{"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\/ro\/standards\/iso-8537","title":{"rendered":"ISO 8537"},"content":{"rendered":"
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ISO 8537
Seringi sterile de unic\u0103 folosin\u021b\u0103, cu sau f\u0103r\u0103 ac, pentru insulin\u0103<\/small><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Seringile sterile de insulin\u0103 necesit\u0103 performan\u021be func\u021bionale precise pentru a asigura siguran\u021ba pacientului, acurate\u021bea dozei \u0219i administrarea fiabil\u0103 a medicamentului. ISO 8537<\/strong> specific\u0103 cerin\u021bele \u0219i metodele de testare corespunz\u0103toare pentru seringile sterile de unic\u0103 folosin\u021b\u0103, cu sau f\u0103r\u0103 ace, destinate inject\u0103rii insulinei. Standardul se concentreaz\u0103 pe caracteristici critice, cum ar fi rezisten\u021ba la scurgere, for\u021ba de ac\u021bionare a pistonului, spa\u021biul mort \u0219i integritatea conexiunii dintre componentele seringii, inclusiv duz\u0103, butuc, ac, cilindru, piston \u0219i dop de cauciuc<\/strong>.<\/p>

Pentru produc\u0103torii de seringi \u0219i laboratoarele de control al calit\u0103\u021bii, conformitatea cu ISO 8537<\/strong> ajut\u0103 la verificarea consisten\u021bei produsului, la reducerea riscurilor de scurgere \u0219i la \u00eembun\u0103t\u0103\u021birea performan\u021bei injectabilit\u0103\u021bii \u00een timpul utiliz\u0103rii clinice. Sistemele moderne de testare suport\u0103, de asemenea, achizi\u021bia automat\u0103 de date, analiza repetabilit\u0103\u021bii \u0219i documenta\u021bia trasabil\u0103 privind calitatea.<\/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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Cerin\u021be ISO 8537 pentru testarea performan\u021bei seringilor<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ISO 8537 stabile\u0219te multiple proceduri de verificare pentru a evalua performan\u021bele mecanice \u0219i de etan\u0219are ale seringilor sterile de insulin\u0103. Standardul acoper\u0103:<\/p>

  • Performan\u021ba de etan\u0219are a pistonului seringii<\/li>
  • Rezisten\u021ba la scurgeri de aer<\/li>
  • Rezisten\u021b\u0103 la scurgeri de lichid<\/li>
  • Determinarea spa\u021biului mort<\/li>
  • Testarea for\u021bei de desprindere \u0219i de alunecare<\/li>
  • Integritatea conexiunii acului \u0219i a butucului<\/li>
  • Performan\u021be de seringabilitate \u0219i injectabilitate<\/li><\/ul>

    Aceste evalu\u0103ri asigur\u0103 men\u021binerea capacit\u0103\u021bii de etan\u0219are a seringii \u00een timpul aspira\u021biei \u0219i injec\u021biei, asigur\u00e2nd \u00een acela\u0219i timp o mi\u0219care lin\u0103 a pistonului \u0219i o administrare precis\u0103 a dozei.<\/p>

    Pentru produc\u0103tori, aceste teste influen\u021beaz\u0103 \u00een mod direct:<\/p>

    • Siguran\u021ba produsului<\/li>
    • Confortul injec\u021biei<\/li>
    • Precizia dozei<\/li>
    • Conformitatea cu reglement\u0103rile<\/li>
    • Constan\u021ba calit\u0103\u021bii produc\u021biei<\/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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      Test de seringabilitate \u0219i injectabilitate \u00een conformitate cu ISO 8537<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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      The testul de seringabilitate \u0219i injectabilitate<\/strong> evalueaz\u0103 caracteristicile opera\u021bionale ale pistonului seringii \u00een timpul administr\u0103rii fluidului. Anexa C la ISO 8537 define\u0219te determinarea for\u021belor necesare pentru ac\u021bionarea pistonului.<\/p>

