{"id":7956,"date":"2026-05-07T15:44:25","date_gmt":"2026-05-07T07:44:25","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=7956"},"modified":"2026-05-07T16:19:47","modified_gmt":"2026-05-07T08:19:47","slug":"iso-8537","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/sk\/standards\/iso-8537\/","title":{"rendered":"ISO 8537"},"content":{"rendered":"<p data-start=\"397\" data-end=\"745\">Norma ISO 8537 definuje kritick\u00e9 v\u00fdkonnostn\u00e9 sk\u00fa\u0161ky pre steriln\u00e9 jednorazov\u00e9 inzul\u00ednov\u00e9 strieka\u010dky, vr\u00e1tane injek\u010dnej schopnosti, tesnosti strieka\u010dky, odolnosti vo\u010di \u00faniku v\u00e1kua, k\u013azavosti a merania m\u0155tveho priestoru. Tieto sk\u00fa\u0161ky hodnotia tesnos\u0165, silu potrebn\u00fa na pohyb piestu, v\u00fdkonnos\u0165 pri nas\u00e1van\u00ed a presnos\u0165 merania zvy\u0161kov\u00e9ho objemu s cie\u013eom zabezpe\u010di\u0165 bezpe\u010dnos\u0165 strieka\u010dky a spo\u013eahlivos\u0165 d\u00e1vkovania. Pokro\u010dil\u00e9 testovacie syst\u00e9my pom\u00e1haj\u00fa v\u00fdrobcom dosiahnu\u0165 konzistentn\u00fa kontrolu kvality, s\u00falad s regula\u010dn\u00fdmi po\u017eiadavkami a zlep\u0161en\u00fd v\u00fdkon v\u00fdrobkov v aplik\u00e1ci\u00e1ch vo farmaceutickom priemysle a v oblasti zdravotn\u00edckych pom\u00f4cok.<\/p>\n<p data-start=\"397\" data-end=\"745\">Steriln\u00e9 inzul\u00ednov\u00e9 strieka\u010dky musia pri klinickom pou\u017e\u00edvan\u00ed pod\u00e1va\u0165 presn\u00e9 d\u00e1vky, zachov\u00e1va\u0165 tesnos\u0165 a zabezpe\u010dova\u0165 plynul\u00fd pohyb piestu. <strong data-start=\"535\" data-end=\"547\">ISO 8537<\/strong>, medzin\u00e1rodn\u00e1 norma pre steriln\u00e9 inzul\u00ednov\u00e9 injek\u010dn\u00e9 strieka\u010dky na jedno pou\u017eitie s ihlou alebo bez nej, stanovuje k\u013e\u00fa\u010dov\u00e9 po\u017eiadavky na v\u00fdkonnos\u0165 a bezpe\u010dnos\u0165 pre v\u00fdrobcov a laborat\u00f3ri\u00e1 kontroly kvality.<\/p>\n<p data-start=\"747\" data-end=\"1121\">Norma zah\u0155\u0148a nieko\u013eko z\u00e1kladn\u00fdch funk\u010dn\u00fdch hodnoten\u00ed, ako napr\u00edklad <strong data-start=\"823\" data-end=\"845\">test injek\u010dnej aplikovate\u013enosti<\/strong>, <strong data-start=\"847\" data-end=\"871\">sk\u00fa\u0161ka tesnosti injek\u010dnej strieka\u010dky<\/strong>, <strong data-start=\"873\" data-end=\"908\">v\u00e1kuov\u00e1 sk\u00fa\u0161ka tesnosti vo farmaceutickom priemysle<\/strong>, <strong data-start=\"910\" data-end=\"941\">sk\u00fa\u0161anie sily potrebnej na posun injek\u010dnej strieka\u010dky<\/strong>a <strong data-start=\"947\" data-end=\"973\">meranie m\u0155tveho priestoru<\/strong>. Tieto testy pom\u00e1haj\u00fa v\u00fdrobcom overova\u0165 spo\u013eahlivos\u0165 injek\u010dn\u00fdch strieka\u010diek, minimalizova\u0165 chyby pri d\u00e1vkovan\u00ed a zabezpe\u010di\u0165 s\u00falad s glob\u00e1lnymi predpismi t\u00fdkaj\u00facimi sa zdravotn\u00edckych pom\u00f4cok.