{"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\/hu\/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>Az inzulin-injekci\u00f3s t\u0171 m\u0171k\u00f6d\u00e9s\u00e9nek ellen\u0151rz\u00e9se<\/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\">Az ISO 8537 szabv\u00e1ny meghat\u00e1rozza a k\u00f6vetkez\u0151kre vonatkoz\u00f3 teljes\u00edtm\u00e9ny- \u00e9s vizsg\u00e1lati k\u00f6vetelm\u00e9nyeket: <strong data-start=\"378\" data-end=\"417\">steril, egyszer haszn\u00e1latos inzulin fecskend\u0151k<\/strong>, t\u0171vel vagy an\u00e9lk\u00fcl. A szabv\u00e1ny a fecskend\u0151k biztons\u00e1g\u00e1ra, m\u0171k\u00f6d\u0151k\u00e9pess\u00e9g\u00e9re, t\u00f6m\u00edt\u00e9si teljes\u00edtm\u00e9ny\u00e9re, adagol\u00e1si pontoss\u00e1g\u00e1ra \u00e9s m\u0171k\u00f6d\u00e9si megb\u00edzhat\u00f3s\u00e1g\u00e1ra \u00f6sszpontos\u00edt. A gy\u00e1rt\u00f3k \u00e9s a min\u0151s\u00e9gellen\u0151rz\u0151 laborat\u00f3riumok az ISO 8537 szabv\u00e1nyt alkalmazz\u00e1k annak ellen\u0151rz\u00e9s\u00e9re, hogy a fecskend\u0151k klinikai haszn\u00e1lat sor\u00e1n k\u00f6vetkezetesen m\u0171k\u00f6djenek.<\/p><p data-start=\"685\" data-end=\"1021\">A fecskend\u0151gy\u00e1rt\u00f3k sz\u00e1m\u00e1ra az ISO 8537 szabv\u00e1nynak val\u00f3 megfelel\u00e9s jav\u00edtja a term\u00e9kek megb\u00edzhat\u00f3s\u00e1g\u00e1t, el\u0151seg\u00edti a hat\u00f3s\u00e1gi enged\u00e9lyez\u00e9si k\u00e9relmek beny\u00fajt\u00e1s\u00e1t, valamint cs\u00f6kkenti a sziv\u00e1rg\u00e1ssal, a dugatty\u00fa meghib\u00e1sod\u00e1s\u00e1val vagy a pontatlan adagol\u00e1ssal kapcsolatos kock\u00e1zatokat. A min\u0151s\u00e9g-ellen\u0151rz\u0151 laborat\u00f3riumok sz\u00e1m\u00e1ra a szabv\u00e1ny valid\u00e1lt elj\u00e1r\u00e1sokat biztos\u00edt a fecskend\u0151k teljes\u00edtm\u00e9ny\u00e9nek ellen\u0151rz\u00f6tt k\u00f6r\u00fclm\u00e9nyek k\u00f6z\u00f6tti \u00e9rt\u00e9kel\u00e9s\u00e9hez.<\/p><p data-start=\"1023\" data-end=\"1207\">Mivel az inzulin-injekci\u00f3s t\u0171kn\u00e9l pontos adagol\u00e1sra \u00e9s stabil t\u00f6m\u00edt\u00e9si teljes\u00edtm\u00e9nyre van sz\u00fcks\u00e9g, <strong data-start=\"1105\" data-end=\"1138\">fecskend\u0151 funkcionalit\u00e1s\u00e1nak vizsg\u00e1lata<\/strong> kritikus szerepet j\u00e1tszik a term\u00e9kfejleszt\u00e9s \u00e9s a gy\u00e1rt\u00e1s teljes folyamata sor\u00e1n.<\/p><p data-start=\"1209\" data-end=\"1536\">A Cell Instruments speci\u00e1lis vizsg\u00e1lati rendszereket k\u00edn\u00e1l, amelyeket fecskend\u0151gy\u00e1rt\u00f3k, orvostechnikai eszk\u00f6z\u00f6kkel foglalkoz\u00f3 laborat\u00f3riumok \u00e9s gy\u00f3gyszercsomagol\u00e1si min\u0151s\u00e9gbiztos\u00edt\u00e1si csapatok sz\u00e1m\u00e1ra fejlesztettek ki. Ezek a m\u0171szerek az ISO 8537 szabv\u00e1nyban meghat\u00e1rozott m\u00f3dszereknek megfelel\u0151en t\u00e1mogatj\u00e1k az automatiz\u00e1lt er\u0151m\u00e9r\u00e9s, a v\u00e1kuumsziv\u00e1rg\u00e1s-vizsg\u00e1lat, a sziv\u00e1rg\u00e1svizsg\u00e1lat \u00e9s a holtt\u00e9r-elemz\u00e9s elv\u00e9gz\u00e9s\u00e9t.