{"id":6661,"date":"2025-05-12T11:00:20","date_gmt":"2025-05-12T03:00:20","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=6661"},"modified":"2025-05-12T11:27:11","modified_gmt":"2025-05-12T03:27:11","slug":"iso-9626","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/ro\/standards\/iso-9626\/","title":{"rendered":"ISO 9626"},"content":{"rendered":"<h1 style=\"text-align: center;\" data-start=\"553\" data-end=\"1074\">ISO 9626<br \/>\n<small>Test pentru tubulatura seringii cu ac<\/small><\/h1>\n<p class=\"\" data-start=\"553\" data-end=\"1074\"><a href=\"https:\/\/www.qualitester.com\/ro\/standards\/iso-9626\/\"><em data-start=\"553\" data-end=\"563\">ISO 9626<\/em><\/a> define\u0219te standardul interna\u021bional pentru <strong data-start=\"603\" data-end=\"636\">tub de ac din o\u021bel inoxidabil<\/strong> utilizate \u00een fabricarea dispozitivelor medicale, cum ar fi acele hipodermice. Dezvoltat\u0103 pentru a asigura siguran\u021ba, consecven\u021ba \u0219i performan\u021ba, ISO 9626 ofer\u0103 specifica\u021bii riguroase pentru dimensiunile \u0219i propriet\u0103\u021bile mecanice ale tuburilor de la 3,4 mm (10 Gauge) la 0,18 mm (34 Gauge). Se aplic\u0103 strict la <em data-start=\"933\" data-end=\"940\">rigid<\/em> tuburi din o\u021bel inoxidabil - cu excep\u021bia variantelor flexibile - ceea ce le face esen\u021biale pentru produc\u0103torii de ace de sering\u0103 \u0219i produc\u0103torii de dispozitive medicale.<\/p>\n<p class=\"\" data-start=\"1076\" data-end=\"1420\">Pentru profesioni\u0219tii din domeniul controlului calit\u0103\u021bii \u0219i produc\u0103torii de dispozitive medicale, \u00een\u021belegerea standardului ISO 9626 este esen\u021bial\u0103. Acest standard nu numai c\u0103 reglementeaz\u0103 proiectarea tuburilor medicale, dar prescrie \u0219i teste specifice, cum ar fi <strong data-start=\"1286\" data-end=\"1316\">test sering\u0103 ac tubulatur\u0103<\/strong>, <strong data-start=\"1318\" data-end=\"1343\">testul de rigiditate a acului<\/strong>, <strong data-start=\"1345\" data-end=\"1377\">test de rezisten\u021b\u0103 la rupere a tubului<\/strong>, \u0219i <strong data-start=\"1383\" data-end=\"1419\">test de rezisten\u021b\u0103 la coroziune a acului<\/strong>.<\/p>\n<p class=\"\" data-start=\"1422\" data-end=\"1601\">S\u0103 explor\u0103m metodele cheie de testare cerute de ISO 9626 \u0219i modul \u00een care produc\u0103torii pot asigura conformitatea folosind echipamente specializate precum Cell Instruments\u2019 <strong data-start=\"1576\" data-end=\"1585\">TS-01<\/strong> \u0219i <strong data-start=\"1590\" data-end=\"1600\">NTT-01<\/strong>.<\/p>\n<hr class=\"\" data-start=\"1603\" data-end=\"1606\" \/>\n<h2 data-start=\"1608\" data-end=\"1666\">Cerin\u021be de testare a tubului acului seringii conform ISO 9626<\/h2>\n<p class=\"\" data-start=\"1668\" data-end=\"1815\">Pentru a se asigura c\u0103 un tub cu ac din o\u021bel inoxidabil \u00eendepline\u0219te acest standard, produc\u0103torii trebuie s\u0103 \u00eel evalueze \u00een func\u021bie de mai mul\u021bi parametri critici de performan\u021b\u0103. Acestea includ:<\/p>\n<ul>\n<li data-start=\"1819\" data-end=\"1843\"><strong data-start=\"1819\" data-end=\"1843\">Precizia dimensional\u0103<\/strong><\/li>\n<li data-start=\"1846\" data-end=\"1892\"><strong data-start=\"1846\" data-end=\"1873\">Categoria grosimii peretelui<\/strong> (RW, TW, ETW, UTW)<\/li>\n<li data-start=\"1895\" data-end=\"1930\"><strong data-start=\"1895\" data-end=\"1930\">Rezisten\u021ba \u0219i integritatea materialelor<\/strong><\/li>\n<li data-start=\"1933\" data-end=\"1976\"><strong data-start=\"1933\" data-end=\"1976\">Rezisten\u021b\u0103 la deformare \u0219i coroziune<\/strong><\/li>\n<\/ul>\n<p class=\"\" data-start=\"1978\" data-end=\"2143\">Fiecare metric\u0103 este asociat\u0103 cu proceduri de testare standardizate pentru a asigura calitatea tuburilor \u00een timpul produc\u021biei \u0219i \u00eenainte de utilizarea \u00een seringi \u0219i alte dispozitive medicale.