{"id":824,"date":"2026-03-30T06:33:39","date_gmt":"2026-03-30T06:33:39","guid":{"rendered":"https:\/\/www.syringetest.com\/?p=824"},"modified":"2026-03-30T06:33:40","modified_gmt":"2026-03-30T06:33:40","slug":"iso9626-annex-b","status":"publish","type":"post","link":"https:\/\/www.syringetest.com\/cs\/iso9626-annex-b","title":{"rendered":"Pochopen\u00ed normy ISO9626 P\u0159\u00edloha B: Metoda zkou\u0161ky tuhosti jehlov\u00fdch trubek"},"content":{"rendered":"

\u00davod do normy ISO9626 P\u0159\u00edloha B<\/h2>\n\n\n\n

Na str\u00e1nk\u00e1ch ISO9626 P\u0159\u00edloha B<\/strong> norma poskytuje komplexn\u00ed zku\u0161ebn\u00ed metodu pro hodnocen\u00ed tuhosti jehlov\u00fdch trubi\u010dek pou\u017e\u00edvan\u00fdch ve zdravotnick\u00fdch prost\u0159edc\u00edch. Tato zkou\u0161ka je nezbytn\u00e1 pro zaji\u0161t\u011bn\u00ed toho, aby jehlov\u00e9 hadi\u010dky<\/strong> zachov\u00e1v\u00e1 pot\u0159ebnou tuhost pro bezpe\u010dn\u00e9 a \u00fa\u010dinn\u00e9 pou\u017eit\u00ed v l\u00e9ka\u0159sk\u00fdch aplikac\u00edch, jako jsou injek\u010dn\u00ed st\u0159\u00edka\u010dky a injek\u010dn\u00ed p\u0159\u00edpravky. Dodr\u017eov\u00e1n\u00edm t\u00e9to normy mohou v\u00fdrobci zaru\u010dit, \u017ee jejich v\u00fdrobky spl\u0148uj\u00ed po\u017eadovan\u00e1 bezpe\u010dnostn\u00ed a v\u00fdkonnostn\u00ed krit\u00e9ria.<\/p>\n\n\n\n

Na str\u00e1nk\u00e1ch zkou\u0161ka tuhosti jehlov\u00fdch trubek<\/strong> popsan\u00fd v p\u0159\u00edloze B normy ISO9626 je kritick\u00fdm postupem pro v\u00fdrobce zdravotnick\u00fdch prost\u0159edk\u016f, zejm\u00e9na pro v\u00fdrobce injek\u010dn\u00edch st\u0159\u00edka\u010dek a jin\u00fdch injek\u010dn\u00edch v\u00fdrobk\u016f. Tato zkou\u0161ka pom\u00e1h\u00e1 ur\u010dit, zda m\u00e1 hadi\u010dka jehly spr\u00e1vn\u00e9 mechanick\u00e9 vlastnosti, aby mohla \u00fa\u010dinn\u011b fungovat bez rizika selh\u00e1n\u00ed b\u011bhem pou\u017e\u00edv\u00e1n\u00ed.<\/p>\n\n\n\n

\"ISO9626<\/a><\/figure>\n\n\n\n

Co je p\u0159\u00edloha B normy ISO9626?<\/h2>\n\n\n\n

ISO9626 je norma, kter\u00e1 upravuje v\u00fdroba a testov\u00e1n\u00ed l\u00e9ka\u0159sk\u00fdch jehlov\u00fdch hadi\u010dek<\/strong> pou\u017e\u00edvan\u00e9 p\u0159i v\u00fdrob\u011b injek\u010dn\u00edch st\u0159\u00edka\u010dek a jin\u00fdch zdravotnick\u00fdch prost\u0159edk\u016f. P\u0159\u00edloha B se konkr\u00e9tn\u011b zam\u011b\u0159uje na tuhost hadi\u010dek, kter\u00e1 m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro v\u00fdkon st\u0159\u00edka\u010dek a jejich schopnost spolehliv\u011b a bezpe\u010dn\u011b vst\u0159ikovat obsah.<\/p>\n\n\n\n

