{"id":9825,"date":"2026-02-24T15:11:44","date_gmt":"2026-02-24T07:11:44","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/iso-9626\/"},"modified":"2026-04-16T09:54:22","modified_gmt":"2026-04-16T01:54:22","slug":"iso-9626","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/sk\/standard\/iso-9626\/","title":{"rendered":"ISO 9626"},"content":{"rendered":"<p><\/p>\n\n\n\n<h1 class=\"wp-block-heading\">ISO 9626<\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">\u010co je ISO 9626?<\/h2>\n\n\n\n<p>Poskytuje \u0161tandardizovan\u00e9 \u0161pecifik\u00e1cie pre r\u00farky z nehrdzavej\u00facej ocele pou\u017e\u00edvan\u00e9 pri v\u00fdrobe lek\u00e1rskych ihiel v rozsahu od 3,4 mm (10 Gauge) do 0,18 mm (34 Gauge). Norma sa vz\u0165ahuje len na tuh\u00e9 r\u00farky, s v\u00fdnimkou ohybn\u00fdch variantov z d\u00f4vodu odli\u0161n\u00e9ho mechanick\u00e9ho spr\u00e1vania.<\/p>\n\n\n\n<p>K\u013e\u00fa\u010dov\u00e9 oblasti, na ktor\u00e9 sa vz\u0165ahuje norma ISO 9626, zah\u0155\u0148aj\u00fa:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><b>Rozmerov\u00e9 tolerancie<\/b> z ihlovej r\u00farky z nehrdzavej\u00facej ocele<\/li>\n\n\n\n<li>Mechanick\u00e9 vlastnosti, ako napr. <b>tuhos\u0165 a odolnos\u0165 proti po\u0161kodeniu<\/b><\/li>\n\n\n\n<li><b>Odolnos\u0165 proti kor\u00f3zii<\/b> v simulovan\u00fdch fyziologick\u00fdch podmienkach<\/li>\n\n\n\n<li>Pr\u00edprava a hodnotenie extraktov na testovanie biokompatibility<\/li>\n<\/ul>\n\n\n\n<p>T\u00e1to norma je nevyhnutn\u00e1 pre v\u00fdrobcov ihiel na injek\u010dn\u00e9 pou\u017eitie, odber vzoriek tekut\u00edn a in\u00e9 lek\u00e1rske aplik\u00e1cie. Dodr\u017eiavanie tejto normy zabezpe\u010duje konzistentnos\u0165 v\u00fdkonu, bezpe\u010dnos\u0165 pacientov a s\u00falad s glob\u00e1lnymi regula\u010dn\u00fdmi org\u00e1nmi.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testovanie injek\u010dnej strieka\u010dky pod\u013ea normy ISO 9626<\/h2>\n\n\n\n<p>V norme ISO 9626 je uveden\u00fdch nieko\u013eko k\u013e\u00fa\u010dov\u00fdch postupov testovania injek\u010dn\u00fdch ihiel, ktor\u00fdmi sa overuje mechanick\u00e1 integrita a trvanlivos\u0165 ihlov\u00fdch hadi\u010diek:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Test tuhosti injek\u010dnej ihly<\/h3>\n\n\n\n<p>T\u00fdmto testom sa hodnot\u00ed tuhos\u0165 ihlovej trubice pri kontrolovanom za\u0165a\u017een\u00ed. Postup zah\u0155\u0148a:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Podopretie r\u00fary na rozp\u00e4t\u00ed ur\u010denom jej rozchodom<\/li>\n\n\n\n<li>P\u00f4sobenie sily smerom nadol prostredn\u00edctvom piestu s ur\u010denou geometriou<\/li>\n\n\n\n<li>Meranie priehybu v strede na pos\u00fadenie tuhosti<\/li>\n<\/ul>\n\n\n\n<p>Pr\u00edli\u0161n\u00e1 flexibilita m\u00f4\u017ee ma\u0165 za n\u00e1sledok zl\u00e9 zaobch\u00e1dzanie alebo nepresn\u00e9 vstrekovanie. V\u00fdrobcovia musia zabezpe\u010di\u0165, aby si ihla zachovala mechanick\u00fa stabilitu za o\u010dak\u00e1van\u00fdch podmienok klinick\u00e9ho pou\u017e\u00edvania.