{"id":1228,"date":"2025-06-24T11:24:43","date_gmt":"2025-06-24T03:24:43","guid":{"rendered":"https:\/\/www.puncturetest.com\/?page_id=1228"},"modified":"2025-07-03T15:43:22","modified_gmt":"2025-07-03T07:43:22","slug":"iso-11040-4","status":"publish","type":"page","link":"https:\/\/www.puncturetest.com\/fi\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1228\" class=\"elementor elementor-1228\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c60fdbb e-flex e-con-boxed e-con e-parent\" data-id=\"c60fdbb\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-db6fcba e-con-full e-flex e-con e-child\" data-id=\"db6fcba\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-9d1f798 e-con-full e-flex e-con e-child\" data-id=\"9d1f798\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-8cc5a79 e-con-full e-flex e-con e-child\" data-id=\"8cc5a79\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b6b67d4 elementor-widget elementor-widget-heading\" data-id=\"b6b67d4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4<br><small>Neulan tunkeutumistesti<\/small><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-69f526a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"69f526a\" 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\t\t<p class=\"\" data-start=\"0\" data-end=\"201\">Esit\u00e4ytettyjen ruiskujen suorituskyvyn ja turvallisuuden varmistaminen on elint\u00e4rke\u00e4\u00e4 l\u00e4\u00e4ketieteellisiss\u00e4 ja farmaseuttisissa sovelluksissa. <strong data-start=\"521\" data-end=\"536\">ISO 11040-4<\/strong> esitet\u00e4\u00e4n seuraavat olennaiset eritelm\u00e4t <strong data-start=\"579\" data-end=\"667\">injektoitavien l\u00e4\u00e4kkeiden lasitynnyrit ja steriloidut, valmiiksi kootut ruiskut, jotka ovat valmiita t\u00e4ytett\u00e4viksi.<\/strong>. Yksi t\u00e4m\u00e4n standardin mukaisista kriittisist\u00e4 laadunarvioinneista on <strong data-start=\"736\" data-end=\"770\">neulan tunkeutumistestausmenetelm\u00e4<\/strong>, jossa arvioidaan, kuinka helposti ruiskuneula tunkeutuu vakiomateriaalin l\u00e4pi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eff30d4 elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"eff30d4\" data-element_type=\"widget\" data-settings=\"{&quot;button_width&quot;:&quot;25&quot;,&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"New Form\" action=\"\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"1228\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"eff30d4\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Puncture Test\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-name elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-name\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tNimi\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[name]\" id=\"form-field-name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Nimi\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_26b0101 elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_26b0101\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tYritys\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_26b0101]\" id=\"form-field-field_26b0101\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Yritys\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tS\u00e4hk\u00f6posti\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"S\u00e4hk\u00f6posti\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tViesti\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Viesti\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-recaptcha elementor-field-group elementor-column elementor-field-group-field_50f0fd6 elementor-col-100\">\n\t\t\t\t\t<div class=\"elementor-field\" id=\"form-field-field_50f0fd6\"><div class=\"elementor-g-recaptcha\" data-sitekey=\"6LcO3HUrAAAAAKhAi3KjswdM4-_7i5zKd1s5FO2N\" data-type=\"v2_checkbox\" data-theme=\"light\" data-size=\"normal\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-25 