<\/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: Inzulin-fecskend\u0151k m\u0171k\u00f6d\u00e9si vizsg\u00e1lata\" 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\">ISO 8537: A fecskend\u0151k m\u0171k\u00f6d\u0151k\u00e9pess\u00e9g\u00e9nek vizsg\u00e1lata<\/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\">Az ISO 8537 szabv\u00e1ny sz\u00e1mos teljes\u00edtm\u00e9ny\u00e9rt\u00e9kel\u00e9st tartalmaz, amelyek alapj\u00e1n meg\u00e1llap\u00edthat\u00f3, hogy egy fecskend\u0151 biztons\u00e1gosan \u00e9s pontosan m\u0171k\u00f6dik-e a folyad\u00e9k felsz\u00edv\u00e1sa \u00e9s befecskendez\u00e9se sor\u00e1n. A szabv\u00e1ny a k\u00f6vetkez\u0151 vizsg\u00e1latokat \u00edrja el\u0151:<\/p><ul data-start=\"1771\" data-end=\"1938\"><li data-section-id=\"1oxsryt\" data-start=\"1771\" data-end=\"1802\">Leveg\u0151sziv\u00e1rg\u00e1s az aspir\u00e1ci\u00f3 sor\u00e1n<\/li><li data-section-id=\"b62ksi\" data-start=\"1803\" data-end=\"1837\">Nyom\u00e1s hat\u00e1s\u00e1ra fell\u00e9p\u0151 folyad\u00e9k sziv\u00e1rg\u00e1s<\/li><li data-section-id=\"143ln9z\" data-start=\"1838\" data-end=\"1862\">A dugatty\u00fa m\u0171k\u00f6dtet\u0151 ereje<\/li><li data-section-id=\"1trb4xg\" data-start=\"1863\" data-end=\"1879\">A t\u00f6m\u00edt\u00e9s \u00e9ps\u00e9ge<\/li><li data-section-id=\"77dvwg\" data-start=\"1880\" data-end=\"1899\">Holt t\u00e9rfogat<\/li><li data-section-id=\"gfc932\" data-start=\"1900\" data-end=\"1938\">Sziv\u00e1rg\u00e1s a t\u0171 \u00e9s a f\u00fav\u00f3ka csatlakoz\u00e1s\u00e1n\u00e1l<\/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\">Ezek a tesztek seg\u00edtenek a gy\u00e1rt\u00f3knak a k\u00f6vetkez\u0151ket felm\u00e9rni:<\/p><ul data-start=\"1980\" data-end=\"2145\"><li data-section-id=\"4m7yx6\" data-start=\"1980\" data-end=\"2009\">A dugatty\u00fat\u00f6m\u00edt\u00e9s konzisztenci\u00e1ja<\/li><li data-section-id=\"jtny4m\" data-start=\"2010\" data-end=\"2039\">A henger \u00e9s a f\u00fav\u00f3ka \u00e9ps\u00e9ge<\/li><li data-section-id=\"13p4qmo\" data-start=\"2040\" data-end=\"2067\">A ken\u00e9s hat\u00e9konys\u00e1ga<\/li><li data-section-id=\"1rxkfq7\" data-start=\"2068\" data-end=\"2093\">Az adag lead\u00e1s\u00e1nak pontoss\u00e1ga<\/li><li data-section-id=\"njxgtt\" data-start=\"2094\" data-end=\"2145\">A fecskend\u0151 \u00e9s a t\u0171 k\u00f6z\u00f6tti csatlakoz\u00e1s megb\u00edzhat\u00f3s\u00e1ga<\/li><\/ul><p data-start=\"2147\" data-end=\"2270\">A modern laborat\u00f3riumok egyre gyakrabban alkalmazz\u00e1k az automatiz\u00e1lt vizsg\u00e1lati rendszereket az eredm\u00e9nyek ism\u00e9telhet\u0151s\u00e9g\u00e9nek jav\u00edt\u00e1sa \u00e9s a kezel\u0151i t\u00e9nyez\u0151b\u0151l ad\u00f3d\u00f3 elt\u00e9r\u00e9sek cs\u00f6kkent\u00e9se \u00e9rdek\u00e9ben.<\/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\">Fecskend\u0151k sziv\u00e1rg\u00e1svizsg\u00e1lata az ISO 8537 szabv\u00e1ny szerint<\/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\">Fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1lat<\/strong> az ISO 8537 szabv\u00e1nyban le\u00edrt legfontosabb elj\u00e1r\u00e1sok egyike. A szabv\u00e1ny k\u00fcl\u00f6nb\u00f6z\u0151 nyom\u00e1sviszonyok mellett mind a leveg\u0151-, mind a folyad\u00e9k-sziv\u00e1rg\u00e1st \u00e9rt\u00e9keli.<\/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\">Leveg\u0151sziv\u00e1rg\u00e1s az aspir\u00e1ci\u00f3 sor\u00e1n<\/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\">A B. \u00e9s az F. mell\u00e9klet bemutatja azokat a m\u00f3dszereket, amelyekkel v\u00e1kuumk\u00f6r\u00fclm\u00e9nyek k\u00f6z\u00f6tt kimutathat\u00f3 a dugatty\u00fat\u00f6m\u00edt\u00e9s \u00e9s a fecskend\u0151 f\u00fav\u00f3k\u00e1j\u00e1nak csatlakoz\u00e1sain\u00e1l fell\u00e9p\u0151 leveg\u0151sziv\u00e1rg\u00e1s.