<\/p>\n<h3 data-start=\"2150\" data-end=\"2194\"><strong data-start=\"2150\" data-end=\"2194\">1. Testul de rigiditate a acului - ISO 9626 Anexa B<\/strong><\/h3>\n<p class=\"\" data-start=\"2196\" data-end=\"2468\">The <strong data-start=\"2200\" data-end=\"2225\">testul de rigiditate a acului<\/strong> evalueaz\u0103 capacitatea tubului de a rezista la deformare sub ac\u021biunea unei for\u021be aplicate. \u00cen conformitate cu anexa B la acest standard, un pistona\u0219 aplic\u0103 o for\u021b\u0103 de p\u00e2n\u0103 la 60 N \u00een centrul unui tub cu ac sus\u021binut la ambele capete. Deflec\u021bia este apoi m\u0103surat\u0103 cu precizie.<\/p>\n<p class=\"\" data-start=\"2470\" data-end=\"2595\">Acest test asigur\u0103 c\u0103 tubulatura \u00ee\u0219i p\u0103streaz\u0103 integritatea structural\u0103 \u00een timpul introducerii \u00een corpul uman, f\u0103r\u0103 \u00eendoire sau deformare.<\/p>\n<p class=\"\" data-start=\"2597\" data-end=\"2779\"><strong data-start=\"2597\" data-end=\"2654\">Instrument recomandat: <a href=\"https:\/\/www.qualitester.com\/ro\/produs\/medical-needle-tubing-stiffness-tester\/\" target=\"_blank\" rel=\"noopener\">TS-01 Tester de rigiditate a tuburilor<\/a><\/strong><br data-start=\"2654\" data-end=\"2657\" \/>Instrumente celulare' <strong data-start=\"2675\" data-end=\"2684\">TS-01<\/strong> este special conceput pentru testarea rigidit\u0103\u021bii \u00een conformitate cu ISO 9626 Anexa B. Acesta ofer\u0103:<\/p>\n<ul>\n<li data-start=\"2783\" data-end=\"2807\">Precizia for\u021bei \u00b10,01 N<\/li>\n<li data-start=\"2810\" data-end=\"2853\">Rezolu\u021bie de m\u0103surare a devia\u021biei de 0,01 mm<\/li>\n<li data-start=\"2856\" data-end=\"2893\">Viteze de testare variabile (1-500 mm\/min)<\/li>\n<li data-start=\"2896\" data-end=\"2930\">Operare cu ecran tactil HMI de 7 inchi<\/li>\n<li data-start=\"2933\" data-end=\"2973\">Retur automat \u0219i protec\u021bie la suprasarcin\u0103<\/li>\n<\/ul>\n<p class=\"\" data-start=\"2975\" data-end=\"3083\">Cu <strong data-start=\"2984\" data-end=\"2993\">TS-01<\/strong>, echipele de control al calit\u0103\u021bii pot evalua cu \u00eencredere rigiditatea mecanic\u0103 a tuburilor cu ace.<\/p>\n<h3 data-start=\"3090\" data-end=\"3141\">2. \u00cencercarea de rezisten\u021b\u0103 la rupere a tubului - ISO 9626 Anexa C<\/h3>\n<p class=\"\" data-start=\"3143\" data-end=\"3433\">Anexa C la ISO 9626 define\u0219te <strong data-start=\"3172\" data-end=\"3204\">test de rezisten\u021b\u0103 la rupere a tubului<\/strong>, care evalueaz\u0103 performan\u021ba la oboseal\u0103 a tubului prin cicluri de \u00eendoire repetate. Tubulatura este fixat\u0103 la un cap\u0103t \u0219i \u00eendoit\u0103 la unghiuri specificate (25\u00b0, 20\u00b0 sau 15\u00b0, \u00een func\u021bie de grosimea peretelui) timp de 20 de cicluri complete la 0,5 Hz.<\/p>\n<p class=\"\" data-start=\"3435\" data-end=\"3542\">Acest test simuleaz\u0103 utilizarea clinic\u0103 \u0219i asigur\u0103 c\u0103 tubulatura poate rezista la solicit\u0103ri repetate f\u0103r\u0103 a ceda.