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">L\u00e4het\u00e4<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<input type=\"hidden\" name=\"trp-form-language\" value=\"fi\"\/><\/form>\n\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<div class=\"elementor-element elementor-element-163fe1b e-con-full e-flex e-con e-child\" data-id=\"163fe1b\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\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<div class=\"elementor-element elementor-element-3f2b60d e-flex e-con-boxed e-con e-parent\" data-id=\"3f2b60d\" 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-7c5f6d2 elementor-widget elementor-widget-heading\" data-id=\"7c5f6d2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Mik\u00e4 on ISO 11040-4 ja miksi sill\u00e4 on merkityst\u00e4?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6126588 elementor-widget elementor-widget-text-editor\" data-id=\"6126588\" 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\t\t<p data-start=\"1111\" data-end=\"1465\"><strong data-start=\"1111\" data-end=\"1126\">ISO 11040-4<\/strong> on maailmanlaajuisesti tunnustettu ISO 11040 -sarjan standardi, joka k\u00e4sittelee erityisesti seuraavia asioita <strong data-start=\"1213\" data-end=\"1246\">injektoitavien l\u00e4\u00e4kkeiden lasitynnyrit<\/strong> ja <strong data-start=\"1251\" data-end=\"1288\">valmiiksi kootut steriloidut ruiskut<\/strong> tarkoitettu aseptiseen t\u00e4ytt\u00f6\u00f6n. Se varmistaa, ett\u00e4 n\u00e4m\u00e4 komponentit t\u00e4ytt\u00e4v\u00e4t tiukat mitta- ja toimintakriteerit tuotteen steriiliyden, yhteensopivuuden ja potilasturvallisuuden yll\u00e4pit\u00e4miseksi.<\/p><p data-start=\"1467\" data-end=\"1763\">Merkitt\u00e4v\u00e4 osa t\u00e4t\u00e4 standardia on <strong data-start=\"1510\" data-end=\"1537\">neulan tunkeutumistesti<\/strong>, joka todentaa <strong data-start=\"1558\" data-end=\"1584\">mekaaninen suorituskyky<\/strong> neulaa k\u00e4yt\u00f6n aikana. Se, miten helposti neula pystyy l\u00e4vist\u00e4m\u00e4\u00e4n alustan, heijastuu sen ominaisuuksiin. <strong data-start=\"1681\" data-end=\"1731\">ter\u00e4vyys, materiaalin laatu, pintak\u00e4sittely<\/strong>ja valmistuksen johdonmukaisuus.<\/p><p data-start=\"1765\" data-end=\"1794\">T\u00e4m\u00e4 testaus on ratkaisevan t\u00e4rke\u00e4\u00e4:<\/p><ul><li data-start=\"1798\" data-end=\"1858\">Varmistetaan sujuva injektio, jossa potilaan ep\u00e4mukavuus on mahdollisimman v\u00e4h\u00e4ist\u00e4.<\/li><li data-start=\"1861\" data-end=\"1900\">Neulan rikkoutumisen tai taipumisen est\u00e4minen<\/li><li data-start=\"1903\" data-end=\"1956\">Yhteensopivuuden takaaminen pakkausmateriaalien kanssa<\/li><li data-start=\"1959\" data-end=\"2008\">Vaatimustenmukaisuuden varmistaminen s\u00e4\u00e4ntelyn toimittamista varten<\/li><\/ul>\t\t\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<div class=\"elementor-element elementor-element-580df19 e-flex e-con-boxed e-con e-parent\" data-id=\"580df19\" 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-8262e73 elementor-widget elementor-widget-heading\" data-id=\"8262e73\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Neulan tunkeutumistestimenetelm\u00e4 selitetty<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c71437 elementor-widget elementor-widget-text-editor\" data-id=\"7c71437\" 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\t\t<p data-start=\"2061\" data-end=\"2365\">The <strong data-start=\"2065\" data-end=\"2099\">neulan tunkeutumistestausmenetelm\u00e4<\/strong>ISO 11040-4 -standardin liitteen F mukaisesti, arvioidaan <strong data-start=\"2153\" data-end=\"2222\">voima, joka tarvitaan ruiskuneulan l\u00e4vist\u00e4miseen m\u00e4\u00e4ritellyn testikalvon l\u00e4pi.