<\/p>\n<h2 data-section-id=\"3lxdx6\" data-start=\"1322\" data-end=\"1380\">ISO 8537 \u2013 Po\u017eiadavky na kvalitu injek\u010dn\u00fdch strieka\u010diek<\/h2>\n<p data-start=\"1382\" data-end=\"1497\">Norma ISO 8537 sa zameriava na v\u00fdkonnostn\u00e9 charakteristiky steriln\u00fdch inzul\u00ednov\u00fdch injek\u010dn\u00fdch strieka\u010diek na jedno pou\u017eitie. Norma hodnot\u00ed:<\/p>\n<ul data-start=\"1499\" data-end=\"1705\">\n<li data-section-id=\"km50lt\" data-start=\"1499\" data-end=\"1523\">Odolnos\u0165 proti \u00faniku vzduchu<\/li>\n<li data-section-id=\"413t8n\" data-start=\"1524\" data-end=\"1551\">Odolnos\u0165 proti \u00faniku kvapal\u00edn<\/li>\n<li data-section-id=\"fak85b\" data-start=\"1552\" data-end=\"1576\">P\u00f4sobiaca sila piesta<\/li>\n<li data-section-id=\"1iislmh\" data-start=\"1577\" data-end=\"1617\">Tesnos\u0165 spoja medzi ihlou a tryskou<\/li>\n<li data-section-id=\"w4478w\" data-start=\"1618\" data-end=\"1648\">Zvy\u0161kov\u00fd objem (m\u0155tvy priestor)<\/li>\n<li data-section-id=\"1pxb9hs\" data-start=\"1649\" data-end=\"1705\">Kon\u0161truk\u010dn\u00e1 integrita po\u010das nas\u00e1vania a stla\u010dovania<\/li>\n<\/ul>\n<p data-start=\"1707\" data-end=\"1816\">Tieto v\u00fdkonnostn\u00e9 parametre priamo ovplyv\u0148uj\u00fa presnos\u0165 vstrekovania, zaru\u010denie sterility a pou\u017e\u00edvate\u013esk\u00fd komfort.<\/p>\n<p data-start=\"1818\" data-end=\"2034\">Na rozdiel od jednoduch\u00fdch vizu\u00e1lnych kontrol si testovanie pod\u013ea normy ISO 8537 vy\u017eaduje kontrolovan\u00e9 laborat\u00f3rne postupy a presn\u00e9 meracie pr\u00edstroje, ktor\u00e9 s\u00fa schopn\u00e9 vyv\u00edja\u0165 opakovan\u00fa mechanick\u00fa silu, v\u00e1kuov\u00fd tlak a zabezpe\u010di\u0165 presnos\u0165 merania.<\/p>\n<h2 data-section-id=\"rfstg1\" data-start=\"2041\" data-end=\"2084\">Sk\u00fa\u0161ka vstrekovate\u013enosti pod\u013ea normy ISO 8537<\/h2>\n<p data-start=\"2086\" data-end=\"2328\">Str\u00e1nka <strong data-start=\"2090\" data-end=\"2112\">test injek\u010dnej aplikovate\u013enosti<\/strong> ur\u010duje prev\u00e1dzkov\u00fa silu potrebn\u00fa na spustenie a udr\u017eanie pohybu piestu po\u010das pod\u00e1vania tekutiny. V pr\u00edlohe C normy ISO 8537 sa injek\u010dn\u00e1 strieka\u010dka pred sk\u00fa\u0161kou napln\u00ed destilovanou vodou do v\u00fd\u0161ky 50% jej menovit\u00e9ho objemu.<\/p>\n<p data-start=\"2330\" data-end=\"2377\">Tento postup meria dva k\u013e\u00fa\u010dov\u00e9 parametre:<\/p>\n<ul data-start=\"2379\" data-end=\"2530\">\n<li data-section-id=\"psx7ug\" data-start=\"2379\" data-end=\"2457\"><strong data-start=\"2381\" data-end=\"2402\">Sila uvo\u013enenia<\/strong> \u2014 po\u010diato\u010dn\u00e1 sila potrebn\u00e1 na spustenie pohybu piestu<\/li>\n<li data-section-id=\"x7byum\" data-start=\"2458\" data-end=\"2530\"><strong data-start=\"2460\" data-end=\"2475\">K\u013azav\u00e1 sila<\/strong> \u2014 trval\u00e1 sila potrebn\u00e1 na udr\u017eanie pohybu piesta<\/li>\n<\/ul>\n<p data-start=\"2532\" data-end=\"2561\">Nadmern\u00e9 pou\u017eitie sily m\u00f4\u017ee nazna\u010dova\u0165:<\/p>\n<ul data-start=\"2562\" data-end=\"2680\">\n<li data-section-id=\"165iqxg\" data-start=\"2562\" data-end=\"2580\">Nedostato\u010dn\u00e9 mazanie<\/li>\n<li data-section-id=\"qnjztr\" data-start=\"2581\" data-end=\"2610\">Po\u0161koden\u00e9 elastom\u00e9rne tesnenia<\/li>\n<li data-section-id=\"19shynq\" data-start=\"2611\" data-end=\"2645\">Rozmerov\u00e1 nejednotnos\u0165 hlavne<\/li>\n<li data-section-id=\"z1rwsc\" data-start=\"2646\" data-end=\"2680\">Nedostato\u010dn\u00e1 kontrola v\u00fdroby<\/li>\n<\/ul>\n<p data-start=\"2682\" data-end=\"2763\">Nedostato\u010dn\u00e1 sila m\u00f4\u017ee zn\u00ed\u017ei\u0165 presnos\u0165 d\u00e1vkovania a ohrozi\u0165 stabilitu manipul\u00e1cie.