{"id":2610,"date":"2026-05-07T08:15:19","date_gmt":"2026-05-07T08:15:19","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2610"},"modified":"2026-05-07T08:46:47","modified_gmt":"2026-05-07T08:46:47","slug":"iso-8537","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/cs\/iso-8537\/","title":{"rendered":"ISO 8537"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2610\" class=\"elementor elementor-2610\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0662493 e-flex e-con-boxed e-con e-parent\" data-id=\"0662493\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fc37773 elementor-widget elementor-widget-heading\" data-id=\"fc37773\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 8537 <br><small><small>Testov\u00e1n\u00ed funk\u010dnosti inzul\u00ednov\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/small><\/small><\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-25d7b19 e-con-full e-flex e-con e-child\" data-id=\"25d7b19\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d257432 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d257432\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"314\" data-end=\"683\">Norma ISO 8537 stanovuje po\u017eadavky na v\u00fdkonnost a zkou\u0161en\u00ed pro <strong data-start=\"378\" data-end=\"417\">steriln\u00ed jednor\u00e1zov\u00e9 inzul\u00ednov\u00e9 st\u0159\u00edka\u010dky<\/strong>, s jehlami i bez nich. Tato norma se zam\u011b\u0159uje na bezpe\u010dnost injek\u010dn\u00edch st\u0159\u00edka\u010dek, jejich funk\u010dnost, t\u011bsnost, p\u0159esnost d\u00e1vkov\u00e1n\u00ed a provozn\u00ed spolehlivost. V\u00fdrobci a laborato\u0159e zab\u00fdvaj\u00edc\u00ed se kontrolou kvality vyu\u017e\u00edvaj\u00ed normu ISO 8537 k ov\u011b\u0159en\u00ed, zda injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159i klinick\u00e9m pou\u017eit\u00ed funguj\u00ed konzistentn\u011b.<\/p><p data-start=\"685\" data-end=\"1021\">Pro v\u00fdrobce injek\u010dn\u00edch st\u0159\u00edka\u010dek znamen\u00e1 dodr\u017eov\u00e1n\u00ed normy ISO 8537 zv\u00fd\u0161en\u00ed spolehlivosti v\u00fdrobk\u016f, usnadn\u011bn\u00ed pod\u00e1v\u00e1n\u00ed \u017e\u00e1dost\u00ed o schv\u00e1len\u00ed a sn\u00ed\u017een\u00ed rizik spojen\u00fdch s net\u011bsnost\u00ed, poruchou p\u00edstu nebo nep\u0159esn\u00fdm d\u00e1vkov\u00e1n\u00edm. Laborato\u0159\u00edm zab\u00fdvaj\u00edc\u00edm se kontrolou kvality tato norma poskytuje ov\u011b\u0159en\u00e9 postupy pro hodnocen\u00ed funk\u010dnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek za kontrolovan\u00fdch podm\u00ednek.<\/p><p data-start=\"1023\" data-end=\"1207\">Vzhledem k tomu, \u017ee inzulinov\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky vy\u017eaduj\u00ed p\u0159esn\u00e9 d\u00e1vkov\u00e1n\u00ed a spolehliv\u00e9 ut\u011bsn\u011bn\u00ed, <strong data-start=\"1105\" data-end=\"1138\">testov\u00e1n\u00ed funk\u010dnosti st\u0159\u00edka\u010dky<\/strong> hraje kl\u00ed\u010dovou roli v pr\u016fb\u011bhu cel\u00e9ho procesu v\u00fdvoje a v\u00fdroby produktu.<\/p><p data-start=\"1209\" data-end=\"1536\">Spole\u010dnost Cell Instruments dod\u00e1v\u00e1 specializovan\u00e9 testovac\u00ed syst\u00e9my ur\u010den\u00e9 pro v\u00fdrobce injek\u010dn\u00edch st\u0159\u00edka\u010dek, laborato\u0159e zab\u00fdvaj\u00edc\u00ed se zdravotnick\u00fdmi prost\u0159edky a t\u00fdmy zaji\u0161\u0165uj\u00edc\u00ed kvalitu farmaceutick\u00fdch obal\u016f. Tyto p\u0159\u00edstroje umo\u017e\u0148uj\u00ed automatizovan\u00e9 m\u011b\u0159en\u00ed s\u00edly, hodnocen\u00ed t\u011bsnosti ve vakuu, zkou\u0161ky t\u011bsnosti a anal\u00fdzu mrtv\u00e9ho prostoru v souladu s metodikami normy ISO 8537.