{"id":878,"date":"2026-05-08T04:11:57","date_gmt":"2026-05-08T04:11:57","guid":{"rendered":"https:\/\/www.syringetest.com\/?page_id=878"},"modified":"2026-05-19T07:20:57","modified_gmt":"2026-05-19T07:20:57","slug":"iso-8537","status":"publish","type":"page","link":"https:\/\/www.syringetest.com\/lt\/standartai\/iso-8537","title":{"rendered":"ISO 8537"},"content":{"rendered":"
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ISO 8537
Steril\u016bs vienkartiniai \u0161virk\u0161tai su adata arba be adatos, skirti insulinui<\/small><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Steriliems insulino \u0161virk\u0161tams reikia tiksli\u0173 funkcini\u0173 savybi\u0173, kad b\u016bt\u0173 u\u017etikrinta pacient\u0173 sauga, dozavimo tikslumas ir patikimas vaisto tiekimas. ISO 8537<\/strong> nustato reikalavimus ir atitinkamus bandymo metodus steriliems vienkartiniams \u0161virk\u0161tams su adatomis arba be j\u0173, skirtiems insulino injekcijoms. Standarte daugiausia d\u0117mesio skiriama tokioms svarbiausioms charakteristikoms kaip atsparumas nuot\u0117kiui, st\u016bmoklio veikimo j\u0117ga, negyvoji erdv\u0117 ir \u0161virk\u0161to sudedam\u0173j\u0173 dali\u0173 sujungimo vientisumas, \u012fskaitant antgalis, stebul\u0117, adata, cilindras, st\u016bmoklis ir guminis kam\u0161tis.<\/strong>.<\/p>

\u0160virk\u0161t\u0173 gamintojams ir kokyb\u0117s kontrol\u0117s laboratorijoms reikia laikytis ISO 8537<\/strong> padeda patikrinti produkto nuoseklum\u0105, suma\u017einti nutek\u0117jimo rizik\u0105 ir pagerinti \u0161virk\u0161timo savybes klinikinio naudojimo metu. \u0160iuolaikin\u0117s bandym\u0173 sistemos taip pat padeda automatizuotai rinkti duomenis, atlikti pakartojamumo analiz\u0119 ir atsekam\u0105 kokyb\u0117s dokumentacij\u0105.<\/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

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ISO 8537 reikalavimai \u0161virk\u0161t\u0173 veiksmingumo bandymams<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ISO 8537 nustato kelet\u0105 patikros proced\u016br\u0173, skirt\u0173 sterili\u0173 insulino \u0161virk\u0161t\u0173 mechanin\u0117ms ir sandarinimo savyb\u0117ms \u012fvertinti. Standartas apima:<\/p>

  • \u0160virk\u0161to st\u016bmoklio sandarinimo charakteristikos<\/li>
  • Atsparumas oro nuot\u0117kiui<\/li>
  • Atsparumas skys\u010di\u0173 nutek\u0117jimui<\/li>
  • Negyvosios erdv\u0117s nustatymas<\/li>
  • Atsipalaidavimo ir slydimo j\u0117gos bandymas<\/li>
  • Adatos ir stebul\u0117s jungties vientisumas<\/li>
  • \u0160virk\u0161timo ir \u0161virk\u0161timo savyb\u0117s<\/li><\/ul>

    Atlikus \u0161iuos vertinimus u\u017etikrinama, kad \u0161virk\u0161tas i\u0161likt\u0173 sandarus aspiravimo ir \u0161virk\u0161timo metu, o st\u016bmoklio jud\u0117jimas b\u016bt\u0173 sklandus ir doz\u0117 b\u016bt\u0173 tiksliai dozuojama.<\/p>

    Gamintojams \u0161ie bandymai daro tiesiogin\u0119 \u012ftak\u0105:<\/p>

    • Produkto sauga<\/li>
    • Injekcijos patogumas<\/li>
    • Doz\u0117s tikslumas<\/li>
    • Atitiktis teis\u0117s aktams<\/li>
    • Gamybos kokyb\u0117s nuoseklumas<\/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
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      \u0160virk\u0161\u010diamumo ir \u0161virk\u0161timo bandymas pagal ISO 8537<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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      Svetain\u0117 \u0161virk\u0161timo ir \u0161virk\u0161\u010diamumo bandymas<\/strong> \u012fvertina \u0161virk\u0161to st\u016bmoklio veikimo charakteristikas skys\u010dio tiekimo metu. ISO 8537 C priede apibr\u0117\u017eiamas j\u0117g\u0173, reikaling\u0173 st\u016bmokliui veikti, nustatymas.<\/p>