<\/strong>. T\u00e4m\u00e4 menettely on johdettu standardista DIN 13097-4, ja siihen viitataan seuraavassa asiakirjassa <a href=\"https:\/\/www.puncturetest.com\/fi\/standards\/iso-7864-needle-penetration-drag-force-test\/\"><strong data-start=\"2288\" data-end=\"2300\">ISO 7864<\/strong><\/a>toinen t\u00e4rke\u00e4 standardi, joka kattaa steriilit injektioneulat.<\/p><p data-start=\"2367\" data-end=\"2404\">Menetelm\u00e4n keskeisi\u00e4 osia ovat:<\/p><ul><li data-start=\"2408\" data-end=\"2534\"><strong data-start=\"2408\" data-end=\"2426\">Testilaite<\/strong>: A <strong data-start=\"2430\" data-end=\"2474\">yleinen veto- ja puristusmittari<\/strong> jonka voima-alue on enint\u00e4\u00e4n 10 N ja nopeus 20-200 mm\/min.<\/li><li data-start=\"2537\" data-end=\"2612\"><strong data-start=\"2537\" data-end=\"2554\">N\u00e4ytteenottotaajuus<\/strong>: 500 Hz suositellaan tarkkaa huippuvoiman havaitsemista varten.<\/li><li data-start=\"2615\" data-end=\"2685\"><strong data-start=\"2615\" data-end=\"2632\">Neulanpidin<\/strong>: Varmistaa pystysuoran kohdistuksen tarkkaa tunkeutumista varten.<\/li><li data-start=\"2688\" data-end=\"2779\"><strong data-start=\"2688\" data-end=\"2701\">Testifolio<\/strong>: Valmistajan ja asiakkaan on sovittava materiaalista ja paksuudesta.<\/li><li data-start=\"2782\" data-end=\"2861\"><strong data-start=\"2782\" data-end=\"2800\">Neulan\u00e4ytteet<\/strong>: Voidaan silikonoida tai j\u00e4tt\u00e4\u00e4 k\u00e4sittelem\u00e4tt\u00e4 k\u00e4ytt\u00f6tarkoituksen mukaan.<\/li><li data-start=\"2864\" data-end=\"2992\"><strong data-start=\"2864\" data-end=\"2883\">Tietojen keruu<\/strong>: A <strong data-start=\"2887\" data-end=\"2919\">voima vs. siirtym\u00e4 -k\u00e4yr\u00e4<\/strong> luodaan jokaista testi\u00e4 varten ja mitataan <strong data-start=\"2958\" data-end=\"2972\">huippuvoima<\/strong> ja <strong data-start=\"2977\" data-end=\"2991\">vetovoima<\/strong>.<\/li><\/ul><p data-start=\"2994\" data-end=\"3141\">Menetelm\u00e4 takaa, ett\u00e4 <strong data-start=\"3025\" data-end=\"3068\">neulan ter\u00e4vyys ja pinnoitteen tasaisuus<\/strong> ovat hyv\u00e4ksytt\u00e4vien parametrien sis\u00e4ll\u00e4, mik\u00e4 takaa ruiskun luotettavan toiminnan.<\/p>\t\t\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<div class=\"elementor-element elementor-element-a9693b2 e-flex e-con-boxed e-con e-parent\" data-id=\"a9693b2\" 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-b44c843 elementor-widget elementor-widget-heading\" data-id=\"b44c843\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ruiskuneulatestin parhaat k\u00e4yt\u00e4nn\u00f6t<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e38b53 elementor-widget elementor-widget-text-editor\" data-id=\"3e38b53\" 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\t\t<p data-start=\"3188\" data-end=\"3329\">Kun suoritetaan <strong data-start=\"3206\" data-end=\"3229\">ruiskun neulatesti<\/strong>, on t\u00e4rke\u00e4\u00e4 noudattaa ISO-ohjeita ja optimoida prosessi johdonmukaisuuden ja tarkkuuden varmistamiseksi:<\/p><ol><li><strong data-start=\"3334\" data-end=\"3362\">K\u00e4yt\u00e4 validoituja substraatteja<\/strong>: Kuten <strong data-start=\"3372\" data-end=\"3388\">lateksikumi<\/strong>, <strong data-start=\"3390\" data-end=\"3406\">polyuretaani<\/strong>, tai <strong data-start=\"3411\" data-end=\"3427\">polyeteeni<\/strong> jotka j\u00e4ljittelev\u00e4t iho- tai pakkausolosuhteita.<\/li><li><strong data-start=\"3472\" data-end=\"3507\">Ymp\u00e4rist\u00f6muuttujien valvonta<\/strong>: S\u00e4ilyt\u00e4 johdonmukainen <strong data-start=\"3529\" data-end=\"3557\">l\u00e4mp\u00f6tila ja kosteus<\/strong> testauksen aikana.<\/li><li><strong data-start=\"3577\" data-end=\"3599\">V\u00e4lt\u00e4 n\u00e4ytteen uudelleenk\u00e4ytt\u00f6\u00e4<\/strong>: Jokaisessa testiss\u00e4 on k\u00e4ytett\u00e4v\u00e4 uutta kalvon tai alustan osaa.