<\/p>\n<p class=\"\" data-start=\"3544\" data-end=\"3746\"><strong data-start=\"3544\" data-end=\"3600\">Instrument recomandat: <a href=\"https:\/\/www.qualitester.com\/ro\/produs\/syringe-needle-break-resistance-testing\/\" target=\"_blank\" rel=\"noopener\">NTT-01 Tester de rezisten\u021b\u0103 la ruperea acului seringii<\/a><\/strong><br data-start=\"3600\" data-end=\"3603\" \/>Instrumente celulare' <strong data-start=\"3621\" data-end=\"3631\">NTT-01<\/strong> este adaptat pentru a executa testarea rezisten\u021bei la rupere a tuburilor \u00een conformitate cu parametrii exac\u021bi ai ISO 9626 Anexa C. Acesta asigur\u0103:<\/p>\n<ul>\n<li>Controlul precis al deplas\u0103rii unghiulare<\/li>\n<li>Aplicarea for\u021bei reglabile<\/li>\n<li>Vitez\u0103 de ciclism constant\u0103 pentru evaluarea oboselii<\/li>\n<\/ul>\n<p class=\"\" data-start=\"3878\" data-end=\"3985\">Utilizarea <strong data-start=\"3888\" data-end=\"3898\">NTT-01<\/strong> ajut\u0103 produc\u0103torii s\u0103 evite problemele legate de ruperea tuburilor care ar putea compromite siguran\u021ba pacien\u021bilor.<\/p>\n<hr class=\"\" data-start=\"3987\" data-end=\"3990\" \/>\n<h3 data-start=\"3992\" data-end=\"4047\">3. \u00cencercarea de rezisten\u021b\u0103 la coroziune a acului - ISO 9626 Anexa D<\/h3>\n<p class=\"\" data-start=\"4049\" data-end=\"4339\">The <strong data-start=\"4053\" data-end=\"4089\">test de rezisten\u021b\u0103 la coroziune a acului<\/strong> m\u0103soar\u0103 capacitatea tubului de a rezista la expunerea chimic\u0103. \u00cen conformitate cu ISO 9626 anexa D, tubulatura este par\u021bial scufundat\u0103 \u00eentr-o solu\u021bie de clorur\u0103 de sodiu 0,5 mol\/L timp de \u0219apte ore la 23 \u00b0C. Dup\u0103 imersiune, tubulatura este inspectat\u0103 pentru coroziune vizibil\u0103.<\/p>\n<p class=\"\" data-start=\"4341\" data-end=\"4451\">Acest test este vital pentru confirmarea biocompatibilit\u0103\u021bii \u0219i durabilit\u0103\u021bii pe termen lung a acului din o\u021bel inoxidabil.<\/p>\n<p class=\"\" data-start=\"4453\" data-end=\"4622\">Pentru a sprijini aceast\u0103 procedur\u0103, Cell Instruments ofer\u0103 sisteme de testare a rezisten\u021bei la coroziune compatibile cu standardele de ap\u0103 ISO 3696 \u0219i sisteme adecvate de manipulare a reactivilor.<\/p>\n<hr class=\"\" data-start=\"4624\" data-end=\"4627\" \/>\n<h2 data-start=\"4629\" data-end=\"4668\">Beneficiile conform\u0103rii cu ISO 9626<\/h2>\n<p class=\"\" data-start=\"4670\" data-end=\"4730\">Conformitatea cu acest standard asigur\u0103 c\u0103 tubulatura acului seringii:<\/p>\n<ul>\n<li data-start=\"4734\" data-end=\"4772\">Respect\u0103 standardele interna\u021bionale de siguran\u021b\u0103<\/li>\n<li data-start=\"4775\" data-end=\"4830\">Minimizeaz\u0103 riscul de \u00eendoire, rupere sau coroziune<\/li>\n<li data-start=\"4833\" data-end=\"4882\">\u00cembun\u0103t\u0103\u021be\u0219te confortul pacientului \u0219i fiabilitatea dispozitivului<\/li>\n<li data-start=\"4885\" data-end=\"4919\">Simplific\u0103 aprob\u0103rile de reglementare<\/li>\n<\/ul>\n<p class=\"\" data-start=\"4921\" data-end=\"5071\">\u00cen plus, respectarea ISO 9626 contribuie la construirea \u00eencrederii profesioni\u0219tilor din domeniul s\u0103n\u0103t\u0103\u021bii \u0219i a utilizatorilor finali, reduc\u00e2nd \u00een acela\u0219i timp retragerile de produse sau e\u0219ecurile clinice.