<\/p>\n\n\n\n<p>Tester tuhosti ihlov\u00fdch r\u00farok Cell Instruments\u2019 TS-01 je optimalizovan\u00fd pre t\u00fato aplik\u00e1ciu. Pon\u00faka:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Presnos\u0165 sily \u00b10,1 N<\/li>\n\n\n\n<li>Meranie odch\u00fdlky na \u00farovni mikr\u00f3nov<\/li>\n\n\n\n<li>Prisp\u00f4sobite\u013en\u00e9 nastavenia rozp\u00e4tia pod\u013ea \u0161pecifik\u00e1cie meradla<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Test odolnosti proti pretrhnutiu ihly<\/h3>\n\n\n\n<p>Odolnos\u0165 proti pretrhnutiu je ve\u013emi d\u00f4le\u017eit\u00e1, aby sa predi\u0161lo zlyhaniu r\u00farok po\u010das pou\u017e\u00edvania. Norma ISO 9626 predpisuje cyklick\u00fa sk\u00fa\u0161ku ohybom, pri ktorej sa r\u00farky podrobia a\u017e 20 striedav\u00fdm ohybom pod definovan\u00fdm uhlom:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>R\u00farky s be\u017en\u00fdmi stenami: (25 \u00b11)\u00b0<\/li>\n\n\n\n<li>Tenkostenn\u00e9 r\u00farky: (20 \u00b11)\u00b0<\/li>\n\n\n\n<li>Mimoriadne tenk\u00e9\/ultratenk\u00e9 steny: (15 \u00b11)\u00b0<\/li>\n<\/ul>\n\n\n\n<p>Test pom\u00e1ha pos\u00fadi\u0165 odolnos\u0165 proti \u00fanave pri opakovanom nam\u00e1han\u00ed. Vidite\u013en\u00fd lom znamen\u00e1 zlyhanie.<\/p>\n\n\n\n<p>Cell Instruments\u2019 NTT-01 Needle Tubing Resistance Tester vykon\u00e1va tento test pomocou:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Programovate\u013en\u00e9 uhly ohybu a cykly<\/li>\n\n\n\n<li>Pr\u00edpravky na vizu\u00e1lnu kontrolu<\/li>\n\n\n\n<li>Nastavite\u013en\u00e9 up\u00ednanie pre r\u00f4zne priemery r\u00far<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Hodnotenie odolnosti proti kor\u00f3zii<\/h3>\n\n\n\n<p>Pr\u00edloha D normy ISO 9626 sa zaober\u00e1 odolnos\u0165ou vo\u010di kor\u00f3zii, \u010d\u00edm sa zabezpe\u010duje, \u017ee ihly sa pri kontakte s telesn\u00fdmi tekutinami neznehodnotia. R\u00farky z nehrdzavej\u00facej ocele musia by\u0165 odoln\u00e9 vo\u010di tvorbe jamiek a hrdze po ponoren\u00ed do testovac\u00edch roztokov, ako je fyziologick\u00fd roztok.<\/p>\n\n\n\n<p>Hoci to nie je v\u017edy povinn\u00e9, mnoh\u00ed v\u00fdrobcovia zah\u0155\u0148aj\u00fa odolnos\u0165 vo\u010di kor\u00f3zii ako s\u00fa\u010das\u0165 be\u017en\u00e9ho testovania injek\u010dn\u00fdch ihiel na zn\u00ed\u017eenie rizika.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u010eal\u0161ie \u00favahy o testovan\u00ed pod\u013ea normy ISO 9626<\/h3>\n\n\n\n<p>Okrem z\u00e1kladn\u00fdch mechanick\u00fdch hodnoten\u00ed sa v norme ISO 9626 vy\u017eaduje aj:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Presn\u00e9 rozmerov\u00e9 merania<\/li>\n\n\n\n<li>Identifik\u00e1cia typu steny (RW, TW, ETW, UTW)<\/li>\n\n\n\n<li>Klasifik\u00e1cia zliatiny pod\u013ea normy ISO 15510 alebo ASTM A959<\/li>\n\n\n\n<li>Testovacia dokument\u00e1cia vr\u00e1tane ve\u013ekosti meradla, hodn\u00f4t deform\u00e1cie a testovac\u00edch podmienok<\/li>\n<\/ul>\n\n\n\n<p>Presn\u00e9 testovanie nielen sp\u013a\u0148a po\u017eiadavky na zhodu, ale tie\u017e posil\u0148uje spo\u013eahlivos\u0165 v\u00fdrobku a dobr\u00e9 meno zna\u010dky.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testovanie pod\u013ea normy ISO 9626 - nevyhnutn\u00e9 pre kontrolu kvality injek\u010dn\u00fdch strieka\u010diek<\/h2>\n\n\n\n<p>Nesplnenie noriem ISO 9626 m\u00f4\u017ee vies\u0165 k:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ohnutie alebo zlomenie ihly po\u010das injekcie<\/li>\n\n\n\n<li>Ned\u00f4sledn\u00e9 pod\u00e1vanie tekut\u00edn<\/li>\n\n\n\n<li>Zv\u00fd\u0161en\u00e9 riziko poranenia pacienta<\/li>\n\n\n\n<li>Nedodr\u017eiavanie pr\u00e1vnych predpisov a stiahnutia z trhu<\/li>\n<\/ul>\n\n\n\n<p>Integr\u00e1ciou testovania injek\u010dn\u00fdch ihiel v s\u00falade s normou ISO 9626 