<\/li><li><strong data-start=\"3661\" data-end=\"3683\">Varmista kalibrointi<\/strong>: Testauskone on kalibroitava s\u00e4\u00e4nn\u00f6llisesti j\u00e4ljitett\u00e4vill\u00e4 standardeilla.<\/li><li><strong data-start=\"3765\" data-end=\"3788\">Dokumentoi perusteellisesti<\/strong>: Testausraporttiin on sis\u00e4llytett\u00e4v\u00e4 kalvon tekniset tiedot, testinopeus, n\u00e4ytteiden lukum\u00e4\u00e4r\u00e4 ja kaikki voimak\u00e4yr\u00e4t.<\/li><\/ol>\t\t\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<div class=\"elementor-element elementor-element-a6df764 e-flex e-con-boxed e-con e-parent\" data-id=\"a6df764\" 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-15bd215 elementor-widget elementor-widget-heading\" data-id=\"15bd215\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.puncturetest.com\/fi\/tissue-paper-ball-burst-strength-test\/\">Neulan tunkeutumistestauslaitteet ISO 11040-4 -standardin noudattamista varten<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e5f91e3 e-con-full e-flex e-con e-child\" data-id=\"e5f91e3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-44c6d75 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"44c6d75\" 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\t\t<p data-start=\"3963\" data-end=\"4156\">Laboratorioille ja valmistajille, jotka haluavat suorittaa neulan tunkeutumistestej\u00e4 ISO 11040-4 -standardin mukaisesti, <strong data-start=\"4060\" data-end=\"4114\">Cell Instrumentsin NPT-01-neulan l\u00e4p\u00e4isytesteri<\/strong> on luotettava ja suorituskykyinen ratkaisu.<\/p><p data-start=\"4158\" data-end=\"4197\">Keskeiset ominaisuudet <strong data-start=\"4178\" data-end=\"4188\">NPT-01<\/strong> sis\u00e4lt\u00e4v\u00e4t:<\/p><ul><li>Korkean tarkkuuden voima-anturit, joiden tarkkuus on \u00b10,5%<\/li><li>S\u00e4\u00e4dett\u00e4v\u00e4t testinopeudet 20 mm\/min - 200 mm\/min v\u00e4lill\u00e4<\/li><li>Reaaliaikainen <strong data-start=\"4320\" data-end=\"4349\">voima-siirtym\u00e4-k\u00e4yr\u00e4t<\/strong> jossa on siirrett\u00e4vi\u00e4 tietoja<\/li><li>Mukautettavat neulapidikkeet ja kalvopuristimet<\/li><li>Yhteensopiva eri ruiskukokojen ja neulamittojen kanssa.<\/li><\/ul><p data-start=\"4482\" data-end=\"4726\">K\u00e4ytt\u00e4m\u00e4ll\u00e4 <strong data-start=\"4492\" data-end=\"4502\">NPT-01<\/strong> tehostaa ISO 11040-4- ja ISO 7864 -standardien noudattamista, v\u00e4hent\u00e4\u00e4 vaihtelua ja parantaa tietojen eheytt\u00e4. Se soveltuu erityisen hyvin <strong data-start=\"4648\" data-end=\"4684\">T&amp;K-laboratoriot, QC-osastot<\/strong>ja <strong data-start=\"4690\" data-end=\"4725\">s\u00e4\u00e4ntelyn validointiprosessit<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e5f0632 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"e5f0632\" 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\t\t\t<a href=\"https:\/\/www.puncturetest.com\/fi\/penetrability-tester-needle-penetration-test-method\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"500\" height=\"400\" src=\"https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method.webp\" class=\"attachment-full size-full wp-image-1230\" alt=\"ISO 11040-4 Neulan tunkeutumistestimenetelm\u00e4\" srcset=\"https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method.webp 500w, https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method-300x240.webp 300w, https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method-15x12.webp 15w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6821011 e-con-full e-flex e-con e-parent\" data-id=\"6821011\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-665057d elementor-cta--skin-classic elementor-animated-content elementor-bg-transform elementor-bg-transform-zoom-in elementor-widget elementor-widget-call-to-action\" data-id=\"665057d\" data-element_type=\"widget\" data-widget_type=\"call-to-action.