{"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\/sk\/iso9626-annex-b","title":{"rendered":"Pochopenie normy ISO9626 Pr\u00edloha B: Met\u00f3da sk\u00fa\u0161ky tuhosti ihlov\u00fdch r\u00farok"},"content":{"rendered":"

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

Str\u00e1nka ISO9626 Pr\u00edloha B<\/strong> norma poskytuje komplexn\u00fa sk\u00fa\u0161obn\u00fa met\u00f3du na hodnotenie tuhosti ihlov\u00fdch hadi\u010diek pou\u017e\u00edvan\u00fdch v zdravotn\u00edckych pom\u00f4ckach. T\u00e1to sk\u00fa\u0161ka je nevyhnutn\u00e1 na zabezpe\u010denie toho, aby ihlov\u00e9 hadi\u010dky<\/strong> zachov\u00e1va potrebn\u00fa tuhos\u0165 na bezpe\u010dn\u00e9 a \u00fa\u010dinn\u00e9 pou\u017eitie v lek\u00e1rskych aplik\u00e1ci\u00e1ch, ako s\u00fa injek\u010dn\u00e9 strieka\u010dky a injek\u010dn\u00e9 materi\u00e1ly. Dodr\u017eiavan\u00edm tejto normy m\u00f4\u017eu v\u00fdrobcovia zaru\u010di\u0165, \u017ee ich v\u00fdrobky sp\u013a\u0148aj\u00fa po\u017eadovan\u00e9 krit\u00e9ri\u00e1 bezpe\u010dnosti a v\u00fdkonu.<\/p>\n\n\n\n

Str\u00e1nka sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok<\/strong> uveden\u00fd v pr\u00edlohe B normy ISO9626 je kritick\u00fdm postupom pre v\u00fdrobcov zdravotn\u00edckych pom\u00f4cok, najm\u00e4 pre v\u00fdrobcov injek\u010dn\u00fdch strieka\u010diek a in\u00fdch injek\u010dn\u00fdch v\u00fdrobkov. T\u00e1to sk\u00fa\u0161ka pom\u00e1ha ur\u010di\u0165, \u010di m\u00e1 hadi\u010dka ihly spr\u00e1vne mechanick\u00e9 vlastnosti, aby mohla \u00fa\u010dinne fungova\u0165 bez rizika zlyhania po\u010das pou\u017e\u00edvania.<\/p>\n\n\n\n

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

\u010co je pr\u00edloha B k norme ISO9626?<\/h2>\n\n\n\n

ISO9626 je \u0161tandard, ktor\u00fd upravuje v\u00fdroba a testovanie lek\u00e1rskych ihlov\u00fdch hadi\u010diek<\/strong> pou\u017e\u00edvan\u00e9 pri v\u00fdrobe injek\u010dn\u00fdch strieka\u010diek a in\u00fdch zdravotn\u00edckych pom\u00f4cok. Pr\u00edloha B sa osobitne zameriava na tuhos\u0165 hadi\u010diek, ktor\u00e1 je rozhoduj\u00faca pre v\u00fdkonnos\u0165 injek\u010dn\u00fdch strieka\u010diek a ich schopnos\u0165 spo\u013eahlivo a bezpe\u010dne vstrekova\u0165 obsah.<\/p>\n\n\n\n

V pr\u00edlohe B testovac\u00ed postup zah\u0155\u0148a p\u00f4sobenie sily na stred r\u00farky, ktor\u00e1 je podopret\u00e1 na oboch koncoch, a meranie vzniknutej deform\u00e1cie. To umo\u017e\u0148uje v\u00fdrobcom pos\u00fadi\u0165, \u010di tuhos\u0165 hadi\u010dky sp\u013a\u0148a po\u017eadovan\u00e9 \u0161pecifik\u00e1cie na pou\u017eitie v injek\u010dn\u00fdch strieka\u010dk\u00e1ch, ihl\u00e1ch a podobn\u00fdch zdravotn\u00edckych pom\u00f4ckach.<\/p>\n\n\n\n

Sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok: K\u013e\u00fa\u010dov\u00fd postup<\/h2>\n\n\n\n

Str\u00e1nka sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok<\/strong> sa vykon\u00e1va pomocou \u0161pecializovan\u00e9ho pr\u00edstroja, ktor\u00fd p\u00f4sob\u00ed \u0161pecifickou silou na hadi\u010dku a meria jej priehyb. Sk\u00fa\u0161ka sa vykon\u00e1va pod\u013ea pokynov uveden\u00fdch v pr\u00edlohe B k norme ISO9626, ktor\u00e1 \u0161pecifikuje po\u017eadovan\u00e9 parametre a vybavenie.<\/p>\n\n\n\n

