{"id":5662,"date":"2026-05-21T05:48:10","date_gmt":"2026-05-21T05:48:10","guid":{"rendered":"https:\/\/staging.relish-tech.com\/?p=5662"},"modified":"2026-07-18T01:03:51","modified_gmt":"2026-07-18T01:03:51","slug":"ce-%e8%aa%8d%e8%a8%bc%e9%9b%bb%e5%8b%95%e6%ad%af%e3%83%96%e3%83%a9%e3%82%b7","status":"publish","type":"post","link":"https:\/\/staging.relish-tech.com\/jp\/ce-certification-electric-toothbrush\/","title":{"rendered":"\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306eCE\u8a8d\u8a3cEU\u5e02\u5834\u53c2\u5165\u30ac\u30a4\u30c9 2026"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5662\" class=\"elementor elementor-5662\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-95277c7 e-flex e-con-boxed e-con e-parent\" data-id=\"95277c7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23de696 elementor-widget elementor-widget-html\" data-id=\"23de696\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t <style>\r\n    *, *::before, *::after { box-sizing: border-box; margin: 0; padding: 0; }\r\n    body { font-family: 'Poppins', sans-serif; font-size: 16px; line-height: 1.65; color: #252827; background: #fff; }\r\n    .container { max-width: 1440px; margin: 0 auto; padding: 0 24px; }\r\n\r\n    \/* Hero *\/\r\n    .hero { background: linear-gradient(135deg, #1e3a5f, #2563eb, #60a5fa); color: #fff; padding: 72px 0 56px; }\r\n    .hero-badge { display: inline-block; background: rgba(255,255,255,0.2); border: 1px solid rgba(255,255,255,0.35); border-radius: 20px; padding: 5px 16px; font-size: 12px; font-weight: 600; letter-spacing: normal; text-transform: uppercase; margin-bottom: 20px; }\r\n    .hero h1 { font-size: clamp(26px, 4vw, 44px); font-weight: 800; line-height: 1.15; margin-bottom: 20px;  color: #ffffff; }\r\n    .hero-lead { font-size: 17px; opacity: 0.92; max-width: 1440px; margin-bottom: 32px; line-height: 1.6; }\r\n    .hero-meta { display: flex; gap: 24px; flex-wrap: wrap; font-size: 13px; opacity: 0.85; }\r\n    .hero-meta span::before { content: \"\u2713 \"; }\r\n\r\n    \/* Breadcrumb *\/\r\n    .breadcrumb { padding: 14px 0; font-size: 13px; color: #888; border-bottom: 1px solid #f0f0f0; }\r\n    .breadcrumb a { color: #2563eb; text-decoration: none; }\r\n    .breadcrumb span { margin: 0 6px; }\r\n\r\n    \/* Article *\/\r\n    article { padding: 52px 0 72px; }\r\n    h2 { font-size: 25px; font-weight: 700; color: #111827; margin: 52px 0 18px; line-height: 1.5; }\r\n    h3 { font-size: 19.2px; font-weight: 700; color: #14532d; margin: 30px 0 12px; line-height: 1.5; }\r\n    p { margin-bottom: 1.5em; }\r\n    ul, ol { margin: 12px 0 20px 24px; }\r\n    li { font-size: 15px; line-height: 1.3; margin-bottom: 8px; }\r\n    strong { color: #1e3a5f; }\r\n    a { color: #2563eb; 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}\r\n    table { width: 100%; border-collapse: collapse; font-size: 14px; }\r\n    thead { background: linear-gradient(90deg, #1e3a5f, #2563eb); color: #fff; }\r\n    th { padding: 14px 16px; text-align: left; font-weight: 600; font-size: 13px; }\r\n    td { padding: 12px 16px; border-bottom: 1px solid #f0f0f0; vertical-align: top; }\r\n    tbody tr:last-child td { border-bottom: none; }\r\n    tbody tr:hover { background: #f8fafd; }\r\n\r\n    \/* FAQ *\/\r\n    .faq-section { margin: 60px 0; }\r\n    .faq-item { border-bottom: 1px solid #eee; padding: 20px 0; }\r\n    .faq-q { font-weight: 600; font-size: 16px; color: #1e3a5f; margin-bottom: 10px; }\r\n    .faq-a { font-size: 14.5px; color: #444; }\r\n\r\n    \/* CTA *\/\r\n    .cta-section { background: linear-gradient(135deg, #1e3a5f, #2563eb); border-radius: 20px; padding: 48px 40px; text-align: center; margin: 60px 0 40px; color: #fff; }\r\n    .cta-section h2 { color: #fff; margin: 0 0 16px; font-size: 26px; }\r\n    .cta-section p { opacity: 0.9; margin-bottom: 28px; }\r\n    .cta-btn { display: inline-block; background: #fff; color: #1e3a5f; font-weight: 700; padding: 14px 36px; border-radius: 50px; font-size: 15px; text-decoration: none; }\r\n    .cta-btn:hover { text-decoration: none; opacity: 0.95; }\r\n\r\n    \/* Related *\/\r\n    .related { background: #f0f4fc; border-radius: 16px; padding: 32px; margin: 40px 0; }\r\n    .related h3 { font-size: 18px; margin-bottom: 18px; color: #1e3a5f; }\r\n    .related-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(200px, 1fr)); gap: 12px; }\r\n    .related-link { background: #fff; border-radius: 10px; padding: 14px 18px; font-size: 14px; font-weight: 500; color: #2563eb; border: 1px solid #bfdbfe; text-decoration: none; display: block; }\r\n    .related-link:hover { background: #e0edfc; text-decoration: none; }\r\n\r\n    \/* References *\/\r\n    .references { background: #f9f9fb; border-radius: 12px; padding: 28px; margin: 40px 0; }\r\n    .references h3 { font-size: 16px; margin-bottom: 16px; color: #333; }\r\n    .references ol { font-size: 13.5px; color: #555; padding-left: 20px; }\r\n    .references li { margin-bottom: 8px; }\r\n\r\n    \/* Directive cards *\/\r\n    .directive-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(260px, 1fr)); gap: 16px; margin: 24px 0; }\r\n    .directive-card { background: #f0f4fc; border: 1px solid #bfdbfe; border-radius: 12px; padding: 20px; }\r\n    .directive-card h4 { color: #1e3a5f; font-size: 15px; margin-bottom: 8px; }\r\n    .directive-card p { font-size: 14px; margin: 0; color: #444; }\r\n\r\n    \/* Step process *\/\r\n    .process-steps { counter-reset: step; margin: 28px 0; }\r\n    .process-step { display: flex; gap: 16px; margin-bottom: 20px; align-items: flex-start; }\r\n    .step-num { counter-increment: step; flex-shrink: 0; width: 36px; height: 36px; background: linear-gradient(135deg, #1e3a5f, #2563eb); color: #fff; border-radius: 50%; display: flex; align-items: center; justify-content: center; font-weight: 700; font-size: 14px; }\r\n    .step-num::before { content: counter(step); }\r\n    .step-content { flex: 1; }\r\n    .step-content h4 { font-size: 15px; color: #1e3a5f; margin-bottom: 4px; }\r\n    .step-content p { font-size: 14px; margin: 0; color: #555; }\r\n\r\n    @media (max-width: 640px) {\r\n      .hero { padding: 48px 0 36px; }\r\n      h2 { font-size: 22px; }\r\n      .cta-section { padding: 36px 24px; }\r\n    }\r\n  <\/style>\r\n<\/head>\r\n<body>\r\n\r\n  <!