V p\u0159\u00edloze B zahrnuje zku\u0161ebn\u00ed postup p\u016fsoben\u00ed s\u00edly na st\u0159ed trubky, kter\u00e1 je podep\u0159ena na obou konc\u00edch, a m\u011b\u0159en\u00ed vznikl\u00e9 deformace. To umo\u017e\u0148uje v\u00fdrobc\u016fm posoudit, zda tuhost hadi\u010dky spl\u0148uje po\u017eadovan\u00e9 specifikace pro pou\u017eit\u00ed v injek\u010dn\u00edch st\u0159\u00edka\u010dk\u00e1ch, jehl\u00e1ch a podobn\u00fdch zdravotnick\u00fdch prost\u0159edc\u00edch.<\/p>\n\n\n\n

Zkou\u0161ka tuhosti jehlov\u00fdch trubek: Kl\u00ed\u010dov\u00fd postup<\/h2>\n\n\n\n

Na str\u00e1nk\u00e1ch zkou\u0161ka tuhosti jehlov\u00fdch trubek<\/strong> se prov\u00e1d\u00ed pomoc\u00ed specializovan\u00e9ho p\u0159\u00edstroje, kter\u00fd p\u016fsob\u00ed na trubku ur\u010ditou silou a m\u011b\u0159\u00ed jej\u00ed pr\u016fhyb. Zkou\u0161ka se prov\u00e1d\u00ed podle pokyn\u016f uveden\u00fdch v p\u0159\u00edloze B normy ISO9626, kter\u00e1 specifikuje po\u017eadovan\u00e9 parametry a vybaven\u00ed.<\/p>\n\n\n\n

Zkou\u0161ka tuhosti trubek v ohybu ve 3 bodech<\/h3>\n\n\n\n

Na str\u00e1nk\u00e1ch 3bodov\u00e1 zkou\u0161ka ohybem<\/strong> je nezbytnou sou\u010d\u00e1st\u00ed zkou\u0161ka tuhosti jehlov\u00fdch trubek<\/strong>. P\u0159i tomto postupu se hadi\u010dka um\u00edst\u00ed na zku\u0161ebn\u00ed p\u0159\u00edstroj, kter\u00fd p\u016fsob\u00ed na st\u0159ed hadi\u010dky silou sm\u011brem dol\u016f. Na adrese span<\/strong> mezi ob\u011bma op\u011brn\u00fdmi konci se nastavuje podle normy pro konkr\u00e9tn\u00ed velikost trubek.<\/p>\n\n\n\n

Zm\u011b\u0159\u00ed se velikost pr\u016fhybu ve st\u0159edu trubky a tato hodnota pr\u016fhybu se pou\u017eije k posouzen\u00ed tuhosti trubky. Tato zkou\u0161ka zaji\u0161\u0165uje, \u017ee jehlov\u00e9 hadi\u010dky<\/strong> m\u00e1 spr\u00e1vnou rovnov\u00e1hu mezi tuhost\u00ed a pru\u017enost\u00ed, co\u017e je nezbytn\u00e9 pro bezpe\u010dnost a funk\u010dnost injek\u010dn\u00edch st\u0159\u00edka\u010dek a dal\u0161\u00edch zdravotnick\u00fdch prost\u0159edk\u016f.<\/p>\n\n\n\n

P\u0159\u00edstroj pro zkou\u0161ku tuhosti jehlov\u00fdch trubek<\/h2>\n\n\n\n

Proveden\u00ed zkou\u0161ka tuhosti jehlov\u00fdch trubek<\/strong>, mus\u00ed p\u0159\u00edstroj spl\u0148ovat zvl\u00e1\u0161tn\u00ed po\u017eadavky uveden\u00e9 v p\u0159\u00edloze B normy ISO9626:<\/p>\n\n\n\n

