{"id":4803,"date":"2026-07-21T14:38:53","date_gmt":"2026-07-21T12:38:53","guid":{"rendered":"https:\/\/www.linkidoc.fr\/blog\/2026\/07\/21\/sgs-decerne-a-yesight-la-premiere-certification-cb-iec-81001-5-1-au-monde-pour-la-cybersecurite-des-dispositifs-medicaux\/"},"modified":"2026-07-21T14:38:54","modified_gmt":"2026-07-21T12:38:54","slug":"sgs-decerne-a-yesight-la-premiere-certification-cb-iec-81001-5-1-au-monde-pour-la-cybersecurite-des-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/www.linkidoc.fr\/blog\/2026\/07\/21\/sgs-decerne-a-yesight-la-premiere-certification-cb-iec-81001-5-1-au-monde-pour-la-cybersecurite-des-dispositifs-medicaux\/","title":{"rendered":"SGS d\u00e9cerne \u00e0 YESight la premi\u00e8re certification CB IEC 81001-5-1 au monde pour la cybers\u00e9curit\u00e9 des dispositifs m\u00e9dicaux"},"content":{"rendered":"<\/p>\n

SGS d\u00e9cerne \u00e0 YESight la premi\u00e8re certification IECEE CB au monde conform\u00e9ment \u00e0 la norme CEI 81001-5-1:2021 pour son ophtalmoscope laser \u00e0 balayage ultra-large (SLO) \u00e0 la suite d’un processus complet d’\u00e9valuation et de v\u00e9rification de la conformit\u00e9.<\/span><\/p>\n

Fournisseur de technologies avanc\u00e9es d\u2019imagerie ophtalmique, OUIVue<\/span> a atteint cette \u00e9tape mondiale pour sa s\u00e9rie Yetsea 300. En plus de cette certification de cybers\u00e9curit\u00e9, des certifications CB pour la s\u00e9curit\u00e9 \u00e9lectrique et la compatibilit\u00e9 \u00e9lectromagn\u00e9tique (CEM) ont \u00e9galement \u00e9t\u00e9 d\u00e9livr\u00e9es, d\u00e9montrant l’approche globale de SGS en mati\u00e8re de conformit\u00e9 en mati\u00e8re de s\u00e9curit\u00e9, de performance et de cybers\u00e9curit\u00e9.<\/p>\n

La CEI 81001-5-1 est une norme internationale qui traite de la cybers\u00e9curit\u00e9 tout au long du cycle de vie des logiciels de sant\u00e9 et des syst\u00e8mes informatiques, depuis la conception et le d\u00e9veloppement jusqu’aux activit\u00e9s de test et de post-commercialisation. En tant que premi\u00e8re application de cette norme au sein du programme IECEE CB, cette certification \u00e9tablit une nouvelle r\u00e9f\u00e9rence en mati\u00e8re de cybers\u00e9curit\u00e9 dans les dispositifs m\u00e9dicaux.<\/p>\n

SGS a men\u00e9 un programme d’\u00e9valuation structur\u00e9 et complet pour \u00e9valuer OUIVue<\/span>Conformit\u00e9 aux exigences de la norme CEI 81001-5-1. Au niveau du produit, les activit\u00e9s comprenaient la mod\u00e9lisation des menaces, l’\u00e9valuation des risques, les tests d’intrusion, l’analyse des vuln\u00e9rabilit\u00e9s, l’audit du code et l’examen de la nomenclature logicielle (SBOM) pour identifier les risques potentiels.<\/p>\n

Au niveau du syst\u00e8me, SGS a \u00e9valu\u00e9 les processus de gestion de la cybers\u00e9curit\u00e9 et la documentation \u00e0 l’appui, v\u00e9rifiant l’int\u00e9gration des pratiques de s\u00e9curit\u00e9 dans les activit\u00e9s de gestion de la qualit\u00e9, de d\u00e9veloppement, de test et de surveillance et de r\u00e9ponse apr\u00e8s commercialisation. En adoptant une approche de v\u00e9rification ind\u00e9pendante, SGS a confirm\u00e9 son alignement sur les exigences internationales en mati\u00e8re de cybers\u00e9curit\u00e9, de s\u00fbret\u00e9 et de performance.<\/p>\n