-- Hero -->\r\n  <section class=\"hero\">\r\n    <div class=\"container\">\r\n      <div class=\"hero-badge\">\u8a18\u4e8b \u00b7 \u30af\u30e9\u30b9\u30bf\u30fc6<\/div>\r\n      <h1>CE\u8a8d\u8a3c\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\uff1aEU\u5e02\u5834\u53c2\u5165\u30ac\u30a4\u30c92026<\/h1>\r\n      <p class=\"hero-lead\">EU\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306eCE\u8a8d\u8a3c\u8981\u4ef6\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306e\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u3002MDR 2017\/745\u3001EMC\u6307\u4ee4\u3001RoHS\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u304a\u3088\u3073OEM\u30e1\u30fc\u30ab\u30fc\u304c\u898f\u5236\u4e0a\u306e\u6210\u529f\u3092\u3069\u306e\u3088\u3046\u306b\u652f\u63f4\u3059\u308b\u304b\u3092\u89e3\u8aac\u3057\u307e\u3059\u3002.<\/p>\r\n      <div class=\"hero-meta\">\r\n        <span>MDR 2017\/745\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/span>\r\n        <span>EMC\u304a\u3088\u3073\u4f4e\u96fb\u5727\u6307\u4ee4<\/span>\r\n        <span>RoHS\u8a8d\u8a3c<\/span>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <!-- Breadcrumb -->\r\n  <div class=\"breadcrumb\">\r\n    <div class=\"container\">\r\n      <a href=\"https:\/\/staging.relish-tech.com\/jp\/\">\u30db\u30fc\u30e0<\/a><span>\/<\/span><a href=\"https:\/\/staging.relish-tech.com\/jp\/%e3%83%8b%e3%83%a5%e3%83%bc%e3%82%b9\/\">\u30d6\u30ed\u30b0<\/a><span>\/<\/span>CE\u8a8d\u8a3c<br>\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\r\n    <\/div>\r\n  <\/div>\r\n\r\n<img decoding=\"async\" src=\"https:\/\/staging.relish-tech.com\/wp-content\/uploads\/2026\/05\/ce-certification-electric-toothbrush-eu-market-scaled.webp\" class=\"product-img\" alt=\"\" title=\"\">\r\n\r\n  <article>\r\n    <div class=\"container\">\r\n\r\n      <h2>CE\u8a8d\u8a3c\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u898f\u683c\u306e\u898f\u5236\u74b0\u5883<\/h2>\r\n\r\n      <p>CE\u30de\u30fc\u30af\u306f\u5358\u306a\u308b\u54c1\u8cea\u306e\u30b7\u30f3\u30dc\u30eb\u3067\u306f\u306a\u304f\u3001\u516827\u306eEU\u52a0\u76df\u56fd\u306b\u30a2\u30a4\u30b9\u30e9\u30f3\u30c9\u3001\u30ea\u30d2\u30c6\u30f3\u30b7\u30e5\u30bf\u30a4\u30f3\u3001\u30ce\u30eb\u30a6\u30a7\u30fc\u3092\u52a0\u3048\u305f\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u3078\u306e\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u306b\u6cd5\u7684\u306b\u5fc5\u9808\u306e\u8981\u4ef6\u3067\u3059\u3002EU\u6cd5\u306e\u4e0b\u3067\u306f\u3001\u6709\u52b9\u306aCE\u30de\u30fc\u30af\u306a\u3057\u306b\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u3092\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u306f\u9055\u6cd5\u3067\u3042\u308a\u3001\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u3001\u591a\u984d\u306e\u7f70\u91d1\u3001\u304a\u3088\u3073\u4f1a\u793e\u5f79\u54e1\u306e\u5211\u4e8b\u8cac\u4efb\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>CE\u30de\u30fc\u30ad\u30f3\u30b0\u5236\u5ea6\u306f\u3001EEA\u5185\u3067\u8ca9\u58f2\u3055\u308c\u308b\u88fd\u54c1\u304c\u4e00\u8cab\u3057\u305f\u5b89\u5168\u6027\u3001\u5065\u5eb7\u3001\u304a\u3088\u3073\u74b0\u5883\u4fdd\u8b77\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u8a2d\u7acb\u3055\u308c\u307e\u3057\u305f\u3002\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u5834\u5408\u3001\u3053\u308c\u306f\u96fb\u6c17\u7684\u5b89\u5168\u6027\u3001\u96fb\u78c1\u5e72\u6e09\u3001\u6709\u5bb3\u7269\u8cea\u542b\u6709\u91cf\u306a\u3069\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u306e\u3055\u307e\u3056\u307e\u306a\u5074\u9762\u306b\u5bfe\u51e6\u3059\u308b\u8907\u6570\u306eEU\u6307\u4ee4\u3078\u306e\u6e96\u62e0\u3092\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u5e02\u5834\u306e\u89b3\u70b9\u304b\u3089\u3001CE\u8a8d\u8a3c\u306f\u3001\u6b27\u5dde\u306e\u5c0f\u58f2\u696d\u8005\u304c\u88fd\u54c1\u3092\u5728\u5eab\u3059\u308b\u524d\u306b\u5fc5\u8981\u3068\u3059\u308b\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6587\u66f8\u5316\u3055\u308c\u305f\u8a3c\u62e0\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u6b27\u5dde\u306e\u30d8\u30eb\u30b9\u30b1\u30a2\u5c0f\u58f2\u696d\u8005\u3001\u85ac\u5c40\u30c1\u30a7\u30fc\u30f3\u3001\u304a\u3088\u3073Amazon EU\u3092\u542b\u3080\u30aa\u30f3\u30e9\u30a4\u30f3\u30de\u30fc\u30b1\u30c3\u30c8\u30d7\u30ec\u30a4\u30b9\u306f\u3059\u3079\u3066\u3001\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u51fa\u54c1\u306bCE\u5ba3\u8a00\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u8a66\u9a13\u5831\u544a\u66f8\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8d85\u3048\u3066\u3001CE\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306f\u88fd\u54c1\u54c1\u8cea\u306e\u5411\u4e0a\u3092\u4fc3\u9032\u3057\u307e\u3059\u3002\u30ea\u30b9\u30af\u5206\u6790\u3001\u8a66\u9a13\u3001\u304a\u3088\u3073\u6587\u66f8\u5316\u8981\u4ef6\u306b\u3088\u308a\u3001\u8a2d\u8a08\u4e0a\u306e\u5f31\u70b9\u304c\u65e9\u671f\u306b\u660e\u3089\u304b\u306b\u306a\u308a\u3001\u4fdd\u8a3c\u8acb\u6c42\u3084\u73fe\u5834\u3067\u306e\u6545\u969c\u304c\u6e1b\u5c11\u3057\u307e\u3059\u3002\u5fb9\u5e95\u3057\u305fCE\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6295\u8cc7\u3059\u308b\u30d6\u30e9\u30f3\u30c9\u306f\u3001\u901a\u5e38\u3001\u5e02\u8ca9\u5f8c\u306e\u5b89\u5168\u6027\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u304c\u5c11\u306a\u304f\u3001\u88fd\u54c1\u306b\u5bfe\u3059\u308b\u6d88\u8cbb\u8005\u306e\u4fe1\u983c\u304c\u3088\u308a\u5f37\u56fa\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u4e2d\u56fd\u304b\u3089\u8abf\u9054\u3059\u308b\u30aa\u30fc\u30e9\u30eb\u30b1\u30a2\u30d6\u30e9\u30f3\u30c9\u306b\u3068\u3063\u3066\u3001CE\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u81ea\u7136\u306a\u54c1\u8cea\u30b2\u30fc\u30c8\u3082\u751f\u307f\u51fa\u3057\u307e\u3059\u3002CE\u8a8d\u8a3c\u306e\u8a66\u9a13\u5831\u544a\u66f8\u3001\u5de5\u5834\u76e3\u67fb\u3001\u304a\u3088\u3073\u6587\u66f8\u5316\u8981\u4ef6\u306f\u3001\u6a19\u6e96\u4ee5\u4e0b\u306e\u30e1\u30fc\u30ab\u30fc\u3092\u3075\u308b\u3044\u843d\u3068\u3057\u3001\u88fd\u54c1\u304c\u6b27\u5dde\u306e\u6d88\u8cbb\u8005\u306b\u5c4a\u304f\u524d\u306b\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u660e\u78ba\u306a\u54c1\u8cea\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002. <a