{"id":4110,"date":"2025-05-26T17:13:43","date_gmt":"2025-05-26T09:13:43","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4110"},"modified":"2025-05-27T08:28:34","modified_gmt":"2025-05-27T00:28:34","slug":"iso-11040-4","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/hu\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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ISO 11040-4<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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El\u0151ret\u00f6lt\u00f6tt fecskend\u0151k
4. r\u00e9sz: \u00dcveghord\u00f3k injekci\u00f3s k\u00e9sz\u00edtm\u00e9nyekhez \u00e9s steriliz\u00e1lt, t\u00f6lt\u00e9sre k\u00e9sz, \u00f6sszeszerelt fecskend\u0151k<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tK\u00e9rjen \u00e1raj\u00e1nlatot<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t
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Szabv\u00e1nyos \u00f6sszefoglal\u00f3<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1lat c\u00e9lja a a fecskend\u0151z\u00e1r\u00f3 rendszerek folyad\u00e9ksziv\u00e1rg\u00e1s-ellen\u00e1ll\u00e1sa<\/strong> meghat\u00e1rozott nyom\u00e1sviszonyok mellett. Az al\u00e1bbiak szerint Az ISO 11040-4 G2 mell\u00e9klete<\/em>, a vizsg\u00e1lat olyan bels\u0151 t\u00falnyom\u00e1st (jellemz\u0151en 110 kPa) szimul\u00e1l, amelyet a fecskend\u0151k t\u00f6lt\u00e9s vagy sz\u00e1ll\u00edt\u00e1s sor\u00e1n tapasztalhatnak.<\/p>\n

Ez a teszt \u00e9rt\u00e9keli mind a t\u0171pajzsok<\/strong> \u00e9s cs\u00facskupakok<\/strong>, biztos\u00edtva, hogy ezek a z\u00e1r\u00f3elemek biztons\u00e1gosak maradjanak, \u00e9s ne sziv\u00e1rogjanak ki terhel\u00e9s alatt.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"ISO\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
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Az ilyen \u00e9rt\u00e9kel\u00e9s l\u00e9tfontoss\u00e1g\u00fa a gy\u00f3gyszeripari min\u0151s\u00e9gellen\u0151rz\u00e9shez, a szennyez\u0151d\u00e9sek megel\u0151z\u00e9s\u00e9hez \u00e9s az adagol\u00e1s pontoss\u00e1g\u00e1nak biztos\u00edt\u00e1s\u00e1hoz.<\/p>\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

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Fecskend\u0151z\u00e1r\u00f3 rendszer folyad\u00e9ksziv\u00e1rg\u00e1s vizsg\u00e1lati m\u00f3dszere<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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F\u0151bb vizsg\u00e1lati l\u00e9p\u00e9sek (az ISO 11040-4 G2. mell\u00e9klet\u00e9nek megfelel\u0151en):<\/strong><\/p>\n

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  • Minta el\u0151k\u00e9sz\u00edt\u00e9s:<\/strong> Haszn\u00e1ljon steriliz\u00e1lt, felt\u00f6lt\u00e9sre k\u00e9sz, alul-\u00f6sszeszerelt fecskend\u0151ket. A vizsg\u00e1lat el\u0151tt ker\u00fclje a z\u00e1r\u00e1s megbolygat\u00e1s\u00e1t.<\/li>\n
  • V\u00e1rakoz\u00e1si id\u0151:<\/strong> A lez\u00e1r\u00e1s megszil\u00e1rdul\u00e1sa \u00e9s a vizsg\u00e1lat k\u00f6z\u00f6tt legal\u00e1bb 12 \u00f3r\u00e1t kell hagyni.<\/li>\n
  • T\u00f6ltel\u00e9k:<\/strong> T\u00f6ltse a fecskend\u0151t a n\u00e9vleges t\u00e9rfogat 1\/3 \u00e9s 2\/3 r\u00e9sz\u00e9ig desztill\u00e1lt vagy azzal egyen\u00e9rt\u00e9k\u0171 tisztas\u00e1g\u00fa v\u00edzzel.<\/li>\n
  • Nyom\u00e1start\u00e1s:<\/strong> Alkalmazza a 110 kPa<\/strong> nyom\u00e1s s\u0171r\u00edtett leveg\u0151vel vagy univerz\u00e1lis szak\u00edt\u00f3- \u00e9s nyom\u00f3vizsg\u00e1lati g\u00e9p<\/strong>. Tartsa a 5 m\u00e1sodperc<\/strong>.<\/li>\n
  • Megfigyel\u00e9s:<\/strong> Figyelje meg a folyad\u00e9ksziv\u00e1rg\u00e1st a vizsg\u00e1lat alatt \u00e9s ut\u00e1n. A sziv\u00e1rg\u00e1s l\u00e1that\u00f3 cseppek form\u00e1j\u00e1ban jelenik meg a k\u00fcls\u0151 z\u00e1r\u00f3fel\u00fcleten.<\/li>\n
  • \u00c1tmen\u00e9si krit\u00e9riumok:<\/strong> Nem szabad, hogy cseppek legyenek l\u00e1that\u00f3k, \u00e9s a lez\u00e1r\u00e1snak (hegyes sapka vagy t\u0171v\u00e9d\u0151) a hely\u00e9n kell maradnia.<\/li>\n<\/ul>\n
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    A vizsg\u00e1lat mind a fecskend\u0151hord\u00f3kra, mind a steril r\u00e9szegys\u00e9gekre \u00e9rv\u00e9nyes. A vizu\u00e1lis ellen\u0151rz\u00e9s elengedhetetlen a megfelel\u0151\/nem megfelel\u0151 eredm\u00e9nyek meghat\u00e1roz\u00e1s\u00e1hoz.<\/p>\n<\/blockquote>\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