<\/p><p data-start=\"2686\" data-end=\"2719\">Az elj\u00e1r\u00e1s \u00e1ltal\u00e1ban a k\u00f6vetkez\u0151ket tartalmazza:<\/p><ol data-start=\"2721\" data-end=\"2926\"><li data-section-id=\"8f51yc\" data-start=\"2721\" data-end=\"2764\">A fecskend\u0151 desztill\u00e1lt v\u00edzzel val\u00f3 felt\u00f6lt\u00e9se<\/li><li data-section-id=\"11xil91\" data-start=\"2765\" data-end=\"2822\">A fecskend\u0151 csatlakoztat\u00e1sa egy kompatibilis k\u00fapos csatlakoz\u00f3hoz<\/li><li data-section-id=\"1w8sjai\" data-start=\"2823\" data-end=\"2852\">Negat\u00edv nyom\u00e1s alkalmaz\u00e1sa<\/li><li data-section-id=\"nzi51v\" data-start=\"2853\" data-end=\"2885\">A nyom\u00e1sstabilit\u00e1s figyelemmel k\u00eds\u00e9r\u00e9se<\/li><li data-section-id=\"ad7xt5\" data-start=\"2886\" data-end=\"2926\">Sziv\u00e1rg\u00e1s vagy bubor\u00e9kok kialakul\u00e1s\u00e1nak \u00e9szlel\u00e9se<\/li><\/ol><p data-start=\"2928\" data-end=\"3143\">Az ISO 8537 szabv\u00e1ny a k\u00f6vetkez\u0151 v\u00e1kuumszintet \u00edrja el\u0151: <strong data-start=\"2965\" data-end=\"3010\">88 kPa a k\u00f6rnyezeti l\u00e9gk\u00f6ri nyom\u00e1s alatt<\/strong> az aspir\u00e1ci\u00f3s sziv\u00e1rg\u00e1s \u00e9rt\u00e9kel\u00e9s\u00e9hez. A kezel\u0151k figyelik a fecskend\u0151t, hogy \u00e9szlelj\u00e9k-e a nyom\u00e1ses\u00e9st, a bubor\u00e9kok kialakul\u00e1s\u00e1t \u00e9s a gumidug\u00f3 elv\u00e1l\u00e1s\u00e1t.<\/p><p data-start=\"3145\" data-end=\"3164\">Ez a teszt a k\u00f6vetkez\u0151ket ellen\u0151rzi:<\/p><ul data-start=\"3166\" data-end=\"3287\"><li data-section-id=\"31dbu3\" data-start=\"3166\" data-end=\"3189\">A dugatty\u00fat\u00f6m\u00edt\u00e9s \u00e9ps\u00e9ge<\/li><li data-section-id=\"10m5ixj\" data-start=\"3190\" data-end=\"3222\">A t\u0171csatlakoz\u00f3 t\u00f6m\u00edt\u00e9si teljes\u00edtm\u00e9nye<\/li><li data-section-id=\"17ziab\" data-start=\"3223\" data-end=\"3252\">A f\u00fav\u00f3ka csatlakoz\u00e1s\u00e1nak stabilit\u00e1sa<\/li><li data-section-id=\"1way5n8\" data-start=\"3253\" data-end=\"3287\">Az aspir\u00e1ci\u00f3s sziv\u00e1rg\u00e1s ellen\u00e1ll\u00e1sa<\/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\">V\u00e1kuumsziv\u00e1rg\u00e1s-vizsg\u00e1lat a gy\u00f3gyszeriparban<\/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\">v\u00e1kuumsziv\u00e1rg\u00e1s-vizsg\u00e1lat a gy\u00f3gyszeriparban<\/strong> Ez az elj\u00e1r\u00e1s elengedhetetlen az inzulinszolg\u00e1ltat\u00e1shoz haszn\u00e1lt orvosi fecskend\u0151k eset\u00e9ben, mivel m\u00e9g a legkisebb sziv\u00e1rg\u00e1s is befoly\u00e1solhatja az adagol\u00e1s pontoss\u00e1g\u00e1t vagy a sterilit\u00e1st.<\/p><p data-start=\"3515\" data-end=\"3595\">A Cell Instruments az al\u00e1bbi felszerelts\u00e9ggel rendelkez\u0151 automatiz\u00e1lt v\u00e1kuumsziv\u00e1rg\u00e1s-vizsg\u00e1l\u00f3 rendszereket aj\u00e1nlja:<\/p><ul data-start=\"3597\" data-end=\"3738\"><li data-section-id=\"le59d7\" data-start=\"3597\" data-end=\"3632\">Nagy pontoss\u00e1g\u00fa v\u00e1kuumszab\u00e1lyoz\u00f3k<\/li><li data-section-id=\"1jdfnmj\" data-start=\"3633\" data-end=\"3662\">Digit\u00e1lis nyom\u00e1sfigyel\u00e9s<\/li><li data-section-id=\"105a6xv\" data-start=\"3663\" data-end=\"3684\">A sziv\u00e1rg\u00e1scs\u00f6kken\u00e9s elemz\u00e9se<\/li><li data-section-id=\"fca3b5\" data-start=\"3685\" data-end=\"3712\">Programozhat\u00f3 tart\u00e1si id\u0151<\/li><li data-section-id=\"cixp3u\" data-start=\"3713\" data-end=\"3738\">Adatr\u00f6gz\u00edt\u0151 szoftver<\/li><\/ul><p data-start=\"3740\" data-end=\"3896\">Ezek a rendszerek jav\u00edtj\u00e1k az ism\u00e9telhet\u0151s\u00e9get a k\u00e9zi v\u00e1kuumm\u00e9r\u00e9si m\u00f3dszerekhez k\u00e9pest, \u00e9s seg\u00edtik a laborat\u00f3riumokat a GMP- \u00e9s az ISO-dokument\u00e1ci\u00f3s k\u00f6vetelm\u00e9nyek betart\u00e1s\u00e1ban.