Sk\u00fa\u0161ka tuhosti r\u00farok ohybom v 3 bodoch<\/h3>\n\n\n\n

Str\u00e1nka Trojbodov\u00fd test ohybu<\/strong> je d\u00f4le\u017eitou s\u00fa\u010das\u0165ou sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok<\/strong>. Pri tomto postupe sa hadi\u010dka umiestni na testovac\u00ed pr\u00edstroj, ktor\u00fd p\u00f4sob\u00ed na stred hadi\u010dky silou smerom nadol. Na str\u00e1nke . span<\/strong> medzi dvoma oporn\u00fdmi koncami sa nastav\u00ed pod\u013ea normy pre konkr\u00e9tnu ve\u013ekos\u0165 r\u00farky.<\/p>\n\n\n\n

Meria sa ve\u013ekos\u0165 priehybu v strede r\u00farky a t\u00e1to hodnota priehybu sa pou\u017e\u00edva na pos\u00fadenie tuhosti r\u00farky. Touto sk\u00fa\u0161kou sa zabezpe\u010d\u00ed, \u017ee ihlov\u00e9 hadi\u010dky<\/strong> m\u00e1 spr\u00e1vnu rovnov\u00e1hu medzi tuhos\u0165ou a pru\u017enos\u0165ou, \u010do je nevyhnutn\u00e9 pre bezpe\u010dnos\u0165 a funk\u010dnos\u0165 injek\u010dn\u00fdch strieka\u010diek a in\u00fdch zdravotn\u00edckych pom\u00f4cok.<\/p>\n\n\n\n

Pr\u00edstroj na sk\u00fa\u0161ku tuhosti ihlov\u00fdch r\u00farok<\/h2>\n\n\n\n

Ak chcete vykona\u0165 sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok<\/strong>, mus\u00ed pr\u00edstroj sp\u013a\u0148a\u0165 osobitn\u00e9 po\u017eiadavky uveden\u00e9 v pr\u00edlohe B k norme ISO9626:<\/p>\n\n\n\n

    \n
  • Piest<\/strong>: Na p\u00f4sobenie sily na hadi\u010dku sa pou\u017e\u00edva tup\u00fd klinov\u00fd piest s polomerom valca 1 mm. Piest by mal by\u0165 schopn\u00fd vyvin\u00fa\u0165 silu do 60 N s presnos\u0165ou \u00b10,1 N.<\/li>\n\n\n\n
  • Zariadenia na meranie priehybu<\/strong>: Zariadenie pou\u017e\u00edvan\u00e9 na meranie v\u00fdchylky by malo ma\u0165 vysok\u00fa \u00farove\u0148 presnosti a malo by by\u0165 schopn\u00e9 mera\u0165 v\u00fdchylku s presnos\u0165ou 0,01 mm.<\/li>\n\n\n\n
  • Podpora a rozp\u00e4tie<\/strong>: R\u00farky musia by\u0165 na oboch koncoch podopret\u00e9 a rozp\u00e4tie medzi podperami by malo by\u0165 upraven\u00e9 pod\u013ea \u0161pecifikovan\u00fdch rozmerov r\u00farok.<\/li>\n<\/ul>\n\n\n\n

    Test vstrekovate\u013enosti a jeho v\u00fdznam<\/h2>\n\n\n\n

    Okrem sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok<\/strong>,. test injektovate\u013enosti<\/strong> je \u010fal\u0161\u00edm d\u00f4le\u017eit\u00fdm hodnoten\u00edm lek\u00e1rskych ihiel a strieka\u010diek. T\u00fdmto testom sa posudzuje, ako \u013eahko sa d\u00e1 obsah vstrekn\u00fa\u0165 cez ihlu, \u010d\u00edm sa zabezpe\u010d\u00ed, \u017ee ihla nesp\u00f4sobuje nadmern\u00fd odpor alebo probl\u00e9my po\u010das procesu vstrekovania.<\/p>\n\n\n\n