      \u00cen timpul procedurii:<\/p>

      1. Seringa este umplut\u0103 cu ap\u0103 distilat\u0103 p\u00e2n\u0103 la 50% din capacitatea nominal\u0103.<\/li>
      2. Seringa este fixat\u0103 vertical, cu acul \u00eendreptat \u00een jos.<\/li>
      3. O for\u021b\u0103 axial\u0103 controlat\u0103 este aplicat\u0103 pistonului.<\/li>
      4. Se \u00eenregistreaz\u0103 for\u021ba necesar\u0103 pentru ini\u021bierea mi\u0219c\u0103rii pistonului.<\/li>
      5. De asemenea, se m\u0103soar\u0103 for\u021ba continu\u0103 necesar\u0103 pentru a sus\u021bine mi\u0219carea.<\/li><\/ol>

        Acest proces determin\u0103 doi parametri importan\u021bi:<\/p>

        • For\u021ba de desprindere<\/strong> - for\u021ba ini\u021bial\u0103 necesar\u0103 pentru a porni mi\u0219carea pistonului<\/li>
        • For\u021ba de alunecare<\/strong> - for\u021ba continu\u0103 necesar\u0103 pentru men\u021binerea cursei pistonului<\/li><\/ul>

          For\u021ba excesiv\u0103 de sl\u0103bire poate provoca o opera\u021biune de injectare inconfortabil\u0103, \u00een timp ce for\u021ba de alunecare instabil\u0103 poate afecta negativ controlul injec\u021biei \u0219i precizia dozei.<\/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 Anexa C<\/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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          SSR-01 Tester de rezisten\u021b\u0103 la alunecare a seringii<\/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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          Testarea for\u021bei de desprindere \u0219i de alunecare<\/h3>

          Testarea for\u021bei de desprindere \u0219i de alunecare<\/strong> joac\u0103 un rol esen\u021bial \u00een evaluarea capacit\u0103\u021bii de utilizare a seringilor. Seringile de \u00eenalt\u0103 calitate ar trebui s\u0103 demonstreze:<\/p>

          • Curs\u0103 lin\u0103 a pistonului<\/li>
          • Comportament de frecare stabil<\/li>
          • Fluctua\u021bie minim\u0103 a for\u021bei<\/li>
          • Performan\u021b\u0103 fiabil\u0103 a lubrifiantului<\/li><\/ul>

            O ma\u0219in\u0103 universal\u0103 de testare a materialelor echipat\u0103 cu senzori de for\u021b\u0103 \u0219i dispozitive de fixare a seringilor personalizate poate m\u0103sura cu precizie ace\u0219ti parametri.<\/p>

            Cell Instruments recomand\u0103 sisteme de testare de precizie la compresie \u0219i trac\u021biune capabile s\u0103:<\/p>

            • Achizi\u021bionarea de for\u021be de \u00eenalt\u0103 rezolu\u021bie<\/li>
            • Curbe for\u021b\u0103-deplasare \u00een timp real<\/li>
            • Control programabil al vitezei de testare<\/li>
            • Analiza statistic\u0103 pentru verificarea calit\u0103\u021bii loturilor<\/li><\/ul>

              Aceste sisteme ajut\u0103 produc\u0103torii de seringi s\u0103 optimizeze finisarea suprafe\u021bei cilindrului, geometria pistonului \u0219i procesele de lubrifiere cu silicon.<\/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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              Testarea scurgerilor pentru seringa steril\u0103 de unic\u0103 folosin\u021b\u0103<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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              Testarea scurgerilor pentru seringa steril\u0103 de unic\u0103 folosin\u021b\u0103<\/strong> este una dintre cele mai importante sec\u021biuni ale ISO 8537 deoarece scurgerile pot compromite sterilitatea, precizia injec\u021biei \u0219i siguran\u021ba pacien\u021bilor.<\/p>

              Standardul le evalueaz\u0103 pe am\u00e2ndou\u0103:<\/p>

              • Scurgere de aer \u00een timpul aspira\u021biei<\/li>
              • Scurgeri de lichid \u00een timpul compresiei<\/li><\/ul>

                Testarea scurgerilor implic\u0103 mai multe componente ale seringii, inclusiv:<\/p>

                • Butoi<\/li>
                • Piston<\/li>
                • Dop de cauciuc<\/li>
                • Ac<\/li>
                • Hub<\/li>
                • Conexiuni duz\u0103<\/li><\/ul>

