{"id":2474,"date":"2026-01-06T08:38:10","date_gmt":"2026-01-06T08:38:10","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2474"},"modified":"2026-01-06T08:44:48","modified_gmt":"2026-01-06T08:44:48","slug":"needle-testing-according-to-iso-7864","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/sk\/needle-testing-according-to-iso-7864\/","title":{"rendered":"Testovanie penetr\u00e1cie ihiel pod\u013ea normy ISO 7864 pre podko\u017en\u00e9 ihly"},"content":{"rendered":"
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Testovanie penetr\u00e1cie ihiel pod\u013ea normy ISO 7864 pre podko\u017en\u00e9 ihly<\/h1>\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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ISO 7864<\/strong> je medzin\u00e1rodn\u00e1 norma pre steriln\u00e9 podko\u017en\u00e9 ihly na jedno pou\u017eitie<\/strong> ktor\u00e1 \u0161pecifikuje po\u017eiadavky a sk\u00fa\u0161obn\u00e9 met\u00f3dy na pos\u00fadenie mechanick\u00e9 vlastnosti<\/strong> t\u00fdchto ihiel. Norma sa vz\u0165ahuje na Met\u00f3da penetra\u010dnej sk\u00fa\u0161ky ihlou<\/strong>, ktor\u00fd sa pou\u017e\u00edva na meranie sily potrebnej na zavedenie ihly do ur\u010dit\u00e9ho substr\u00e1tu. T\u00e1to sk\u00fa\u0161obn\u00e1 met\u00f3da je k\u013e\u00fa\u010dov\u00e1 pre hodnotenie funk\u010dnosti a v\u00fdkonu podko\u017en\u00fdch ihiel, \u010d\u00edm sa zabezpe\u010duje ich vhodnos\u0165 na lek\u00e1rske pou\u017eitie.<\/p>

Met\u00f3da sk\u00fa\u0161ky penetr\u00e1cie ihlou<\/strong> je nevyhnutn\u00fd na testovanie sila odporu<\/strong> a penetra\u010dn\u00e1 sila<\/strong> podko\u017en\u00fdch ihiel. Obe sily s\u00fa rozhoduj\u00face pri ur\u010dovan\u00ed jednoduchosti zav\u00e1dzania a celkovej sk\u00fasenosti pou\u017e\u00edvate\u013ea pri pou\u017e\u00edvan\u00ed lek\u00e1rskych ihiel na injekcie alebo odbery krvi. Presn\u00e9 meranie t\u00fdchto s\u00edl je nevyhnutn\u00e9 na zabezpe\u010denie kvality v\u00fdrobkov a dodr\u017eiavanie predpisov v zdravotn\u00edckom priemysle.<\/p>\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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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"Testovanie\t\t\t\t\t\t\t\t<\/a>\n\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Pochopenie normy ISO 7864<\/h2>\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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Norma ISO 7864 stanovuje postupy testovania pre podko\u017en\u00e9 ihly<\/strong>. Konkr\u00e9tne norma poskytuje met\u00f3du na meranie sila prieniku ihly<\/strong> a sila odporu<\/strong> s pou\u017eit\u00edm r\u00f4znych testovac\u00edch substr\u00e1tov. Hlavn\u00fdm cie\u013eom testu je simulova\u0165 skuto\u010dn\u00e9 zavedenie ihly a vyhodnoti\u0165 trecie vlastnosti<\/strong> ktor\u00e9 by mohli ovplyvni\u0165 v\u00fdkon ihly.<\/p>

T\u00e1to str\u00e1nka testovanie prieniku ihiel<\/strong> met\u00f3da pom\u00e1ha zabezpe\u010di\u0165, aby sa ihly \u013eahko zav\u00e1dzali a vy\u017eadovali minim\u00e1lnu silu, \u010do je rozhoduj\u00face pre pohodlie pacienta. Testom sa tie\u017e meria trec\u00ed odpor<\/strong> ktor\u00e9 sa vyskytli po\u010das prechodu ihly cez substr\u00e1t, \u010do poskytuje inform\u00e1cie o materi\u00e1loch a kon\u0161trukcii ihly.<\/p>\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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K\u013e\u00fa\u010dov\u00e9 aspekty testu penetr\u00e1cie ihlou<\/h2>\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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Str\u00e1nka penetra\u010dn\u00fd test ihlou<\/strong> met\u00f3da zah\u0155\u0148a zavedenie ihly do substr\u00e1tu kon\u0161tantnou r\u00fdchlos\u0165ou a z\u00e1rove\u0148 meranie sily potrebnej na penetr\u00e1ciu. Test poskytuje dva hlavn\u00e9 v\u00fdstupy:<\/p>

