{"id":1748,"date":"2021-02-11T12:02:48","date_gmt":"2021-02-11T12:02:48","guid":{"rendered":"http:\/\/medicallab.coreco.es\/?p=1536"},"modified":"2026-07-01T15:54:11","modified_gmt":"2026-07-01T15:54:11","slug":"norme-din-58345-specifications-relatives-au-stockage-des-medicaments-necessitant-une-refrigeration","status":"publish","type":"post","link":"https:\/\/medicallab.coreco.es\/fr\/din-58345-especificaciones-para-el-almacenamiento-de-medicamentos-que-requieren-refrigeracion\/","title":{"rendered":"Norme DIN 58345 : crit\u00e8res relatifs au stockage des produits thermolabiles dans les r\u00e9frig\u00e9rateurs."},"content":{"rendered":"<p class=\"wp-block-paragraph\">Dans cet article, nous allons d\u00e9crire bri\u00e8vement les sp\u00e9cifications exig\u00e9es par la norme DIN 58345 pour le stockage correct des produits thermolabiles, c'est-\u00e0-dire les m\u00e9dicaments, les vaccins et les \u00e9chantillons physiologiques qui doivent \u00eatre conserv\u00e9s dans une plage de temp\u00e9rature sp\u00e9cifique (entre 2 \u00b0C et 8 \u00b0C). <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Comme on pouvait s'y attendre, chez Coreco, tous nos r\u00e9frig\u00e9rateurs sont conformes \u00e0 cette r\u00e9glementation, ce qui nous permet de proposer une gamme compl\u00e8te de produits m\u00e9dicaux r\u00e9pondant \u00e0 des normes de qualit\u00e9 tr\u00e8s \u00e9lev\u00e9es.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Qu'est-ce que la norme DIN 58345 ?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">DIN signifie \u00ab Deutsches Institut f\u00fcr Normung \u00bb (Institut allemand de normalisation).<br>La norme DIN 58345 concerne les r\u00e9frig\u00e9rateurs \u00e0 usage m\u00e9dical destin\u00e9s \u00e0 la conservation de produits thermolabiles \u00e0 une temp\u00e9rature de fonctionnement comprise entre 2 \u00b0C et 8 \u00b0C. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Les 10 exigences de la norme DIN 58345<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La norme DIN peut se r\u00e9sumer en 10 exigences auxquelles doit satisfaire un r\u00e9frig\u00e9rateur destin\u00e9 aux m\u00e9dicaments. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Le respect de ces 10 dispositions permet de garantir un stockage efficace. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Par ailleurs, la norme DIN vise non seulement \u00e0 garantir le stockage ad\u00e9quat des m\u00e9dicaments n\u00e9cessitant une r\u00e9frig\u00e9ration, mais aussi \u00e0 s'assurer que ces m\u00e9dicaments sont prot\u00e9g\u00e9s contre tout acc\u00e8s non autoris\u00e9 et que les directives en mati\u00e8re de sant\u00e9 et de s\u00e9curit\u00e9 au travail sont respect\u00e9es en ce qui concerne la protection contre le bruit.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">1. Temp\u00e9rature de fonctionnement<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Conform\u00e9ment \u00e0 la norme DIN 58345, la temp\u00e9rature de fonctionnement d'un r\u00e9frig\u00e9rateur \u00e0 m\u00e9dicaments doit \u00eatre comprise entre +2 \u00b0C au minimum et +8 \u00b0C au maximum. Cela garantit que les m\u00e9dicaments et les vaccins conserv\u00e9s dans le r\u00e9frig\u00e9rateur ne g\u00e8lent pas et ne chauffent pas trop.&nbsp;<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">2. Temp\u00e9rature ambiante<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Les armoires r\u00e9frig\u00e9r\u00e9es pour m\u00e9dicaments conformes \u00e0 la norme DIN 58345 doivent garantir une temp\u00e9rature int\u00e9rieure constante comprise entre +2 \u00b0C et +8 \u00b0C, lorsque la temp\u00e9rature ambiante est comprise entre +10 \u00b0C et +35 \u00b0C. Cette plage de temp\u00e9rature correspond \u00e0 la temp\u00e9rature ambiante \u00e0 prendre en compte. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Cette plage de temp\u00e9ratures correspond \u00e0 la temp\u00e9rature ambiante minimale ou maximale \u00e0 prendre en compte dans la majeure partie de l'Europe.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">3. \u00c9mission sonore<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Conform\u00e9ment \u00e0 la norme DIN 58345, le niveau sonore d'un r\u00e9frig\u00e9rateur destin\u00e9 aux m\u00e9dicaments doit \u00eatre inf\u00e9rieur \u00e0 60 dB. Cette sp\u00e9cification permet de maintenir le niveau sonore dans l'environnement de travail des pharmacies, des h\u00f4pitaux et des cabinets m\u00e9dicaux aussi bas que possible.