                  Performan\u021ba fiabil\u0103 a etan\u0219\u0103rii asigur\u0103 c\u0103 niciun lichid sau aer nu ocole\u0219te interfe\u021bele de etan\u0219are \u00een condi\u021bii normale de utilizare.<\/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>capacul acului<\/td>10<\/td>capacul pistonului<\/td><\/tr>
                  2<\/td>capacul duzei<\/td>11<\/td>m\u00e2nere pentru degete<\/td><\/tr>
                  3<\/td>lumen duz\u0103<\/td>12<\/td>linie fiducial\u0103<\/td><\/tr>
                  4<\/td>duz\u0103<\/td>13<\/td>capacitate nominal\u0103<\/td><\/tr>
                  5<\/td>butoi<\/td>14<\/td>linii de absolvire<\/td><\/tr>
                  6<\/td>Dop de piston<\/td>15<\/td>linia zero<\/td><\/tr>
                  7<\/td>sigilii<\/td>16<\/td>tub ac<\/td><\/tr>
                  8<\/td>piston<\/td>17<\/td>hub<\/td><\/tr>
                  9<\/td>buton<\/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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                  Test de scurgere a aerului cu sering\u0103 \u0219i metode de detectare a scurgerilor \u00een vid<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                  The test de scurgere a aerului din sering\u0103<\/strong> descris\u0103 \u00een anexa B \u0219i \u00een anexa F evalueaz\u0103 scurgerile \u00een condi\u021bii de presiune negativ\u0103.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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                  \u00cen anexa B, duza seringii se conecteaz\u0103 la un racord de referin\u021b\u0103, iar seringa este par\u021bial umplut\u0103 cu ap\u0103. Un vid de 88 kPa sub presiunea atmosferic\u0103<\/strong> este aplicat treptat. Operatorul examineaz\u0103 apoi:<\/p>

                  • Scurgere de aer pe l\u00e2ng\u0103 garnitura pistonului<\/li>
                  • Stabilitatea presiunii peste 60 de secunde<\/li>
                  • Separare \u00eentre dopul de cauciuc \u0219i piston<\/li><\/ul>

                    Aceast\u0103 procedur\u0103 reprezint\u0103 una dintre cele mai eficiente metode de detectare a scurgerilor \u00een vid<\/strong> pentru seringile de insulin\u0103.<\/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 Anexa B Scurgeri de aer \u00een timpul aspira\u021biei<\/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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                    SLT-02 Tester de scurgere a seringii<\/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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                    Test de scurgere a lichidului din sering\u0103 sub compresie<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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                    The test de scurgere a lichidului din sering\u0103<\/strong> specificate \u00een anexa E evalueaz\u0103 performan\u021bele de etan\u0219are \u00een condi\u021bii de presiune intern\u0103.<\/p>

                    Seringa este:<\/p>

                    1. Umplut peste capacitatea nominal\u0103<\/li>
                    2. Purificat de aer<\/li>
                    3. Presurizat la 300 kPa<\/li>
                    4. Men\u021binut sub presiune timp de 30 de secunde<\/li><\/ol>

                      \u00cen timpul testului, inspectorii evalueaz\u0103:<\/p>

                      • Mi\u0219carea pistonului<\/li>
                      • Scurgeri pe l\u00e2ng\u0103 garniturile pistonului<\/li>
                      • Scurgeri la jonc\u021biunile duzei sau ale acului<\/li><\/ul>

                        Aceast\u0103 metod\u0103 verific\u0103 integritatea interfe\u021belor de etan\u0219are \u00een timpul simul\u0103rii injec\u021biei.<\/p>

                        Un sistem de testare a scurgerilor de presiune proiectat corespunz\u0103tor poate ajuta produc\u0103torii s\u0103 evalueze:<\/p>

                        • Calitatea etan\u0219\u0103rii dopului de cauciuc<\/li>
                        • Fiabilitatea conexiunii Luer<\/li>
                        • Consisten\u021ba dimensional\u0103 a \u021bevii<\/li>
                        • Performan\u021ba de lipire a acului<\/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 Tester de etan\u0219eitate cu presiune pozitiv\u0103 a seringii<\/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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                          M\u0103surarea spa\u021biului mort pentru acurate\u021bea seringii<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                          M\u0103surarea spa\u021biului mort<\/strong> este esen\u021bial\u0103 pentru seringile de insulin\u0103, deoarece lichidul rezidual afecteaz\u0103 \u00een mod direct precizia dozei.<\/p>

