{"id":40928,"date":"2012-02-22T16:37:11","date_gmt":"2012-02-22T21:37:11","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/manufacturers-exporters-and-initial-importersdistributors-of-sunglasses-and-lenses-did-you-know\/"},"modified":"2022-11-29T07:03:53","modified_gmt":"2022-11-29T12:03:53","slug":"manufacturers-exporters-and-initial-importersdistributors-of-sunglasses-and-lenses-did-you-know","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/fr\/manufacturers-exporters-and-initial-importersdistributors-of-sunglasses-and-lenses-did-you-know\/","title":{"rendered":"Fabricants, exportateurs, et importateurs\/distributeurs initiaux de lunettes de soleil et de lentilles \u2013 Le saviez-vous ?"},"content":{"rendered":"
[vc_row][vc_column][vc_column_text]La Food and Drug Administration (FDA) v\u00e9rifie les cargaisons de lunettes de soleil et de lentilles pour v\u00e9rifier les documentations. La FDA exige que les cargaisons de lunettes de soleil et\/ou de lentilles incluent le certificat \u00ab\u00a0Drop Ball Test\u00a0\u00bb.<\/p>\n

La FDA r\u00e9gule les produits de la vue pour garantir leur s\u00e9curit\u00e9. La r\u00e9sistance aux impacts est un crit\u00e8re essentiel pour les lunettes et\/ou lentilles. La FDA ne d\u00e9finit pas explicitement un nombre de lentilles qui doivent \u00eatre test\u00e9es avant l\u2019approbation\u00a0; cela d\u00e9pend de la taille de la cargaison et du mat\u00e9riau\/type des lentilles. Cependant la FDA exige que le \u00ab\u00a0Drop Ball Test\u00a0\u00bb soit r\u00e9alis\u00e9 sur toutes les lentilles de verre d\u00e9livr\u00e9es sous prescription.<\/p>\n

Il existe un document de guidance pour le \u00ab\u00a0Drop Ball Test\u00a0\u00bb. La r\u00e8glementation \u00e9nonce les exigences suivantes\u00a0:<\/p>\n

    \n
  1. Le test d\u2019impact consiste en une balle d\u2019acier de 15,875 mm (5\/8 inch) pesant approximativement 15,9 g (0.56 ounces)<\/li>\n
  2. La balle doit \u00eatre l\u00e2ch\u00e9e d\u2019une hauteur de 127 cm de la surface horizontale sup\u00e9rieure de la lentille<\/li>\n
  3. Le centre g\u00e9om\u00e9trique de la lentille doit \u00eatre frapp\u00e9 par la balle dans un cercle de 15,875 mm (5\/8 inch) de diam\u00e8tre.<\/li>\n
  4. Rien ne doit restreindre la chute de la balle.<\/li>\n
  5. Un tube peut \u00eatre utilis\u00e9 pour guider la balle vers la lentille\u00a0; la balle peut \u00eatre l\u00e2ch\u00e9e dans un tube s\u2019\u00e9tendant jusqu\u2019\u00e0 environ 10 cm (4 inches) de la lentille<\/li>\n<\/ol>\n

    Le Title 21<\/a> du Code of Federal Regulations de la FDA stipule que la lentille ne doit pas \u00eatre fractur\u00e9e \u00e0 l\u2019impact pour r\u00e9ussir le test. Une lentille est consid\u00e9r\u00e9e comme fractur\u00e9e si\u00a0:<\/p>\n

      \n
    1. Elle se fend dans toute son \u00e9paisseur incluant une couche laminaire, le cas \u00e9ch\u00e9ant, et sur un diam\u00e8tre complet en deux ou plus pi\u00e8ces s\u00e9par\u00e9es<\/li>\n
    2. Tout mat\u00e9riau de lentille visible \u00e0 l\u2019\u0153il nu se d\u00e9tache de la surface oculaire (i.e. la surface de la lentille la plus proche de l\u2019\u0153il quand la lentille est utilis\u00e9e)<\/li>\n<\/ol>\n

      Un \u00e9chec pour inclure le certificat\u00a0 \u00ab\u00a0Drop Ball\u00a0\u00bb avec votre cargaison peut r\u00e9sulter dans un retardement de votre cargaison par la FDA. Pour \u00e9viter tout d\u00e9lai assurez vous que les r\u00e9sultats au \u00ab\u00a0Drop Ball Test\u00a0\u00bb soient joints \u00e0 vos documents d\u2019exp\u00e9dition.<\/p>\n

      Pour plus de questions \u00e0 propos du \u00ab\u00a0Drop Ball\u00a0Test\u00a0\u00bb ou toute autre r\u00e8glementation U.S. FDA, veuillez contacter Registrar Corp 24\/7 \u00e0 regstaging.wpengine.com\/livehelp<\/a> ou nous appeler au +1-757-224-0177.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

      [vc_row][vc_column][vc_column_text]La Food and Drug Administration (FDA) v\u00e9rifie les cargaisons de lunettes de soleil et de lentilles pour v\u00e9rifier les documentations. La FDA exige que les cargaisons de lunettes de soleil et\/ou de lentilles incluent le certificat \u00ab\u00a0Drop Ball Test\u00a0\u00bb. La FDA r\u00e9gule les produits de la vue pour garantir leur s\u00e9curit\u00e9. La r\u00e9sistance aux impacts<\/p>\n","protected":false},"author":30,"featured_media":39543,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[91],"tags":[],"class_list":{"0":"post-40928","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-fr","8":"entry"},"yoast_head":"\nFabricants, exportateurs, et importateurs\/distributeurs initiaux de lunettes de soleil et de lentilles \u2013 Le saviez-vous ? - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fabricants, exportateurs, et importateurs\/distributeurs initiaux de lunettes de soleil et de lentilles \u2013 Le saviez-vous ?\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_column_text]La Food and Drug Administration (FDA) v\u00e9rifie les cargaisons de lunettes de soleil et de lentilles pour v\u00e9rifier les documentations. La FDA exige que les cargaisons de lunettes de soleil et\/ou de lentilles incluent le certificat \u00ab\u00a0Drop Ball Test\u00a0\u00bb. La FDA r\u00e9gule les produits de la vue pour garantir leur s\u00e9curit\u00e9. 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