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b939f5 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"5b939f5\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"500\" height=\"630\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes.webp\" class=\"attachment-full size-full wp-image-2613\" alt=\"ISO 8537 \u2013 Zkou\u0161ky funk\u010dnosti inzulinov\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes.webp 500w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes-238x300.webp 238w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes-10x12.webp 10w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\t\t\t\t\t\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 class=\"elementor-element elementor-element-77936bb elementor-widget elementor-widget-heading\" data-id=\"77936bb\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Zkou\u0161ky funk\u010dnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek podle normy ISO 8537<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e0637a3 e-grid e-con-full e-con e-child\" data-id=\"e0637a3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d71bda6 elementor-widget elementor-widget-text-editor\" data-id=\"d71bda6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"1586\" data-end=\"1769\">Norma ISO 8537 zahrnuje \u0159adu hodnocen\u00ed v\u00fdkonnosti, kter\u00e1 ur\u010duj\u00ed, zda je injek\u010dn\u00ed st\u0159\u00edka\u010dka schopna bezpe\u010dn\u011b a p\u0159esn\u011b fungovat p\u0159i ods\u00e1v\u00e1n\u00ed a injek\u010dn\u00edm pod\u00e1v\u00e1n\u00ed. Norma zahrnuje zkou\u0161ky:<\/p><ul data-start=\"1771\" data-end=\"1938\"><li data-section-id=\"1oxsryt\" data-start=\"1771\" data-end=\"1802\">\u00danik vzduchu b\u011bhem ods\u00e1v\u00e1n\u00ed<\/li><li data-section-id=\"b62ksi\" data-start=\"1803\" data-end=\"1837\">\u00danik kapaliny p\u0159i stla\u010den\u00ed<\/li><li data-section-id=\"143ln9z\" data-start=\"1838\" data-end=\"1862\">Pracovn\u00ed s\u00edla p\u00edstu<\/li><li data-section-id=\"1trb4xg\" data-start=\"1863\" data-end=\"1879\">T\u011bsnost<\/li><li data-section-id=\"77dvwg\" data-start=\"1880\" data-end=\"1899\">Objem mrtv\u00e9ho prostoru<\/li><li data-section-id=\"gfc932\" data-start=\"1900\" data-end=\"1938\">\u00danik v m\u00edst\u011b spojen\u00ed jehly a trysky<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d841201 elementor-widget elementor-widget-text-editor\" data-id=\"d841201\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"1940\" data-end=\"1978\">Tyto testy pom\u00e1haj\u00ed v\u00fdrobc\u016fm posoudit:<\/p><ul data-start=\"1980\" data-end=\"2145\"><li data-section-id=\"4m7yx6\" data-start=\"1980\" data-end=\"2009\">Konzistence t\u011bsn\u011bn\u00ed p\u00edstu<\/li><li data-section-id=\"jtny4m\" data-start=\"2010\" data-end=\"2039\">Nez\u00e1vadnost v\u00e1lce a trysky<\/li><li data-section-id=\"13p4qmo\" data-start=\"2040\" data-end=\"2067\">\u00da\u010dinnost maz\u00e1n\u00ed<\/li><li data-section-id=\"1rxkfq7\" data-start=\"2068\" data-end=\"2093\">P\u0159esnost pod\u00e1v\u00e1n\u00ed d\u00e1vky<\/li><li data-section-id=\"njxgtt\" data-start=\"2094\" data-end=\"2145\">Spolehlivost spojen\u00ed mezi injek\u010dn\u00ed st\u0159\u00edka\u010dkou a jehlou<\/li><\/ul><p data-start=\"2147\" data-end=\"2270\">Modern\u00ed laborato\u0159e st\u00e1le \u010dast\u011bji zav\u00e1d\u011bj\u00ed automatizovan\u00e9 testovac\u00ed syst\u00e9my, aby zlep\u0161ily opakovatelnost v\u00fdsledk\u016f a omezily vliv obsluhy.<\/p>\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 class=\"elementor-element elementor-element-84b6ee2 elementor-widget elementor-widget-heading\" data-id=\"84b6ee2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Zkou\u0161ka t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek podle normy ISO 8537<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d186872 elementor-widget elementor-widget-text-editor\" data-id=\"d186872\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"2324\" data-end=\"2507\"><strong data-start=\"2324\" data-end=\"2348\">Testov\u00e1n\u00ed t\u011bsnosti st\u0159\u00edka\u010dek<\/strong> je jedn\u00edm z nejd\u016fle\u017eit\u011bj\u0161\u00edch postup\u016f popsan\u00fdch v norm\u011b ISO 8537. Tato norma hodnot\u00ed jak \u00fanik vzduchu, tak \u00fanik kapaliny za r\u016fzn\u00fdch tlakov\u00fdch podm\u00ednek.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-47c3651 e-grid e-con-full e-con e-child\" data-id=\"47c3651\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bd0c720 e-con-full e-flex e-con e-child\" data-id=\"bd0c720\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eb605b0 elementor-widget elementor-widget-heading\" data-id=\"eb605b0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00danik vzduchu b\u011bhem ods\u00e1v\u00e1n\u00ed<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1310954 elementor-widget elementor-widget-text-editor\" data-id=\"1310954\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"2544\" data-end=\"2684\">P\u0159\u00edloha B a p\u0159\u00edloha F popisuj\u00ed metody detekce \u00faniku vzduchu kolem t\u011bsn\u011bn\u00ed p\u00edstu a spoj\u016f trysky injek\u010dn\u00ed st\u0159\u00edka\u010dky za podtlaku.