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">4. Avertisseur visuel et sonore en cas d'\u00e9carts de temp\u00e9rature<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Afin de garantir une intervention aussi rapide que possible lorsque les temp\u00e9ratures int\u00e9rieures sp\u00e9cifi\u00e9es sont d\u00e9pass\u00e9es ou non atteintes, la norme DIN 58345 pr\u00e9voit le d\u00e9clenchement d'une alarme visuelle et sonore en cas d'\u00e9carts de temp\u00e9rature.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">5. Alarme visuelle et sonore en cas de coupure d'alimentation<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">La norme DIN 58345 stipule que le r\u00e9frig\u00e9rateur \u00e0 m\u00e9dicaments doit utiliser un signal d'avertissement visuel et sonore pour signaler qu'une coupure d'alimentation s'est produite. Cette alarme de coupure d'alimentation doit rester active pendant au moins 12 heures.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">6. Pr\u00e9paration \u00e0 l'enregistrement de la temp\u00e9rature de fonctionnement<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Afin de pouvoir prouver que les m\u00e9dicaments et les vaccins stock\u00e9s dans le r\u00e9frig\u00e9rateur \u00e0 m\u00e9dicaments ont \u00e9t\u00e9 conserv\u00e9s correctement \u00e0 tout moment, la norme DIN stipule que le r\u00e9frig\u00e9rateur doit \u00eatre capable d'enregistrer les temp\u00e9ratures internes.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">7. Thermostat de s\u00e9curit\u00e9&nbsp;<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Afin de garantir que la temp\u00e9rature int\u00e9rieure ne descende jamais en dessous de +2 \u00b0C, ce qui entra\u00eenerait le gel et, par cons\u00e9quent, la destruction des m\u00e9dicaments stock\u00e9s, un r\u00e9frig\u00e9rateur \u00e0 m\u00e9dicaments conforme \u00e0 la norme DIN 58345 doit \u00eatre \u00e9quip\u00e9 d\u2019un thermostat de s\u00e9curit\u00e9 afin d\u2019emp\u00eacher les temp\u00e9ratures minimales.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">8. Capacit\u00e9 de charge m\u00e9canique des \u00e9l\u00e9ments internes<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Conform\u00e9ment \u00e0 la norme DIN 58345, les \u00e9l\u00e9ments encastr\u00e9s des r\u00e9frig\u00e9rateurs destin\u00e9s aux m\u00e9dicaments (tiroirs et \u00e9tag\u00e8res) doivent pr\u00e9senter une capacit\u00e9 de charge d'au moins 100 kg\/m\u00b2. Cette capacit\u00e9 de charge \u00e9lev\u00e9e garantit que les \u00e9l\u00e9ments int\u00e9gr\u00e9s ne c\u00e8dent pas, m\u00eame lorsqu'ils sont charg\u00e9s de solutions de perfusion ou d'autres r\u00e9cipients lourds.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">9. Porte avec serrure&nbsp;<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">De nombreux m\u00e9dicaments sont non seulement pr\u00e9cieux, mais aussi dangereux s'ils tombent entre de mauvaises mains. Pour des raisons de s\u00e9curit\u00e9, les armoires r\u00e9frig\u00e9r\u00e9es destin\u00e9es aux m\u00e9dicaments doivent \u00eatre \u00e9quip\u00e9es d'une porte verrouillable conforme \u00e0 la norme DIN. La cl\u00e9 ne doit \u00eatre accessible qu'au personnel sp\u00e9cialis\u00e9 habilit\u00e9.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">10. Possibilit\u00e9 de maintenance \u00e0 distance&nbsp;<\/h5>\n\n\n\n<p class=\"wp-block-paragraph\">Dans les h\u00f4pitaux notamment, les r\u00e9frig\u00e9rateurs destin\u00e9s aux m\u00e9dicaments sont g\u00e9n\u00e9ralement surveill\u00e9s \u00e0 distance afin de pouvoir r\u00e9agir imm\u00e9diatement en cas de coupure de courant ou d'\u00e9carts de temp\u00e9rature. Conform\u00e9ment \u00e0 la norme DIN 58345, ces r\u00e9frig\u00e9rateurs doivent \u00eatre \u00e9quip\u00e9s d'un contact sans potentiel permettant cette surveillance \u00e0 distance.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Objectif de la norme<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">De nombreux m\u00e9dicaments doivent simplement \u00eatre conserv\u00e9s dans un endroit frais pour conserver leur efficacit\u00e9. Parmi ces m\u00e9dicaments, on trouve, par exemple, divers collyres, plusieurs inhalateurs-doseurs et de nombreux produits biopharmaceutiques, tels que certains types de vaccins, l'insuline ou les interf\u00e9rons.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Il existe toutefois un autre type de compos\u00e9s, les compos\u00e9s thermolabiles, qui n\u00e9cessitent des plages de temp\u00e9rature plus pr\u00e9cises. Afin de garantir le respect des sp\u00e9cifications de stockage de ce type de produits, qui n\u00e9cessitent effectivement une r\u00e9frig\u00e9ration, la norme DIN 58345 a \u00e9t\u00e9 \u00e9labor\u00e9e. .<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Que pr\u00e9voit la norme ?