<\/p>\n<h3 data-start=\"2981\" data-end=\"3195\"><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/syringe-piston-glide-force-tester\/\" target=\"_blank\" rel=\"noopener\">SSR-01 Tester posuvn\u00e9ho odporu strieka\u010dky<\/a><\/h3>\n<p><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/syringe-piston-glide-force-tester\/\"><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone wp-image-6642 size-medium\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/Syringe-Piston-Glide-Force-Tester-ISO-7886-1-Annex-E-300x300.webp\" alt=\"Tester sily posunu piestu strieka\u010dky - ISO 7886-1 pr\u00edloha E\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/Syringe-Piston-Glide-Force-Tester-ISO-7886-1-Annex-E-300x300.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/Syringe-Piston-Glide-Force-Tester-ISO-7886-1-Annex-E-150x150.webp 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/Syringe-Piston-Glide-Force-Tester-ISO-7886-1-Annex-E-12x12.webp 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/Syringe-Piston-Glide-Force-Tester-ISO-7886-1-Annex-E-100x100.webp 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/Syringe-Piston-Glide-Force-Tester-ISO-7886-1-Annex-E.webp 600w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<h2 data-section-id=\"1sgck7w\" data-start=\"3202\" data-end=\"3251\">Sk\u00fa\u0161ka tesnosti injek\u010dnej strieka\u010dky z h\u013eadiska kompresnej integrity<\/h2>\n<p data-start=\"3253\" data-end=\"3383\">Str\u00e1nka <strong data-start=\"3257\" data-end=\"3281\">sk\u00fa\u0161ka tesnosti injek\u010dnej strieka\u010dky<\/strong> pop\u00edsan\u00e1 v pr\u00edlohe E normy ISO 8537 overuje tesnos\u0165 vo\u010di kvapalin\u00e1m za podmienok vn\u00fatorn\u00e9ho tlaku.<\/p>\n<p data-start=\"3385\" data-end=\"3406\">Po\u010das z\u00e1kroku:<\/p>\n<ol data-start=\"3407\" data-end=\"3646\">\n<li data-section-id=\"1gqsp1l\" data-start=\"3407\" data-end=\"3455\">Strieka\u010dka je naplnen\u00e1 nad nomin\u00e1lny objem.<\/li>\n<li data-section-id=\"1tw1yle\" data-start=\"3456\" data-end=\"3486\">Vzduch je \u00faplne vypusten\u00fd.<\/li>\n<li data-section-id=\"139f7ck\" data-start=\"3487\" data-end=\"3525\">Tryska alebo hrot ihly je utesnen\u00fd.<\/li>\n<li data-section-id=\"1w1iqbn\" data-start=\"3526\" data-end=\"3589\">Na dosiahnutie maxim\u00e1lneho vych\u00fdlenia piestu sa p\u00f4sob\u00ed bo\u010dn\u00e9 za\u0165a\u017eenie.<\/li>\n<li data-section-id=\"jl8kyz\" data-start=\"3590\" data-end=\"3646\">Vn\u00fatorn\u00fd tlak dosahuje <strong data-start=\"3619\" data-end=\"3630\">300 kPa<\/strong> po dobu 30 sek\u00fand.