<\/p>\n<hr class=\"\" data-start=\"5073\" data-end=\"5076\" \/>\n<h2 data-start=\"5078\" data-end=\"5138\">Parteneriat cu Cell Instruments pentru conformitatea cu ISO 9626<\/h2>\n<p class=\"\" data-start=\"5140\" data-end=\"5408\">Cell Instruments este un produc\u0103tor de \u00eencredere de produse avansate <strong data-start=\"5195\" data-end=\"5228\">sisteme de testare a tuburilor cu ac<\/strong>. Oferim echipamente de \u00eenalt\u0103 performan\u021b\u0103 adaptate pentru a \u00eendeplini aceste cerin\u021be de testare standard pentru tuburile acului de sering\u0103, inclusiv rigiditatea, rezisten\u021ba la rupere \u0219i rezisten\u021ba la coroziune.<\/p>\n<p class=\"\" data-start=\"5410\" data-end=\"5619\">noastre <strong data-start=\"5414\" data-end=\"5423\">TS-01<\/strong> \u0219i <strong data-start=\"5428\" data-end=\"5438\">NTT-01<\/strong> sunt proiectate cu control de precizie, repetabilitate ridicat\u0103 \u0219i operare intuitiv\u0103 - ideale pentru laboratoarele de asigurare a calit\u0103\u021bii, produc\u0103torii de seringi \u0219i dezvoltatorii de dispozitive medicale.<\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignright wp-image-6666\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-300x300.webp\" alt=\"ISO 9626\" width=\"400\" height=\"400\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-300x300.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-150x150.webp 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-12x12.webp 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626-100x100.webp 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-9626.webp 600w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/><\/p>\n<p class=\"\" data-start=\"5621\" data-end=\"5674\">Lucr\u00e2nd cu Cell Instruments, ob\u021bine\u021bi acces la:<\/p>\n<ul>\n<li data-start=\"5678\" data-end=\"5724\">Echipament proiectat pentru respectarea strict\u0103 a ISO<\/li>\n<li data-start=\"5727\" data-end=\"5784\">Solu\u021bii de testare personalizabile pentru nevoile unice ale produselor<\/li>\n<li data-start=\"5787\" data-end=\"5839\">Asisten\u021b\u0103 tehnic\u0103 continu\u0103 \u0219i servicii de calibrare<\/li>\n<\/ul>\n<p class=\"\" data-start=\"5862\" data-end=\"6249\">\u00cen\u021belegerea \u0219i implementarea standardelor ISO 9626 este esen\u021bial\u0103 pentru oricine este implicat \u00een proiectarea, fabricarea sau controlul calit\u0103\u021bii tuburilor cu ace medicale. Prin efectuarea cu precizie <strong data-start=\"6041\" data-end=\"6072\">teste sering\u0103 ac tubulatur\u0103<\/strong>, inclusiv <strong data-start=\"6084\" data-end=\"6104\">rigiditatea acului<\/strong>, <strong data-start=\"6106\" data-end=\"6133\">rezisten\u021ba la rupere a tubului<\/strong>, \u0219i <strong data-start=\"6139\" data-end=\"6176\">teste de rezisten\u021b\u0103 la coroziune a acului<\/strong>, produc\u0103torii pot garanta performan\u021ba, siguran\u021ba \u0219i conformitatea global\u0103.<\/p>\n<p class=\"\" data-start=\"6251\" data-end=\"6446\">Cell Instruments este partenerul dumneavoastr\u0103 de \u00eencredere \u00een realizarea <a href=\"https:\/\/www.iso.org\/standard\/60480.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 9626<\/a> succesul test\u0103rii. Cu exper\u021bii no\u0219tri <strong data-start=\"6354\" data-end=\"6363\">TS-01<\/strong> \u0219i <strong data-start=\"6368\" data-end=\"6378\">NTT-01<\/strong> ve\u021bi face fa\u021b\u0103 cu \u00eencredere celor mai dificile cerin\u021be din industrie.