  1. \u0160pi\u010dkov\u00e1 penetra\u010dn\u00e1 sila<\/strong>: Je to maxim\u00e1lna sila potrebn\u00e1 na zavedenie ihly do podkladu pri predp\u00edsanej r\u00fdchlosti. Predstavuje po\u010diato\u010dn\u00fd odpor, ktor\u00fd vznik\u00e1 pri prvom vniknut\u00ed ihly do materi\u00e1lu.<\/p><\/li>

  2. Sila odporu<\/strong>: Ide o priemern\u00fa silu potrebn\u00fa na udr\u017eanie pohybu ihly po tom, ako za\u010dne vnika\u0165 do podkladu. Meria sa, ke\u010f ihla pokra\u010duje v pohybe materi\u00e1lom, a pom\u00e1ha pos\u00fadi\u0165 trecie vlastnosti ihly a substr\u00e1tu.<\/p><\/li><\/ol>\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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    V\u00fdber substr\u00e1tu na penetra\u010dn\u00e9 testovanie ihlou<\/h2>\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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    Str\u00e1nka substr\u00e1t<\/strong> pou\u017e\u00edvan\u00e9 v Testovanie pod\u013ea normy ISO 7864<\/strong> mus\u00ed napodob\u0148ova\u0165 podmienky, ktor\u00fdm by ihla \u010delila po\u010das re\u00e1lneho pou\u017e\u00edvania. Medzi be\u017en\u00e9 podklady patria:<\/p>

    • Pr\u00edrodn\u00fd latexov\u00fd kau\u010duk<\/strong>: Obvykle sa pou\u017e\u00edva pre svoju podobnos\u0165 s \u013eudskou ko\u017eou.<\/p><\/li>

    • Polyuret\u00e1n<\/strong>: Materi\u00e1l s r\u00f4znym stup\u0148om tvrdosti, ktor\u00fd sa \u010dasto pou\u017e\u00edva na simul\u00e1ciu r\u00f4znych typov tkan\u00edv.<\/p><\/li>

    • Silik\u00f3nov\u00e1 guma<\/strong>: Zn\u00e1ma svojou trvanlivos\u0165ou a st\u00e1lymi trec\u00edmi vlastnos\u0165ami.<\/p><\/li>

    • Polyetyl\u00e9n (LDPE)<\/strong>: Pou\u017e\u00edva sa na testovanie prieniku ihly do m\u00e4kk\u00fdch materi\u00e1lov.<\/p><\/li><\/ul>

      Str\u00e1nka dr\u017eiak substr\u00e1tu<\/strong> zohr\u00e1va d\u00f4le\u017eit\u00fa \u00falohu pri udr\u017eiavan\u00ed konzistencie po\u010das testovania t\u00fdm, \u017ee zabezpe\u010duje materi\u00e1l medzi dvoma rovnobe\u017en\u00fdmi doskami a zais\u0165uje rovnomern\u00fa tlakov\u00fa silu.<\/p>\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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      Ako sa vykon\u00e1va penetra\u010dn\u00fd test ihlou<\/h2>\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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      Str\u00e1nka ISO 7864<\/strong> test zah\u0155\u0148a nieko\u013eko k\u013e\u00fa\u010dov\u00fdch krokov na meranie sila odporu<\/strong> a sila prieniku ihly<\/strong>:<\/p>

      1. Pr\u00edprava vzorky<\/strong>: Testovacie vzorky (ihly) a substr\u00e1t sa pred testovan\u00edm kondicionuj\u00fa v \u0161tandardn\u00fdch laborat\u00f3rnych podmienkach najmenej 24 hod\u00edn. T\u00fdm sa zabezpe\u010dia presn\u00e9 a reprodukovate\u013en\u00e9 v\u00fdsledky.<\/p><\/li>