<\/p><p data-start=\"2686\" data-end=\"2719\">Tento postup obvykle zahrnuje:<\/p><ol data-start=\"2721\" data-end=\"2926\"><li data-section-id=\"8f51yc\" data-start=\"2721\" data-end=\"2764\">Napln\u011bn\u00ed injek\u010dn\u00ed st\u0159\u00edka\u010dky destilovanou vodou<\/li><li data-section-id=\"11xil91\" data-start=\"2765\" data-end=\"2822\">P\u0159ipojen\u00ed injek\u010dn\u00ed st\u0159\u00edka\u010dky ke kompatibiln\u00ed ku\u017eelov\u00e9 spojce<\/li><li data-section-id=\"1w8sjai\" data-start=\"2823\" data-end=\"2852\">Vytvo\u0159en\u00ed podtlaku<\/li><li data-section-id=\"nzi51v\" data-start=\"2853\" data-end=\"2885\">Sledov\u00e1n\u00ed stability tlaku<\/li><li data-section-id=\"ad7xt5\" data-start=\"2886\" data-end=\"2926\">Zji\u0161t\u011bn\u00ed \u00faniku nebo tvorby bublin<\/li><\/ol><p data-start=\"2928\" data-end=\"3143\">Norma ISO 8537 stanovuje \u00farove\u0148 vakua <strong data-start=\"2965\" data-end=\"3010\">88 kPa pod okoln\u00edm atmosf\u00e9rick\u00fdm tlakem<\/strong> pro posouzen\u00ed net\u011bsnosti ods\u00e1vac\u00edho syst\u00e9mu. Obsluha sleduje injek\u010dn\u00ed st\u0159\u00edka\u010dku z hlediska poklesu tlaku, tvorby bublin a uvoln\u011bn\u00ed gumov\u00e9 z\u00e1tky.<\/p><p data-start=\"3145\" data-end=\"3164\">Tento test ov\u011b\u0159uje:<\/p><ul data-start=\"3166\" data-end=\"3287\"><li data-section-id=\"31dbu3\" data-start=\"3166\" data-end=\"3189\">T\u011bsnost p\u00edstn\u00edho t\u011bsn\u011bn\u00ed<\/li><li data-section-id=\"10m5ixj\" data-start=\"3190\" data-end=\"3222\">T\u011bsnic\u00ed vlastnosti n\u00e1boje jehly<\/li><li data-section-id=\"17ziab\" data-start=\"3223\" data-end=\"3252\">Stabilita p\u0159ipojen\u00ed trysky<\/li><li data-section-id=\"1way5n8\" data-start=\"3253\" data-end=\"3287\">Odolnost proti \u00faniku p\u0159i aspiraci<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28726d3 e-con-full e-flex e-con e-child\" data-id=\"28726d3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4cf6b78 elementor-widget elementor-widget-heading\" data-id=\"4cf6b78\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Vakuov\u00e9 zkou\u0161ky t\u011bsnosti \u2013 farmaceutick\u00e9 aplikace<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a833751 elementor-widget elementor-widget-text-editor\" data-id=\"a833751\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"3339\" data-end=\"3513\">A <strong data-start=\"3341\" data-end=\"3376\">vakuov\u00e1 zkou\u0161ka t\u011bsnosti ve farmaceutick\u00e9m pr\u016fmyslu<\/strong> Tento postup je u l\u00e9ka\u0159sk\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek pou\u017e\u00edvan\u00fdch k pod\u00e1v\u00e1n\u00ed inzul\u00ednu z\u00e1sadn\u00ed, proto\u017ee i sebemen\u0161\u00ed \u00fanik m\u016f\u017ee ovlivnit p\u0159esnost d\u00e1vkov\u00e1n\u00ed nebo sterilitu.<\/p><p data-start=\"3515\" data-end=\"3595\">Spole\u010dnost Cell Instruments doporu\u010duje automatizovan\u00e9 syst\u00e9my pro testov\u00e1n\u00ed t\u011bsnosti ve vakuu, kter\u00e9 jsou vybaveny:<\/p><ul data-start=\"3597\" data-end=\"3738\"><li data-section-id=\"le59d7\" data-start=\"3597\" data-end=\"3632\">Vysoce p\u0159esn\u00e9 regul\u00e1tory vakua<\/li><li data-section-id=\"1jdfnmj\" data-start=\"3633\" data-end=\"3662\">Digit\u00e1ln\u00ed monitorov\u00e1n\u00ed tlaku<\/li><li data-section-id=\"105a6xv\" data-start=\"3663\" data-end=\"3684\">Anal\u00fdza \u00fatlumu \u00faniku<\/li><li data-section-id=\"fca3b5\" data-start=\"3685\" data-end=\"3712\">Programovateln\u00e1 doba dr\u017een\u00ed<\/li><li data-section-id=\"cixp3u\" data-start=\"3713\" data-end=\"3738\">Software pro z\u00e1znam dat<\/li><\/ul><p data-start=\"3740\" data-end=\"3896\">Tyto syst\u00e9my zvy\u0161uj\u00ed opakovatelnost ve srovn\u00e1n\u00ed s ru\u010dn\u00edmi metodami m\u011b\u0159en\u00ed vakua a pom\u00e1haj\u00ed laborato\u0159\u00edm splnit po\u017eadavky na dokumentaci podle GMP a ISO.