                          ISO 8537 define\u0219te spa\u021biul mort ca fiind volumul de ap\u0103 r\u0103mas dup\u0103 depresiunea complet\u0103 a pistonului.<\/p>

                          Procedura include:<\/p>

                          • C\u00e2nt\u0103rirea precis\u0103 a seringilor goale<\/li>
                          • Umplere cu ap\u0103 distilat\u0103<\/li>
                          • Expulzarea complet\u0103 a lichidului<\/li>
                          • Reevaluarea greut\u0103\u021bii dup\u0103 desc\u0103rcare<\/li><\/ul>

                            Masa r\u0103mas\u0103 corespunde volumului rezidual.<\/p>

                            Seringile cu spa\u021biu mort redus ajut\u0103:<\/p>

                            • Reducerea risipei de medicamente<\/li>
                            • \u00cembun\u0103t\u0103\u021birea preciziei dozelor<\/li>
                            • Minimizarea reten\u021biei reziduale de insulin\u0103<\/li><\/ul>

                              Echipamentele de testare cu balan\u021be analitice \u0219i dispozitive de manipulare controlat\u0103 \u00eembun\u0103t\u0103\u021besc consecven\u021ba m\u0103sur\u0103torilor pentru programele de asigurare a calit\u0103\u021bii.<\/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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                              Importan\u021ba test\u0103rii componentelor seringii
                              --- Duz\u0103, butuc, ac, cilindru, piston \u0219i dop de cauciuc<\/small><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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                              Testarea ISO 8537 evalueaz\u0103 interac\u021biunea dintre mai multe componente ale seringii, mai degrab\u0103 dec\u00e2t p\u0103r\u021bile izolate.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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                              \u00a0Interfe\u021bele critice includ:<\/p>

                              Component\u0103<\/th>Importan\u021b\u0103 func\u021bional\u0103<\/th><\/tr><\/thead>
                              Duz\u0103<\/td>Integritatea transferului de fluide<\/td><\/tr>
                              Hub<\/td>Stabilitatea conexiunii acului<\/td><\/tr>
                              Ac<\/td>Performan\u021ba injec\u021biei<\/td><\/tr>
                              Butoi<\/td>Precizia dimensional\u0103<\/td><\/tr>
                              Piston<\/td>Func\u021bionare \u0219i etan\u0219are f\u0103r\u0103 probleme<\/td><\/tr>
                              Dop de cauciuc<\/td>Prevenirea scurgerilor<\/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
                              \n\t\t\t\t
                              \n\t\t\t\t\t\t\t\t\t

                              Orice neconcordan\u021b\u0103 \u00eentre aceste componente poate duce la:<\/p>

                              • Scurgeri<\/li>
                              • Instabilitatea inject\u0103rii<\/li>
                              • For\u021b\u0103 de operare excesiv\u0103<\/li>
                              • Inexactitatea dozei<\/li><\/ul>

                                Prin urmare, testarea cuprinz\u0103toare necesit\u0103 sisteme integrate de evaluare mecanic\u0103 \u0219i a scurgerilor.<\/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 define\u0219te metodele de testare critice pentru seringile sterile de insulin\u0103 de unic\u0103 folosin\u021b\u0103, inclusiv testarea scurgerilor seringii, procedurile de testare a integrit\u0103\u021bii etan\u0219\u0103rii seringii, testarea for\u021bei de alunecare a seringii \u0219i m\u0103surarea spa\u021biului mort.<\/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\/ro\/wp-json\/wp\/v2\/pages\/878","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syringetest.com\/ro\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.syringetest.com\/ro\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/ro\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/ro\/wp-json\/wp\/v2\/comments?post=878"}],"version-history":[{"count":0,"href":"https:\/\/www.syringetest.com\/ro\/wp-json\/wp\/v2\/pages\/878\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/ro\/wp-json\/wp\/v2\/pages\/603"}],"wp:attachment":[{"href":"https:\/\/www.syringetest.com\/ro\/wp-json\/wp\/v2\/media?parent=878"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}