      Proced\u016bros metu:<\/p>

      1. \u0160virk\u0161tas pripildomas distiliuotu vandeniu iki 50% vardin\u0117s talpos.<\/li>
      2. \u0160virk\u0161tas tvirtinamas vertikaliai, adata nukreipta \u017eemyn.<\/li>
      3. St\u016bmokl\u012f veikia kontroliuojama a\u0161in\u0117 j\u0117ga.<\/li>
      4. Registruojama j\u0117ga, reikalinga st\u016bmoklio jud\u0117jimui inicijuoti.<\/li>
      5. Taip pat matuojama nuolatin\u0117 j\u0117ga, reikalinga jud\u0117jimui i\u0161laikyti.<\/li><\/ol>

        \u0160io proceso metu nustatomi du svarb\u016bs parametrai:<\/p>

        • Atsilaisvinimo j\u0117ga<\/strong> - pradin\u0117 j\u0117ga, reikalinga st\u016bmoklio jud\u0117jimui prad\u0117ti.<\/li>
        • Slydimo j\u0117ga<\/strong> - nuolatin\u0117 j\u0117ga, reikalinga st\u016bmoklio eigai palaikyti.<\/li><\/ul>

          D\u0117l per didel\u0117s atsipalaidavimo j\u0117gos gali b\u016bti nepatogus \u012fpur\u0161kimas, o nestabili slydimo j\u0117ga gali tur\u0117ti neigiamos \u012ftakos \u012fpur\u0161kimo kontrolei ir dozavimo tikslumui.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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          ISO 8537 C priedas<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\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
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          \n\t\t\t\t\t\t\t\t\t\t\"SSR-01\t\t\t\t\t\t\t\t\t\t\t
          SSR-01 \u0160virk\u0161to slankiojo pasiprie\u0161inimo testeris<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\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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          Atsipalaidavimo ir slydimo j\u0117gos bandymas<\/h3>

          Atsipalaidavimo ir slydimo j\u0117gos bandymas<\/strong> atlieka labai svarb\u0173 vaidmen\u012f vertinant \u0161virk\u0161t\u0173 tinkamum\u0105 naudoti. Auk\u0161tos kokyb\u0117s \u0161virk\u0161tai tur\u0117t\u0173 b\u016bti:<\/p>

          • Sklandi st\u016bmoklio eiga<\/li>
          • Stabili trinties elgsena<\/li>
          • Minimalus j\u0117gos svyravimas<\/li>
          • Patikimas tepalo veikimas<\/li><\/ul>

            \u0160iuos parametrus galima tiksliai i\u0161matuoti universalia med\u017eiag\u0173 bandymo ma\u0161ina, kurioje \u012frengti j\u0117gos jutikliai ir pritaikyti \u0161virk\u0161t\u0173 tvirtinimo \u012ftaisai.<\/p>

            \"Cell Instruments\" rekomenduoja precizi\u0161kas suspaudimo ir tempimo bandym\u0173 sistemas, galin\u010dias:<\/p>

            • Didel\u0117s skiriamosios gebos j\u0117gos surinkimas<\/li>
            • Realaus laiko j\u0117gos ir poslinkio kreiv\u0117s<\/li>
            • Programuojamas bandym\u0173 grei\u010dio valdymas<\/li>
            • Partijos kokyb\u0117s patikros statistin\u0117 analiz\u0117<\/li><\/ul>

              \u0160ios sistemos padeda \u0161virk\u0161t\u0173 gamintojams optimizuoti cilindro pavir\u0161iaus apdail\u0105, st\u016bmoklio geometrij\u0105 ir silikono tepimo procesus.<\/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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              Sterilaus vienkartinio \u0161virk\u0161to nuot\u0117kio bandymas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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              Sterilaus vienkartinio \u0161virk\u0161to sandarumo bandymas<\/strong> produktai yra vienas svarbiausi\u0173 ISO 8537 skirsni\u0173, nes nuot\u0117kis gali pakenkti sterilumui, injekcij\u0173 tikslumui ir pacient\u0173 saugai.<\/p>

              Standarte vertinami abu \u0161ie dalykai:<\/p>

              • Oro nutek\u0117jimas aspiracijos metu<\/li>
              • Skys\u010dio nuot\u0117kis suspaudimo metu<\/li><\/ul>

                Nuot\u0117kio bandymas apima kelias \u0161virk\u0161to sudedam\u0105sias dalis, \u012fskaitant:<\/p>

                • Statin\u0117<\/li>
                • St\u016bmoklis<\/li>
                • Guminis kam\u0161tis<\/li>
                • Adata<\/li>
                • Centratorius<\/li>
                • Purk\u0161tuk\u0173 jungtys<\/li><\/ul>

