{"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\/ro\/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\">Ce este ISO 9626?<\/h2>\n\n\n\n<p>Acesta prevede specifica\u021bii standardizate pentru tuburile din o\u021bel inoxidabil utilizate la fabricarea acelor medicale, de la 3,4 mm (10 Gauge) p\u00e2n\u0103 la 0,18 mm (34 Gauge). Standardul se aplic\u0103 numai tuburilor rigide, excluz\u00e2nd variantele flexibile din cauza comportamentelor mecanice diferite.<\/p>\n\n\n\n<p>Domeniile cheie acoperite de ISO 9626 includ:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><b>Toleran\u021be dimensionale<\/b> de tuburi ac din o\u021bel inoxidabil<\/li>\n\n\n\n<li>Propriet\u0103\u021bi mecanice, cum ar fi <b>rigiditate \u0219i rezisten\u021b\u0103 la rupere<\/b><\/li>\n\n\n\n<li><b>Rezisten\u021b\u0103 la coroziune<\/b> \u00een condi\u021bii fiziologice simulate<\/li>\n\n\n\n<li>Prepararea \u0219i evaluarea extractelor pentru testarea biocompatibilit\u0103\u021bii<\/li>\n<\/ul>\n\n\n\n<p>Standardul este esen\u021bial pentru produc\u0103torii care produc ace pentru injectare, prelevare de fluide \u0219i alte aplica\u021bii medicale. Respectarea acestuia asigur\u0103 consecven\u021ba performan\u021belor, siguran\u021ba pacien\u021bilor \u0219i conformitatea cu organismele globale de reglementare.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testarea acului seringii conform ISO 9626<\/h2>\n\n\n\n<p>ISO 9626 prezint\u0103 mai multe proceduri cruciale de testare a acului de sering\u0103 care valideaz\u0103 integritatea mecanic\u0103 \u0219i durabilitatea tuburilor acului:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Test de rigiditate a acului de injec\u021bie<\/h3>\n\n\n\n<p>Acest test evalueaz\u0103 rigiditatea tubului acului sub o sarcin\u0103 controlat\u0103. Procedura implic\u0103:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sus\u021binerea tubului pe o distan\u021b\u0103 determinat\u0103 de gabaritul acestuia<\/li>\n\n\n\n<li>Aplicarea unei for\u021be descendente prin intermediul unui piston cu o geometrie specific\u0103<\/li>\n\n\n\n<li>M\u0103surarea devia\u021biei la centru pentru a evalua rigiditatea<\/li>\n<\/ul>\n\n\n\n<p>Flexibilitatea excesiv\u0103 poate duce la o manipulare necorespunz\u0103toare sau la injec\u021bii imprecise. Produc\u0103torii trebuie s\u0103 se asigure c\u0103 acul \u00ee\u0219i men\u021bine stabilitatea mecanic\u0103 \u00een condi\u021biile de utilizare clinic\u0103 preconizate.<\/p>\n\n\n\n<p>Testerul de rigiditate a tuburilor cu ac Cell Instruments\u2019 TS-01 este optimizat pentru aceast\u0103 aplica\u021bie. Acesta ofer\u0103:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Precizia for\u021bei \u00b10,1 N<\/li>\n\n\n\n<li>M\u0103surarea devia\u021biei la nivel de microni<\/li>\n\n\n\n<li>Set\u0103ri personalizabile ale intervalului de m\u0103surare \u00een func\u021bie de specifica\u021biile gabaritului<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Test de rezisten\u021b\u0103 la ruperea acului<\/h3>\n\n\n\n<p>Rezisten\u021ba la rupere este vital\u0103 pentru a preveni defectarea tuburilor \u00een timpul utiliz\u0103rii. ISO 9626 prescrie un test de \u00eendoire ciclic\u0103, \u00een care tubulatura este supus\u0103 la p\u00e2n\u0103 la 20 de \u00eendoiri alternante la un unghi definit:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tuburi cu pere\u021bi normali: (25 \u00b11)\u00b0<\/li>\n\n\n\n<li>Tuburi cu pere\u021bi sub\u021biri: (20 \u00b11)\u00b0<\/li>\n\n\n\n<li>Pere\u021bi extra-sub\u021biri\/ultra-sub\u021biri: (15 \u00b11)\u00b0<\/li>\n<\/ul>\n\n\n\n<p>Testul ajut\u0103 la evaluarea rezisten\u021bei la oboseal\u0103 sub stres repetat. O fractur\u0103 vizibil\u0103 indic\u0103 e\u0219ecul.