<\/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\">A fecskend\u0151 t\u00f6m\u00edt\u00e9s\u00e9nek \u00e9ps\u00e9g\u00e9t vizsg\u00e1l\u00f3 m\u00f3dszerek<\/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\">A <strong data-start=\"3947\" data-end=\"3978\">a fecskend\u0151 t\u00f6m\u00edt\u00e9s\u00e9nek \u00e9ps\u00e9gvizsg\u00e1lata<\/strong> megvizsg\u00e1lja, hogy a folyad\u00e9k vagy a leveg\u0151 k\u00e9pes-e \u00e1thaladni a t\u00f6m\u00edt\u0151fel\u00fcleteken a nyom\u00e1s al\u00e1 helyez\u00e9s vagy a sz\u00edv\u00e1s sor\u00e1n.<\/p><p data-start=\"4076\" data-end=\"4122\">Az ISO 8537 szabv\u00e1ny E. mell\u00e9klete a k\u00f6vetkez\u0151 ter\u00fcleteken el\u0151fordul\u00f3 folyad\u00e9k-sziv\u00e1rg\u00e1sra \u00f6sszpontos\u00edt:<\/p><ul data-start=\"4124\" data-end=\"4190\"><li data-section-id=\"z11dbz\" data-start=\"4124\" data-end=\"4138\">Dugatty\u00fat\u00f6m\u00edt\u00e9sek<\/li><li data-section-id=\"1p89988\" data-start=\"4139\" data-end=\"4167\">Fecskend\u0151-csatlakoz\u00f3k<\/li><li data-section-id=\"1aynqcu\" data-start=\"4168\" data-end=\"4190\">T\u0171\/henger csatlakoz\u00f3k<\/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\">A tesztel\u00e9s sor\u00e1n a kezel\u0151k bels\u0151 nyom\u00e1st hoznak l\u00e9tre, amelynek \u00e9rt\u00e9ke <strong data-start=\"4251\" data-end=\"4277\">300 kPa nyom\u00e1sm\u00e9r\u0151nyom\u00e1s<\/strong> \u00e9s tartsa fenn a nyom\u00e1st 30 m\u00e1sodpercig, mik\u00f6zben oldalir\u00e1ny\u00fa er\u0151t fejt ki a dugatty\u00fara.<\/p><p data-start=\"4365\" data-end=\"4389\">Az elj\u00e1r\u00e1s a k\u00f6vetkez\u0151ket \u00e9rt\u00e9keli:<\/p><ul data-start=\"4391\" data-end=\"4508\"><li data-section-id=\"1k1t3bu\" data-start=\"4391\" data-end=\"4420\">A t\u00f6m\u00edt\u00e9s alakv\u00e1ltoz\u00e1snak val\u00f3 ellen\u00e1ll\u00e1sa<\/li><li data-section-id=\"vhj5a5\" data-start=\"4421\" data-end=\"4457\">Sziv\u00e1rg\u00e1s oldalir\u00e1ny\u00fa terhel\u00e9s eset\u00e9n<\/li><li data-section-id=\"1ubek41\" data-start=\"4458\" data-end=\"4485\">A dugatty\u00fa mozg\u00e1s\u00e1nak stabilit\u00e1sa<\/li><li data-section-id=\"tj03kp\" data-start=\"4486\" data-end=\"4508\">A kapcsolat integrit\u00e1sa<\/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\">Egy megb\u00edzhat\u00f3 t\u00f6m\u00edt\u00e9sellen\u0151rz\u0151 rendszernek a k\u00f6vetkez\u0151ket kell biztos\u00edtania:<\/p><ul data-start=\"4560\" data-end=\"4689\"><li data-section-id=\"1ogn8km\" data-start=\"4560\" data-end=\"4588\">Stabil nyom\u00e1sk\u00e9pz\u00e9s<\/li><li data-section-id=\"81fo7t\" data-start=\"4589\" data-end=\"4617\">Pontos er\u0151hat\u00e1s<\/li><li data-section-id=\"vtwu91\" data-start=\"4618\" data-end=\"4647\">Val\u00f3s idej\u0171 sziv\u00e1rg\u00e1s\u00e9rz\u00e9kel\u00e9s<\/li><li data-section-id=\"198rl1a\" data-start=\"4648\" data-end=\"4689\">Nagy felbont\u00e1s\u00fa elmozdul\u00e1sfigyel\u00e9s<\/li><\/ul><p data-start=\"4691\" data-end=\"4868\">A Cell Instruments nyom\u00e1ssziv\u00e1rg\u00e1s- \u00e9s t\u00f6m\u00edt\u00e9sintegrit\u00e1s-ellen\u0151rz\u00e9si megold\u00e1sokat k\u00edn\u00e1l, amelyek alkalmasak inzulin-fecskend\u0151k, Luer-rendszerek, gy\u00f3gyszeripari tart\u00e1lyok \u00e9s orvosi csomagol\u00e1si alkalmaz\u00e1sokhoz.