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    A fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1lathoz sz\u00fcks\u00e9ges berendez\u00e9sek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    A vizsg\u00e1lathoz sz\u00fcks\u00e9ges felszerel\u00e9s a k\u00f6vetkez\u0151ket tartalmazza:<\/p>\n

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    • Univerz\u00e1lis szak\u00edt\u00f3- \u00e9s nyom\u00f3pr\u00f3ba<\/strong> vagy s\u0171r\u00edtett leveg\u0151s nyom\u00e1sfokoz\u00f3 rendszer<\/strong><\/li>\n
    • Fecskend\u0151 tart\u00f3<\/strong> biztons\u00e1gos z\u00e1r\u00f3mechanizmussal<\/li>\n
    • Nyom\u00e1sm\u00e9r\u0151 vagy szoftver<\/strong> 110 kPa el\u00e9r\u00e9s\u00e9re \u00e9s fenntart\u00e1s\u00e1ra k\u00e9pes<\/li>\n
    • Nagy mintav\u00e9teli sebess\u00e9g\u0171 adatgy\u0171jt\u0151 rendszer<\/strong> (aj\u00e1nlott 500 Hz a cs\u00facsm\u00e9r\u00e9sekhez)<\/li>\n<\/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
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      Cell Instruments megold\u00e1sok:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      A fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1latok elv\u00e9gz\u00e9se az ISO 11040-4 szabv\u00e1nynak megfelel\u0151en, A Cell Instruments testreszabhat\u00f3 fecskend\u0151s tesztplatformokat k\u00edn\u00e1l<\/strong>, kompatibilis mind a s\u0171r\u00edtett leveg\u0151vel, mind a mechanikus er\u0151 alkalmaz\u00e1s\u00e1val. Rendszereink biztos\u00edtj\u00e1k:<\/p>\n

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      • A bels\u0151 nyom\u00e1s pontos szab\u00e1lyoz\u00e1sa<\/strong><\/li>\n
      • Nagyfrekvenci\u00e1s mintav\u00e9telez\u00e9s 500 Hz-ig<\/strong><\/li>\n
      • Teljes megfelel\u00e9s az ISO vizsg\u00e1lati elj\u00e1r\u00e1soknak<\/strong><\/li>\n
      • Automatiz\u00e1lt dokument\u00e1ci\u00f3s funkci\u00f3k<\/strong> az audit\u00e1l\u00e1sra k\u00e9sz jelent\u00e9sk\u00e9sz\u00edt\u00e9shez<\/li>\n<\/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
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        Cell Instruments megold\u00e1sok:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        A fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1latok elv\u00e9gz\u00e9se az ISO 11040-4 szabv\u00e1nynak megfelel\u0151en, A Cell Instruments testreszabhat\u00f3 fecskend\u0151s tesztplatformokat k\u00edn\u00e1l<\/strong>, kompatibilis mind a s\u0171r\u00edtett leveg\u0151vel, mind a mechanikus er\u0151 alkalmaz\u00e1s\u00e1val. Rendszereink biztos\u00edtj\u00e1k:<\/p>\n

          \n
        • A bels\u0151 nyom\u00e1s pontos szab\u00e1lyoz\u00e1sa<\/strong><\/li>\n
        • Nagyfrekvenci\u00e1s mintav\u00e9telez\u00e9s 500 Hz-ig<\/strong><\/li>\n
        • Teljes megfelel\u00e9s az ISO vizsg\u00e1lati elj\u00e1r\u00e1soknak<\/strong><\/li>\n
        • Automatiz\u00e1lt dokument\u00e1ci\u00f3s funkci\u00f3k<\/strong> az audit\u00e1l\u00e1sra k\u00e9sz jelent\u00e9sk\u00e9sz\u00edt\u00e9shez<\/li>\n<\/ul>\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
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          Adatfelv\u00e9tel \u00e9s dokument\u00e1ci\u00f3<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          A G2. mell\u00e9klet<\/em>, a teljes vizsg\u00e1lati jelent\u00e9snek tartalmaznia kell:<\/p>\n