<\/p>\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\t\t<div class=\"elementor-element elementor-element-fa6d2ef elementor-widget elementor-widget-heading\" data-id=\"fa6d2ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Metody zkou\u0161en\u00ed t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0cbf91c elementor-widget elementor-widget-text-editor\" data-id=\"0cbf91c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"3943\" data-end=\"4074\">Na str\u00e1nk\u00e1ch <strong data-start=\"3947\" data-end=\"3978\">zkou\u0161ka t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> posuzuje, zda m\u016f\u017ee b\u011bhem komprese nebo aspirace doch\u00e1zet k \u00faniku kapaliny nebo vzduchu p\u0159es t\u011bsnic\u00ed plochy.<\/p><p data-start=\"4076\" data-end=\"4122\">P\u0159\u00edloha E normy ISO 8537 se zam\u011b\u0159uje na \u00fanik kapaliny v n\u00e1sleduj\u00edc\u00edch p\u0159\u00edpadech:<\/p><ul data-start=\"4124\" data-end=\"4190\"><li data-section-id=\"z11dbz\" data-start=\"4124\" data-end=\"4138\">T\u011bsn\u011bn\u00ed p\u00edst\u016f<\/li><li data-section-id=\"1p89988\" data-start=\"4139\" data-end=\"4167\">P\u0159ipojen\u00ed trysky injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/li><li data-section-id=\"1aynqcu\" data-start=\"4168\" data-end=\"4190\">Spojky jehly a v\u00e1lce<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b34aa1c e-grid e-con-full e-con e-child\" data-id=\"b34aa1c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7afb7c0 elementor-widget elementor-widget-text-editor\" data-id=\"7afb7c0\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"4365\" data-end=\"4389\">B\u011bhem testov\u00e1n\u00ed oper\u00e1to\u0159i vytv\u00e1\u0159ej\u00ed vnit\u0159n\u00ed tlak ve v\u00fd\u0161i <strong data-start=\"4251\" data-end=\"4277\">300 kPa manometrick\u00fd tlak<\/strong> a udr\u017eujte tlak po dobu 30 sekund, p\u0159i\u010dem\u017e na p\u00edst vyv\u00edjejte bo\u010dn\u00ed s\u00edlu.<\/p><p data-start=\"4365\" data-end=\"4389\">Tento postup vyhodnocuje:<\/p><ul data-start=\"4391\" data-end=\"4508\"><li data-section-id=\"1k1t3bu\" data-start=\"4391\" data-end=\"4420\">Odolnost t\u011bsn\u011bn\u00ed proti deformaci<\/li><li data-section-id=\"vhj5a5\" data-start=\"4421\" data-end=\"4457\">\u00danik za podm\u00ednek bo\u010dn\u00edho zat\u00ed\u017een\u00ed<\/li><li data-section-id=\"1ubek41\" data-start=\"4458\" data-end=\"4485\">Stabilita pohybu p\u00edstu<\/li><li data-section-id=\"tj03kp\" data-start=\"4486\" data-end=\"4508\">Integrita p\u0159ipojen\u00ed<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5283d17 elementor-widget elementor-widget-text-editor\" data-id=\"5283d17\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"4510\" data-end=\"4558\">Spolehliv\u00fd syst\u00e9m kontroly t\u011bsnosti by m\u011bl zaji\u0161\u0165ovat:<\/p><ul data-start=\"4560\" data-end=\"4689\"><li data-section-id=\"1ogn8km\" data-start=\"4560\" data-end=\"4588\">Stabiln\u00ed vytv\u00e1\u0159en\u00ed tlaku<\/li><li data-section-id=\"81fo7t\" data-start=\"4589\" data-end=\"4617\">P\u0159esn\u00e9 vyvinut\u00ed s\u00edly<\/li><li data-section-id=\"vtwu91\" data-start=\"4618\" data-end=\"4647\">Detekce \u00fanik\u016f v re\u00e1ln\u00e9m \u010dase<\/li><li data-section-id=\"198rl1a\" data-start=\"4648\" data-end=\"4689\">Sledov\u00e1n\u00ed posunu ve vysok\u00e9m rozli\u0161en\u00ed<\/li><\/ul><p data-start=\"4691\" data-end=\"4868\">Spole\u010dnost Cell Instruments nab\u00edz\u00ed \u0159e\u0161en\u00ed pro testov\u00e1n\u00ed tlakov\u00e9 t\u011bsnosti a integrity t\u011bsn\u011bn\u00ed, kter\u00e1 jsou vhodn\u00e1 pro inzulinov\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky, syst\u00e9my Luer, farmaceutick\u00e9 obaly a l\u00e9ka\u0159sk\u00e9 obaly.<\/p>\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 class=\"elementor-element elementor-element-d1592e7 elementor-widget elementor-widget-heading\" data-id=\"d1592e7\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Testov\u00e1n\u00ed kluzn\u00e9 s\u00edly st\u0159\u00edka\u010dky<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86fac58 elementor-widget elementor-widget-text-editor\" data-id=\"86fac58\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"4907\" data-end=\"5032\"><strong data-start=\"4907\" data-end=\"4938\">Testov\u00e1n\u00ed kluzn\u00e9 s\u00edly st\u0159\u00edka\u010dky<\/strong> m\u011b\u0159\u00ed s\u00edlu pot\u0159ebnou k zah\u00e1jen\u00ed a udr\u017een\u00ed pohybu p\u00edstu p\u0159i vytla\u010dov\u00e1n\u00ed kapaliny.