<\/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\">Fecskend\u0151 cs\u00fasz\u00e1si er\u0151 vizsg\u00e1lata<\/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\">Fecskend\u0151 cs\u00fasz\u00e1si er\u0151 vizsg\u00e1lata<\/strong> m\u00e9ri azt az er\u0151t, amely a dugatty\u00fa mozg\u00e1s\u00e1nak elind\u00edt\u00e1s\u00e1hoz \u00e9s fenntart\u00e1s\u00e1hoz sz\u00fcks\u00e9ges a folyad\u00e9k kinyom\u00e1sakor.<\/p><p data-start=\"5034\" data-end=\"5176\">Az ISO 8537 szabv\u00e1ny C. mell\u00e9klete el\u0151\u00edrja egy mechanikus vizsg\u00e1lati berendez\u00e9s haszn\u00e1lat\u00e1t a dugatty\u00fa m\u0171k\u00f6d\u00e9si erej\u00e9nek r\u00f6gz\u00edt\u00e9s\u00e9re, mik\u00f6zben a vizet kinyomj\u00e1k a fecskend\u0151b\u0151l.<\/p><p data-start=\"5178\" data-end=\"5206\">A teszt \u00e1ltal\u00e1ban a k\u00f6vetkez\u0151ket m\u00e9ri:<\/p><ul data-start=\"5208\" data-end=\"5305\"><li data-section-id=\"uhip3k\" data-start=\"5208\" data-end=\"5227\">Szabadul\u00f3 er\u0151<\/li><li data-section-id=\"d3dsxi\" data-start=\"5228\" data-end=\"5241\">Cs\u00fasz\u00e1si er\u0151<\/li><li data-section-id=\"td0rt7\" data-start=\"5242\" data-end=\"5267\">\u00c1tlagos m\u0171k\u00f6dtet\u0151 er\u0151<\/li><li data-section-id=\"fqmeyx\" data-start=\"5268\" data-end=\"5305\">A mozdulat teljes hossz\u00e1n biztos\u00edtsuk az er\u0151 egyenletess\u00e9g\u00e9t<\/li><\/ul><p data-start=\"5307\" data-end=\"5456\">A cs\u00fasz\u00e1si er\u0151 stabil teljes\u00edtm\u00e9nye d\u00f6nt\u0151 fontoss\u00e1g\u00fa, mivel a t\u00fal nagy er\u0151 ronthatja a haszn\u00e1lhat\u00f3s\u00e1got, m\u00edg a nem megfelel\u0151 ellen\u00e1ll\u00e1s vesz\u00e9lyeztetheti az adagol\u00e1s szab\u00e1lyoz\u00e1s\u00e1t.<\/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\">A sikl\u00f3er\u0151t befoly\u00e1sol\u00f3 legfontosabb t\u00e9nyez\u0151k<\/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\">A fecskend\u0151 cs\u00fasz\u00e1si tulajdons\u00e1gait t\u00f6bb param\u00e9ter is befoly\u00e1solja:<\/p><ul data-start=\"5558\" data-end=\"5684\"><li data-section-id=\"1futzim\" data-start=\"5558\" data-end=\"5591\">A szilikon ken\u0151anyag egyenletes eloszl\u00e1sa<\/li><li data-section-id=\"kuh4lo\" data-start=\"5592\" data-end=\"5617\">A gumidug\u00f3 anyaga<\/li><li data-section-id=\"53gmea\" data-start=\"5618\" data-end=\"5647\">A henger m\u00e9retpontoss\u00e1ga<\/li><li data-section-id=\"5t72bj\" data-start=\"5648\" data-end=\"5666\">Fel\u00fcleti s\u00farl\u00f3d\u00e1s<\/li><li data-section-id=\"198q7yk\" data-start=\"5667\" data-end=\"5684\">A t\u0171 \u00e1tm\u00e9r\u0151je<\/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\">Egy professzion\u00e1lis fecskend\u0151-er\u0151m\u00e9r\u0151 rendszernek a k\u00f6vetkez\u0151ket kell tartalmaznia:<\/p><ul data-start=\"5747\" data-end=\"5906\"><li data-section-id=\"ne6nqw\" data-start=\"5747\" data-end=\"5779\">Prec\u00edzi\u00f3s terhel\u00e9sm\u00e9r\u0151 technol\u00f3gia<\/li><li data-section-id=\"1wxb0hx\" data-start=\"5780\" data-end=\"5811\">\u00c1lland\u00f3 sebess\u00e9g\u0171 mozg\u00e1svez\u00e9rl\u00e9s<\/li><li