<\/li>\n<\/ol>\n<p data-start=\"3648\" data-end=\"3675\">Prev\u00e1dzkovate\u013e n\u00e1sledne skontroluje:<\/p>\n<ul data-start=\"3676\" data-end=\"3777\">\n<li data-section-id=\"1v1bjqk\" data-start=\"3676\" data-end=\"3697\">\u00danik z tesnenia piesta<\/li>\n<li data-section-id=\"bqbg1c\" data-start=\"3698\" data-end=\"3718\">\u00danik z trysky\/rozbo\u010dova\u010da<\/li>\n<li data-section-id=\"e0n55p\" data-start=\"3719\" data-end=\"3748\">Netesnos\u0165 spoja ihly a valca<\/li>\n<li data-section-id=\"12599qq\" data-start=\"3749\" data-end=\"3777\">Ne\u00famyseln\u00fd pohyb piesta<\/li>\n<\/ul>\n<p data-start=\"3779\" data-end=\"3897\">Tento test simuluje skuto\u010dn\u00e9 klinick\u00e9 podmienky pou\u017e\u00edvania, pri ktor\u00fdch m\u00f4\u017eu s\u00fa\u010dasne p\u00f4sobi\u0165 bo\u010dn\u00e9 za\u0165a\u017eenia a vn\u00fatorn\u00fd tlak.<\/p>\n<p data-start=\"3899\" data-end=\"3932\">Poruchy sp\u00f4soben\u00e9 \u00fanikom m\u00f4\u017eu ma\u0165 nasleduj\u00face pr\u00ed\u010diny:<\/p>\n<ul data-start=\"3933\" data-end=\"4042\">\n<li data-section-id=\"1hlhp7v\" data-start=\"3933\" data-end=\"3957\">Nedostato\u010dn\u00e9 tesnenie z elastom\u00e9ru<\/li>\n<li data-section-id=\"1ls3zqh\" data-start=\"3958\" data-end=\"3989\">Nepresn\u00e9 tolerancie pri formovan\u00ed<\/li>\n<li data-section-id=\"1ho49jl\" data-start=\"3990\" data-end=\"4009\">Slab\u00e1 zostava n\u00e1boja<\/li>\n<li data-section-id=\"bxum84\" data-start=\"4010\" data-end=\"4042\">Nedostato\u010dn\u00e1 pri\u013enavos\u0165<\/li>\n<\/ul>\n<h3 data-start=\"4236\" data-end=\"4373\"><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/syringe-liquid-leakage-tester\/\" target=\"_blank\" rel=\"noopener\">SPPT-01 Injek\u010dn\u00fd tester \u00faniku kvapal\u00edn<\/a><\/h3>\n<p><img decoding=\"async\" class=\"size-medium wp-image-6634\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester-300x300.jpg\" alt=\"SPPT-01 ISO 7886-1 Tester \u00faniku kvapaliny z injek\u010dnej strieka\u010dky\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester-150x150.jpg 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester-768x768.jpg 768w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester-12x12.jpg 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester-600x600.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester-100x100.jpg 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SPPT-01-ISO-7886-1-Syringe-Liquid-Leakage-Tester.jpg 800w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<h2 data-section-id=\"1i0hskc\" data-start=\"4380\" data-end=\"4439\">Sk\u00fa\u0161ky tesnosti v\u00e1kuom \u2013 farmaceutick\u00e9 aplik\u00e1cie pod\u013ea normy ISO 8537<\/h2>\n<p data-start=\"4441\" data-end=\"4575\">Str\u00e1nka <strong data-start=\"4445\" data-end=\"4480\">v\u00e1kuov\u00e1 sk\u00fa\u0161ka tesnosti vo farmaceutickom priemysle<\/strong> Postup uveden\u00fd v pr\u00edlohe B normy ISO 8537 sl\u00fa\u017ei na hodnotenie \u00faniku vzduchu okolo piestu injek\u010dnej strieka\u010dky po\u010das ods\u00e1vania.<\/p>\n<p data-start=\"4577\" data-end=\"4763\">Strieka\u010dka je \u010diasto\u010dne naplnen\u00e1 destilovanou vodou a pripojen\u00e1 k referen\u010dnej ku\u017ee\u013eovej pr\u00edpojke. V syst\u00e9me sa postupne vytv\u00e1ra podtlak, ktor\u00fd dosahuje <strong data-start=\"4725\" data-end=\"4762\">o 88 kPa menej ako atmosf\u00e9rick\u00fd tlak<\/strong>.