href=\"https:\/\/staging.relish-tech.com\/jp\/oem-odm-%e9%9b%bb%e5%8b%95%e6%ad%af%e3%83%96%e3%83%a9%e3%82%b7%e8%a3%bd%e9%80%a0%e3%82%ac%e3%82%a4%e3%83%89\/\">\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7OEM\u30ac\u30a4\u30c9\u3092\u304a\u8aad\u307f\u304f\u3060\u3055\u3044<\/a> \u7d4c\u9a13\u8c4a\u5bcc\u306a\u30e1\u30fc\u30ab\u30fc\u304c\u3069\u306e\u3088\u3046\u306b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9\u3092\u652f\u63f4\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u306e\u8a73\u7d30\u3092\u3054\u89a7\u3044\u305f\u3060\u3051\u307e\u3059\u3002.<\/p>\r\n\r\n      <h2>\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306b\u9069\u7528\u3055\u308c\u308bEU\u6307\u4ee4<\/h2>\r\n\r\n      <p>\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306f\u901a\u5e38\u3001\u8907\u6570\u306eEU\u6307\u4ee4\u306b\u540c\u6642\u306b\u8a72\u5f53\u3057\u307e\u3059\u3002\u7279\u5b9a\u306e\u88fd\u54c1\u306b\u3069\u306e\u6307\u4ee4\u304c\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u6b63\u78ba\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3092\u69cb\u7bc9\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u9069\u7528\u3055\u308c\u308b\u6307\u4ee4\u306f\u3001\u88fd\u54c1\u306e\u6a5f\u80fd\u3001\u96fb\u6e90\u3001\u610f\u56f3\u3055\u308c\u305f\u4e3b\u5f35\u3001\u304a\u3088\u3073\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <h3>MDR 2017\/745\uff08\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09<\/h3>\r\n\r\n      <p>2021\u5e745\u670826\u65e5\u306b\u533b\u7642\u6a5f\u5668\u6307\u4ee493\/42\/EEC\u3092\u5b8c\u5168\u306b\u7f6e\u304d\u63db\u3048\u305f\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08EU\uff092017\/745\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u533b\u7642\u307e\u305f\u306f\u6cbb\u7642\u52b9\u679c\u3092\u4e3b\u5f35\u3059\u308b\u5834\u5408\u306b\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u88fd\u54c1\u304c\u6b6f\u79d1\u75be\u60a3\u306e\u6cbb\u7642\u307e\u305f\u306f\u4e88\u9632\u3001\u30d7\u30e9\u30fc\u30af\u4f4e\u6e1b\u3001\u6b6f\u830e\u306e\u5065\u5eb7\u6539\u5584\u3001\u307e\u305f\u306f\u6cbb\u7642\u52b9\u679c\u306e\u63d0\u4f9b\u3092\u76ee\u7684\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001MDR\u306b\u57fa\u3065\u304f\u533b\u7642\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>MDR\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0\uff08\u30af\u30e9\u30b9I\u304b\u3089III\uff09\u3067\u306f\u3001\u6cbb\u7642\u52b9\u679c\u3092\u4e3b\u5f35\u3057\u306a\u3044\u4e00\u822c\u7684\u306a\u30a6\u30a7\u30eb\u30cd\u30b9\u88fd\u54c1\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u308b\u5834\u5408\u3001\u307b\u3068\u3093\u3069\u306e\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306f\u30af\u30e9\u30b9I\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u81e8\u5e8a\u52b9\u679c\u304c\u4e3b\u5f35\u3055\u308c\u308b\u5834\u5408\u3001\u5206\u985e\u306f\u30af\u30e9\u30b9IIa\u307e\u305f\u306fIIb\u306b\u4e0a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u5206\u985e\u304c\u9ad8\u304f\u306a\u308b\u3068\u3001\u9069\u5408\u6027\u8a55\u4fa1\u306e\u305f\u3081\u306b\u6307\u5b9a\u6a5f\u95a2\uff08Notified Body\uff09\u306e\u95a2\u4e0e\u304c\u5fc5\u9808\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u30af\u30e9\u30b9I\u6a5f\u5668\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u7dad\u6301\u3057\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3092\u7de8\u96c6\u3059\u308b\u3053\u3068\u3092\u6761\u4ef6\u306b\u3001\u4e00\u822c\u7684\u306bMDR\u306b\u57fa\u3065\u304f\u81ea\u5df1\u5ba3\u8a00\u30eb\u30fc\u30c8\u306b\u5f93\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u3059\u3079\u3066\u306e\u6a5f\u5668\uff08\u30af\u30e9\u30b9I\u3092\u542b\u3080\uff09\u306f\u3001\u767b\u9332\u30e2\u30b8\u30e5\u30fc\u30eb\u304c\u5b8c\u5168\u306b\u904b\u7528\u53ef\u80fd\u306b\u306a\u3063\u305f\u6642\u70b9\u3067\u3001EUDAMED\uff08\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff09\u306b\u767b\u9332\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <div class=\"info-box\">\r\n        <strong>\u5206\u985e\u306b\u95a2\u3059\u308b\u6ce8\u610f\uff1a<\/strong> \u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u304c\u533b\u7642\u52b9\u679c\u3092\u4e3b\u5f35\u305b\u305a\u3001\u7d14\u7c8b\u306b\u6b6f\u3068\u6b6f\u830e\u306e\u7f8e\u5bb9\u76ee\u7684\u306e\u6d17\u6d44\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u308b\u5834\u5408\u3001\u533b\u7642\u6a5f\u5668\u3067\u306f\u306a\u304f\u4e00\u822c\u6d88\u8cbb\u8005\u88fd\u54c1\u3068\u3057\u3066\u5206\u985e\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002Relish Tech\u306eOEM\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e60%\u4ee5\u4e0a\u306f\u3001\u521d\u671f\u5206\u985e\u306b\u95a2\u4fc2\u306a\u304fMDR\u4e92\u63db\u306e\u54c1\u8cea\u57fa\u6e96\u3092\u63a1\u7528\u3057\u3066\u304a\u308a\u3001\u3053\u308c\u306b\u3088\u308a\u6b27\u5dde\u306e\u5c0f\u58f2\u696d\u8005\u3068\u306e\u5e02\u5834\u3067\u306e\u4fe1\u983c\u6027\u304c\u9ad8\u307e\u308a\u3001\u898f\u5236\u5bfe\u8c61\u306e\u533b\u7642\u6a5f\u5668\u5e02\u5834\u3078\u306e\u5c06\u6765\u306e\u62e1\u5927\u304c\u5bb9\u6613\u306b\u306a\u308a\u307e\u3059\uff08\u793e\u5185\u9867\u5ba2\u30c7\u30fc\u30bf\u30012025\u5e74\uff09\u3002.