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          • Alkalmazott nyom\u00e1s<\/strong> (kPa) vagy egyen\u00e9rt\u00e9k\u0171 er\u0151 (N)<\/li>\n
          • A vizsg\u00e1lt fecskend\u0151k sz\u00e1ma<\/strong><\/li>\n
          • A megfelelt\/nem felelt meg mint\u00e1k sz\u00e1ma<\/strong><\/li>\n
          • Vizu\u00e1lis megfigyel\u00e9sek vagy elt\u00e9r\u00e9sek<\/strong><\/li>\n
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            A be\u00e1ll\u00edt\u00e1si param\u00e9terek nyomon k\u00f6vethet\u0151s\u00e9ge<\/strong> (manu\u00e1lisan vagy szoftverrel)<\/p>\n<\/li>\n<\/ul>\n

            A vizsg\u00e1lati felt\u00e9telek \u00e9s eredm\u00e9nyek dokument\u00e1l\u00e1s\u00e1val a gy\u00e1rt\u00f3k bizony\u00edtj\u00e1k az ISO 11040-4 szabv\u00e1nynak val\u00f3 megfelel\u00e9st, \u00e9s biztos\u00edtj\u00e1k, hogy szab\u00e1lyoz\u00e1si nyomon k\u00f6vethet\u0151s\u00e9g<\/strong>-a gy\u00f3gyszeripari min\u0151s\u00e9gbiztos\u00edt\u00e1si rendszerek elengedhetetlen r\u00e9sze.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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            Bels\u0151 er\u0151 kisz\u00e1m\u00edt\u00e1sa<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            A l\u00e9gnyom\u00e1s helyett mechanikus er\u0151t alkalmaz\u00f3 l\u00e9tes\u00edtm\u00e9nyek eset\u00e9ben a sz\u00fcks\u00e9ges er\u0151 (F)<\/strong> a 110 kPa bels\u0151 nyom\u00e1s szimul\u00e1l\u00e1s\u00e1hoz az ISO 11040-4 szabv\u00e1nyban szerepl\u0151 k\u00e9pletek seg\u00edts\u00e9g\u00e9vel lehet kisz\u00e1m\u00edtani:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10-\u00b3<\/strong>
            Hol:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = Er\u0151 newtonban<\/li>\n
            • p<\/strong> = Nyom\u00e1s (110 kPa)<\/li>\n
            • d<\/strong> = Fecskend\u0151 bels\u0151 \u00e1tm\u00e9r\u0151je (mm)<\/li>\n<\/ul>\n

              Ez a sz\u00e1m\u00edt\u00e1s seg\u00edt biztos\u00edtani pontos tesztreplik\u00e1ci\u00f3<\/strong> \u00e9s a k\u00e9sz\u00fcl\u00e9k kalibr\u00e1l\u00e1sa.<\/p>\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"

              ISO 11040-4 El\u0151re t\u00f6lt\u00f6tt fecskend\u0151k4. r\u00e9sz: \u00dcveghord\u00f3k injekci\u00f3s k\u00e9sz\u00edtm\u00e9nyekhez \u00e9s steriliz\u00e1lt, t\u00f6lt\u00e9sre k\u00e9sz, \u00f6sszeszerelt fecskend\u0151k Aj\u00e1nlatk\u00e9r\u00e9s Szabv\u00e1ny \u00f6sszefoglal\u00e1sa A fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1lat c\u00e9lja a fecskend\u0151z\u00e1r\u00f3 rendszerek folyad\u00e9ksziv\u00e1rg\u00e1s-\u00e1ll\u00f3s\u00e1g\u00e1nak ellen\u0151rz\u00e9se meghat\u00e1rozott nyom\u00e1sviszonyok mellett. Az ISO 11040-4 szabv\u00e1ny G2. mell\u00e9klete szerint a vizsg\u00e1lat bels\u0151 t\u00falnyom\u00e1st (jellemz\u0151en 110 kPa) szimul\u00e1l [...]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4110","page","type-page","status-publish","hentry"],"yoast_head":"\nISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage<\/title>\n<meta name=\"description\" content=\"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. Discover the test method, apparatus.\" \/>\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.leakagetester.com\/hu\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"hu_HU\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage\" \/>\n<meta property=\"og:description\" content=\"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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