<\/p><p data-start=\"5034\" data-end=\"5176\">P\u0159\u00edloha C normy ISO 8537 stanov\u00ed pou\u017eit\u00ed mechanick\u00e9ho zku\u0161ebn\u00edho za\u0159\u00edzen\u00ed k zaznamen\u00e1v\u00e1n\u00ed s\u00edly p\u016fsob\u00edc\u00ed na p\u00edst p\u0159i vytla\u010dov\u00e1n\u00ed vody ze st\u0159\u00edka\u010dky.<\/p><p data-start=\"5178\" data-end=\"5206\">Tento test obecn\u011b m\u011b\u0159\u00ed:<\/p><ul data-start=\"5208\" data-end=\"5305\"><li data-section-id=\"uhip3k\" data-start=\"5208\" data-end=\"5227\">Voln\u00e1 s\u00edla<\/li><li data-section-id=\"d3dsxi\" data-start=\"5228\" data-end=\"5241\">Kluzn\u00e1 s\u00edla<\/li><li data-section-id=\"td0rt7\" data-start=\"5242\" data-end=\"5267\">Pr\u016fm\u011brn\u00e1 provozn\u00ed s\u00edla<\/li><li data-section-id=\"fqmeyx\" data-start=\"5268\" data-end=\"5305\">Zajist\u011bte rovnom\u011brnost s\u00edly v pr\u016fb\u011bhu cel\u00e9ho tahu<\/li><\/ul><p data-start=\"5307\" data-end=\"5456\">Stabiln\u00ed v\u00fdkon v oblasti kluzn\u00e9 s\u00edly je z\u00e1sadn\u00ed, proto\u017ee p\u0159\u00edli\u0161 velk\u00e1 s\u00edla m\u016f\u017ee sn\u00ed\u017eit u\u017eivatelsk\u00fd komfort, zat\u00edmco nedostate\u010dn\u00fd odpor m\u016f\u017ee ohrozit p\u0159esnost d\u00e1vkov\u00e1n\u00ed.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18cc935 elementor-widget elementor-widget-heading\" data-id=\"18cc935\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Kl\u00ed\u010dov\u00e9 faktory ovliv\u0148uj\u00edc\u00ed klouzavou s\u00edlu<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d703620 e-grid e-con-full e-con e-child\" data-id=\"d703620\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c02067 elementor-widget elementor-widget-text-editor\" data-id=\"5c02067\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"5497\" data-end=\"5556\">Na kluznost injek\u010dn\u00ed st\u0159\u00edka\u010dky m\u00e1 vliv n\u011bkolik parametr\u016f:<\/p><ul data-start=\"5558\" data-end=\"5684\"><li data-section-id=\"1futzim\" data-start=\"5558\" data-end=\"5591\">Rovnom\u011brnost nan\u00e1\u0161en\u00ed silikonov\u00e9ho maziva<\/li><li data-section-id=\"kuh4lo\" data-start=\"5592\" data-end=\"5617\">Materi\u00e1l gumov\u00e9 z\u00e1tky<\/li><li data-section-id=\"53gmea\" data-start=\"5618\" data-end=\"5647\">Rozm\u011brov\u00e1 p\u0159esnost hlavn\u011b<\/li><li data-section-id=\"5t72bj\" data-start=\"5648\" data-end=\"5666\">T\u0159en\u00ed o povrch<\/li><li data-section-id=\"198q7yk\" data-start=\"5667\" data-end=\"5684\">Pr\u016fm\u011br jehly<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a9cd7bf elementor-widget elementor-widget-text-editor\" data-id=\"a9cd7bf\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"5686\" data-end=\"5745\">Profesion\u00e1ln\u00ed syst\u00e9m pro m\u011b\u0159en\u00ed s\u00edly na injek\u010dn\u00ed st\u0159\u00edka\u010dce by m\u011bl zahrnovat:<\/p><ul data-start=\"5747\" data-end=\"5906\"><li data-section-id=\"ne6nqw\" data-start=\"5747\" data-end=\"5779\">Technologie p\u0159esn\u00fdch sn\u00edma\u010d\u016f zat\u00ed\u017een\u00ed<\/li><li data-section-id=\"1wxb0hx\" data-start=\"5780\" data-end=\"5811\">\u0158\u00edzen\u00ed pohybu s konstantn\u00ed rychlost\u00ed<\/li><li data-section-id=\"h51txm\" data-start=\"5812\" data-end=\"5847\">Anal\u00fdza k\u0159ivky s\u00edla\u2013posunut\u00ed<\/li><li data-section-id=\"gjpujf\" data-start=\"5848\" data-end=\"5874\">Nastaviteln\u00e9 zku\u0161ebn\u00ed p\u0159\u00edpravky<\/li><li data-section-id=\"19afykk\" data-start=\"5875\" data-end=\"5906\">Po\u010d\u00edta\u010dov\u00e9 sb\u011br dat<\/li><\/ul>\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 class=\"elementor-element elementor-element-ef0db14 elementor-widget elementor-widget-text-editor\" data-id=\"ef0db14\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Spole\u010dnost Cell Instruments doporu\u010duje univerz\u00e1ln\u00ed syst\u00e9my pro zkou\u0161en\u00ed materi\u00e1l\u016f vybaven\u00e9 na m\u00edru p\u0159izp\u016fsoben\u00fdmi dr\u017e\u00e1ky injek\u010dn\u00edch st\u0159\u00edka\u010dek pro zkou\u0161ky s\u00edly p\u00edstu podle normy ISO 8537.