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-cta\">\n\t\t\t\t\t<div class=\"elementor-cta__bg-wrapper\">\n\t\t\t\t<div class=\"elementor-cta__bg elementor-bg\" style=\"background-image: url(https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/02\/Elastomeric-Closures-Penetrability-Test-1024x256.webp);\" role=\"img\" aria-label=\"Elastomeeriset sulkimet L\u00e4p\u00e4isevyystesti\"><\/div>\n\t\t\t\t<div class=\"elementor-cta__bg-overlay\"><\/div>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-cta__content\">\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<h2 class=\"elementor-cta__title elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t\tVarmista ruiskuneulojen vaatimustenmukaisuus t\u00e4n\u00e4\u00e4n\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-cta__description elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t\tYmm\u00e4rt\u00e4minen ja soveltaminen <b>ISO 11040-4 Neulan tunkeutumistestausmenetelm\u00e4<\/b> on elint\u00e4rke\u00e4\u00e4 kaikille valmistajille, jotka tuottavat <b>esit\u00e4ytetyt ruiskut tai injektioneulat<\/b>. Standardissa annetaan selke\u00e4t ohjeet laitteille, testausmenettelylle ja raportoinnille, jotta varmistetaan neulojen eheys ja potilasturvallisuus. Integroimalla <b>luotettava ruiskun neulan testauslaitteisto<\/b> kuten <b>Puncturetest.com NPT-01<\/b>, yritykset voivat tehostaa vaatimustenmukaisuutta, v\u00e4hent\u00e4\u00e4 riskej\u00e4 ja parantaa tuotteiden laatua.\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-cta__button-wrapper elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t<a class=\"elementor-cta__button elementor-button elementor-size-\" href=\"https:\/\/www.puncturetest.com\/fi\/contact\/\">\n\t\t\t\t\t\tKlikkaa t\u00e4st\u00e4\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\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>","protected":false},"excerpt":{"rendered":"<p>ISO 11040-4Needle Penetration Test Ensuring the performance and safety of prefilled syringes is vital in medical and pharmaceutical applications. ISO 11040-4 outlines the essential specifications for glass barrels for injectables and sterilized subassembled syringes ready for filling. One of the critical quality assessments under this standard is the needle penetration test method, which evaluates how [&hellip;]<\/p>","protected":false},"author":3,"featured_media":0,"parent":974,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1228","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 11040-4 Needle Penetration Test Method - Syringe Needle Test<\/title>\n<meta name=\"description\" content=\"ISO 11040-4 Annex F needle penetration test method, syringe needle testing, and reliable test equipment like the NPT-01.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.puncturetest.com\/fi\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"fi_FI\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 11040-4 Needle Penetration Test Method - Syringe Needle Test\" \/>\n<meta property=\"og:description\" content=\"ISO 11040-4 Annex F needle penetration test method, syringe needle testing, and reliable test equipment like the NPT-01.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.puncturetest.com\/fi\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:site_name\" content=\"Puncture Test\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-03T07:43:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"500\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Arvioitu lukuaika\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minuuttia\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.puncturetest.com\/standards\/iso-11040-4\/\",\"url\":\"https:\/\/www.puncturetest.com\/standards\/iso-11040-4\/\",\"name\":\"ISO 11040-4 Needle Penetration Test Method - 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