\r\n      <\/div>\r\n\r\n      <h3>EMC\u6307\u4ee42014\/30\/EU\uff08\u96fb\u78c1\u4e21\u7acb\u6027\uff09<\/h3>\r\n\r\n      <p>\u3059\u3079\u3066\u306e\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306b\u306f\u3001\u96fb\u78c1\u653e\u5c04\u3092\u767a\u751f\u3055\u305b\u3001\u305d\u306e\u5f71\u97ff\u3092\u53d7\u3051\u3084\u3059\u3044\u96fb\u5b50\u56de\u8def\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002EMC\u6307\u4ee42014\/30\/EU\u306f\u3001\u88fd\u54c1\u304c\u4ed6\u306e\u96fb\u5b50\u6a5f\u5668\u306b\u5e72\u6e09\u305b\u305a\u3001\u4e00\u822c\u7684\u306a\u96fb\u78c1\u59a8\u5bb3\u304c\u3042\u308b\u74b0\u5883\u3067\u3082\u6b63\u3057\u304f\u52d5\u4f5c\u3067\u304d\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u5834\u5408\u3001EMC\u8a66\u9a13\u306f\u901a\u5e38\u3001\u653e\u5c04\u30a8\u30df\u30c3\u30b7\u30e7\u30f3\u3001\u4f1d\u5c0e\u30a8\u30df\u30c3\u30b7\u30e7\u30f3\u3001\u9759\u96fb\u6c17\u653e\u96fb\u306b\u5bfe\u3059\u308b\u30a4\u30df\u30e5\u30cb\u30c6\u30a3\u3001\u653e\u5c04RF\u30a4\u30df\u30e5\u30cb\u30c6\u30a3\u3001\u96fb\u6c17\u7684\u9ad8\u901f\u904e\u6e21\u73fe\u8c61\u30a4\u30df\u30e5\u30cb\u30c6\u30a3\u3001\u304a\u3088\u3073\u30b5\u30fc\u30b8\u30a4\u30df\u30e5\u30cb\u30c6\u30a3\u3092\u5bfe\u8c61\u3068\u3057\u307e\u3059\u3002\u8a66\u9a13\u898f\u683c\u306b\u306f\u3001EN 55014-1\uff08\u5bb6\u5ead\u7528\u96fb\u6c17\u6a5f\u5668\u306e\u30a8\u30df\u30c3\u30b7\u30e7\u30f3\uff09\u304a\u3088\u3073EN 55014-2\uff08\u30a4\u30df\u30e5\u30cb\u30c6\u30a3\u8981\u4ef6\uff09\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u5145\u96fb\u30d9\u30fc\u30b9\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u5225\u9014EMC\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u5927\u304d\u306a\u4f1d\u5c0e\u304a\u3088\u3073\u653e\u5c04\u30a8\u30df\u30c3\u30b7\u30e7\u30f3\u3092\u767a\u751f\u3055\u305b\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u30d1\u30ef\u30fc\u30a8\u30ec\u30af\u30c8\u30ed\u30cb\u30af\u30b9\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u305f\u3081\u3067\u3059\u3002\u30ef\u30a4\u30e4\u30ec\u30b9\u5145\u96fb\u5f0f\u6b6f\u30d6\u30e9\u30b7\u306f\u3001\u30ef\u30a4\u30e4\u30ec\u30b9\u96fb\u529b\u8ee2\u9001\u6a5f\u80fd\u306b\u3064\u3044\u3066\u7121\u7dda\u6a5f\u5668\u6307\u4ee42014\/53\/EU\uff08RED\uff09\u306b\u3082\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u305f\u3081\u3001\u3055\u3089\u306b\u8907\u96d1\u3055\u304c\u5897\u3057\u307e\u3059\u3002.<\/p>\r\n\r\n      <h3>\u4f4e\u96fb\u5727\u6307\u4ee42014\/35\/EU<\/h3>\r\n\r\n      <p>\u4f4e\u96fb\u5727\u6307\u4ee4\u306f\u3001\u96fb\u5727\u5b9a\u683c\u304c50\uff5e1,000 VAC\uff08\u4ea4\u6d41\uff09\u307e\u305f\u306f75\uff5e1,500 VDC\uff08\u76f4\u6d41\uff09\u306e\u7bc4\u56f2\u3067\u4f7f\u7528\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u305f\u96fb\u6c17\u6a5f\u5668\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u307b\u3068\u3093\u3069\u306e\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306f\u5145\u96fb\u5f0f\u30d0\u30c3\u30c6\u30ea\u30fc\u3067\u52d5\u4f5c\u3057\u3001\u4e3b\u96fb\u6e90\u306b\u63a5\u7d9a\u3059\u308b\u5145\u96fb\u30d9\u30fc\u30b9\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u5982\u679c\u7259\u5237\u5145\u7535\u5e95\u5ea7\u4f7f\u7528\u5e02\u7535\u7535\u538b\uff08\u6b27\u6d32\u901a\u5e38\u4e3a220-240V\uff09\uff0c\u5219\u9002\u7528\u4f4e\u7535\u538b\u6307\u4ee4\u3002\u5173\u952e\u5b89\u5168\u8981\u6c42\u7531\u534f\u8c03\u6807\u51c6EN 60335-1\uff08\u5bb6\u7528\u7535\u5668\u901a\u7528\u8981\u6c42\uff09\u53ca\u76f8\u5173\u4ea7\u54c1\u7279\u5b9a\u6807\u51c6\u89c4\u5b9a\u3002\u6d4b\u8bd5\u6db5\u76d6\u7535\u51fb\u9632\u62a4\u3001\u673a\u68b0\u5b8c\u6574\u6027\u3001\u70ed\u5b89\u5168\u53ca\u5f02\u5e38\u64cd\u4f5c\u6761\u4ef6\u3002.<\/p>\r\n\r\n      <p>\u90e8\u5206\u4e0d\u8fde\u63a5\u5e02\u7535\u7684\u4f4e\u538b\u7535\u6c60\u4f9b\u7535\u7259\u5237\u53ef\u80fd\u4e0d\u5728\u4f4e\u7535\u538b\u6307\u4ee4\u8303\u56f4\u5185\u3002\u7136\u800c\uff0c\u5b83\u4eec\u4ecd\u53ef\u80fd\u9700\u8981\u6839\u636e\u9002\u7528\u4e8e\u6240\u6709\u6d88\u8d39\u54c1\u7684\u300a\u901a\u7528\u4ea7\u54c1\u5b89\u5168\u6307\u4ee4\u300b(EU) 2023\/988\u8fdb\u884c\u6d4b\u8bd5\u3002.<\/p>\r\n\r\n      <h3>RoHS\u6307\u4ee42011\/65\/EU\uff08\u6709\u5bb3\u7269\u8d28\u9650\u5236\uff09<\/h3>\r\n\r\n      <p>\u6709\u5bb3\u7269\u8d28\u9650\u5236\uff08RoHS\uff09\u6307\u4ee4\u9650\u5236\u4e86\u5728\u6b27\u76df\u9500\u552e\u7684\u7535\u6c14\u7535\u5b50\u4ea7\u54c1\u4e2d\u5341\u79cd\u5371\u9669\u5316\u5b66\u7269\u8d28\u7684\u4f7f\u7528\u3002\u7535\u52a8\u7259\u5237\u5c5e\u4e8e\u7b2c11\u7c7b\uff0c\u6db5\u76d6\u5176\u4ed6\u7c7b\u522b\u672a\u5305\u542b\u7684\u7535\u6c14\u7535\u5b50\u4ea7\u54c1\u3002.<\/p>\r\n\r\n      <p>\u53d7\u9650\u7269\u8d28\u5305\u62ec\u94c5\u3001\u6c5e\u3001\u9549\u3001\u516d\u4ef7\u94ec\u3001\u591a\u6eb4\u8054\u82ef\uff08PBB\uff09\u3001\u591a\u6eb4\u4e8c\u82ef\u919a\uff08PBDE\uff09\u4ee5\u53caRoHS 3\uff08EU 2015\/863\uff09\u65b0\u589e\u7684\u56db\u79cd\u90bb\u82ef\u4e8c\u7532\u9178\u916f\uff08DEHP\u3001BBP\u3001DBP\u3001DIBP\uff09\u3002\u5408\u89c4\u6027\u901a\u5e38\u901a\u8fc7\u4f9b\u5e94\u5546\u58f0\u660e\u3001\u7269\u6599\u6e05\u5355\u5206\u6790\u548c\u9009\u62e9\u6027\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5\u6765\u8bc1\u660e\u3002.<\/p>\r\n\r\n      <p>\u5bf9\u4e8eOEM\u5236\u9020\u5546\uff0cRoHS\u5408\u89c4\u9700\u8981\u4e0e\u7ec4\u4ef6\u4f9b\u5e94\u5546\u534f\u8c03\uff0c\u7279\u522b\u662f\u7535\u6c60\u3001\u7535\u673a\u3001\u63a7\u5236\u7535\u5b50\u8bbe\u5907\u548c\u5916\u58f3\u6750\u6599\u3002\u4fe1\u8a89\u826f\u597d\u7684\u4e2d\u56fdOEM\u5236\u9020\u5546\u4f1a\u4e3a\u6807\u51c6\u7ec4\u4ef6\u4fdd\u7559RoHS\u5408\u89c4\u6587\u4ef6\uff0c\u5e76\u53ef\u5e94\u8981\u6c42\u63d0\u4f9b\u6d4b\u8bd5\u62a5\u544a\u3002.<\/p>\r\n\r\n      <div class=\"directive-grid\">\r\n        <div class=\"directive-card\">\r\n          <h4>MDR 2017\/745<\/h4>\r\n          <p>\u9002\u7528\u4e8e\u58f0\u79f0\u5177\u6709\u6cbb\u7597\/\u533b\u7597\u529f\u6548\u7684\u4ea7\u54c1\u3002\u51b3\u5b9a\u8bbe\u5907\u5206\u7c7b\u548c\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84\u3002.<\/p>\r\n        <\/div>\r\n        <div class=\"directive-card\">\r\n          <h4>EMC\u6307\u4ee42014\/30\/EU<\/h4>\r\n          <p>\u6240\u6709\u7535\u52a8\u7259\u5237\u5f3a\u5236\u8981\u6c42\u3002\u786e\u4fdd\u4e0e\u5176\u4ed6\u8bbe\u5907\u548c\u73af\u5883\u7684\u7535\u78c1\u517c\u5bb9\u6027\u3002.<\/p>\r\n        <\/div>\r\n        <div class=\"directive-card\">\r\n          <h4>\u4f4e\u96fb\u5727\u6307\u4ee42014\/35\/EU<\/h4>\r\n          <p>\u9002\u7528\u4e8e\u8fde\u63a5\u5e02\u7535\u7684\u5145\u7535\u5e95\u5ea7\u3002\u786e\u4fdd\u5728\u5e02\u7535\u7535\u538b\u4e0b\u8fd0\u884c\u7684\u4ea7\u54c1\u7684\u7535\u6c14\u5b89\u5168\u3002.