                  Patikimas sandarinimas u\u017etikrina, kad \u012fprastomis naudojimo s\u0105lygomis per sandarinimo s\u0105sajas nepatekt\u0173 skys\u010dio ar oro.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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                  1<\/td>adatos dangtelis<\/td>10<\/td>st\u016bmoklio dangtelis<\/td><\/tr>
                  2<\/td>antgalio dangtelis<\/td>11<\/td>pir\u0161t\u0173 rankenos<\/td><\/tr>
                  3<\/td>purk\u0161tuko liumenas<\/td>12<\/td>kontrolin\u0117 linija<\/td><\/tr>
                  4<\/td>antgalis<\/td>13<\/td>nominali talpa<\/td><\/tr>
                  5<\/td>statin\u0117<\/td>14<\/td>diplom\u0173 i\u0161davimo linijos<\/td><\/tr>
                  6<\/td>st\u016bmoklio kam\u0161tis<\/td>15<\/td>nulin\u0117 linija<\/td><\/tr>
                  7<\/td>plombos<\/td>16<\/td>adatos vamzdelis<\/td><\/tr>
                  8<\/td>st\u016bmoklis<\/td>17<\/td>stebul\u0117<\/td><\/tr>
                  9<\/td>Mygtukas<\/td>\u00a0<\/td>\u00a0<\/td><\/tr><\/tbody><\/table>\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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                  \u0160virk\u0161to oro nuot\u0117kio bandymas ir vakuuminio nuot\u0117kio aptikimo metodai<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                  Svetain\u0117 \u0161virk\u0161to oro nuot\u0117kio bandymas<\/strong> apra\u0161yta B ir F prieduose, vertinamas nuot\u0117kis esant neigiamam sl\u0117giui.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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                  B priede \u0161virk\u0161to antgalis prijungiamas prie etalonin\u0117s jungties, o \u0161virk\u0161tas i\u0161 dalies pripildomas vandens. Vakuumas 88 kPa \u017eemiau atmosferos sl\u0117gio<\/strong> palaipsniui taikomas. Tada operatorius patikrina:<\/p>

                  • Oro nuot\u0117kis pro st\u016bmoklio sandarikl\u012f<\/li>
                  • Sl\u0117gio stabilumas per 60 sekund\u017ei\u0173<\/li>
                  • Guminio kam\u0161\u010dio ir st\u016bmoklio atsiskyrimas<\/li><\/ul>

                    \u0160i proced\u016bra yra viena veiksmingiausi\u0173 vakuuminio nuot\u0117kio aptikimo metodai<\/strong> insulino \u0161virk\u0161t\u0173.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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                    ISO 8537 B priedas Oro nuot\u0117kis aspiracijos metu<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\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
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                    \n\t\t\t\t\t\t\t\t\t\t\"SLT-02\t\t\t\t\t\t\t\t\t\t\t
                    SLT-02 \u0161virk\u0161t\u0173 nuot\u0117kio testeris<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\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
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                    \u0160virk\u0161to skys\u010dio nuot\u0117kio bandymas suspaud\u017eiant<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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                    Svetain\u0117 \u0161virk\u0161to skys\u010dio nuot\u0117kio bandymas<\/strong> nurodyta E priede, \u012fvertinamas sandarinimo efektyvumas esant vidiniam sl\u0117giui.<\/p>

                    \u0160virk\u0161tas yra:<\/p>

                    1. U\u017epildyta vir\u0161ijant vardin\u0119 talp\u0105<\/li>
                    2. I\u0161valytas nuo oro<\/li>
                    3. Susl\u0117gtas iki 300 kPa<\/li>
                    4. 30 sekund\u017ei\u0173 palaikomas sl\u0117gis<\/li><\/ol>

                      Bandymo metu inspektoriai vertina:<\/p>

                      • St\u016bmoklio jud\u0117jimas<\/li>
                      • Nuot\u0117kis pro st\u016bmoklio sandariklius<\/li>
                      • Nuot\u0117kis antgalio arba adatos jungtyse<\/li><\/ul>

                        \u0160iuo metodu tikrinamas sandarinimo s\u0105saj\u0173 vientisumas atliekant \u012fpur\u0161kimo modeliavim\u0105.<\/p>

                        Tinkamai suprojektuota sl\u0117gio nuot\u0117kio bandymo sistema gali pad\u0117ti gamintojams \u012fvertinti:<\/p>

