natan\u010dnosti odmerjanja.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Preskusna metoda za zapiranje brizgalk za pu\u0161\u010danje teko\u010dine<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Klju\u010dni preskusni koraki (v skladu s Prilogo G2 k standardu ISO 11040-4):<\/strong><\/p>\n

    \n
  • Priprava vzorca:<\/strong> Uporabite sterilizirane, sestavljene brizge, pripravljene za polnjenje. Pred preskusom ne smete motiti zapiranja.<\/li>\n
  • \u010cakalna doba:<\/strong> Od nastavitve zaprtja do testiranja je treba po\u010dakati najmanj 12 ur.<\/li>\n
  • Polnjenje:<\/strong> Brizgo napolnite z destilirano vodo ali vodo enakovredne \u010distosti do 1\/3 do 2\/3 njene nazivne prostornine.<\/li>\n
  • Tlak:<\/strong> Uporabi 110 kPa<\/strong> tlak s stisnjenim zrakom ali univerzalni stroj za natezno in tla\u010dno testiranje<\/strong>. Zadr\u017eite za 5 sekund<\/strong>.<\/li>\n
  • Spremljanje:<\/strong> Med preskusom in po njem opazujte uhajanje teko\u010dine. Pu\u0161\u010danje se ka\u017ee kot vidne kapljice na zunanji povr\u0161ini zapirala.<\/li>\n
  • Merila za sprejem:<\/strong> Kapljice ne smejo biti vidne, zapiralo (pokrov\u010dek konice ali \u0161\u010ditnik igle) pa mora ostati na mestu.<\/li>\n<\/ul>\n
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    Testiranje velja tako za cilindre brizgalk kot za sterilne podsklope. Vizualni pregled je bistvenega pomena za ugotavljanje pozitivnih\/negativnih rezultatov.<\/p>\n<\/blockquote>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    Osnovna oprema za testiranje pu\u0161\u010danja brizge<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Oprema za ta preskus vklju\u010duje:<\/p>\n

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    • Univerzalni natezni in tla\u010dni preizku\u0161evalnik<\/strong> oz sistem za uravnavanje tlaka stisnjenega zraka<\/strong><\/li>\n
    • Nosilec brizge<\/strong> z mehanizmom za varno zapiranje<\/li>\n
    • Merilnik tlaka ali programska oprema<\/strong> ki lahko dose\u017ee in vzdr\u017euje 110 kPa<\/li>\n
    • Sistem za zajem podatkov z visoko frekvenco vzor\u010denja<\/strong> (priporo\u010deno 500 Hz za meritve najvi\u0161jih vrednosti)<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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      Re\u0161itve Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Izvajanje preskusov tesnosti brizge v skladu s standardom ISO 11040-4, Cell Instruments ponuja prilagodljive platforme za testiranje z brizgalko<\/strong>, zdru\u017eljiv z uporabo stisnjenega zraka in mehanske sile. Na\u0161i sistemi zagotavljajo:<\/p>\n

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      • Natan\u010den nadzor notranjega tlaka<\/strong><\/li>\n
      • Visokofrekven\u010dno vzor\u010denje do 500 Hz<\/strong><\/li>\n
      • Popolna skladnost s postopki testiranja ISO<\/strong><\/li>\n
      • Funkcije samodejnega dokumentiranja<\/strong> za poro\u010danje, pripravljeno na revizijo<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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        Re\u0161itve Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Izvajanje preskusov tesnosti brizge v skladu s standardom ISO 11040-4, Cell Instruments ponuja prilagodljive platforme za testiranje z brizgalko<\/strong>, zdru\u017eljiv z uporabo stisnjenega zraka in mehanske sile. Na\u0161i sistemi zagotavljajo:<\/p>\n

          \n
        • Natan\u010den nadzor notranjega tlaka<\/strong><\/li>\n
        • Visokofrekven\u010dno vzor\u010denje do 500 Hz<\/strong><\/li>\n
        • Popolna skladnost s postopki testiranja ISO<\/strong><\/li>\n
        • Funkcije samodejnega dokumentiranja<\/strong> za poro\u010danje, pripravljeno na revizijo<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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          Zapisovanje in dokumentiranje podatkov<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Po podatkih Priloga G2<\/em>, popolno poro\u010dilo o preskusu mora vsebovati:<\/p>\n

            \n
          • Uporabljeni tlak<\/strong> (kPa) ali enakovredna sila (N)<\/li>\n
          • \u0160tevilo testiranih brizg<\/strong><\/li>\n
          • \u0160tevilo pozitivnih\/neuspe\u0161nih vzorcev<\/strong><\/li>\n
          • Vizualna opa\u017eanja ali odstopanja<\/strong><\/li>\n
          • \n

            Sledljivost parametrov nastavitev<\/strong> (ro\u010dno ali prek programske opreme)<\/p>\n<\/li>\n<\/ul>\n

            Z dokumentiranjem preskusnih pogojev in rezultatov proizvajalci doka\u017eejo skladnost s standardom ISO 11040-4 in zagotovijo regulativna sledljivost<\/strong>-obvezno za farmacevtske sisteme kakovosti.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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            Izra\u010dun notranje sile<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Pri objektih, ki namesto zra\u010dnega tlaka uporabljajo mehansko silo, je potrebna sila (F)<\/strong> za simulacijo notranjega tlaka 110 kPa se lahko izra\u010duna z uporabo formul iz standarda ISO 11040-4:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10-\u00b3<\/strong>
            Kje:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = sila v newtonih<\/li>\n
            • p<\/strong> = tlak (110 kPa)<\/li>\n
            • d<\/strong> = Notranji premer brizge (mm)<\/li>\n<\/ul>\n

              Ta izra\u010dun pomaga zagotoviti. natan\u010dna replikacija testov<\/strong> in umerjanje naprave.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

              ISO 11040-4 Prednapolnjene brizge4. del: Stekleni sodi za injiciranje in sterilizirane sestavljene brizge, pripravljene za polnjenje Zahtevek za ponudbo Povzetek standarda Namen preskusa pu\u0161\u010danja brizge je preveriti odpornost sistemov za zapiranje brizge proti pu\u0161\u010danju teko\u010dine pod dolo\u010denimi tla\u010dnimi pogoji. V skladu s Prilogo G2 k standardu ISO 11040-4 preskus simulira notranji nadtlak (obi\u010dajno 110 kPa), pri \u010demer je [...]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4110","page","type-page","status-publish","hentry"],"yoast_head":"\nISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage<\/title>\n<meta name=\"description\" content=\"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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Spoznajte preskusno metodo in napravo.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.leakagetester.com\/sl\/standards\/iso-11040-4\/","og_locale":"sl_SI","og_type":"article","og_title":"ISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage","og_description":"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}