{"id":2798,"date":"2023-05-17T15:27:35","date_gmt":"2023-05-17T14:27:35","guid":{"rendered":"https:\/\/vosfoxmedical.com\/validation\/test-de-duree-de-conservation\/"},"modified":"2025-03-05T17:03:55","modified_gmt":"2025-03-05T16:03:55","slug":"test-de-duree-de-conservation","status":"publish","type":"page","link":"https:\/\/vosfoxmedical.com\/fr\/services-2\/validation\/test-de-duree-de-conservation\/","title":{"rendered":"Test de dur\u00e9e de conservation"},"content":{"rendered":"\t<section class=\"section dark\" id=\"section_1008417169\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t<div class=\"section-bg-overlay absolute fill\"><\/div>\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\" style=\"max-width:1300px\" id=\"row-1968350556\">\n\n\t<div id=\"col-414130983\" class=\"col medium-12 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-1408847229\" class=\"text\">\n\t\t\n<h1 class=\"entry-title\"><span style=\"font-size: 100%;\">Test de dur\u00e9e de conservation<\/span><\/h1>\n\t\t\n<style>\n#text-1408847229 {\n  font-size: 2.75rem;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1008417169 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  min-height: 400px;\n  background-color: #5a0958;\n}\n#section_1008417169 .section-bg-overlay {\n  background-color: rgba(90, 9, 88, 0.89);\n}\n#section_1008417169 .section-bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/06\/img-thunderstorm.jpg);\n}\n#section_1008417169 .section-bg {\n  background-position: 90% 59%;\n}\n#section_1008417169 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1008417169 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_1008417169 {\n    min-height: 400px;\n  }\n}\n@media (min-width:850px) {\n  #section_1008417169 {\n    min-height: 600px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n<div class=\"row align-bottom\" style=\"max-width:1300px\" id=\"row-293821572\">\n\n\t<div id=\"col-1810568871\" class=\"col medium-12 small-12 large-8 medium-col-first\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-2023646777\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-2023646777 {\n  padding-top: 300px;\n  background-color: rgb(255,255,255);\n}\n#banner-2023646777 .bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-shelf-life.jpg);\n}\n#banner-2023646777 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-2023646777 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #banner-2023646777 {\n    padding-top: 600px;\n  }\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1810568871 > .col-inner {\n  margin: -120px 0px 0px 0px;\n}\n@media (min-width:550px) {\n  #col-1810568871 > .col-inner {\n    margin: -120px 0px 0px 0px;\n  }\n}\n@media (min-width:850px) {\n  #col-1810568871 > .col-inner {\n    margin: -500px 0px 0px 0px;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<section class=\"section\" id=\"section_666737900\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row row-large align-equal align-right\"  id=\"row-45667943\">\n\n\t<div id=\"col-2074556732\" class=\"col medium-12 small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p class=\"lead\">Les tests de dur\u00e9e de conservation font partie des \u00e9tapes de d\u00e9veloppement pr\u00e9alables \u00e0 la production. Les \u00e9tiquettes des dispositifs m\u00e9dicaux doivent comporter une date de p\u00e9remption, et cette date doit \u00eatre fond\u00e9e sur des preuves. \u00c0 la date de p\u00e9remption, la qualit\u00e9 et la fonctionnalit\u00e9 du produit doivent \u00eatre conformes aux sp\u00e9cifications. Sur ce site web, nous vous donnons quelques informations sur les tests de dur\u00e9e de vie.   <\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row row-small\"  id=\"row-523113815\">\n\n\t<div id=\"col-132607640\" class=\"col medium-6 small-11 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-530413752\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-2058258320\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-2058258320 {\n  width: 60%;\n}\n#text-box-2058258320 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-530413752 {\n  padding-top: 400px;\n}\n#banner-530413752 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/photo-medical-equipment-consumables.jpg?fit=468%2C282&ssl=1);\n}\n#banner-530413752 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-530413752 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-132607640 > .col-inner {\n  padding: 0px 0px 0px 0;\n}\n@media (min-width:550px) {\n  #col-132607640 > .col-inner {\n    padding: 0px 0px 0px 0;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-154511214\" class=\"col medium-6 small-11 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u00c9chantillons<\/h2>\n<p>Le nombre de points dans le temps et le type d&rsquo;essais doivent \u00eatre d\u00e9termin\u00e9s afin de d\u00e9terminer le nombre d&rsquo;\u00e9chantillons requis. Tous les \u00e9chantillons doivent \u00eatre repr\u00e9sentatifs des produits utilis\u00e9s dans le commerce ou en clinique. Diff\u00e9rentes s\u00e9ries d&rsquo;\u00e9chantillons doivent \u00eatre pr\u00e9par\u00e9es (temps 0, 6 mois, un an, deux ans, etc.) en fonction des besoins. Les tests effectu\u00e9s lors de la validation du processus et de l&#8217;emballage constituent un bon point de d\u00e9part pour tester la dur\u00e9e de conservation. Il s&rsquo;agit par exemple des dimensions, de la r\u00e9sistance m\u00e9canique, de la stabilit\u00e9 chimique, de l&rsquo;int\u00e9grit\u00e9 du scellage et de l&#8217;emballage.    <\/p>\n<p>Le nombre total de points dans le temps x le nombre d&rsquo;\u00e9chantillons par test doit \u00eatre doubl\u00e9 si des tests en temps r\u00e9el et des tests acc\u00e9l\u00e9r\u00e9s sont effectu\u00e9s. Les essais en temps r\u00e9el sont toujours requis, tandis que les essais acc\u00e9l\u00e9r\u00e9s sont facultatifs.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-154511214 > .col-inner {\n  padding: 0px 0px 0px 0;\n}\n@media (min-width:550px) {\n  #col-154511214 > .col-inner {\n    padding: 0px 0px 0px 0;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-1740182822\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1740182822 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-1471407129\">\n\n\t<div id=\"col-1901750711\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Essais acc\u00e9l\u00e9r\u00e9s de dur\u00e9e de conservation<\/h2>\n<p>Les tests de dur\u00e9e de conservation acc\u00e9l\u00e9r\u00e9e visent \u00e0 simuler le processus de vieillissement du produit sur une p\u00e9riode plus courte, ce qui permet de pr\u00e9dire sa stabilit\u00e9 dans des conditions de stockage normales.<\/p>\n<ul>\n<li>D\u00e9terminez la dur\u00e9e de conservation cible.<\/li>\n<li>D\u00e9finissez les conditions de stockage acc\u00e9l\u00e9r\u00e9 : Il s&rsquo;agit g\u00e9n\u00e9ralement d&rsquo;une temp\u00e9rature et d&rsquo;un taux d&rsquo;humidit\u00e9 \u00e9lev\u00e9s. Les conditions choisies d\u00e9pendent de la stabilit\u00e9 du produit \u00e0 ces temp\u00e9ratures et influencent l&rsquo;acc\u00e9l\u00e9ration. Les points de temps acc\u00e9l\u00e9r\u00e9s peuvent \u00eatre calcul\u00e9s \u00e0 l&rsquo;aide de l&rsquo;\u00e9quation d&rsquo;Arrhenius.  <\/li>\n<li>Conservez les produits dans ces conditions, g\u00e9n\u00e9ralement dans un four \u00e0 temp\u00e9rature et humidit\u00e9 contr\u00f4l\u00e9es.<\/li>\n<li>Testez les attributs tels que d\u00e9finis dans le protocole, aux moments requis.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-419670063\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1231448654\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-24022900\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-24022900 {\n  width: 60%;\n}\n#text-box-24022900 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1231448654 {\n  padding-top: 430px;\n}\n#banner-1231448654 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-accelerated-shelf-life.jpg?fit=460%2C460&ssl=1);\n}\n#banner-1231448654 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1231448654 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-1391548593\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1391548593 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-490750186\">\n\n\t<div id=\"col-427060873\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1997367835\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-583841125\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-583841125 {\n  width: 60%;\n}\n#text-box-583841125 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1997367835 {\n  padding-top: 355px;\n}\n#banner-1997367835 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-warehouse.jpg?fit=1020%2C680&ssl=1);\n}\n#banner-1997367835 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1997367835 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1341687618\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Test de dur\u00e9e de conservation en temps r\u00e9el<\/h2>\n<p>Un ensemble d&rsquo;\u00e9chantillons par point dans le temps est stock\u00e9 dans des conditions de stockage cens\u00e9es \u00eatre repr\u00e9sentatives des conditions normales. Si les conditions de stockage sont ambiantes, les \u00e9chantillons doivent \u00eatre stock\u00e9s dans des conditions ambiantes, y compris les changements de temp\u00e9rature et d&rsquo;humidit\u00e9. Le vieillissement en temps r\u00e9el des \u00e9chantillons doit \u00eatre effectu\u00e9 dans l&rsquo;environnement dans lequel ils seront normalement stock\u00e9s. Ainsi, le vieillissement dans un cong\u00e9lateur doit \u00eatre effectu\u00e9 lorsque l&rsquo;\u00e9chantillon est stock\u00e9 dans un cong\u00e9lateur.   <\/p>\n<p>Il est toujours conseill\u00e9 d&rsquo;enregistrer la temp\u00e9rature et l&rsquo;humidit\u00e9 pendant le stockage des \u00e9chantillons et de consigner les r\u00e9sultats dans le rapport de synth\u00e8se sur la dur\u00e9e de conservation.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-397047211\">\n\n\t<div id=\"col-1312617067\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-828217912\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/vosfoxmedical.com\/services\/\" target=\"_self\" class=\"button primary\"  >\n    <span>Retour \u00e0 la page d&#039;aper\u00e7u du d\u00e9veloppement de la pr\u00e9production<\/span>\n  <\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_666737900 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_666737900 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_666737900 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_666737900 {\n    padding-top: 70px;\n    padding-bottom: 70px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":2510,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-2798","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.2 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ 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