      2. Nastavenie testu<\/strong>: Ihla je namontovan\u00e1 na pr\u00edstroji na meranie sily, ktor\u00fd zvy\u010dajne obsahuje sn\u00edma\u010d za\u0165a\u017eenia na meranie zav\u00e1dzacej sily v r\u00f4znych f\u00e1zach. Ihla sa potom pohybuje smerom k substr\u00e1tu kon\u0161tantnou r\u00fdchlos\u0165ou (zvy\u010dajne 100 mm\/min).<\/p><\/li>

      3. Proces prieniku<\/strong>: Ihla sa zav\u00e1dza do substr\u00e1tu, k\u00fdm nedosiahne vopred definovan\u00fa h\u013abku prieniku (80% d\u013a\u017eky ihly). Sila potrebn\u00e1 na zavedenie sa meria priebe\u017ene.<\/p><\/li>

      4. Zaznamen\u00e1vanie profilu sily<\/strong>: Ako ihla vnik\u00e1 do podkladu, zaznamen\u00e1va sa sila, pri\u010dom sa zobrazuje profil sily, ktor\u00fd zah\u0155\u0148a po\u010diato\u010dn\u00fa hodnotu \u0161pi\u010dkov\u00e1 penetra\u010dn\u00e1 sila<\/strong> a sila odporu<\/strong>. Profil pom\u00e1ha pos\u00fadi\u0165 v\u00fdkonnos\u0165 ihly a jednoduchos\u0165 jej zavedenia.<\/p><\/li>

      5. Anal\u00fdza \u00fadajov<\/strong>: Na str\u00e1nke sila odporu<\/strong> sa vypo\u010d\u00edta spriemerovan\u00edm sily za posledn\u00fdch 80% h\u013abky prieniku, zatia\u013e \u010do maxim\u00e1lna sila prieniku sa zaznamen\u00e1 ako najvy\u0161\u0161ia sila po\u010das zav\u00e1dzania. Tieto hodnoty sa potom analyzuj\u00fa na ur\u010denie vhodnosti ihly.<\/p><\/li><\/ol>\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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        V\u00fdznam penetra\u010dn\u00e9ho testovania ihlou<\/h2>\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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        Testovanie prieniku ihlou<\/strong> je ve\u013emi d\u00f4le\u017eit\u00fd na zabezpe\u010denie efekt\u00edvneho fungovania podko\u017en\u00fdch ihiel a dodr\u017eiavania bezpe\u010dnostn\u00fdch noriem. Vysok\u00e1 penetra\u010dn\u00e1 sila<\/strong> m\u00f4\u017ee ma\u0165 za n\u00e1sledok nepohodlie pacienta, zatia\u013e \u010do n\u00edzka sila odporu<\/strong> zabezpe\u010duje hladk\u00fd pohyb ihly cez tkanivo. Pri\u013enut\u00edm k ISO 7864<\/strong> a testovanie sila prieniku ihly<\/strong>, m\u00f4\u017eu v\u00fdrobcovia vyr\u00e1ba\u0165 ihly, ktor\u00e9 minimalizuj\u00fa boles\u0165 a traumu pacienta po\u010das postupov, ako s\u00fa injekcie alebo odbery krvi.<\/p>

        Okrem pohodlia pacienta, testovanie ihiel<\/strong> pom\u00e1ha v\u00fdrobcom plni\u0165 regula\u010dn\u00e9 po\u017eiadavky a zabezpe\u010di\u0165, aby ich v\u00fdrobky boli bezpe\u010dn\u00e9, \u00fa\u010dinn\u00e9 a kvalitn\u00e9. Str\u00e1nka meranie odporovej sily<\/strong> po\u010das penetra\u010dn\u00e9ho testovania je rozhoduj\u00faca pri ur\u010dovan\u00ed trec\u00edch vlastnost\u00ed ihly, ktor\u00e9 priamo ovplyv\u0148uj\u00fa v\u00fdkonnos\u0165 ihly v klinick\u00fdch podmienkach.<\/p>\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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        Pou\u017eitie penetra\u010dn\u00e9ho testovania ihlou v lek\u00e1rskom priemysle<\/h2>\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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        Zdravotn\u00edcky priemysel sa spolieha na pr\u00edsne testovacie normy, ako napr. ISO 7864<\/strong>, aby sa zabezpe\u010dila funk\u010dnos\u0165 zdravotn\u00edckych pom\u00f4cok, ako napr. podko\u017en\u00e9 ihly<\/strong>. Pou\u017eit\u00edm testovanie prieniku ihiel<\/strong>, v\u00fdrobcovia m\u00f4\u017eu:<\/p>