<\/p>\r\n        <\/div>\r\n        <div class=\"directive-card\">\r\n          <h4>RoHS\u6307\u4ee42011\/65\/EU<\/h4>\r\n          <p>\u9650\u5236\u6240\u6709\u7535\u6c14\u7ec4\u4ef6\u4e2d\u768410\u79cd\u6709\u5bb3\u7269\u8d28\u3002\u6240\u6709\u5728\u6b27\u76df\u9500\u552e\u7684\u7535\u52a8\u7259\u5237\u5747\u9700\u9075\u5b88\u3002.<\/p>\r\n        <\/div>\r\n      <\/div>\r\n\r\n      <h2>\u7535\u52a8\u7259\u5237CE\u8ba4\u8bc1\u6d41\u7a0b\u2014\u2014\u5206\u6b65\u6307\u5357<\/h2>\r\n\r\n      <p>\u83b7\u5f97\u7535\u52a8\u7259\u5237CE\u8ba4\u8bc1\u6d89\u53ca\u4e00\u4e2a\u7cfb\u7edf\u5316\u6d41\u7a0b\uff0c\u9010\u6b65\u5efa\u7acb\u5408\u89c4\u6587\u4ef6\u3002\u867d\u7136\u5177\u4f53\u6b65\u9aa4\u56e0\u4ea7\u54c1\u5206\u7c7b\u548c\u6240\u9009\u7b26\u5408\u6027\u8bc4\u4f30\u8def\u5f84\u800c\u5f02\uff0c\u4f46\u4ee5\u4e0b\u6846\u67b6\u9002\u7528\u4e8e\u5927\u591a\u6570\u7535\u52a8\u7259\u5237\u5236\u9020\u5546\u3002.<\/p>\r\n\r\n      <div class=\"process-steps\">\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u786e\u5b9a\u9002\u7528\u8981\u6c42<\/h4>\r\n            <p>\u786e\u5b9a\u54ea\u4e9b\u6b27\u76df\u6307\u4ee4\u548c\u534f\u8c03\u6807\u51c6\u9002\u7528\u4e8e\u60a8\u7684\u7279\u5b9a\u4ea7\u54c1\u3002\u8fd9\u9700\u8981\u5206\u6790\u4ea7\u54c1\u7684\u6280\u672f\u7279\u6027\u3001\u9884\u671f\u7528\u9014\u3001\u8425\u9500\u58f0\u660e\u548c\u76ee\u6807\u5e02\u573a\u3002\u5728\u6cd5\u89c4\u9002\u7528\u6027\u77e9\u9635\u4e2d\u8bb0\u5f55\u60a8\u7684\u7406\u7531\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u8fdb\u884c\u98ce\u9669\u5206\u6790<\/h4>\r\n            <p>\u6309\u7167EN ISO 14971\uff08\u533b\u7597\u5668\u68b0\uff09\u6216EN 12182\uff08\u4e00\u822c\u6d88\u8d39\u54c1\uff09\u8fdb\u884c\u5168\u9762\u7684\u98ce\u9669\u8bc4\u4f30\u3002\u8bc6\u522b\u5371\u5bb3\u3001\u8bc4\u4f30\u98ce\u9669\u3001\u8bc4\u4ef7\u98ce\u9669\u53ef\u63a5\u53d7\u6027\u5e76\u5b9e\u65bd\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u3002\u8bb0\u5f55\u6240\u6709\u98ce\u9669\u5206\u6790\u6d3b\u52a8\u548c\u7ed3\u679c\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u7f16\u5236\u6280\u672f\u6587\u4ef6<\/h4>\r\n            <p>\u6c47\u7f16\u5168\u9762\u7684\u6280\u672f\u6587\u6863\uff0c\u5305\u62ec\u4ea7\u54c1\u89c4\u683c\u3001\u8bbe\u8ba1\u56fe\u7eb8\u3001\u7269\u6599\u6e05\u5355\u3001\u5236\u9020\u5de5\u827a\u3001\u98ce\u9669\u5206\u6790\u3001\u9002\u7528\u6807\u51c6\u6587\u6863\u548c\u6d4b\u8bd5\u62a5\u544a\u3002\u6280\u672f\u6587\u4ef6\u5fc5\u987b\u5728\u6d4b\u8bd5\u5f00\u59cb\u524d\u5b8c\u6210\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u8fdb\u884c\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5<\/h4>\r\n            <p>\u59d4\u6258\u7ecf\u8ba4\u53ef\u7684\u6d4b\u8bd5\u5b9e\u9a8c\u5ba4\uff0c\u6839\u636e\u9002\u7528\u7684\u534f\u8c03\u6807\u51c6\u8fdb\u884c\u6240\u6709\u5fc5\u8981\u6d4b\u8bd5\u3002\u5bf9\u4e8e\u7535\u52a8\u7259\u5237\uff0c\u8fd9\u901a\u5e38\u5305\u62ec\u7535\u6c14\u5b89\u5168\u6d4b\u8bd5\u3001EMC\u6d4b\u8bd5\u548cRoHS\u7269\u8d28\u5206\u6790\u3002\u83b7\u53d6\u82f1\u6587\u7b7e\u5b57\u7684\u6d4b\u8bd5\u62a5\u544a\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u81e8\u5e8a\u8a55\u4fa1<\/h4>\r\n            <p>\u88fd\u54c1\u304cMDR\u306b\u57fa\u3065\u304f\u533b\u7642\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u308b\u5834\u5408\u3001EN ISO 14155\u306b\u5f93\u3063\u3066\u81e8\u5e8a\u8a55\u4fa1\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3001\u5e02\u8ca9\u6a5f\u5668\u3068\u306e\u540c\u7b49\u6027\u5206\u6790\u3001\u307e\u305f\u306f\u81e8\u5e8a\u8a66\u9a13\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u4e00\u822c\u6d88\u8cbb\u8005\u5411\u3051\u88fd\u54c1\u306e\u5834\u5408\u306f\u3001\u5b89\u5168\u6027\u8a55\u4fa1\u3067\u5341\u5206\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165<\/h4>\r\n            <p>\u88fd\u54c1\u5206\u985e\u306b\u9069\u3057\u305f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u78ba\u7acb\u3057\u7dad\u6301\u3057\u307e\u3059\u3002MDR\u30af\u30e9\u30b9I\u6a5f\u5668\u306e\u5834\u5408\u3001\u81ea\u5df1\u5ba3\u8a00\u304c\u53ef\u80fd\u3067\u3059\u3002\u3088\u308a\u9ad8\u3044\u30af\u30e9\u30b9\u3067\u306fEN ISO 13485\u8a8d\u8a3c\u304c\u5fc5\u8981\u3067\u3059\u3002\u4e00\u822c\u88fd\u54c1\u306e\u5834\u5408\u3001EN ISO 9001\u304c\u8a8d\u77e5\u3055\u308c\u305f\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u8a8d\u8a3c\u6a5f\u95a2\u5be9\u67fb\uff08\u5fc5\u8981\u306a\u5834\u5408\uff09<\/h4>\r\n            <p>\u8a8d\u8a3c\u6a5f\u95a2\u306e\u95a2\u4e0e\u304c\u5fc5\u8981\u306a\u9ad8\u30ea\u30b9\u30af\u88fd\u54c1\u306e\u5834\u5408\u3001\u6280\u8853\u6587\u66f8\u3092\u5be9\u67fb\u306b\u63d0\u51fa\u3057\u307e\u3059\u3002\u8cea\u554f\u3084\u8ffd\u52a0\u6587\u66f8\u306e\u8981\u6c42\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002\u5be9\u67fb\u5408\u683c\u5f8c\u3001\u9069\u5408\u8a3c\u660e\u66f8\u3092\u53d7\u3051\u53d6\u308a\u307e\u3059\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u9069\u5408\u5ba3\u8a00\u66f8\u306e\u767a\u884c<\/h4>\r\n            <p>\u8a72\u5f53\u3059\u308b\u3059\u3079\u3066\u306e\u6307\u4ee4\u3068\u898f\u683c\u3092\u8a18\u8f09\u3057\u305fEU\u9069\u5408\u5ba3\u8a00\u66f8\uff08DoC\uff09\u3092\u4f5c\u6210\u3057\u7f72\u540d\u3057\u307e\u3059\u3002DoC\u306f\u7d44\u7e54\u5185\u306e\u8cac\u4efb\u8005\u304c\u7f72\u540d\u3057\u3001\u6700\u7d42\u88fd\u54c1\u304c\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u3066\u304b\u308910\u5e74\u9593\u4fdd\u7ba1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>CE\u30de\u30fc\u30af\u306e\u8cbc\u4ed8<\/h4>\r\n            <p>\u88fd\u54c1\u3001\u5305\u88c5\u3001\u304a\u3088\u3073\u4ed8\u5c5e\u6587\u66f8\u306bCE\u30de\u30fc\u30af\u3092\u9069\u7528\u3057\u307e\u3059\u3002CE\u30de\u30fc\u30af\u306f\u8996\u8a8d\u53ef\u80fd\u3067\u3001\u8aad\u307f\u3084\u3059\u304f\u3001\u6d88\u3048\u306a\u3044\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u8a8d\u8a3c\u6a5f\u95a2\u756a\u53f7\u3092CE\u30de\u30fc\u30af\u306e\u96a3\u306b\u542b\u3081\u307e\u3059\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n        <div class=\"process-step\">\r\n          <div class=\"step-num\"><\/div>\r\n          <div class=\"step-content\">\r\n            <h4>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u78ba\u7acb<\/h4>\r\n            <p>\u5e02\u5834\u306b\u304a\u3051\u308b\u88fd\u54c1\u6027\u80fd\u306e\u7d99\u7d9a\u7684\u306a\u76e3\u8996\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u9867\u5ba2\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3001\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u3001\u304a\u3088\u3073\u73fe\u5834\u6027\u80fd\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u6280\u8853\u6587\u66f8\u3068\u9069\u5408\u5ba3\u8a00\u66f8\u3092\u66f4\u65b0\u3057\u307e\u3059\u3002\u91cd\u5927\u306a\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u306f\u3001\u8981\u6c42\u3055\u308c\u308b\u671f\u9593\u5185\u306b\u95a2\u9023\u5f53\u5c40\u306b\u5831\u544a\u3057\u307e\u3059\u3002.<\/p>\r\n          <\/div>\r\n        <\/div>\r\n      <\/div>\r\n\r\n      <h2>\u8a8d\u8a3c\u6a5f\u95a2 vs \u81ea\u5df1\u5ba3\u8a00\uff1a\u88fd\u54c1\u306b\u9069\u3057\u305f\u9078\u629e\u306f\uff1f<\/h2>\r\n\r\n      <p>CE\u8a8d\u8a3c\u306b\u304a\u3051\u308b\u6700\u3082\u91cd\u8981\u306a\u6c7a\u5b9a\u306e\u4e00\u3064\u306f\u3001\u8a8d\u8a3c\u6a5f\u95a2\u306e\u95a2\u4e0e\u3068\u81ea\u5df1\u5ba3\u8a00\u30eb\u30fc\u30c8\u306e\u9078\u629e\u3067\u3059\u3002\u3053\u306e\u9078\u629e\u306f\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001\u4e88\u7b97\u3001\u5e02\u5834\u306e\u4fe1\u983c\u6027\u3001\u304a\u3088\u3073CE\u30de\u30fc\u30af\u304c\u6301\u3064\u5916\u90e8\u691c\u8a3c\u306e\u30ec\u30d9\u30eb\u306b\u5f71\u97ff\u3057\u307e\u3059\u3002.<\/p>\r\n\r\n      <div class=\"table-wrap\">\r\n        <table>\r\n          <thead>\r\n            <tr>\r\n              <th>\u8981\u7d20<\/th>\r\n              <th>\u81ea\u5df1\u5ba3\u8a00<\/th>\r\n              <th>\u8a8d\u8a3c\u6a5f\u95a2\u5be9\u67fb<\/th>\r\n            <\/tr>\r\n          <\/thead>\r\n          <tbody>\r\n            <tr>\r\n              <td><strong>\u898f\u5236\u8981\u4ef6<\/strong><\/td>\r\n              <td>\u8a8d\u8a3c\u6a5f\u95a2\u306e\u7fa9\u52d9\u8981\u4ef6\u304c\u306a\u3044\u30af\u30e9\u30b9I\u4e00\u822c\u88fd\u54c1\u306b\u5229\u7528\u53ef\u80fd<\/td>\r\n              <td>\u30af\u30e9\u30b9IIa\u3001IIb\u3001III\u533b\u7642\u6a5f\u5668\u306b\u5fc5\u9808\u3002\u4e00\u90e8\u306e\u30af\u30e9\u30b9I\u6a5f\u5668\u306f\u81ea\u4e3b\u7684\u306b\u8a8d\u8a3c\u6a5f\u95a2\u3092\u5229\u7528<\/td>\r\n            <\/tr>\r\n            <tr>\r\n              <td><strong>\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/strong><\/td>\r\n              <td>4\uff5e8\u9031\u9593\uff08\u8a66\u9a13\u3092\u9664\u304f\uff09<\/td>\r\n              <td>3\uff5e6\u30f6\u6708\uff08\u6e96\u5099\u3092\u9664\u304f\uff09<\/td>\r\n            <\/tr>\r\n            <tr>\r\n              <td><strong>\u30b3\u30b9\u30c8\u7bc4\u56f2<\/strong><\/td>\r\n              <td><strong>2,000\uff5e10,000\u30e6\u30fc\u30ed<\/strong><\/td>\r\n              <td><strong>15,000\uff5e50,000\u30e6\u30fc\u30ed\u4ee5\u4e0a<\/strong><\/td>\r\n            <\/tr>\r\n            <tr>\r\n              <td><strong>\u5e02\u5834\u306e\u4fe1\u983c\u6027<\/strong><\/td>\r\n              <td>\u57fa\u672c\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ec\u30d9\u30eb<\/td>\r\n              <td>\u5c0f\u58f2\u696d\u8005\u3084\u533b\u7642\u5c02\u9580\u5bb6\u3068\u306e\u9ad8\u3044\u4fe1\u983c\u6027<\/td>\r\n            <\/tr>\r\n            <tr>\r\n              <td><strong>\u76e3\u67fb\u8981\u4ef6<\/strong><\/td>\r\n              <td>\u5185\u90e8QMS\u5ba3\u8a00<\/td>\r\n              <td>\u8a8d\u8a3c\u6a5f\u95a2\u306b\u3088\u308b\u30aa\u30f3\u30b5\u30a4\u30c8\u76e3\u67fb<\/td>\r\n            <\/tr>\r\n            <tr>\r\n              <td><strong>\u88fd\u54c1\u5909\u66f4<\/strong><\/td>\r\n              <td>\u66f4\u65b0\u3055\u308c\u305fDoC\u3067\u81ea\u5df1\u7ba1\u7406<\/td>\r\n              <td>\u91cd\u8981\u306a\u5909\u66f4\u306b\u306f\u8a8d\u8a3c\u6a5f\u95a2\u306e\u5be9\u67fb\u304c\u5fc5\u8981\u306a\u5834\u5408\u3042\u308a<\/td>\r\n            <\/tr>\r\n          <\/tbody>\r\n        <\/table>\r\n      <\/div>\r\n\r\n      <p>\u6cbb\u7642\u52b9\u679c\u3092\u8b33\u308f\u306a\u3044\u4e00\u822c\u6d88\u8cbb\u8005\u5411\u3051\u88fd\u54c1\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u308b\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u5834\u5408\u3001\u81ea\u5df1\u5ba3\u8a00\u304c\u901a\u5e38\u9069\u5207\u304b\u3064\u6cd5\u7684\u306b\u5341\u5206\u306a\u30eb\u30fc\u30c8\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u591a\u304f\u306e\u30d6\u30e9\u30f3\u30c9\u306f\u3001\u6df7\u96d1\u3057\u305f\u5e02\u5834\u3067\u88fd\u54c1\u3092\u5dee\u5225\u5316\u3057\u3001\u7b2c\u4e09\u8005\u306b\u3088\u308b\u691c\u8a3c\u3092\u307e\u3059\u307e\u3059\u671f\u5f85\u3059\u308b\u6b27\u5dde\u306e\u5c0f\u58f2\u30d0\u30a4\u30e4\u30fc\u3068\u306e\u4fe1\u983c\u3092\u69cb\u7bc9\u3059\u308b\u305f\u3081\u306b\u3001\u8a8d\u8a3c\u6a5f\u95a2\u306e\u5be9\u67fb\u3092\u9078\u629e\u3057\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u304c\u533b\u7642\u6a5f\u5668\u306e\u4e3b\u5f35\u3092\u884c\u3046\u5834\u5408\u3001\u307e\u305f\u306f\u3088\u308a\u9ad8\u3044\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u306b\u8a72\u5f53\u3059\u308b\u5834\u5408\u3001\u8a8d\u8a3c\u6a5f\u95a2\u306e\u95a2\u4e0e\u304c\u5fc5\u9808\u3067\u3059\u3002\u96fb\u6c17\/\u53e3\u8154\u30b1\u30a2\u88fd\u54c1\u306e\u7d4c\u9a13\u3092\u6301\u3064\u8a8d\u8a3c\u6a5f\u95a2\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u3067\u3001\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u304c\u52a0\u901f\u3055\u308c\u3001\u6280\u8853\u6587\u66f8\u306e\u6280\u8853\u7684\u306b\u9069\u5207\u306a\u8a55\u4fa1\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002.