    \n
  • Plunger<\/strong>: K p\u016fsoben\u00ed s\u00edly na hadi\u010dku se pou\u017e\u00edv\u00e1 tup\u00fd kl\u00edn s polom\u011brem v\u00e1lce 1 mm. P\u00edst by m\u011bl b\u00fdt schopen vyvinout s\u00edlu a\u017e 60 N s p\u0159esnost\u00ed \u00b10,1 N.<\/li>\n\n\n\n
  • Za\u0159\u00edzen\u00ed pro m\u011b\u0159en\u00ed pr\u016fhybu<\/strong>: Za\u0159\u00edzen\u00ed pou\u017e\u00edvan\u00e9 k m\u011b\u0159en\u00ed pr\u016fhybu by m\u011blo m\u00edt vysokou p\u0159esnost, aby bylo schopno m\u011b\u0159it pr\u016fhyb s p\u0159esnost\u00ed na 0,01 mm.<\/li>\n\n\n\n
  • Podpora a rozp\u011bt\u00ed<\/strong>: Trubky mus\u00ed b\u00fdt na obou konc\u00edch podep\u0159eny a rozp\u011bt\u00ed mezi podp\u011brami by m\u011blo b\u00fdt upraveno podle stanoven\u00fdch rozm\u011br\u016f trubek.<\/li>\n<\/ul>\n\n\n\n

    Test vst\u0159ikovatelnosti a jeho v\u00fdznam<\/h2>\n\n\n\n

    Krom\u011b zkou\u0161ka tuhosti jehlov\u00fdch trubek<\/strong>... test injektovatelnosti<\/strong> je dal\u0161\u00edm z\u00e1sadn\u00edm hodnocen\u00edm l\u00e9ka\u0159sk\u00fdch jehel a st\u0159\u00edka\u010dek. Tato zkou\u0161ka hodnot\u00ed, jak snadno lze obsah injek\u010dn\u00ed jehly vst\u0159\u00edknout, a zaji\u0161\u0165uje, \u017ee jehla neklade p\u0159\u00edli\u0161n\u00fd odpor nebo ne\u010din\u00ed probl\u00e9my p\u0159i injek\u010dn\u00edm procesu.<\/p>\n\n\n\n

    Na str\u00e1nk\u00e1ch test injektovatelnosti<\/strong> \u010dasto zahrnuje simulaci re\u00e1ln\u00fdch podm\u00ednek pomoc\u00ed tlaku na st\u0159\u00edka\u010dku a m\u011b\u0159en\u00ed s\u00edly pot\u0159ebn\u00e9 k vst\u0159\u00edknut\u00ed obsahu. P\u0159\u00edli\u0161 tuh\u00e1 jehla m\u016f\u017ee zp\u016fsobit pot\u00ed\u017ee p\u0159i vst\u0159ikov\u00e1n\u00ed, zat\u00edmco p\u0159\u00edli\u0161 pru\u017en\u00e1 m\u016f\u017ee v\u00e9st k nestabilit\u011b nebo mo\u017en\u00e9mu selh\u00e1n\u00ed.<\/p>\n\n\n\n

    \u00daloha za\u0159\u00edzen\u00ed pro testov\u00e1n\u00ed st\u0159\u00edka\u010dek<\/h2>\n\n\n\n

    Pro v\u00fdrobce dodr\u017euj\u00edc\u00ed ISO9626 P\u0159\u00edloha B<\/strong>, s vyu\u017eit\u00edm p\u0159esn\u00fdch za\u0159\u00edzen\u00ed pro testov\u00e1n\u00ed injek\u010dn\u00edch st\u0159\u00edka\u010dek<\/strong> je z\u00e1sadn\u00ed. Toto vybaven\u00ed zaji\u0161\u0165uje, \u017ee zkou\u0161ka tuhosti jehlov\u00fdch trubek<\/strong> a test injektovatelnosti<\/strong> jsou prov\u00e1d\u011bny p\u0159esn\u011b a d\u016fsledn\u011b. Vysoce kvalitn\u00ed testovac\u00ed p\u0159\u00edstroje umo\u017e\u0148uj\u00ed v\u00fdrobc\u016fm splnit po\u017eadavky p\u0159edpis\u016f a dod\u00e1vat bezpe\u010dn\u00e9 a spolehliv\u00e9 v\u00fdrobky.<\/p>\n\n\n\n