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4d61be elementor-widget elementor-widget-heading\" data-id=\"c4d61be\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">M\u011b\u0159\u00edtko pro injek\u010dn\u00ed st\u0159\u00edka\u010dky s inzul\u00ednem v Dead Space<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2c205a elementor-widget elementor-widget-text-editor\" data-id=\"a2c205a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"6115\" data-end=\"6239\"><strong data-start=\"6115\" data-end=\"6141\">M\u011b\u0159en\u00ed mrtv\u00e9ho prostoru<\/strong> ur\u010duje objem kapaliny, kter\u00fd z\u016fstane uvnit\u0159 injek\u010dn\u00ed st\u0159\u00edka\u010dky po \u00fapln\u00e9m stla\u010den\u00ed p\u00edstu.<\/p><p data-start=\"6241\" data-end=\"6394\">Mal\u00fd mrtv\u00fd prostor je obzvl\u00e1\u0161t\u011b d\u016fle\u017eit\u00fd u inzulinov\u00fdch st\u0159\u00edka\u010dek, proto\u017ee zbytky l\u00e9\u010diva mohou ovlivnit p\u0159esnost d\u00e1vkov\u00e1n\u00ed a zv\u00fd\u0161it mno\u017estv\u00ed farmaceutick\u00e9ho odpadu.<\/p><p data-start=\"6396\" data-end=\"6484\">P\u0159\u00edloha D normy ISO 8537 popisuje gravimetrickou zku\u0161ebn\u00ed metodu zalo\u017eenou na m\u011b\u0159en\u00ed hmotnosti vody.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3582f04 e-grid e-con-full e-con e-child\" data-id=\"3582f04\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e4e0eef e-con-full e-flex e-con e-child\" data-id=\"e4e0eef\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ee7135a elementor-widget elementor-widget-heading\" data-id=\"ee7135a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Postup m\u011b\u0159en\u00ed mrtv\u00e9ho prostoru<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60271a8 elementor-widget elementor-widget-text-editor\" data-id=\"60271a8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"6524\" data-end=\"6547\">Postup zahrnuje:<\/p><ol data-start=\"6549\" data-end=\"6719\"><li data-section-id=\"5n54cf\" data-start=\"6549\" data-end=\"6578\">V\u00e1\u017een\u00ed pr\u00e1zdn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/li><li data-section-id=\"1po99wn\" data-start=\"6579\" data-end=\"6622\">Napln\u011bn\u00ed injek\u010dn\u00ed st\u0159\u00edka\u010dky destilovanou vodou<\/li><li data-section-id=\"q59tts\" data-start=\"6623\" data-end=\"6656\">\u00dapln\u00e9 vypu\u0161t\u011bn\u00ed vody<\/li><li data-section-id=\"1w7zx7c\" data-start=\"6657\" data-end=\"6682\">Op\u011btovn\u00e9 zv\u00e1\u017een\u00ed injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/li><li data-section-id=\"1bth81y\" data-start=\"6683\" data-end=\"6719\">V\u00fdpo\u010det objemu zadr\u017een\u00e9 vody<\/li><\/ol><p data-start=\"6721\" data-end=\"6791\">Zb\u00fdvaj\u00edc\u00ed objem vody odpov\u00edd\u00e1 objemu mrtv\u00e9ho prostoru injek\u010dn\u00ed st\u0159\u00edka\u010dky.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c8b1057 e-con-full e-flex e-con e-child\" data-id=\"c8b1057\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7c4747c elementor-widget elementor-widget-heading\" data-id=\"7c4747c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">V\u00fdznam testov\u00e1n\u00ed mrtv\u00e9ho prostoru<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ac04fa1 elementor-widget elementor-widget-text-editor\" data-id=\"ac04fa1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"6831\" data-end=\"6883\">M\u011b\u0159en\u00ed mrtv\u00e9ho prostoru pom\u00e1h\u00e1 v\u00fdrobc\u016fm vyhodnotit:<\/p><ul data-start=\"6885\" data-end=\"6993\"><li data-section-id=\"1yt1bzi\" data-start=\"6885\" data-end=\"6902\">P\u0159esnost d\u00e1vkov\u00e1n\u00ed<\/li><li data-section-id=\"to7kax\" data-start=\"6903\" data-end=\"6928\">Zbytkov\u00e1 retence l\u00e9\u010diva<\/li><li data-section-id=\"1uwyw95\" data-start=\"6929\" data-end=\"6962\">Optimalizace konstrukce injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/li><li data-section-id=\"19wzgi9\" data-start=\"6963\" data-end=\"6993\">\u00da\u010dinnost konstrukce jehlov\u00e9ho n\u00e1boje<\/li><\/ul><p data-start=\"6995\" data-end=\"7121\">Spole\u010dnost Cell Instruments nab\u00edz\u00ed integraci p\u0159esn\u00fdch vah a testovac\u00ed platformy na m\u00edru pro automatizovanou anal\u00fdzu mrtv\u00e9ho prostoru.