<\/p>\n\n\n\n<p>Cell Instruments\u2019 NTT-01 Tester de rezisten\u021b\u0103 la rupere a tuburilor cu ac efectueaz\u0103 acest test cu:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Unghiuri \u0219i cicluri de \u00eendoire programabile<\/li>\n\n\n\n<li>Dispozitive de inspec\u021bie vizual\u0103<\/li>\n\n\n\n<li>Fixare reglabil\u0103 pentru diferite diametre ale tuburilor<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Evaluarea rezisten\u021bei la coroziune<\/h3>\n\n\n\n<p>Anexa D la ISO 9626 abordeaz\u0103 rezisten\u021ba la coroziune, asigur\u00e2ndu-se c\u0103 acele nu se degradeaz\u0103 \u00een contact cu fluidele corporale. Tuburile din o\u021bel inoxidabil trebuie s\u0103 reziste la formarea de gropi \u0219i rugin\u0103 dup\u0103 imersarea \u00een solu\u021bii de testare, cum ar fi solu\u021bia salin\u0103.<\/p>\n\n\n\n<p>De\u0219i nu este \u00eentotdeauna obligatoriu, mul\u021bi produc\u0103tori includ rezisten\u021ba la coroziune ca parte a test\u0103rii de rutin\u0103 a acelor de sering\u0103 pentru reducerea riscurilor.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Considera\u021bii suplimentare privind testarea ISO 9626<\/h3>\n\n\n\n<p>\u00cen afar\u0103 de evalu\u0103rile mecanice de baz\u0103, ISO 9626 impune, de asemenea:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>M\u0103sur\u0103tori dimensionale precise<\/li>\n\n\n\n<li>Identificarea tipului de perete (RW, TW, ETW, UTW)<\/li>\n\n\n\n<li>Clasificarea aliajului conform ISO 15510 sau ASTM A959<\/li>\n\n\n\n<li>Documenta\u021bia de testare, inclusiv dimensiunea gabaritului, valorile de deformare \u0219i condi\u021biile de testare<\/li>\n<\/ul>\n\n\n\n<p>Testarea precis\u0103 nu numai c\u0103 satisface cerin\u021bele de conformitate, ci \u0219i consolideaz\u0103 fiabilitatea produsului \u0219i reputa\u021bia m\u0103rcii.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testarea ISO 9626 - esen\u021bial\u0103 pentru controlul calit\u0103\u021bii seringilor<\/h2>\n\n\n\n<p>Nerespectarea standardelor ISO 9626 poate duce la:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00cendoirea sau ruperea acului \u00een timpul injec\u021biei<\/li>\n\n\n\n<li>Administrarea inconsecvent\u0103 de fluide<\/li>\n\n\n\n<li>Riscuri crescute de r\u0103nire a pacien\u021bilor<\/li>\n\n\n\n<li>Nerespectarea reglement\u0103rilor \u0219i rechem\u0103ri<\/li>\n<\/ul>\n\n\n\n<p>Prin integrarea test\u0103rii acelor de sering\u0103 conform ISO 9626, produc\u0103torii \u0219i echipele de asigurare a calit\u0103\u021bii:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Validarea rezisten\u021bei mecanice \u0219i a durabilit\u0103\u021bii<\/li>\n\n\n\n<li>Asigura\u021bi compatibilitatea cu cerin\u021bele de reglementare<\/li>\n\n\n\n<li>Reducerea r\u0103spunderii \u0219i a ratelor de e\u0219ec ale produselor<\/li>\n\n\n\n<li>\u00cembun\u0103t\u0103\u021birea \u00eencrederii \u0219i satisfac\u021biei clien\u021bilor<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Alegerea solu\u021biei de testare 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\/ro\/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 de rigiditate a tubului seringii - ISO 9626 Anexa 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\/ro\/product\/syringe-tube-stiffness-tester\/\" target=\"_blank\">TS-01 Tester de rigiditate a acului seringii<\/a><\/h3>\n\n\n\n<p>Pentru a evalua cu exactitate caracteristicile de rigiditate ale tubului acului din o\u021bel inoxidabil, astfel cum se specific\u0103 \u00een ISO 9626 Anexa B, testerul de rigiditate a acului de sering\u0103 TS-01 de la Cell Instruments ofer\u0103 o solu\u021bie fiabil\u0103 \u0219i de \u00eenalt\u0103 precizie. Acest instrument asigur\u0103 aplicarea consecvent\u0103 a for\u021bei \u0219i m\u0103surarea precis\u0103 a devia\u021biei tubului, ajut\u00e2nd produc\u0103torii \u0219i echipele de control al calit\u0103\u021bii s\u0103 \u00eendeplineasc\u0103 a\u0219tept\u0103rile de reglementare pentru testarea rigidit\u0103\u021bii acului de injec\u021bie.