<\/p>\n<p data-start=\"4765\" data-end=\"4783\">Sk\u00fa\u0161aj\u00faci potom:<\/p>\n<ul data-start=\"4784\" data-end=\"4918\">\n<li data-section-id=\"p6yoi4\" data-start=\"4784\" data-end=\"4810\">Kontroluje, \u010di nedoch\u00e1dza k \u00faniku vzduchu<\/li>\n<li data-section-id=\"s0iwov\" data-start=\"4811\" data-end=\"4855\">Udr\u017euje stabiln\u00fd tlak po dobu 60 sek\u00fand<\/li>\n<li data-section-id=\"jv7vas\" data-start=\"4856\" data-end=\"4918\">Skontroluje, \u010di sa gumov\u00e1 z\u00e1tka oddel\u00ed od piestu<\/li>\n<\/ul>\n<p data-start=\"4920\" data-end=\"5004\">Tento test je obzvl\u00e1\u0161\u0165 d\u00f4le\u017eit\u00fd, preto\u017ee v\u00fdkonnos\u0165 ods\u00e1vania priamo ovplyv\u0148uje:<\/p>\n<ul data-start=\"5005\" data-end=\"5102\">\n<li data-section-id=\"17ofnkc\" data-start=\"5005\" data-end=\"5030\">Presn\u00e9 d\u00e1vkovanie inzul\u00ednu<\/li>\n<li data-section-id=\"1vsyzsa\" data-start=\"5031\" data-end=\"5054\">Predch\u00e1dzanie vzniku vzduchov\u00fdch bubl\u00edn<\/li>\n<li data-section-id=\"4bkl5w\" data-start=\"5055\" data-end=\"5078\">Zabezpe\u010denie sterility<\/li>\n<li data-section-id=\"6gyd3l\" data-start=\"5079\" data-end=\"5102\">Konzistencia vstrekovania<\/li>\n<\/ul>\n<p data-start=\"5104\" data-end=\"5180\">Stabiln\u00e9 v\u00e1kuum bez poklesu tlaku sved\u010d\u00ed o \u00fa\u010dinnosti tesnosti.<\/p>\n<h3 data-start=\"5370\" data-end=\"5466\"><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/syringe-air-leakage-tester-iso-7886-1\/\" target=\"_blank\" rel=\"noopener\">SLT-02 Tester \u00faniku vzduchu zo strieka\u010dky<\/a><\/h3>\n<p data-start=\"2981\" data-end=\"3195\"><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/syringe-air-leakage-tester-iso-7886-1\/\"><img decoding=\"async\" class=\"wp-image-6628 size-medium\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SLT-02-Syringe-Air-Leakage-Tester-ISO-7886-1-300x300.jpg\" alt=\"SLT-02 Injek\u010dn\u00fd tester \u00faniku vzduchu - ISO 7886-1\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SLT-02-Syringe-Air-Leakage-Tester-ISO-7886-1-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SLT-02-Syringe-Air-Leakage-Tester-ISO-7886-1-150x150.jpg 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SLT-02-Syringe-Air-Leakage-Tester-ISO-7886-1-12x12.jpg 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SLT-02-Syringe-Air-Leakage-Tester-ISO-7886-1-100x100.jpg 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/04\/SLT-02-Syringe-Air-Leakage-Tester-ISO-7886-1.jpg 600w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<h2 data-section-id=\"1a8ay7g\" data-start=\"5473\" data-end=\"5526\">Sk\u00fa\u0161ka k\u013azavosti strieka\u010dky na pos\u00fadenie v\u00fdkonu piestu<\/h2>\n<p data-start=\"5528\" data-end=\"5642\"><strong data-start=\"5528\" data-end=\"5559\">Sk\u00fa\u0161anie sily potrebnej na posun injek\u010dnej strieka\u010dky<\/strong> je jedn\u00fdm z najd\u00f4le\u017eitej\u0161\u00edch hodnoten\u00ed pou\u017eite\u013enosti v r\u00e1mci testovania zhody s normou ISO 8537.