{"id":9833,"date":"2026-02-24T15:11:44","date_gmt":"2026-02-24T07:11:44","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/iso-7864\/"},"modified":"2026-04-16T09:54:22","modified_gmt":"2026-04-16T01:54:22","slug":"iso-7864","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/ro\/standard\/iso-7864\/","title":{"rendered":"ISO 7864"},"content":{"rendered":"<h2 class=\"wp-block-heading\">ISO 7864 pentru testul cu ac hipodermic steril<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong data-start=\"1102\" data-end=\"1114\">ISO 7864<\/strong>, intitulat <em data-start=\"1123\" data-end=\"1200\">\"Ace hipodermice sterile de unic\u0103 folosin\u021b\u0103 - Cerin\u021be \u0219i metode de testare\"<\/em>define\u0219te principalele criterii mecanice \u0219i de performan\u021b\u0103 pentru acele hipodermice. Standardul garanteaz\u0103 c\u0103 fiecare ac prezint\u0103 o ascu\u021bime suficient\u0103, integritate structural\u0103 \u0219i o aderen\u021b\u0103 fiabil\u0103 \u00eentre <strong data-start=\"1402\" data-end=\"1425\">tubul acului \u0219i butuc<\/strong>. De asemenea, acesta prevede proceduri detaliate at\u00e2t pentru <strong data-start=\"1475\" data-end=\"1504\">testarea for\u021bei de penetrare<\/strong> \u015fi <strong data-start=\"1509\" data-end=\"1534\">testarea rezisten\u021bei la lipire<\/strong>, care sunt parametri de calitate esen\u021biali \u00een fabricarea acelor sterile.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testul for\u021bei de penetrare a acului<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong data-start=\"1671\" data-end=\"1698\">test de penetrare cu acul<\/strong> m\u0103soar\u0103 c\u00e2t\u0103 for\u021b\u0103 este necesar\u0103 pentru a introduce un ac \u00eentr-un substrat specificat la o vitez\u0103 constant\u0103. \u00cen conformitate cu <strong>ISO 7864 Anexa D<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>O <strong data-start=\"1839\" data-end=\"1870\">aparat de m\u0103surare a for\u021bei<\/strong> (de exemplu, un tester bazat pe celule de sarcin\u0103).<\/li>\n\n\n\n<li>Viteza de testare este de obicei <strong data-start=\"1943\" data-end=\"1957\">100 mm\/min<\/strong>.<\/li>\n\n\n\n<li>Acele trebuie s\u0103 penetreze p\u00e2n\u0103 la <strong data-start=\"1990\" data-end=\"2021\">80% din lungimea lor nominal\u0103<\/strong>.<\/li>\n\n\n\n<li>Substraturile precum latexul natural de cauciuc sau poliuretanul simuleaz\u0103 pielea uman\u0103.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Sunt captura\u021bi doi parametri critici:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2140\" data-end=\"2166\">For\u021ba de penetrare maxim\u0103<\/strong>: For\u021ba maxim\u0103 necesar\u0103 pentru ca acul s\u0103 str\u0103pung\u0103 substratul.<\/li>\n\n\n\n<li><strong data-start=\"2237\" data-end=\"2251\">For\u021ba de rezisten\u021b\u0103<\/strong>: Rezisten\u021ba medie la frecare \u00een timpul inser\u021biei.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments ofer\u0103 a <strong data-start=\"2513\" data-end=\"2551\">tester de for\u021b\u0103 de penetrare de precizie<\/strong>, ideal pentru efectuarea <strong data-start=\"2578\" data-end=\"2605\">test de penetrare cu acul<\/strong>. Senzorii s\u0103i de \u00eenalt\u0103 rezolu\u021bie \u0219i controlul programabil al vitezei asigur\u0103 conformitatea deplin\u0103 cu ISO 7864.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test de rezisten\u021b\u0103 a lipirii acului<br>-<small>\u00centre tubul acului \u0219i butuc<\/small><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Anexa E<\/strong> din ISO 7864 se concentreaz\u0103 pe <strong data-start=\"2807\" data-end=\"2839\">test de rezisten\u021b\u0103 la lipirea acului<\/strong>, ceea ce asigur\u0103 c\u0103 leg\u0103tura dintre <strong data-start=\"2881\" data-end=\"2904\">tubul acului \u0219i butuc<\/strong> pot rezista la solicit\u0103ri mecanice f\u0103r\u0103 a se desprinde.