<\/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\/ro\/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 de duritate a acului - Test de rezisten\u021b\u0103 la rupere 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\/ro\/product\/needle-toughness-tester\/\" target=\"_blank\">NTT-01 Tester de rezisten\u021b\u0103 la ruperea acului<\/a><\/h3>\n\n\n\n<p>Pentru a evalua durabilitatea mecanic\u0103 a tuburilor acelor medicale la for\u021be de \u00eendoire repetate conform ISO 9626 Anexa C, testerul de rezisten\u021b\u0103 la ruperea acului NTT-01 este un instrument esen\u021bial. Conceput pentru medii riguroase de asigurare a calit\u0103\u021bii, acest tester simuleaz\u0103 condi\u021biile reale de utilizare \u0219i furnizeaz\u0103 date precise privind rezisten\u021ba \u0219i integritatea structural\u0103 a tubului - esen\u021biale pentru prevenirea ced\u0103rii acului \u00een timpul aplic\u0103rii clinice.<\/p>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tContacta\u021bi-ne pentru a ob\u021bine solu\u021bia de testare ISO 9626\t\t\t\t<\/h2>\n\n\n\n<p><strong>ISO 9626<\/strong> joac\u0103 un rol esen\u021bial \u00een <strong>testarea acului seringii<\/strong> prin stabilirea de repere pentru<strong> rigiditate, rezisten\u021b\u0103 la rupere \u0219i integritate structural\u0103 general\u0103<\/strong> de tuburi cu ac din o\u021bel inoxidabil. Prin evalu\u0103ri mecanice precise, produc\u0103torii se pot asigura c\u0103 produsele lor \u00eendeplinesc at\u00e2t cerin\u021bele de reglementare, c\u00e2t \u0219i pe cele func\u021bionale.<\/p>\n\n\n\n<p>Testerele Cell Instruments\u2019 TS-01 \u0219i NTT-01 ofer\u0103 o solu\u021bie cuprinz\u0103toare, conform\u0103 cu ISO, pentru a r\u0103spunde cerin\u021belor \u00een continu\u0103 evolu\u021bie ale controlului calit\u0103\u021bii dispozitivelor medicale. Investi\u021bi \u00eentr-o mai bun\u0103 conformitate, risc redus \u0219i performan\u021b\u0103 superioar\u0103 cu Cell Instruments ca partener \u00een testarea acelor de sering\u0103.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00centreb\u0103ri frecvente<\/h2>\n\n\n\n<p>1. Care este scopul principal al standaardului?<br>ISO 9626 define\u0219te cerin\u021bele dimensionale \u0219i mecanice pentru tuburile rigide cu ace din o\u021bel inoxidabil utilizate \u00een dispozitivele medicale pentru a asigura siguran\u021ba \u0219i performan\u021ba.<\/p>\n\n\n\n<p>2. Ce tipuri de teste sunt acoperite de ISO 9626?<br>Testele includ rigiditatea acului de injectare, rezisten\u021ba la rupere a acului, rezisten\u021ba la coroziune \u0219i preg\u0103tirea extractului pentru evaluarea biocompatibilit\u0103\u021bii.<\/p>\n\n\n\n<p>3. Care sunt tipurile de tuburi RW, TW, ETW \u0219i UTW?<br>Acestea se refer\u0103 la categoriile de grosime a pere\u021bilor: Perete normal (RW), perete sub\u021bire (TW), perete extra-sub\u021bire (ETW) \u0219i perete ultra-sub\u021bire (UTW), care determin\u0103 parametrii de \u00eencercare \u0219i unghiurile de \u00eendoire.<\/p>\n\n\n\n<p>4. Cum poate ajuta echipamentul Cell Instruments la testarea ISO 9626?<br>Cell Instruments\u2019 TS-01 \u0219i NTT-01 ofer\u0103 condi\u021bii de testare precise \u0219i repetabile pentru rigiditate \u0219i rezisten\u021b\u0103 la rupere, ajut\u00e2nd produc\u0103torii s\u0103 respecte <a href=\"https:\/\/www.iso.org\/standard\/60480.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9626<\/a> standardele.<\/p>\n\n\n\n<p>5. De ce este important\u0103 testarea rezisten\u021bei la rupere a acului?<br>Aceasta asigur\u0103 c\u0103 acul nu se va fractura sub stres \u00een timpul utiliz\u0103rii, prevenind defectarea dispozitivului \u0219i r\u0103nirea pacientului.<\/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\/ro\/wp-json\/wp\/v2\/standard\/9825","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media\/5377"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9825"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard-category?post=9825"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}