<\/p>\n<p data-start=\"5644\" data-end=\"5673\">Plynul\u00fd pohyb piesta zaru\u010duje:<\/p>\n<ul data-start=\"5674\" data-end=\"5787\">\n<li data-section-id=\"181tqit\" data-start=\"5674\" data-end=\"5708\">Pohodln\u00e9 pod\u00e1vanie injekcie<\/li>\n<li data-section-id=\"rk7z4p\" data-start=\"5709\" data-end=\"5739\">Presn\u00e9 pod\u00e1vanie liekov<\/li>\n<li data-section-id=\"mf38ad\" data-start=\"5740\" data-end=\"5764\">St\u00e1la r\u00fdchlos\u0165 vstrekovania<\/li>\n<li data-section-id=\"1rflcw2\" data-start=\"5765\" data-end=\"5787\">Men\u0161ia \u00fanava r\u00fak<\/li>\n<\/ul>\n<p data-start=\"5789\" data-end=\"5878\">Pri sk\u00fa\u0161ke sa zaznamen\u00e1va priebeh sily v \u010dase, ke\u010f sa piest pohybuje v valci.<\/p>\n<p data-start=\"5880\" data-end=\"5906\">Typick\u00e1 anal\u00fdza zah\u0155\u0148a:<\/p>\n<ul data-start=\"5907\" data-end=\"5992\">\n<li data-section-id=\"3d9wpq\" data-start=\"5907\" data-end=\"5928\">Maxim\u00e1lna klzov\u00e1 sila<\/li>\n<li data-section-id=\"fj68np\" data-start=\"5929\" data-end=\"5950\">Priemern\u00e1 klzov\u00e1 sila<\/li>\n<li data-section-id=\"1equdqt\" data-start=\"5951\" data-end=\"5970\">Kol\u00edsanie sily<\/li>\n<li data-section-id=\"sf8nbd\" data-start=\"5971\" data-end=\"5992\">Chovanie typu \u201estick-slip\u201c<\/li>\n<\/ul>\n<p data-start=\"5994\" data-end=\"6032\">Nepravideln\u00e9 krivky sily \u010dasto nazna\u010duj\u00fa:<\/p>\n<ul data-start=\"6033\" data-end=\"6144\">\n<li data-section-id=\"1rxq1ai\" data-start=\"6033\" data-end=\"6067\">Probl\u00e9my s distrib\u00faciou silik\u00f3nov\u00e9ho oleja<\/li>\n<li data-section-id=\"15d0d3\" data-start=\"6068\" data-end=\"6095\">Vady drsnosti povrchu<\/li>\n<li data-section-id=\"13y0btp\" data-start=\"6096\" data-end=\"6116\">Deform\u00e1cia piesta<\/li>\n<li data-section-id=\"1ysw8ll\" data-start=\"6117\" data-end=\"6144\">Vari\u00e1cie geometrie hlavne<\/li>\n<\/ul>\n<p data-start=\"6146\" data-end=\"6365\">Spolo\u010dnos\u0165 Cell Instruments pon\u00faka syst\u00e9my na meranie sily, ktor\u00e9 dok\u00e1\u017eu v re\u00e1lnom \u010dase generova\u0165 krivky sily a posunu na \u00fa\u010dely podrobnej anal\u00fdzy v\u00fdkonu injek\u010dn\u00fdch strieka\u010diek. Tieto syst\u00e9my podporuj\u00fa optimaliz\u00e1ciu v\u00fdskumu a v\u00fdvoja a overovanie kvality \u0161ar\u017e\u00ed.<\/p>\n<h3 data-start=\"6146\" data-end=\"6365\"><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/sale-syringe-plunger-glide-force-tester\/\" target=\"_blank\" rel=\"noopener\">MST-01 Tester lek\u00e1rskych strieka\u010diek<\/a><\/h3>\n<p data-start=\"6146\" data-end=\"6365\"><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/sale-syringe-plunger-glide-force-tester\/\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-5116 size-medium\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/10\/MST-01-Syringe-Plunger-Glide-Force-Tester-03-300x300.jpg\" alt=\"MST-01 Pr\u00edstroj na meranie sily posuvu piestu injek\u010dnej strieka\u010dky 03\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/10\/MST-01-Syringe-Plunger-Glide-Force-Tester-03-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/10\/MST-01-Syringe-Plunger-Glide-Force-Tester-03-150x150.jpg 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/10\/MST-01-Syringe-Plunger-Glide-Force-Tester-03-600x600.