data-section-id=\"h51txm\" data-start=\"5812\" data-end=\"5847\">Er\u0151\u2013elmozdul\u00e1s g\u00f6rbe elemz\u00e9se<\/li><li data-section-id=\"gjpujf\" data-start=\"5848\" data-end=\"5874\">\u00c1ll\u00edthat\u00f3 tesztberendez\u00e9sek<\/li><li data-section-id=\"19afykk\" data-start=\"5875\" data-end=\"5906\">Sz\u00e1m\u00edt\u00f3g\u00e9pes adatgy\u0171jt\u00e9s<\/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>A Cell Instruments az ISO 8537 szerinti dugatty\u00faer\u0151-vizsg\u00e1lati alkalmaz\u00e1sokhoz olyan univerz\u00e1lis anyagvizsg\u00e1l\u00f3 rendszereket aj\u00e1nl, amelyek egyedi fecskend\u0151-tart\u00f3kkal vannak felszerelve.<\/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\">Az inzulin-fr\u00f6ccs\u00f6nt\u0151k t\u00e9rfogat\u00e1nak m\u00e9r\u00e9se a Dead Space-m\u00f3dszerrel<\/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\">Holt t\u00e9r m\u00e9r\u00e9se<\/strong> meghat\u00e1rozza a dugatty\u00fa teljes lenyom\u00e1sa ut\u00e1n a fecskend\u0151ben visszamarad\u00f3 folyad\u00e9kmennyis\u00e9get.<\/p><p data-start=\"6241\" data-end=\"6394\">Az alacsony holtt\u00e9r k\u00fcl\u00f6n\u00f6sen fontos az inzulin-injekci\u00f3s t\u0171k eset\u00e9ben, mivel a marad\u00e9k gy\u00f3gyszer befoly\u00e1solhatja az adagol\u00e1s pontoss\u00e1g\u00e1t \u00e9s n\u00f6velheti a gy\u00f3gyszerhullad\u00e9k mennyis\u00e9g\u00e9t.<\/p><p data-start=\"6396\" data-end=\"6484\">Az ISO 8537 szabv\u00e1ny D. mell\u00e9klete a v\u00edzt\u00f6meg-m\u00e9r\u00e9sen alapul\u00f3 gravimetrikus vizsg\u00e1lati m\u00f3dszert \u00edrja le.<\/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\">A holtt\u00e9r m\u00e9r\u00e9si elj\u00e1r\u00e1sa<\/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\">Az elj\u00e1r\u00e1s a k\u00f6vetkez\u0151ket foglalja mag\u00e1ban:<\/p><ol data-start=\"6549\" data-end=\"6719\"><li data-section-id=\"5n54cf\" data-start=\"6549\" data-end=\"6578\">Az \u00fcres fecskend\u0151 s\u00faly\u00e1nak m\u00e9r\u00e9se<\/li><li data-section-id=\"1po99wn\" data-start=\"6579\" data-end=\"6622\">A fecskend\u0151 desztill\u00e1lt v\u00edzzel val\u00f3 felt\u00f6lt\u00e9se<\/li><li data-section-id=\"q59tts\" data-start=\"6623\" data-end=\"6656\">A v\u00edz teljes elt\u00e1vol\u00edt\u00e1sa<\/li><li data-section-id=\"1w7zx7c\" data-start=\"6657\" data-end=\"6682\">A fecskend\u0151 \u00fajram\u00e9r\u00e9se<\/li><li data-section-id=\"1bth81y\" data-start=\"6683\" data-end=\"6719\">A visszatartott v\u00edzmennyis\u00e9g kisz\u00e1m\u00edt\u00e1sa<\/li><\/ol><p data-start=\"6721\" data-end=\"6791\">A fennmarad\u00f3 v\u00edzt\u00e9rfogat a fecskend\u0151 holtt\u00e9r\u00e9nek t\u00e9rfogat\u00e1nak felel meg.<\/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\">A \u201eDead Space\u201d tesztel\u00e9s\u00e9nek fontoss\u00e1ga<\/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\">A holtt\u00e9r m\u00e9r\u00e9se seg\u00edt a gy\u00e1rt\u00f3knak a k\u00f6vetkez\u0151 t\u00e9nyez\u0151k \u00e9rt\u00e9kel\u00e9s\u00e9ben:<\/p><ul data-start=\"6885\" data-end=\"6993\"><li data-section-id=\"1yt1bzi\" data-start=\"6885\" data-end=\"6902\">Az adagol\u00e1s pontoss\u00e1ga<\/li><li data-section-id=\"to7kax\" data-start=\"6903\" data-end=\"6928\">A gy\u00f3gyszer marad\u00e9kmennyis\u00e9ge<\/li><li data-section-id=\"1uwyw95\" data-start=\"6929\" data-end=\"6962\">A fecskend\u0151 szerkezeti optimaliz\u00e1l\u00e1sa<\/li><li data-section-id=\"19wzgi9\" data-start=\"6963\" data-end=\"6993\">A t\u0171csatlakoz\u00f3 kialak\u00edt\u00e1s\u00e1nak hat\u00e9konys\u00e1ga<\/li><\/ul><p data-start=\"6995\" data-end=\"7121\">A Cell Instruments prec\u00edzi\u00f3s m\u00e9rleg-integr\u00e1ci\u00f3t \u00e9s testreszabott tesztel\u00e9si platformokat k\u00edn\u00e1l az automatiz\u00e1lt holtt\u00e9r-elemz\u00e9shez.