<\/p>\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\t\t<div class=\"elementor-element elementor-element-8195461 elementor-widget elementor-widget-heading\" data-id=\"8195461\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Doporu\u010den\u00e9 zku\u0161ebn\u00ed za\u0159\u00edzen\u00ed pro zaji\u0161t\u011bn\u00ed shody s normou ISO 8537<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-129d4b6 elementor-widget elementor-widget-text-editor\" data-id=\"129d4b6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"7186\" data-end=\"7244\">Pro zaji\u0161t\u011bn\u00ed souladu s normou ISO 8537 laborato\u0159e b\u011b\u017en\u011b pou\u017e\u00edvaj\u00ed:<\/p><div class=\"TyagGW_tableContainer\"><div class=\"group TyagGW_tableWrapper flex flex-col-reverse w-fit\" tabindex=\"-1\"><table class=\"w-fit min-w-(--thread-content-width)\" data-start=\"7246\" data-end=\"7579\"><thead data-start=\"7246\" data-end=\"7284\"><tr data-start=\"7246\" data-end=\"7284\"><th class=\"\" data-start=\"7246\" data-end=\"7258\" data-col-size=\"sm\">Testovac\u00ed polo\u017eka<\/th><th class=\"\" data-start=\"7258\" data-end=\"7284\" data-col-size=\"sm\">Doporu\u010den\u00fd n\u00e1stroj<\/th><\/tr><\/thead><tbody data-start=\"7295\" data-end=\"7579\"><tr data-start=\"7295\" data-end=\"7342\"><td style=\"text-align: center;\" data-start=\"7295\" data-end=\"7320\" data-col-size=\"sm\">Vakuov\u00e1 zkou\u0161ka t\u011bsnosti<\/td><td style=\"text-align: center;\" data-start=\"7320\" data-end=\"7342\" data-col-size=\"sm\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/cs\/vacuum-leak-tester-for-syringe-plunger-stopper-and-seal\/\">SLT-02 Tester t\u011bsnosti st\u0159\u00edka\u010dek<\/a><\/td><\/tr><tr data-start=\"7402\" data-end=\"7456\"><td style=\"text-align: center;\" data-start=\"7402\" data-end=\"7427\" data-col-size=\"sm\">Pracovn\u00ed s\u00edla p\u00edstu<\/td><td style=\"text-align: center;\" data-start=\"7427\" data-end=\"7456\" data-col-size=\"sm\"><p class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/cs\/syringes-plunger-glide-force-tester\/\">Tester posuvn\u00e9ho odporu st\u0159\u00edka\u010dky SSR-01<\/a><\/p><\/td><\/tr><tr data-start=\"7457\" data-end=\"7513\"><td style=\"text-align: center;\" data-start=\"7457\" data-end=\"7479\" data-col-size=\"sm\">Anal\u00fdza mrtv\u00e9ho prostoru<\/td><td style=\"text-align: center;\" data-start=\"7479\" data-end=\"7513\" data-col-size=\"sm\">Gravimetrick\u00fd m\u011b\u0159ic\u00ed syst\u00e9m<\/td><\/tr><tr data-start=\"7514\" data-end=\"7579\"><td style=\"text-align: center;\" data-start=\"7514\" data-end=\"7543\" data-col-size=\"sm\">Zkou\u0161ka t\u011bsnosti spoj\u016f<\/td><td style=\"text-align: center;\" data-start=\"7543\" data-end=\"7579\" data-col-size=\"sm\"><div class=\"elementor-element elementor-element-9d87235 elementor-widget elementor-widget-heading\" data-id=\"9d87235\" data-element_type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\"><p class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/cs\/syringe-plunger-seal-integrity-tester\/\">SPPT-01 Tester pozitivn\u00edho tlaku st\u0159\u00edka\u010dky<\/a><\/p><\/div><\/div><\/td><\/tr><\/tbody><\/table><\/div><\/div><p data-start=\"7581\" data-end=\"7773\">Spole\u010dnost Cell Instruments nab\u00edz\u00ed automatiza\u010dn\u00ed \u0159e\u0161en\u00ed na m\u00edru pro laborato\u0159e zab\u00fdvaj\u00edc\u00ed se testov\u00e1n\u00edm injek\u010dn\u00edch st\u0159\u00edka\u010dek, v\u010detn\u011b v\u00edcestani\u010dn\u00edch syst\u00e9m\u016f, softwaru pro spr\u00e1vu dat a integrovan\u00fdch platforem pro kontrolu kvality.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b08dc9a elementor-widget elementor-widget-heading\" data-id=\"b08dc9a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Nej\u010dast\u011bj\u0161\u00ed dotazy<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e8bf18 elementor-widget elementor-widget-text-editor\" data-id=\"3e8bf18\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Co je norma ISO 8537?