                        • Guminio kam\u0161\u010dio sandarinimo kokyb\u0117<\/li>
                        • Luer jungties patikimumas<\/li>
                        • Statin\u0117s matmen\u0173 nuoseklumas<\/li>
                        • Adatinio klijavimo na\u0161umas<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                          SPPT-01 \u0161virk\u0161to teigiamo sl\u0117gio sandarumo testeris<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\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
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                          Mirusios erdv\u0117s matavimas \u0161virk\u0161to tikslumui nustatyti<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                          Negyvosios erdv\u0117s matavimas<\/strong> labai svarbus insulino \u0161virk\u0161tams, nes skys\u010dio liku\u010diai turi tiesiogin\u0117s \u012ftakos dozavimo tikslumui.<\/p>

                          ISO 8537 apibr\u0117\u017eia negyv\u0105j\u0105 erdv\u0119 kaip vandens t\u016br\u012f, likus\u012f visi\u0161kai nuspaudus st\u016bmokl\u012f.<\/p>

                          Proced\u016bra apima:<\/p>

                          • Tikslus tu\u0161\u010di\u0173 \u0161virk\u0161t\u0173 sv\u0117rimas<\/li>
                          • Pripildymas distiliuotu vandeniu<\/li>
                          • Visi\u0161kas skys\u010dio pa\u0161alinimas<\/li>
                          • Pakartotinis sv\u0117rimas po i\u0161krovimo<\/li><\/ul>

                            Likusi mas\u0117 atitinka likutin\u012f t\u016br\u012f.<\/p>

                            Padeda \u0161virk\u0161tai su ma\u017ea negyv\u0105ja erdve:<\/p>

                            • Suma\u017einkite vaist\u0173 \u0161vaistym\u0105<\/li>
                            • Dozavimo tikslumo didinimas<\/li>
                            • Suma\u017einti insulino liku\u010di\u0173 susilaikym\u0105<\/li><\/ul>

                              Bandym\u0173 \u012franga su analitin\u0117mis svarstykl\u0117mis ir kontroliuojamais laikikliais pagerina matavimo nuoseklum\u0105 kokyb\u0117s u\u017etikrinimo programose.<\/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

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                              \u0160virk\u0161t\u0173 komponent\u0173 bandymo svarba
                              ---Turbl\u012f, stebul\u0119, adat\u0105, cilindr\u0105, st\u016bmokl\u012f ir gumin\u012f kam\u0161t\u012f<\/small><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                              Atliekant ISO 8537 bandymus vertinama ne atskir\u0173 dali\u0173, o keli\u0173 \u0161virk\u0161to komponent\u0173 s\u0105veika.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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                              \u00a0Svarbiausios s\u0105sajos:<\/p>

                              Komponentas<\/th>Funkcin\u0117 svarba<\/th><\/tr><\/thead>
                              Antgalis<\/td>Skys\u010di\u0173 perdavimo vientisumas<\/td><\/tr>
                              Centratorius<\/td>Adatos jungties stabilumas<\/td><\/tr>
                              Adata<\/td>\u012epur\u0161kimo na\u0161umas<\/td><\/tr>
                              Statin\u0117<\/td>Matmen\u0173 tikslumas<\/td><\/tr>
                              St\u016bmoklis<\/td>Sklandus veikimas ir sandarinimas<\/td><\/tr>
                              Guminis kam\u0161tis<\/td>Nuot\u0117kio prevencija<\/td><\/tr><\/tbody><\/table><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                              Bet koks \u0161i\u0173 komponent\u0173 neatitikimas gali lemti:<\/p>

                              • Nuot\u0117kis<\/li>
                              • Injekcijos nestabilumas<\/li>
                              • Per didel\u0117 veikimo j\u0117ga<\/li>
                              • Doz\u0117s netikslumas<\/li><\/ul>

                                Tod\u0117l norint atlikti i\u0161sam\u0173 bandym\u0105 reikia integruot\u0173 mechaninio ir nuot\u0117kio vertinimo sistem\u0173.<\/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 8537 apibr\u0117\u017eia svarbiausius sterili\u0173 vienkartini\u0173 insulino \u0161virk\u0161t\u0173 bandymo metodus, \u012fskaitant \u0161virk\u0161t\u0173 sandarumo bandymus, \u0161virk\u0161t\u0173 sandarumo bandymo proced\u016bras, \u0161virk\u0161t\u0173 slydimo j\u0117gos bandymus ir tu\u0161\u010diosios erdv\u0117s matavim\u0105.<\/p>","protected":false},"author":2,"featured_media":0,"parent":603,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-878","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/pages\/878","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/comments?post=878"}],"version-history":[{"count":0,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/pages\/878\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/pages\/603"}],"wp:attachment":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/media?parent=878"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}