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/10\/MST-01-Syringe-Plunger-Glide-Force-Tester-03-100x100.jpg 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/10\/MST-01-Syringe-Plunger-Glide-Force-Tester-03.jpg 750w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<h2 data-section-id=\"sepro\" data-start=\"6372\" data-end=\"6409\">Meranie m\u0155tveho priestoru pod\u013ea normy ISO 8537<\/h2>\n<p data-start=\"6411\" data-end=\"6538\"><strong data-start=\"6411\" data-end=\"6437\">Meranie m\u0155tveho priestoru<\/strong> ur\u010duje objem kvapaliny, ktor\u00fd zost\u00e1va v injek\u010dnej strieka\u010dke po \u00faplnom stla\u010den\u00ed piestu.<\/p>\n<p data-start=\"6540\" data-end=\"6582\">Pr\u00edloha D normy ISO 8537 stanovuje m\u0155tvy priestor takto:<\/p>\n<ol data-start=\"6583\" data-end=\"6756\">\n<li data-section-id=\"5n54cf\" data-start=\"6583\" data-end=\"6612\">V\u00e1\u017eenie pr\u00e1zdnej injek\u010dnej strieka\u010dky<\/li>\n<li data-section-id=\"1po99wn\" data-start=\"6613\" data-end=\"6656\">Naplnenie injek\u010dnej strieka\u010dky destilovanou vodou<\/li>\n<li data-section-id=\"1rejvy1\" data-start=\"6657\" data-end=\"6691\">\u00dapln\u00e9 vypustenie kvapaliny<\/li>\n<li data-section-id=\"1w7zx7c\" data-start=\"6692\" data-end=\"6717\">Op\u00e4tovn\u00e9 zv\u00e1\u017eenie injek\u010dnej strieka\u010dky<\/li>\n<li data-section-id=\"1syj61a\" data-start=\"6718\" data-end=\"6756\">V\u00fdpo\u010det zostatkovej hmotnosti vody<\/li>\n<\/ol>\n<p data-start=\"6758\" data-end=\"6789\">N\u00edzky m\u0155tvy priestor je k\u013e\u00fa\u010dov\u00fd pre:<\/p>\n<ul data-start=\"6790\" data-end=\"6871\">\n<li data-section-id=\"17ofnkc\" data-start=\"6790\" data-end=\"6815\">Presn\u00e9 d\u00e1vkovanie inzul\u00ednu<\/li>\n<li data-section-id=\"1015ofw\" data-start=\"6816\" data-end=\"6836\">Zn\u00ed\u017eenie mno\u017estva odpadu z liekov<\/li>\n<li data-section-id=\"1u8enyk\" data-start=\"6837\" data-end=\"6871\">Zlep\u0161en\u00e1 konzistentnos\u0165 lie\u010dby<\/li>\n<\/ul>\n<p data-start=\"6873\" data-end=\"6979\">Tento parameter nadob\u00fada osobitn\u00fd v\u00fdznam najm\u00e4 v pr\u00edpade biologick\u00fdch liekov s vysokou hodnotou a injek\u010dn\u00fdch pr\u00edpravkov s n\u00edzkou d\u00e1vkou.<\/p>\n<p data-start=\"6981\" data-end=\"7068\">Na vykon\u00e1vanie testov v s\u00falade s predpismi sa zvy\u010dajne vy\u017eaduj\u00fa presn\u00e9 v\u00e1hy s rozl\u00ed\u0161en\u00edm 0,001 g.<\/p>\n<p data-start=\"7070\" data-end=\"7230\">V\u00fdrobcovia \u010dasto kombinuj\u00fa anal\u00fdzu m\u0155tveho priestoru s kontrolou rozmerov a testovan\u00edm vstrekovacej sily, aby dosiahli komplexn\u00e9 overenie v\u00fdkonnosti injek\u010dnej strieka\u010dky.<\/p>\n<h2 data-section-id=\"1r8frcv\" data-start=\"8150\" data-end=\"8179\">\u010casto kladen\u00e9 ot\u00e1zky<\/h2>\n<p data-section-id=\"t3k96d\" data-start=\"8181\" data-end=\"8202\"><strong>\u010co je norma ISO 8537?<\/strong><br \/>\nISO 8537 je medzin\u00e1rodn\u00e1 norma, ktor\u00e1 stanovuje po\u017eiadavky a sk\u00fa\u0161obn\u00e9 met\u00f3dy pre steriln\u00e9 inzul\u00ednov\u00e9 injek\u010dn\u00e9 strieka\u010dky na jedno pou\u017eitie s ihlou alebo bez nej.<\/p>\n<p><strong>Pre\u010do je d\u00f4le\u017eit\u00e9 testovanie k\u013azavosti injek\u010dnej strieka\u010dky?