<\/strong><br \/>ISO 8537 je mezin\u00e1rodn\u00ed norma, kter\u00e1 stanovuje po\u017eadavky a zku\u0161ebn\u00ed metody pro steriln\u00ed jednor\u00e1zov\u00e9 inzulinov\u00e9 st\u0159\u00edka\u010dky s jehlami nebo bez nich.<\/p><p><strong>Co je to zkou\u0161ka t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek podle normy ISO 8537?<\/strong><br \/>Zkou\u0161ka t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek slou\u017e\u00ed k posouzen\u00ed \u00faniku vzduchu nebo kapaliny p\u0159es t\u011bsn\u011bn\u00ed p\u00edstu, trysky injek\u010dn\u00edch st\u0159\u00edka\u010dek a spoje jehel za podm\u00ednek vakua nebo tlaku.<\/p><p><strong>Pro\u010d je zkou\u0161ka kluzn\u00e9 s\u00edly injek\u010dn\u00ed st\u0159\u00edka\u010dky d\u016fle\u017eit\u00e1?<\/strong><br \/>Zkou\u0161ka kluznosti ov\u011b\u0159uje, zda se p\u00edst pohybuje plynule a rovnom\u011brn\u011b, \u010d\u00edm\u017e zaji\u0161\u0165uje p\u0159esn\u00e9 pod\u00e1n\u00ed inzul\u00ednu a spr\u00e1vnou funk\u010dnost injek\u010dn\u00ed st\u0159\u00edka\u010dky.<\/p><p><strong>Co je to zkou\u0161ka t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky?<\/strong><br \/>Zkou\u0161ka t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky zji\u0161\u0165uje, zda t\u011bsnic\u00ed plochy zabra\u0148uj\u00ed \u00faniku tekutiny p\u0159i stla\u010dov\u00e1n\u00ed a ods\u00e1v\u00e1n\u00ed.<\/p><p><strong>Jak se prov\u00e1d\u00ed m\u011b\u0159en\u00ed mrtv\u00e9ho prostoru?<\/strong><br \/>P\u0159i m\u011b\u0159en\u00ed mrtv\u00e9ho prostoru se pou\u017e\u00edv\u00e1 gravimetrick\u00e1 metoda, kter\u00e1 porovn\u00e1v\u00e1 hmotnost injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159ed a po vytla\u010den\u00ed vody, aby se ur\u010dil objem zbytkov\u00e9 kapaliny.<\/p><p><strong>K \u010demu se tyto n\u00e1stroje pou\u017e\u00edvaj\u00ed <a href=\"https:\/\/www.iso.org\/standard\/60510.html\" target=\"_blank\" rel=\"noopener\">ISO 8537<\/a> testov\u00e1n\u00ed?<\/strong><br \/>Mezi b\u011b\u017en\u00e9 p\u0159\u00edstroje pat\u0159\u00ed vakuov\u00e9 testery t\u011bsnosti, univerz\u00e1ln\u00ed zku\u0161ebn\u00ed stroje, syst\u00e9my pro m\u011b\u0159en\u00ed poklesu tlaku a gravimetrick\u00e1 m\u011b\u0159ic\u00ed za\u0159\u00edzen\u00ed.<\/p>\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>ISO 8537 Zkou\u0161ky funk\u010dnosti inzulinov\u00fdch st\u0159\u00edka\u010dek Norma ISO 8537 stanovuje po\u017eadavky na vlastnosti a zkou\u0161ky steriln\u00edch inzulinov\u00fdch st\u0159\u00edka\u010dek na jedno pou\u017eit\u00ed, s jehlami i bez nich. Norma se zam\u011b\u0159uje na bezpe\u010dnost injek\u010dn\u00edch st\u0159\u00edka\u010dek, jejich funk\u010dnost, t\u011bsnost, p\u0159esnost d\u00e1vkov\u00e1n\u00ed a provozn\u00ed spolehlivost. V\u00fdrobci a laborato\u0159e zab\u00fdvaj\u00edc\u00ed se kontrolou kvality pou\u017e\u00edvaj\u00ed normu ISO 8537 k ov\u011b\u0159en\u00ed, zda injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159i klinick\u00e9m pou\u017eit\u00ed vykazuj\u00ed konzistentn\u00ed v\u00fdkon. [\u2026]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","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":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2610","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/cs\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"ISO 8537 Syringe Functionality Testing for Insulin Syringe ISO 8537 specifies the performance and testing requirements for sterile single-use insulin syringes, with or without needles. The standard focuses on syringe safety, functionality, sealing performance, dosage accuracy, and operational reliability. Manufacturers and quality laboratories use ISO 8537 to verify that syringes perform consistently during clinical use.&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts\/2610","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/comments?post=2610"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts\/2610\/revisions"}],"predecessor-version":[{"id":2624,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts\/2610\/revisions\/2624"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/media?parent=2610"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/categories?post=2610"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/tags?post=2610"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}