        • Zabezpe\u010dte, aby ihly sp\u013a\u0148ali krit\u00e9ri\u00e1 v\u00fdkonu, \u010d\u00edm sa zn\u00ed\u017ei nepohodlie pacienta a zv\u00fd\u0161i sa \u00fa\u010dinnos\u0165 lek\u00e1rskych postupov.<\/p><\/li>

        • Dodr\u017eiava\u0165 priemyseln\u00e9 normy, ako napr. Normy ASTM<\/strong> pre zdravotn\u00edcke pom\u00f4cky, \u010d\u00edm sa zabezpe\u010d\u00ed s\u00falad s predpismi.<\/p><\/li>

        • Zlep\u0161ite dizajn a v\u00fdber materi\u00e1lov pre ihly a optimalizujte ich pre r\u00f4zne klinick\u00e9 aplik\u00e1cie.<\/p><\/li><\/ul>\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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          \u00a0ISO 7864<\/strong> poskytuje z\u00e1kladn\u00fd r\u00e1mec pre testovanie podko\u017en\u00e9 ihly<\/strong> prostredn\u00edctvom Met\u00f3da penetra\u010dnej sk\u00fa\u0161ky ihlou<\/strong>. Meran\u00edm penetra\u010dn\u00e1 sila<\/strong> a sila odporu<\/strong>, t\u00e1to testovacia met\u00f3da zaru\u010duje, \u017ee ihly s\u00fa navrhnut\u00e9 tak, aby fungovali efekt\u00edvne, minimalizovali nepohodlie a sp\u013a\u0148ali regula\u010dn\u00e9 normy. Pre podniky v odvetv\u00ed v\u00fdroby zdravotn\u00edckych pom\u00f4cok je dodr\u017eiavanie t\u00fdchto noriem rozhoduj\u00face pre zabezpe\u010denie kvality v\u00fdrobkov a bezpe\u010dnosti pacientov.<\/p>

          Pre t\u00fdch, ktor\u00ed h\u013eadaj\u00fa presnos\u0165 v testovanie prieniku ihiel<\/strong>,. Tester priepustnosti ihly Cell Instruments<\/strong> poskytuje presn\u00e9 a spo\u013eahliv\u00e9 rie\u0161enie. Tento pr\u00edstroj je v s\u00falade s ISO 7864<\/strong> a noriem ASTM, \u010do z neho rob\u00ed ide\u00e1lnu vo\u013ebu pre v\u00fdrobcov, ktor\u00ed chc\u00fa splni\u0165 po\u017eiadavky priemyslu a vyr\u00e1ba\u0165 vysokokvalitn\u00e9 lek\u00e1rske ihly.<\/p>\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"

          Testovanie penetr\u00e1cie ihiel pod\u013ea normy ISO 7864 pre podko\u017en\u00e9 ihly ISO 7864 je medzin\u00e1rodn\u00e1 norma pre steriln\u00e9 podko\u017en\u00e9 ihly na jedno pou\u017eitie, ktor\u00e1 \u0161pecifikuje po\u017eiadavky a sk\u00fa\u0161obn\u00e9 met\u00f3dy na hodnotenie mechanick\u00fdch vlastnost\u00ed t\u00fdchto ihiel. Norma sa vz\u0165ahuje na met\u00f3du penetra\u010dnej sk\u00fa\u0161ky ihly, ktor\u00e1 sa pou\u017e\u00edva na meranie sily, ktor\u00e1 p\u00f4sob\u00ed na ihlu, a na meranie [...]<\/p>","protected":false},"author":5,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","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":"disabled","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":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2474","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"Editor","author_link":"https:\/\/www.pharmacopoeiatest.com\/sk\/author\/editor\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Penetration Testing According to ISO 7864 for Hypodermic Needles ISO 7864 is an international standard for sterile hypodermic needles for single use that specifies the requirements and test methods for assessing the mechanical properties of these needles. The standard covers the needle penetration test method, which is used to measure how much force is…","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2474","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/comments?post=2474"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2474\/revisions"}],"predecessor-version":[{"id":2500,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2474\/revisions\/2500"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/media?parent=2474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/categories?post=2474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/tags?post=2474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}