v\u00fdrobcovia a t\u00edmy zabezpe\u010duj\u00face kvalitu:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Overenie mechanickej pevnosti a odolnosti<\/li>\n\n\n\n<li>Zabezpe\u010denie kompatibility s regula\u010dn\u00fdmi po\u017eiadavkami<\/li>\n\n\n\n<li>Zn\u00ed\u017eenie zodpovednosti a miery zlyhania v\u00fdrobkov<\/li>\n\n\n\n<li>Zlep\u0161enie d\u00f4very a spokojnosti z\u00e1kazn\u00edkov<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdber rie\u0161enia na testovanie pod\u013ea normy ISO 9626<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.packqc.com\/sk\/product\/syringe-tube-stiffness-tester\/\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/www.packqc.com\/wp-content\/uploads\/2025\/05\/Syringe-Tube-Stiffness-Tester-ISO-9626-Annex-B.webp\" alt=\"TS-01 Tester tuhosti injek\u010dnej strieka\u010dky - ISO 9626 pr\u00edloha B\"\/><\/a><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\"><a href=\"https:\/\/www.packqc.com\/sk\/product\/syringe-tube-stiffness-tester\/\" target=\"_blank\">TS-01 Tester tuhosti ihly strieka\u010dky<\/a><\/h3>\n\n\n\n<p>Na presn\u00e9 pos\u00fadenie vlastnost\u00ed tuhosti ihiel z nehrdzavej\u00facej ocele, ako je \u0161pecifikovan\u00e9 v pr\u00edlohe B normy ISO 9626, poskytuje tester tuhosti ihiel strieka\u010diek TS-01 od spolo\u010dnosti Cell Instruments spo\u013eahliv\u00e9 a vysoko presn\u00e9 rie\u0161enie. Tento pr\u00edstroj zabezpe\u010duje konzistentn\u00e9 p\u00f4sobenie sily a presn\u00e9 meranie priehybu hadi\u010dky, \u010d\u00edm pom\u00e1ha v\u00fdrobcom a t\u00edmom kontroly kvality splni\u0165 regula\u010dn\u00e9 o\u010dak\u00e1vania t\u00fdkaj\u00face sa testovania tuhosti injek\u010dn\u00fdch ihiel.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.packqc.com\/sk\/product\/needle-toughness-tester\/\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/www.packqc.com\/wp-content\/uploads\/2025\/04\/Needle-Toughness-Tester-ISO-9626-Breakage-Resistance-Test.webp\" alt=\"NTT-01 Tester h\u00fa\u017eevnatosti ihly - sk\u00fa\u0161ka odolnosti proti zlomeniu pod\u013ea normy ISO 9626\"\/><\/a><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\"><a href=\"https:\/\/www.packqc.com\/sk\/product\/needle-toughness-tester\/\" target=\"_blank\">NTT-01 Tester odporu proti pretrhnutiu ihly<\/a><\/h3>\n\n\n\n<p>Na hodnotenie mechanickej odolnosti lek\u00e1rskych ihlov\u00fdch hadi\u010diek pri opakovanom p\u00f4soben\u00ed ohybov\u00fdch s\u00edl pod\u013ea pr\u00edlohy C normy ISO 9626 je tester odolnosti proti pretrhnutiu ihly NTT-01 z\u00e1kladn\u00fdm n\u00e1strojom. Tento tester, navrhnut\u00fd pre pr\u00edsne podmienky zabezpe\u010denia kvality, simuluje podmienky re\u00e1lneho pou\u017e\u00edvania a poskytuje presn\u00e9 \u00fadaje o odolnosti a \u0161truktur\u00e1lnej integrite hadi\u010diek - \u010do je rozhoduj\u00face pre prevenciu zlyhania ihly po\u010das klinickej aplik\u00e1cie.<\/p>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktujte n\u00e1s Z\u00edskajte rie\u0161enie na testovanie pod\u013ea normy ISO 9626\t\t\t\t<\/h2>\n\n\n\n<p><strong>ISO 9626<\/strong> zohr\u00e1va k\u013e\u00fa\u010dov\u00fa \u00falohu v <strong>testovanie injek\u010dn\u00fdch ihiel<\/strong> stanoven\u00edm referen\u010dn\u00fdch hodn\u00f4t pre<strong> tuhos\u0165, odolnos\u0165 proti zlomeniu a celkov\u00e1 \u0161truktur\u00e1lna integrita<\/strong> z ihlovej r\u00farky z nehrdzavej\u00facej ocele. Prostredn\u00edctvom presn\u00fdch mechanick\u00fdch hodnoten\u00ed m\u00f4\u017eu v\u00fdrobcovia zabezpe\u010di\u0165, aby ich v\u00fdrobky sp\u013a\u0148ali regula\u010dn\u00e9 aj funk\u010dn\u00e9 o\u010dak\u00e1vania.