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Cette norme concerne les chambres froides destin\u00e9es aux produits thermolabiles, qui sont \u00e9quip\u00e9es d'un dispositif de production de froid et sont utilis\u00e9es pour le stockage de ces substances \u00e0 une temp\u00e9rature de fonctionnement comprise entre 2 \u00b0C et 8 \u00b0C.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Si vous souhaitez en savoir plus sur certains aspects, vous pouvez consulter le document r\u00e9dig\u00e9 par le <a href=\"https:\/\/www.din.de\/resource\/blob\/260256\/b9e10e19fdaeaeffb29ca64e6fb42643\/imagebroschuere-2018-data.pdf\" data-type=\"URL\" data-id=\"https:\/\/www.din.de\/resource\/blob\/260256\/b9e10e19fdaeaeffb29ca64e6fb42643\/imagebroschuere-2018-data.pdf\">Comit\u00e9 de travail NA 063-02-06 AA<\/a>  \u00ab R\u00e9frig\u00e9rateurs et cong\u00e9lateurs pour m\u00e9dicaments \u00bb de NAMed en Allemagne.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u00c0 qui s'applique la norme DIN 58345 ?<\/h5>\n\n\n\n<ul class=\"wp-block-list\"><li>Consultations m\u00e9dicales<\/li><li>Centres de sant\u00e9<\/li><li>H\u00f4pitaux<\/li><li>Pharmacies<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><br>R\u00e9sum\u00e9 des exigences <\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Temp\u00e9rature de fonctionnement : de +2 \u00b0C \u00e0 +8 \u00b0C<\/li><li>Temp\u00e9rature d'utilisation ambiante : de +10 \u00b0C \u00e0 +35 \u00b0C<\/li><li>\u00c9missions sonores : &lt; 60 dB(A)<\/li><li>Syst\u00e8me d'alerte visuelle et sonore en cas de temp\u00e9ratures \u00e9lev\u00e9es ou basses<\/li><li>Contact sec pour syst\u00e8mes d'alarme externes<\/li><li>Syst\u00e8me d'alerte actif \u00e0 partir d'un minimum de 12 heures en cas de coupure d'\u00e9lectricit\u00e9<\/li><li>Thermostat de s\u00e9curit\u00e9 destin\u00e9 \u00e0 emp\u00eacher les temp\u00e9ratures de descendre en dessous de +2 \u00b0C<\/li><li>Capacit\u00e9 de charge d'au moins 100 kg\/m\u00b2<\/li><li>Porte avec serrure<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Coreco, bien plus qu'un simple r\u00e9frig\u00e9rateur m\u00e9dical<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Chez Coreco, nous misons sur la qualit\u00e9 et sur des r\u00e9frig\u00e9rateurs bien con\u00e7us. Le fait que nous ayons obtenu toutes les certifications indispensables en mati\u00e8re de qualit\u00e9 des processus vient le confirmer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En cliquant sur ce lien, vous trouverez non seulement celle-ci, mais aussi <a href=\"https:\/\/medicallab.coreco.es\/fr\/certificados-de-calidad\/\" data-type=\"URL\" data-id=\"https:\/\/medicallab.coreco.es\/certificados-de-calidad\/\">toutes les certifications de qualit\u00e9<\/a> dont sont dot\u00e9s nos appareils.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Si vous souhaitez d\u00e9couvrir notre gamme MedicalLab, n'h\u00e9sitez pas \u00e0<a href=\"https:\/\/medicallab.coreco.es\/fr\/catalogo\/\" data-type=\"URL\" data-id=\"https:\/\/medicallab.coreco.es\/catalogo\/\"> demander notre catalogue.<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>DIN 58345 : Sp\u00e9cifications relatives au stockage des m\u00e9dicaments n\u00e9cessitant une r\u00e9frig\u00e9ration<\/p>","protected":false},"author":1,"featured_media":1778,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"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":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","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":"default","ast-page-background-enabled":"default","ast-page-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-opacity":"","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-opacity":"","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-opacity":"","overlay-gradient":""}},"ast-content-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-opacity":"","overlay-gradient":""},"tablet":{"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-opacity":"","overlay-gradient":""},"mobile":{"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-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[9],"tags":[],"class_list":["post-1748","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categoria"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Normativa DIN 58345: criterios para el almacenamiento de termol\u00e1biles en frigor\u00edficos. | Medical Lab<\/title>\n<meta name=\"description\" content=\"\u00bfConoce la norma DIN 58345 sobre especificaciones para el almacenamiento de medicamentos que requieren refrigeraci\u00f3n? 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