<\/p>\n<hr class=\"\" data-start=\"6448\" data-end=\"6451\" \/>\n<h2 data-start=\"6453\" data-end=\"6492\">\u00ceNTREB\u0102RI FRECVENTE<\/h2>\n<p class=\"\" data-start=\"6494\" data-end=\"6712\"><strong data-start=\"6494\" data-end=\"6558\">1. Ce tipuri de tuburi din o\u021bel inoxidabil acoper\u0103 ISO 9626?<\/strong><br data-start=\"6558\" data-end=\"6561\" \/>Acest standard se aplic\u0103 numai pentru <em data-start=\"6586\" data-end=\"6593\">rigid<\/em> tubulatur\u0103 din o\u021bel inoxidabil utilizat\u0103 pentru ace hipodermice \u0219i exclude tubulatura flexibil\u0103 din cauza propriet\u0103\u021bilor mecanice diferite.<\/p>\n<p class=\"\" data-start=\"6714\" data-end=\"6899\"><strong data-start=\"6714\" data-end=\"6764\">2. De ce este important testul de rigiditate a acului?<\/strong><br data-start=\"6764\" data-end=\"6767\" \/>Se asigur\u0103 c\u0103 tubulatura rezist\u0103 la \u00eendoire \u00een timpul utiliz\u0103rii medicale, ceea ce este esen\u021bial pentru inser\u021bia sigur\u0103 a acului \u0219i administrarea precis\u0103 a medicamentului.<\/p>\n<p class=\"\" data-start=\"6901\" data-end=\"7104\"><strong data-start=\"6901\" data-end=\"6974\">3. C\u00e2te cicluri de \u00eendoire sunt necesare \u00een testul de rezisten\u021b\u0103 la rupere?<\/strong><br data-start=\"6974\" data-end=\"6977\" \/>Anexa C la ISO 9626 impune ca tubulatura s\u0103 fie supus\u0103 <strong data-start=\"7025\" data-end=\"7047\">20 de cicluri complete<\/strong> de \u00eencovoiere direc\u021bional\u0103 pentru a-i evalua rezisten\u021ba la oboseal\u0103.<\/p>\n<p class=\"\" data-start=\"7106\" data-end=\"7297\"><strong data-start=\"7106\" data-end=\"7174\">4. Ce semne indic\u0103 e\u0219ecul la testul de rezisten\u021b\u0103 la coroziune?<\/strong><br data-start=\"7174\" data-end=\"7177\" \/>Coroziunea vizibil\u0103 sau decolorarea por\u021biunii imersate a tubului indic\u0103 neconformitatea cu ISO 9626 anexa D.<\/p>\n<p class=\"\" data-start=\"7299\" data-end=\"7540\"><strong data-start=\"7299\" data-end=\"7375\">5. Poate Cell Instruments s\u0103 furnizeze echipamente personalizate de testare a tuburilor cu ace?<\/strong><br data-start=\"7375\" data-end=\"7378\" \/>Da, Cell Instruments este specializat\u0103 \u00een <strong data-start=\"7415\" data-end=\"7443\">solu\u021bii de testare personalizate<\/strong>, inclusiv automatizarea \u0219i dispozitivele de fixare adaptate, pentru a sprijini nevoile specifice ale produselor \u0219i reglement\u0103rile.<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 9626 Syringe Needle Tubing Test ISO 9626 defines the international standard for stainless steel needle tubing used in the manufacture of medical devices such as hypodermic needles. Developed to ensure safety, consistency, and performance, ISO 9626 provides rigorous specifications for tubing dimensions and mechanical properties ranging from 3.4 mm (10 Gauge) to 0.18 mm &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/ro\/standards\/iso-9626\/\"> <span class=\"screen-reader-text\">ISO 9626<\/span> Cite\u0219te mai mult \"<\/a><\/p>","protected":false},"author":4,"featured_media":0,"parent":4948,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-6661","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages\/6661","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/comments?post=6661"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages\/6661\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages\/4948"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/media?parent=6661"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}