<\/p>\r\n\r\n      <h2>MDR\u306b\u57fa\u3065\u304f\u81e8\u5e8a\u8a55\u4fa1\u8981\u4ef6<\/h2>\r\n\r\n      <p>\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u533b\u7642\u6a5f\u5668\u5206\u985e\u3092\u6301\u3064\u88fd\u54c1\u306b\u5bfe\u3059\u308bMDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u57fa\u76e4\u3067\u3059\u3002\u4e00\u822c\u6d88\u8cbb\u8005\u5411\u3051\u88fd\u54c1\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u308b\u307b\u3068\u3093\u3069\u306e\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306f\u6b63\u5f0f\u306a\u81e8\u5e8a\u8a55\u4fa1\u3092\u5fc5\u8981\u3068\u3057\u307e\u305b\u3093\u304c\u3001\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u6cbb\u7642\u52b9\u679c\u3092\u8a08\u753b\u3057\u3066\u3044\u308b\u30d6\u30e9\u30f3\u30c9\u3084\u533b\u7642\u6a5f\u5668\u5206\u985e\u306e\u62e1\u5927\u3092\u691c\u8a0e\u3057\u3066\u3044\u308b\u30d6\u30e9\u30f3\u30c9\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u3067\u3059\u3002.<\/p>\r\n\r\n      <p>MDR\u7b2c61\u6761\u304a\u3088\u3073\u9644\u5c5e\u66f8XIV\u306b\u57fa\u3065\u304d\u3001\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u7684\u5229\u76ca\u304c\u3001\u610f\u56f3\u3055\u308c\u305f\u4f7f\u7528\u6642\u306b\u6b8b\u5b58\u30ea\u30b9\u30af\u3092\u4e0a\u56de\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u53e3\u8154\u30b1\u30a2\u6a5f\u5668\u306e\u5834\u5408\u3001\u81e8\u5e8a\u8a55\u4fa1\u306b\u306f\u901a\u5e38\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\uff1a<\/p>\r\n\r\n      <ul>\r\n        <li><strong>\u6587\u732e\u30ec\u30d3\u30e5\u30fc\uff1a<\/strong> \u985e\u4f3c\u6a5f\u5668\u307e\u305f\u306f\u7279\u5b9a\u88fd\u54c1\u306b\u95a2\u3059\u308b\u516c\u958b\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u7cfb\u7d71\u7684\u306a\u691c\u7d22\u3068\u5206\u6790\u3002\u3053\u308c\u306b\u306f\u3001\u67fb\u8aad\u4ed8\u304d\u7814\u7a76\u3001\u81e8\u5e8a\u8a66\u9a13\u7d50\u679c\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u540c\u7b49\u6a5f\u5668\u304b\u3089\u306e\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u540c\u7b49\u6027\u5206\u6790\uff1a<\/strong> \u81ea\u793e\u88fd\u54c1\u304c\u3001\u6280\u8853\u7684\u7279\u6027\u3001\u751f\u7269\u5b66\u7684\u7279\u6027\u3001\u81e8\u5e8a\u7684\u7279\u6027\u3001\u304a\u3088\u3073\u610f\u56f3\u3055\u308c\u305f\u4f7f\u7528\u306b\u304a\u3044\u3066\u3001\u5e02\u8ca9\u6a5f\u5668\u3068\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3057\u307e\u3059\u3002\u540c\u7b49\u6027\u306b\u3088\u308a\u3001\u81ea\u793e\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u4ee3\u308f\u308a\u306b\u3001\u540c\u7b49\u6a5f\u5668\u304b\u3089\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3067\u304d\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u81e8\u5e8a\u8a66\u9a13\uff1a<\/strong> \u6587\u732e\u3084\u540c\u7b49\u6027\u3092\u901a\u3058\u3066\u5341\u5206\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u5f97\u3089\u308c\u306a\u3044\u5834\u5408\u3001\u81e8\u5e8a\u8a66\u9a13\u304c\u5fc5\u8981\u306b\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u5834\u5408\u3001\u30d7\u30e9\u30fc\u30af\u4f4e\u6e1b\u3001\u6b6f\u8089\u6539\u5584\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u81e8\u5e8a\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3092\u6e2c\u5b9a\u3059\u308b\u7ba1\u7406\u8a66\u9a13\u304c\u542b\u307e\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\uff1a<\/strong> \u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u308b\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u691c\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u5e02\u5834\u6295\u5165\u5f8c\u306b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u7d99\u7d9a\u7684\u306b\u53ce\u96c6\u3057\u307e\u3059\u3002PMCF\u8a08\u753b\u306f\u3001\u30af\u30e9\u30b9IIa\u4ee5\u4e0a\u306e\u6a5f\u5668\u306b\u5fc5\u8981\u3067\u3059\u3002.<\/li>\r\n      <\/ul>\r\n\r\n      <p>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306f\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u5b9a\u671f\u7684\u306b\u66f4\u65b0\u3055\u308c\u3001\u6280\u8853\u6587\u66f8\u306b\u542b\u307e\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u88fd\u9020\u696d\u8005\u306f\u3001\u533b\u7642\u6a5f\u5668\u5206\u985e\u306e\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u6b63\u5f0f\u306a\u81e8\u5e8a\u8a55\u4fa1\u3092\u5b9f\u65bd\u3059\u308b\u969b\u306b\u306f\u3001MDR\u8981\u4ef6\u306b\u7cbe\u901a\u3057\u305f\u81e8\u5e8a\u696d\u52d9\u306e\u5c02\u9580\u5bb6\u3092\u95a2\u4e0e\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <h2>Brexit\u5f8c\u306e\u82f1\u56fdCA\u30de\u30fc\u30ad\u30f3\u30b0<\/h2>\r\n\r\n      <p>\u82f1\u56fd\u306eEU\u96e2\u8131\u5f8c\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u306f\u82f1\u56fd\uff08\u30a4\u30f3\u30b0\u30e9\u30f3\u30c9\u3001\u30a6\u30a7\u30fc\u30eb\u30ba\u3001\u30b9\u30b3\u30c3\u30c8\u30e9\u30f3\u30c9\uff09\u3067\u8ca9\u58f2\u3055\u308c\u308b\u88fd\u54c1\u306b\u306f\u9069\u7528\u3055\u308c\u306a\u304f\u306a\u308a\u307e\u3057\u305f\u3002\u4ee3\u308f\u308a\u306b\u3001\u82f1\u56fd\u306f\u72ec\u81ea\u306e\u9069\u5408\u30de\u30fc\u30ad\u30f3\u30b0\u3067\u3042\u308bUKCA\uff08\u82f1\u56fd\u9069\u5408\u8a55\u4fa1\uff09\u30de\u30fc\u30af\u3092\u5c0e\u5165\u3057\u307e\u3057\u305f\u3002\u305f\u3060\u3057\u3001\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306f\u5317\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u8b70\u5b9a\u66f8\u306b\u57fa\u3065\u304d\u3001\u5f15\u304d\u7d9a\u304dCE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\r\n\r\n      <p>UKCA\u30de\u30fc\u30ad\u30f3\u30b0\u8981\u4ef6\u306f\u3001EU\u306eCE\u67a0\u7d44\u307f\u3068\u307b\u307c\u540c\u3058\u3067\u3059\u304c\u3001\u898f\u683c\u306e\u8abf\u548c\u3001\u627f\u8a8d\u6a5f\u95a2\u3001\u6280\u8853\u6587\u66f8\u8981\u4ef6\u306b\u304a\u3044\u3066\u9855\u8457\u306a\u9055\u3044\u304c\u3042\u308a\u307e\u3059\u3002\u82f1\u56fd\u5e02\u5834\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u3068\u3059\u308b\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u88fd\u9020\u696d\u8005\u5411\u3051\u306e\u4e3b\u306a\u8003\u616e\u4e8b\u9805\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\uff1a<\/p>\r\n\r\n      <ul>\r\n        <li><strong>\u5225\u9014\u8a8d\u8a3c\uff1a<\/strong> CE\u30de\u30fc\u30ad\u30f3\u30b0\u3068UKCA\u30de\u30fc\u30ad\u30f3\u30b0\u306f\u5225\u500b\u306e\u8981\u4ef6\u3067\u3059\u3002CE\u8a3c\u660e\u66f8\u306f\u81ea\u52d5\u7684\u306bUKCA\u6e96\u62e0\u3092\u4ed8\u4e0e\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u305d\u306e\u9006\u3082\u540c\u69d8\u3067\u3059\u3002.