    Str\u00e1nka test injektovate\u013enosti<\/strong> \u010dasto zah\u0155\u0148a simul\u00e1ciu re\u00e1lnych podmienok pomocou tlaku na injek\u010dn\u00fa strieka\u010dku a merania sily potrebnej na vstreknutie obsahu. Pr\u00edli\u0161 tuh\u00e1 ihla m\u00f4\u017ee sp\u00f4sobi\u0165 \u0165a\u017ekosti pri vstrekovan\u00ed, zatia\u013e \u010do pr\u00edli\u0161 pru\u017en\u00e1 ihla m\u00f4\u017ee vies\u0165 k nestabilite alebo mo\u017en\u00e9mu zlyhaniu.<\/p>\n\n\n\n

    \u00daloha testovacieho zariadenia na injek\u010dn\u00e9 strieka\u010dky<\/h2>\n\n\n\n

    Pre v\u00fdrobcov, ktor\u00ed dodr\u017eiavaj\u00fa ISO9626 Pr\u00edloha B<\/strong>, s vyu\u017eit\u00edm presn\u00fdch Injek\u010dn\u00e9 testovacie zariadenie<\/strong> je nevyhnutn\u00fd. Toto zariadenie zabezpe\u010duje, \u017ee sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok<\/strong> a test injektovate\u013enosti<\/strong> sa vykon\u00e1vaj\u00fa presne a d\u00f4sledne. Vysokokvalitn\u00e9 testovacie pr\u00edstroje umo\u017e\u0148uj\u00fa v\u00fdrobcom plni\u0165 regula\u010dn\u00e9 po\u017eiadavky a dod\u00e1va\u0165 bezpe\u010dn\u00e9 a spo\u013eahliv\u00e9 v\u00fdrobky.<\/p>\n\n\n\n

    Napr\u00edklad Tester tuhosti r\u00farok<\/strong> z adresy Mobiln\u00e9 n\u00e1stroje<\/strong> je navrhnut\u00fd tak, aby poskytoval presn\u00e9 merania tuhosti ihlov\u00fdch r\u00farok. Tento pr\u00edstroj je ide\u00e1lny na testovanie tuhos\u0165 ihlovej r\u00farky<\/strong> pou\u017e\u00edvan\u00fdch v injek\u010dn\u00fdch strieka\u010dk\u00e1ch a in\u00fdch zdravotn\u00edckych pom\u00f4ckach, \u010d\u00edm sa zabezpe\u010d\u00ed s\u00falad s ISO9626 Pr\u00edloha B<\/strong> a \u010fal\u0161ie pr\u00edslu\u0161n\u00e9 normy.<\/p>\n\n\n\n

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

    Str\u00e1nka ISO9626 Pr\u00edloha B<\/strong> norma zohr\u00e1va rozhoduj\u00facu \u00falohu pri zabezpe\u010dovan\u00ed bezpe\u010dnosti a v\u00fdkonu ihlov\u00fdch hadi\u010diek pou\u017e\u00edvan\u00fdch v zdravotn\u00edckych pom\u00f4ckach. . sk\u00fa\u0161ka tuhosti ihlov\u00fdch r\u00farok<\/strong> je ve\u013emi d\u00f4le\u017eit\u00e1 na overenie, \u010di hadi\u010dka vydr\u017e\u00ed sily, ktor\u00e9 sa vyskytuj\u00fa po\u010das pou\u017e\u00edvania, a z\u00e1rove\u0148 si zachov\u00e1va potrebn\u00fa pru\u017enos\u0165 pre vstrekovacie postupy.<\/p>\n\n\n\n

    V\u00fdrobcovia m\u00f4\u017eu zabezpe\u010di\u0165, aby ich v\u00fdrobky sp\u013a\u0148ali po\u017eadovan\u00e9 v\u00fdkonnostn\u00e9 normy zaveden\u00edm Trojbodov\u00fd test ohybu<\/strong> pre tuhos\u0165 r\u00farok a spo\u013eahliv\u00e9 Injek\u010dn\u00e9 testovacie zariadenie<\/strong> do svojich procesov kontroly kvality. Mobiln\u00e9 n\u00e1stroje<\/strong> pon\u00faka pokro\u010dil\u00e9 Tester tuhosti r\u00farok<\/strong> pom\u00e1ha\u0165 v\u00fdrobcom pri plnen\u00ed t\u00fdchto pr\u00edsnych po\u017eiadaviek a zabezpe\u010dovan\u00ed kvality ich zdravotn\u00edckych v\u00fdrobkov.<\/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\/sk\/wp-json\/wp\/v2\/posts\/824","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/comments?post=824"}],"version-history":[{"count":0,"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/posts\/824\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/media?parent=824"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/categories?post=824"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.syringetest.com\/sk\/wp-json\/wp\/v2\/tags?post=824"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}