<\/p>\n\n\n\n<p>Tester TS-01 a NTT-01 od spolo\u010dnosti Cell Instruments pon\u00faka komplexn\u00e9, s normou ISO zos\u00faladen\u00e9 rie\u0161enie na splnenie vyv\u00edjaj\u00facich sa po\u017eiadaviek na kontrolu kvality zdravotn\u00edckych pom\u00f4cok. Investujte do lep\u0161ej zhody, zn\u00ed\u017eenia rizika a vynikaj\u00faceho v\u00fdkonu s Cell Instruments ako partnerom v oblasti testovania injek\u010dn\u00fdch ihiel.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u010dasto kladen\u00e9 ot\u00e1zky<\/h2>\n\n\n\n<p>1. Ak\u00fd je hlavn\u00fd \u00fa\u010del standaardu?<br>Norma ISO 9626 definuje rozmerov\u00e9 a mechanick\u00e9 po\u017eiadavky na tuh\u00e9 ihlov\u00e9 r\u00farky z nehrdzavej\u00facej ocele pou\u017e\u00edvan\u00e9 v zdravotn\u00edckych pom\u00f4ckach s cie\u013eom zabezpe\u010di\u0165 bezpe\u010dnos\u0165 a v\u00fdkon.<\/p>\n\n\n\n<p>2. Na ak\u00e9 typy sk\u00fa\u0161ok sa vz\u0165ahuje norma ISO 9626?<br>Testy zah\u0155\u0148aj\u00fa tuhos\u0165 injek\u010dnej ihly, odolnos\u0165 proti zlomeniu ihly, odolnos\u0165 proti kor\u00f3zii a pr\u00edpravu extraktu na hodnotenie biokompatibility.<\/p>\n\n\n\n<p>3. Ak\u00e9 s\u00fa typy r\u00farok RW, TW, ETW a UTW?<br>Tieto sa vz\u0165ahuj\u00fa na kateg\u00f3rie hr\u00fabky stien: S\u00fa to hr\u00fabky stien: Regular Wall (RW), Thin Wall (TW), Extra-Thin Wall (ETW) a Ultra-Thin Wall (UTW), ktor\u00e9 ur\u010duj\u00fa sk\u00fa\u0161obn\u00e9 parametre a uhly ohybu.<\/p>\n\n\n\n<p>4. Ako m\u00f4\u017ee zariadenie Cell Instruments pom\u00f4c\u0165 pri testovan\u00ed pod\u013ea normy ISO 9626?<br>TS-01 a NTT-01 od spolo\u010dnosti Cell Instruments poskytuj\u00fa presn\u00e9 a opakovate\u013en\u00e9 podmienky testovania tuhosti a odolnosti proti zlomeniu, \u010d\u00edm pom\u00e1haj\u00fa v\u00fdrobcom dodr\u017eiava\u0165 <a href=\"https:\/\/www.iso.org\/standard\/60480.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9626<\/a> \u0161tandardy.<\/p>\n\n\n\n<p>5. Pre\u010do je d\u00f4le\u017eit\u00e9 testovanie odolnosti proti pretrhnutiu ihly?<br>Zabezpe\u010duje, aby sa ihla pri pou\u017e\u00edvan\u00ed pod tlakom nezlomila, \u010d\u00edm sa predch\u00e1dza zlyhaniu zariadenia a poraneniu pacienta.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 9626 What is ISO 9626? It provides standardized specifications for stainless steel tubing used in the manufacture of medical needles, ranging from 3.4 mm (10 Gauge) down to 0.18 mm (34 Gauge). The standard applies only to rigid tubing, excluding flexible variants due to differing mechanical behaviors. Key areas covered by ISO 9626 include: [&hellip;]<\/p>","protected":false},"featured_media":5377,"parent":0,"template":"","meta":{"_acf_changed":true,"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":""}}},"standard-category":[612],"class_list":["post-9825","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-iso"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard\/9825","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media\/5377"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media?parent=9825"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard-category?post=9825"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}