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Procedura include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Montarea acului \u00een pozi\u021bie vertical\u0103 \u00eentr-un <strong data-start=\"3019\" data-end=\"3047\">tester de trac\u021biune universal<\/strong>.<\/li>\n\n\n\n<li>Utilizarea de m\u00e2nere specializate pentru a evita alunecarea sau deformarea.<\/li>\n\n\n\n<li>Aplicarea for\u021bei de trac\u021biune la <strong data-start=\"3137\" data-end=\"3150\">50 mm\/min<\/strong> p\u00e2n\u0103 c\u00e2nd leg\u0103tura cedeaz\u0103.<\/li>\n\n\n\n<li>\u00cenregistrarea <strong data-start=\"3189\" data-end=\"3214\">for\u021b\u0103 maxim\u0103 de trac\u021biune<\/strong> la care apare defec\u021biunea.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Acest test valideaz\u0103 integritatea mecanic\u0103 a <strong data-start=\"3293\" data-end=\"3318\">sistem de lipire a acelor<\/strong>, o cerin\u021b\u0103 esen\u021bial\u0103 pentru prevenirea incidentelor medicale \u00een timpul injec\u021biilor sau al transferului de fluide.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong data-start=\"3436\" data-end=\"3477\">Tester de rezisten\u021b\u0103 la lipire Cell Instruments<\/strong> suport\u0103 teste de trac\u021biune conforme cu ISO 7864 cu dispozitive de fixare personalizabile pentru diferite tipuri de ace.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Aplica\u021bii \u00een diverse industrii<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Metodele de testare a acului ISO 7864 nu sunt limitate doar la produc\u0103torii de seringi medicale. Ele se aplic\u0103, de asemenea, pentru:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4658\" data-end=\"4686\">Companii farmaceutice<\/strong> dezvoltarea sistemelor de administrare a medicamentelor prin injectare.<\/li>\n\n\n\n<li><strong data-start=\"4739\" data-end=\"4766\">Produc\u0103tori de ambalaje<\/strong> producerea de seturi de seringi preumplute.<\/li>\n\n\n\n<li><strong data-start=\"4803\" data-end=\"4834\">Agen\u021bii de inspec\u021bie a calit\u0103\u021bii<\/strong> efectuarea de teste de reglementare.<\/li>\n\n\n\n<li><strong data-start=\"4868\" data-end=\"4880\">Laboratoare de cercetare \u0219i dezvoltare<\/strong> studierea compatibilit\u0103\u021bii \u0219i performan\u021bei materialelor.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Echipamentul \"Cell Instruments\" este utilizat la nivel mondial \u00een <strong data-start=\"4981\" data-end=\"5030\">medicale, farmaceutice, adezivi, ambalaje<\/strong>, \u0219i <strong data-start=\"5036\" data-end=\"5063\">sectoare de control al calit\u0103\u021bii<\/strong>, consolid\u00e2nd reputa\u021bia noastr\u0103 de excelen\u021b\u0103 tehnic\u0103.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Alegerea echipamentului de testare potrivit pentru ISO 7864<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Precizia test\u0103rii depinde de utilizarea instrumentelor corecte. Atunci c\u00e2nd selecta\u021bi <a href=\"https:\/\/www.packqc.com\/ro\/product\/needle-penetration-test-equipment-iso-7864\/\"><strong data-start=\"3777\" data-end=\"3814\">echipament de testare a penetr\u0103rii acului<\/strong><\/a> sau un <strong data-start=\"3820\" data-end=\"3844\">tester de rezisten\u021b\u0103 la lipire<\/strong>, lua\u021bi \u00een considerare urm\u0103toarele:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3873\" data-end=\"3895\">Precizia celulei de \u00eenc\u0103rcare<\/strong>: Asigura\u021bi-v\u0103 c\u0103 se aliniaz\u0103 cu domeniul de for\u021b\u0103 necesar (p\u00e2n\u0103 la 500 N pentru testele de lipire).<\/li>\n\n\n\n<li><strong data-start=\"3979\" data-end=\"3996\">Controlul vitezei<\/strong>: ISO 7864 impune viteze exacte (de exemplu, 50 mm\/min, 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"4062\" data-end=\"4084\">Manipularea substratului<\/strong>: Suportul substratului trebuie s\u0103 asigure o zon\u0103 de prindere \u0219i penetrare constant\u0103.<\/li>\n\n\n\n<li><strong data-start=\"4166\" data-end=\"4190\">Integrare software<\/strong>: Func\u021biile de colectare \u0219i analiz\u0103 a datelor sporesc transparen\u021ba \u0219i reproductibilitatea testelor.