Gavin Yin, directeur des services de dispositifs m\u00e9dicaux, Chine orientale, connectivit\u00e9 et produits, SGS : \u00ab\u00a0Cette certification repr\u00e9sente une avanc\u00e9e significative dans la lutte contre les risques de cybers\u00e9curit\u00e9 dans les dispositifs m\u00e9dicaux connect\u00e9s. En combinant notre expertise en cybers\u00e9curit\u00e9, s\u00e9curit\u00e9 \u00e9lectrique et CEM, nous aidons les fabricants \u00e0 r\u00e9pondre \u00e0 l’\u00e9volution des attentes r\u00e9glementaires et \u00e0 renforcer la confiance dans les technologies de sant\u00e9.\u00a0\u00bb<\/p>\n

La cybers\u00e9curit\u00e9 \u00e9tant d\u00e9sormais un \u00e9l\u00e9ment essentiel de la conformit\u00e9 r\u00e9glementaire, la capacit\u00e9 \u00e0 d\u00e9montrer des pratiques de s\u00e9curit\u00e9 robustes et bas\u00e9es sur le cycle de vie est de plus en plus importante pour am\u00e9liorer la s\u00fbret\u00e9, l’efficacit\u00e9 et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux. Le programme IECEE CB soutient l’acceptation internationale des r\u00e9sultats des tests, r\u00e9duisant ainsi la duplication et acc\u00e9l\u00e9rant l’entr\u00e9e sur des march\u00e9s cl\u00e9s tels que l’Europe, l’Am\u00e9rique du Nord et le Japon.<\/p>\n

SGS continue d’\u00e9tendre ses capacit\u00e9s mondiales de certification en mati\u00e8re de cybers\u00e9curit\u00e9, en aidant les fabricants de dispositifs m\u00e9dicaux du monde entier \u00e0 r\u00e9pondre aux exigences changeantes et \u00e0 renforcer la confiance dans les syst\u00e8mes de sant\u00e9 connect\u00e9s. Gr\u00e2ce \u00e0 son r\u00e9seau mondial d’experts en dispositifs m\u00e9dicaux et \u00e0 son savoir-faire technologique, SGS s’engage \u00e0 fournir des services complets couvrant les tests, l’audit et la certification des produits.<\/p>\n

CONFIANCE NUM\u00c9RIQUE SGS<\/strong> est un cadre mondial qui renforce et consolide les services de SGS dans une approche structur\u00e9e et coh\u00e9rente pour aider les organisations \u00e0 naviguer en toute confiance dans le paysage complexe de la confiance num\u00e9rique d’aujourd’hui. S’appuyant sur une expertise \u00e9prouv\u00e9e, SGS DIGITAL TRUST : \u00e0 travers les technologies, les services et les organisations permet aux clients d’\u00e9tablir, de d\u00e9montrer et de maintenir la confiance dans l’ensemble de l’\u00e9cosyst\u00e8me num\u00e9rique.<\/p>\n

L’article SGS d\u00e9cerne \u00e0 YESight la premi\u00e8re certification CB IEC 81001-5-1 au monde pour la cybers\u00e9curit\u00e9 des dispositifs m\u00e9dicaux appara\u00eet en premier sur Digital Health Technology News UK.<\/p>\n","protected":false},"excerpt":{"rendered":"

SGS d\u00e9cerne \u00e0 YESight la premi\u00e8re certification IECEE CB au monde conform\u00e9ment \u00e0 la norme CEI 81001-5-1:2021 pour son ophtalmoscope<\/p>\n","protected":false},"author":1,"featured_media":4804,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[2652,348,3863,62,330,4199,331,305,5,3002,4197,4198],"class_list":["post-4803","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-classe","tag-certification","tag-cybersecurite","tag-decerne","tag-des","tag-dispositifs","tag-iec","tag-medicaux","tag-monde","tag-pour","tag-premiere","tag-sgs","tag-yesight","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50"],"yoast_head":"\nSGS d\u00e9cerne \u00e0 YESight la premi\u00e8re certification CB IEC 81001-5-1 au monde pour la cybers\u00e9curit\u00e9 des dispositifs m\u00e9dicaux - Blog Linkidoc : consultant e-sant\u00e9<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.linkidoc.fr\/blog\/2026\/07\/21\/sgs-decerne-a-yesight-la-premiere-certification-cb-iec-81001-5-1-au-monde-pour-la-cybersecurite-des-dispositifs-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SGS d\u00e9cerne \u00e0 YESight la premi\u00e8re certification CB IEC 81001-5-1 au monde pour la cybers\u00e9curit\u00e9 des dispositifs m\u00e9dicaux - 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