<\/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\">Az ISO 8537 szabv\u00e1nynak val\u00f3 megfelel\u00e9shez aj\u00e1nlott vizsg\u00e1lati berendez\u00e9sek<\/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\">Az ISO 8537 szabv\u00e1nynak val\u00f3 megfelel\u00e9s \u00e9rdek\u00e9ben a laborat\u00f3riumok \u00e1ltal\u00e1ban a k\u00f6vetkez\u0151ket haszn\u00e1lj\u00e1k:<\/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\">Tesztelem<\/th><th class=\"\" data-start=\"7258\" data-end=\"7284\" data-col-size=\"sm\">Aj\u00e1nlott hangszer<\/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\">V\u00e1kuumsziv\u00e1rg\u00e1s-vizsg\u00e1lat<\/td><td style=\"text-align: center;\" data-start=\"7320\" data-end=\"7342\" data-col-size=\"sm\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/hu\/vacuum-leak-tester-for-syringe-plunger-stopper-and-seal\/\">SLT-02 fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1l\u00f3<\/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\">A dugatty\u00fa m\u0171k\u00f6dtet\u0151 ereje<\/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\/hu\/syringes-plunger-glide-force-tester\/\">SSR-01 fecskend\u0151 cs\u00fasz\u00f3 ellen\u00e1ll\u00e1s teszter<\/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\">Holtter\u00fclet-elemz\u00e9s<\/td><td style=\"text-align: center;\" data-start=\"7479\" data-end=\"7513\" data-col-size=\"sm\">Gravimetrikus m\u00e9r\u0151rendszer<\/td><\/tr><tr data-start=\"7514\" data-end=\"7579\"><td style=\"text-align: center;\" data-start=\"7514\" data-end=\"7543\" data-col-size=\"sm\">Csatlakoz\u00e1sok sziv\u00e1rg\u00e1svizsg\u00e1lata<\/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\/hu\/syringe-plunger-seal-integrity-tester\/\">SPPT-01 fecskend\u0151 pozit\u00edv nyom\u00e1snyom\u00e1s\u00fa t\u00f6m\u00f6rs\u00e9gteszter<\/a><\/p><\/div><\/div><\/td><\/tr><\/tbody><\/table><\/div><\/div><p data-start=\"7581\" data-end=\"7773\">A Cell Instruments egyedi automatiz\u00e1l\u00e1si megold\u00e1sokat k\u00edn\u00e1l a fecskend\u0151vizsg\u00e1l\u00f3 laborat\u00f3riumok sz\u00e1m\u00e1ra, ide\u00e9rtve a t\u00f6bb\u00e1llom\u00e1sos rendszereket, az adatkezel\u0151 szoftvereket \u00e9s az integr\u00e1lt min\u0151s\u00e9g-ellen\u0151rz\u00e9si platformokat.<\/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\">GYIK<\/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>Mi az az ISO 8537?<\/strong><br \/>Az ISO 8537 egy nemzetk\u00f6zi szabv\u00e1ny, amely meghat\u00e1rozza a t\u0171vel ell\u00e1tott vagy t\u0171 n\u00e9lk\u00fcli, steril, egyszer haszn\u00e1latos inzulin-fecskend\u0151kkel kapcsolatos k\u00f6vetelm\u00e9nyeket \u00e9s vizsg\u00e1lati m\u00f3dszereket.<\/p><p><strong>Mit jelent a fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1lata az ISO 8537 szabv\u00e1ny szerint?<\/strong><br \/>A fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1lata sor\u00e1n v\u00e1kuum- vagy nyom\u00e1s alatt \u00e9rt\u00e9kelik a dugatty\u00fat\u00f6m\u00edt\u00e9sek, a fecskend\u0151 f\u00fav\u00f3k\u00e1i \u00e9s a t\u0171csatlakoz\u00e1sokon kereszt\u00fcl t\u00f6rt\u00e9n\u0151 leveg\u0151- vagy folyad\u00e9k-sziv\u00e1rg\u00e1st.