    Nap\u0159\u00edklad Tester tuhosti trubek<\/strong> z Cell Instruments<\/strong> je ur\u010den k p\u0159esn\u00e9mu m\u011b\u0159en\u00ed tuhosti jehlov\u00fdch trubek. Tento p\u0159\u00edstroj je ide\u00e1ln\u00ed pro testov\u00e1n\u00ed tuhost jehlov\u00fdch trubek<\/strong> pou\u017e\u00edvan\u00fdch v injek\u010dn\u00edch st\u0159\u00edka\u010dk\u00e1ch a jin\u00fdch zdravotnick\u00fdch prost\u0159edc\u00edch, \u010d\u00edm\u017e se zajist\u00ed shoda s p\u0159edpisy. ISO9626 P\u0159\u00edloha B<\/strong> a dal\u0161\u00ed p\u0159\u00edslu\u0161n\u00e9 normy.<\/p>\n\n\n\n

    <\/h3>\n\n\n\n

    Na str\u00e1nk\u00e1ch ISO9626 P\u0159\u00edloha B<\/strong> hraje z\u00e1sadn\u00ed roli p\u0159i zaji\u0161\u0165ov\u00e1n\u00ed bezpe\u010dnosti a v\u00fdkonnosti jehlov\u00fdch hadi\u010dek pou\u017e\u00edvan\u00fdch ve zdravotnick\u00fdch prost\u0159edc\u00edch. . zkou\u0161ka tuhosti jehlov\u00fdch trubek<\/strong> je z\u00e1sadn\u00ed pro ov\u011b\u0159en\u00ed, zda hadi\u010dky vydr\u017e\u00ed s\u00edly, kter\u00e9 se vyskytuj\u00ed p\u0159i pou\u017eit\u00ed, a z\u00e1rove\u0148 si zachovaj\u00ed pot\u0159ebnou pru\u017enost pro vst\u0159ikovac\u00ed postupy.<\/p>\n\n\n\n

    V\u00fdrobci mohou zajistit, aby jejich v\u00fdrobky spl\u0148ovaly po\u017eadovan\u00e9 v\u00fdkonnostn\u00ed normy t\u00edm, \u017ee implementuj\u00ed 3bodov\u00e1 zkou\u0161ka ohybem<\/strong> pro tuhost trubek a spolehliv\u00e9 zabudov\u00e1n\u00ed za\u0159\u00edzen\u00ed pro testov\u00e1n\u00ed injek\u010dn\u00edch st\u0159\u00edka\u010dek<\/strong> do sv\u00fdch proces\u016f kontroly kvality. Cell Instruments<\/strong> nab\u00edz\u00ed pokro\u010dil\u00e9 Tester tuhosti trubek<\/strong> pom\u00e1hat v\u00fdrobc\u016fm p\u0159i pln\u011bn\u00ed t\u011bchto p\u0159\u00edsn\u00fdch po\u017eadavk\u016f a zaji\u0161\u0165ovat kvalitu jejich zdravotnick\u00fdch v\u00fdrobk\u016f.<\/p>\n\n\n\n

    <\/p>","protected":false},"excerpt":{"rendered":"

    Introduction to ISO9626 Annex B The ISO9626 Annex B standard provides a comprehensive testing method for evaluating the stiffness of needle tubing used in medical devices. This test is essential for ensuring that the needle tubing maintains the necessary rigidity for safe and effective use in medical applications, such as syringes and injectables. By following […]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-824","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/posts\/824","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/comments?post=824"}],"version-history":[{"count":0,"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/posts\/824\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/media?parent=824"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/categories?post=824"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.syringetest.com\/cs\/wp-json\/wp\/v2\/tags?post=824"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}