<br \/>\n<\/strong>Testovanie sily posuvu strieka\u010dky zaru\u010duje plynul\u00fd pohyb piestu, stabiln\u00fd v\u00fdkon pri injekcii a presn\u00e9 pod\u00e1vanie lieku po\u010das klinick\u00e9ho pou\u017eitia.<\/p>\n<p><strong>Ak\u00fd tlak sa pou\u017e\u00edva pri sk\u00fa\u0161ke tesnosti injek\u010dn\u00fdch strieka\u010diek pod\u013ea normy ISO 8537?<br \/>\n<\/strong>Pr\u00edloha E normy ISO 8537 stanovuje po\u017eiadavku na vn\u00fatorn\u00fd tlak vo v\u00fd\u0161ke <strong data-start=\"8655\" data-end=\"8666\">300 kPa<\/strong> udr\u017eiavan\u00e1 po dobu 30 sek\u00fand po\u010das hodnotenia tesnosti.<\/p>\n<p><strong>\u010co sa hodnot\u00ed v r\u00e1mci farmaceutick\u00e9ho postupu sk\u00fa\u0161ky tesnosti vo v\u00e1kuu?<br \/>\n<\/strong>Farmaceutick\u00e1 met\u00f3da v\u00e1kuovej tesnostnej sk\u00fa\u0161ky hodnot\u00ed \u00fanik vzduchu cez tesnenia piestu injek\u010dnej strieka\u010dky a overuje integritu spojenia piestu so z\u00e1tkou v podmienkach podtlakov\u00e9ho stavu.<\/p>\n<p><strong>Pre\u010do je meranie m\u0155tveho priestoru u inzul\u00ednov\u00fdch strieka\u010diek tak d\u00f4le\u017eit\u00e9?<\/strong><br \/>\nMeranie m\u0155tveho priestoru pom\u00e1ha minimalizova\u0165 zvy\u0161kov\u00fd objem lieku, \u010d\u00edm sa zvy\u0161uje presnos\u0165 d\u00e1vkovania a zni\u017euje sa mno\u017estvo vyhoden\u00fdch liekov.<\/p>\n<p><strong>Na \u010do sa be\u017ene pou\u017e\u00edvaj\u00fa tieto n\u00e1stroje <a href=\"http:\/\/iso.org\/standard\/60510.html\" rel=\"nofollow noopener\" target=\"_blank\">ISO 8537<\/a> testovanie?<\/strong><br \/>\nMedzi be\u017en\u00e9 pr\u00edstroje patria univerz\u00e1lne sk\u00fa\u0161obn\u00e9 stroje, v\u00e1kuov\u00e9 tesnostn\u00e9 testery, syst\u00e9my na meranie tlakovej tesnosti, presn\u00e9 v\u00e1hy a automatick\u00e9 analyz\u00e1tory sily.<\/p>","protected":false},"excerpt":{"rendered":"<p>Norma ISO 8537 definuje kritick\u00e9 v\u00fdkonnostn\u00e9 sk\u00fa\u0161ky pre steriln\u00e9 jednorazov\u00e9 inzul\u00ednov\u00e9 strieka\u010dky, vr\u00e1tane injek\u010dnej schopnosti, tesnosti strieka\u010dky, odolnosti proti \u00faniku v\u00e1kua, k\u013azavosti a merania m\u0155tveho priestoru. Tieto sk\u00fa\u0161ky hodnotia tesnos\u0165, silu potrebn\u00fa na pohyb piestu, v\u00fdkonnos\u0165 pri nas\u00e1van\u00ed a presnos\u0165 merania zvy\u0161kov\u00e9ho objemu s cie\u013eom zabezpe\u010di\u0165 bezpe\u010dnos\u0165 strieka\u010dky a spo\u013eahlivos\u0165 d\u00e1vkovania. Pokro\u010dil\u00e9 testovacie syst\u00e9my pom\u00e1haj\u00fa v\u00fdrobcom dosiahnu\u0165 konzistentn\u00fa kontrolu kvality, \u2026<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/sk\/standards\/iso-8537\/\"> <span class=\"screen-reader-text\">ISO 8537<\/span> \u010c\u00edtajte viac \"<\/a><\/p>","protected":false},"author":4,"featured_media":0,"parent":4948,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-7956","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/pages\/7956","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/comments?post=7956"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/pages\/7956\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/pages\/4948"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/media?parent=7956"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}