<\/p><p><strong>Mi\u00e9rt fontos a fecskend\u0151 cs\u00fasz\u00e1si er\u0151j\u00e9nek vizsg\u00e1lata?<\/strong><br \/>A cs\u00fasz\u00e1si er\u0151 vizsg\u00e1lata igazolja, hogy a dugatty\u00fa sim\u00e1n \u00e9s egyenletesen mozog, biztos\u00edtva ezzel a pontos inzulinadagol\u00e1st \u00e9s a fecskend\u0151 megfelel\u0151 haszn\u00e1lhat\u00f3s\u00e1g\u00e1t.<\/p><p><strong>Mi az a fecskend\u0151 t\u00f6m\u00edt\u00e9s\u00e9nek integrit\u00e1svizsg\u00e1lata?<\/strong><br \/>A fecskend\u0151 t\u00f6m\u00edt\u00e9s\u00e9nek integrit\u00e1svizsg\u00e1lata azt \u00e1llap\u00edtja meg, hogy a t\u00f6m\u00edt\u0151fel\u00fcletek megakad\u00e1lyozz\u00e1k-e a sziv\u00e1rg\u00e1st nyom\u00e1s alatt \u00e9s sz\u00edv\u00e1s k\u00f6zben.<\/p><p><strong>Hogyan t\u00f6rt\u00e9nik a holtt\u00e9r m\u00e9r\u00e9se?<\/strong><br \/>A holtt\u00e9r m\u00e9r\u00e9s\u00e9n\u00e9l egy gravimetrikus m\u00f3dszert alkalmaznak, amely \u00f6sszehasonl\u00edtja a fecskend\u0151 t\u00f6meg\u00e9t a v\u00edz kiszor\u00edt\u00e1sa el\u0151tt \u00e9s ut\u00e1n, hogy meghat\u00e1rozz\u00e1k a marad\u00e9k folyad\u00e9k t\u00e9rfogat\u00e1t.<\/p><p><strong>Milyen eszk\u00f6z\u00f6ket haszn\u00e1lnak <a href=\"https:\/\/www.iso.org\/standard\/60510.html\" target=\"_blank\" rel=\"noopener\">ISO 8537<\/a> tesztel\u00e9s?<\/strong><br \/>A leggyakrabban haszn\u00e1lt m\u0171szerek k\u00f6z\u00e9 tartoznak a v\u00e1kuumsziv\u00e1rg\u00e1s-vizsg\u00e1l\u00f3 k\u00e9sz\u00fcl\u00e9kek, az univerz\u00e1lis vizsg\u00e1l\u00f3g\u00e9pek, a nyom\u00e1scs\u00f6kken\u00e9s-m\u00e9r\u0151 rendszerek \u00e9s a gravimetrikus m\u00e9r\u0151berendez\u00e9sek.<\/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: Inzulin-fecskend\u0151k m\u0171k\u00f6d\u00e9si vizsg\u00e1lata \u2013 Az ISO 8537 szabv\u00e1ny meghat\u00e1rozza a steril, egyszer haszn\u00e1latos inzulin-fecskend\u0151k \u2013 t\u0171vel vagy an\u00e9lk\u00fcl \u2013 teljes\u00edtm\u00e9ny\u00e9re \u00e9s vizsg\u00e1lat\u00e1ra vonatkoz\u00f3 k\u00f6vetelm\u00e9nyeket. A szabv\u00e1ny a fecskend\u0151k biztons\u00e1g\u00e1ra, m\u0171k\u00f6d\u0151k\u00e9pess\u00e9g\u00e9re, t\u00f6m\u00edt\u00e9si teljes\u00edtm\u00e9ny\u00e9re, adagol\u00e1si pontoss\u00e1g\u00e1ra \u00e9s m\u0171k\u00f6d\u00e9si megb\u00edzhat\u00f3s\u00e1g\u00e1ra \u00f6sszpontos\u00edt. A gy\u00e1rt\u00f3k \u00e9s a min\u0151s\u00e9gbiztos\u00edt\u00e1si laborat\u00f3riumok az ISO 8537 szabv\u00e1nyt alkalmazz\u00e1k annak ellen\u0151rz\u00e9s\u00e9re, hogy a fecskend\u0151k klinikai haszn\u00e1lat sor\u00e1n k\u00f6vetkezetesen m\u0171k\u00f6dnek-e. [\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\/hu\/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\/hu\/wp-json\/wp\/v2\/posts\/2610","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/comments?post=2610"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/posts\/2610\/revisions"}],"predecessor-version":[{"id":2624,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/posts\/2610\/revisions\/2624"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/media?parent=2610"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/categories?post=2610"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/tags?post=2610"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}