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong data-start=\"4281\" data-end=\"4301\">Instrumente celulare<\/strong> este specializat\u0103 \u00een sisteme de testare personalizate pentru dispozitive medicale, inclusiv ace hipodermice sterile. Serviciile noastre de automatizare \u0219i personalizare v\u0103 permit s\u0103 v\u0103 alinia\u021bi cu ISO 7864 \u00een mod precis \u0219i eficient.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00centreb\u0103ri frecvente<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1. Care este scopul testului de penetrare cu acul?<br>Testul de penetrare a acului m\u0103soar\u0103 for\u021ba necesar\u0103 pentru ca un ac hipodermic s\u0103 str\u0103pung\u0103 un substrat standard, simul\u00e2nd penetrarea pielii pentru a evalua ascu\u021bimea \u0219i u\u0219urin\u021ba de utilizare.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. Cum define\u0219te ISO 7864 rezisten\u021ba de lipire acceptabil\u0103?<br>ISO 7864 specific\u0103 cerin\u021bele minime privind for\u021ba de aderen\u021b\u0103 \u00eentre tubul acului \u0219i butuc \u00een func\u021bie de dimensiunea acului. Testul asigur\u0103 c\u0103 conexiunea nu va ceda \u00een timpul utiliz\u0103rii.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. Ce substrat este utilizat \u00een testarea penetr\u0103rii acului?<br>Substraturile comune includ cauciuc latex natural, poliuretan, cauciuc siliconic sau filme de polietilen\u0103, toate validate pentru consisten\u021ba testelor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. De ce ar trebui ca fiecare test de penetrare s\u0103 utilizeze un site substrat nou?<br>Reutilizarea loca\u021biilor substratului poate afecta precizia testului din cauza deform\u0103rii sau uzurii, duc\u00e2nd la m\u0103sur\u0103tori de for\u021b\u0103 nesigure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contacta\u021bi-ne pentru a ob\u021bine solu\u021bia de testare ISO 7864 <\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Conformitatea cu <strong data-start=\"5156\" data-end=\"5168\"><a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 7864<\/a><\/strong> este nenegociabil\u0103 pentru orice produc\u0103tor de ace hipodermice sterile. \u00cen\u021belegerea <strong data-start=\"5257\" data-end=\"5284\">test de penetrare cu acul<\/strong>, <strong data-start=\"5286\" data-end=\"5312\">testul for\u021bei de penetrare<\/strong>, \u0219i <strong data-start=\"5318\" data-end=\"5350\">test de rezisten\u021b\u0103 la lipirea acului<\/strong> asigur\u0103 c\u0103 acele \u00eendeplinesc standardele de siguran\u021b\u0103 \u0219i de performan\u021b\u0103 necesare. Cu echipamente avansate, aliniate standardelor, de la <strong data-start=\"5468\" data-end=\"5488\">Instrumente celulare<\/strong>, testarea devine mai precis\u0103, mai fiabil\u0103 \u0219i mai eficient\u0103 - ajut\u00e2ndu-v\u0103 s\u0103 livra\u021bi produse care \u00eendeplinesc at\u00e2t a\u0219tept\u0103rile autorit\u0103\u021bilor de reglementare, c\u00e2t \u0219i pe cele ale pacien\u021bilor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 7864 pentru testarea acelor hipodermice sterile ISO 7864, intitulat \u201cAce hipodermice sterile de unic\u0103 folosin\u021b\u0103 - Cerin\u021be \u0219i metode de testare\u201d, define\u0219te principalele criterii mecanice \u0219i de performan\u021b\u0103 pentru acele hipodermice. Standardul garanteaz\u0103 c\u0103 fiecare ac demonstreaz\u0103 o ascu\u021bime suficient\u0103, integritate structural\u0103 \u0219i o leg\u0103tur\u0103 fiabil\u0103 \u00eentre tubul acului \u0219i butuc. De asemenea, acesta prescrie proceduri detaliate [...]<\/p>","protected":false},"featured_media":5505,"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-9833","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\/9833","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\/5505"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9833"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard-category?post=9833"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}