<\/li>\r\n        <li><strong>UK\u627f\u8a8d\u6a5f\u95a2\uff1a<\/strong> EU\u306eNotified Body\u3068\u306f\u7570\u306a\u308a\u3001\u533b\u7642\u6a5f\u5668\u5411\u3051\u306eUK\u627f\u8a8d\u6a5f\u95a2\u306f\u6570\u304c\u9650\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u898f\u5236\u5e81\uff08MHRA\uff09\u304c\u6a5f\u5668\u767b\u9332\u3068\u5e02\u5834\u76e3\u8996\u3092\u76e3\u7763\u3057\u3066\u3044\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u6280\u8853\u6587\u66f8\uff1a<\/strong> UKCA\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u8981\u4ef6\u306fCE\u3068\u985e\u4f3c\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u7570\u306a\u308b\u6307\u5b9a\u898f\u683c\uff08\u56fd\u969b\u898f\u683c\u306b\u6e96\u62e0\u3057\u305f\u82f1\u56fd\u898f\u683c\uff09\u3092\u53c2\u7167\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\r\n        <li><strong>UKCA\u30de\u30fc\u30af\u306e\u914d\u7f6e\uff1a<\/strong> UKCA\u30de\u30fc\u30af\u306f\u88fd\u54c1\u307e\u305f\u306f\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u8868\u793a\u3055\u308c\u3001UKCA\u30ed\u30b4\u304a\u3088\u3073\u8f38\u5165\u696d\u8005\u60c5\u5831\u3092\u4f75\u8a18\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\r\n        <li><strong>MDR\u540c\u7b49\u6027\uff1a<\/strong> \u82f1\u56fdMDR 2002\uff08\u6539\u6b63\u7248\uff09\u3067\u306f\u3001\u5206\u985e\u304a\u3088\u3073\u627f\u8a8d\u8981\u4ef6\u304cEU MDR 2017\/745\u3068\u306f\u7570\u306a\u308a\u307e\u3059\u3002EU\u3067\u627f\u8a8d\u3055\u308c\u305f\u4e00\u90e8\u306e\u6a5f\u5668\u306f\u3001\u82f1\u56fd\u3067\u81ea\u52d5\u7684\u306b\u627f\u8a8d\u3055\u308c\u306a\u3044\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\r\n      <\/ul>\r\n\r\n      <p>\u4e2d\u56fd\u304b\u3089\u8abf\u9054\u3057\u3001EU\u3068\u82f1\u56fd\u306e\u4e21\u5e02\u5834\u3067\u8ca9\u58f2\u3059\u308b\u30d6\u30e9\u30f3\u30c9\u306b\u3068\u3063\u3066\u3001\u5f53\u521d\u304b\u3089\u4e8c\u91cd\u6e96\u62e0\u3092\u8a08\u753b\u3059\u308b\u3053\u3068\u306f\u3001\u5f8c\u4ed8\u3051\u3067\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3088\u308a\u3082\u52b9\u7387\u7684\u3067\u3059\u3002OEM\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u898f\u683c\u304c\u91cd\u8907\u3059\u308b\u5834\u5408\u3001CE\u3068UKCA\u306e\u4e21\u65b9\u306e\u8a66\u9a13\u8981\u4ef6\u3092\u540c\u6642\u306b\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <div class=\"warning-box\">\r\n        <strong>\u91cd\u8981\uff1a<\/strong> 2021\u5e745\u6708\u4ee5\u964d\u3001EU MDR 2017\/745\u304c\u533b\u7642\u6a5f\u5668\u6307\u4ee493\/42\/EEC\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308a\u307e\u3057\u305f\u3002\u65e7MDD\u306e\u4e0b\u3067\u65e2\u306b\u5e02\u5834\u306b\u51fa\u3066\u3044\u308b\u88fd\u54c1\u306f\u30012028\u5e74\u307e\u3067\u306bMDR\u6e96\u62e0\u306b\u79fb\u884c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u304a\u4f7f\u3044\u306e\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u304c\u73fe\u5728MDD\u306b\u57fa\u3065\u304fCE\u8a3c\u660e\u66f8\u3092\u4fdd\u6709\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001Notified Body\u306e\u51e6\u7406\u80fd\u529b\u304c\u9650\u3089\u308c\u3066\u304a\u308a\u3001\u5be9\u67fb\u671f\u9593\u304c\u9577\u671f\u5316\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u4e8b\u524d\u306b\u79fb\u884c\u3092\u8a08\u753b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.\r\n      <\/div>\r\n\r\n      <h2>Relish Tech\u304cEU\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u65b9\u6cd5<\/h2>\r\n\r\n      <p>\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306eCE\u8a8d\u8a3c\u3092\u9032\u3081\u308b\u306b\u306f\u3001\u30d6\u30e9\u30f3\u30c9\u30aa\u30fc\u30ca\u30fc\u3001OEM\u30e1\u30fc\u30ab\u30fc\u3001\u8a66\u9a13\u6a5f\u95a2\u3001\u5834\u5408\u306b\u3088\u3063\u3066\u306fNotified Body\u9593\u306e\u7dca\u5bc6\u306a\u9023\u643a\u304c\u5fc5\u8981\u3067\u3059\u3002. <a href=\"https:\/\/staging.relish-tech.com\/jp\/oem%e3%82%ac%e3%82%a4%e3%83%89\/\">Relish Tech\u306eOEM\/ODM\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306f\u3001<\/a> \u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u4f5c\u6210\u3001\u8a8d\u5b9a\u8a66\u9a13\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u63d0\u51fa\u3092\u8abf\u6574\u3057\u3001EU\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u30aa\u30fc\u30e9\u30eb\u30b1\u30a2\u30d6\u30e9\u30f3\u30c9\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>\u5f53\u793e\u306e\u65e2\u5b58\u306e\u8a8d\u8a3c\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30a4\u30f3\u30d5\u30e9\u306f\u3001EU\u5e02\u5834\u53c2\u5165\u306e\u5f37\u56fa\u306a\u57fa\u76e4\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002ISO 13485\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3001FDA\u767b\u9332\u65bd\u8a2d\u3001EU\u6307\u4ee4\u3092\u542b\u3080\u56fd\u969b\u898f\u5236\u8981\u4ef6\u306b\u95a2\u3059\u308b\u8c4a\u5bcc\u306a\u7d4c\u9a13\u3092\u7dad\u6301\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\r\n\r\n      <p>Relish Tech\u306eEU\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30b5\u30dd\u30fc\u30c8\u6a5f\u80fd\u306f\u4ee5\u4e0b\u3092\u542b\u307f\u307e\u3059\uff1a<\/p>\r\n\r\n      <ul>\r\n        <li><strong>\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u4f5c\u6210\uff1a<\/strong> \u5f53\u793e\u306e\u898f\u5236\u696d\u52d9\u30c1\u30fc\u30e0\u306f\u3001EU\u306e\u6587\u66f8\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5305\u62ec\u7684\u306a\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u4f5c\u6210\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u8a2d\u8a08\u4ed5\u69d8\u66f8\u3001\u30ea\u30b9\u30af\u5206\u6790\u3001\u88fd\u9020\u6587\u66f8\u3092\u6a19\u6e96\u5316\u3055\u308c\u305f\u5f62\u5f0f\u3067\u63d0\u4f9b\u3057\u3001Notified Body\u306e\u5be9\u67fb\u3092\u7c21\u7d20\u5316\u3057\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u4e8b\u524d\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8a66\u9a13\u30b5\u30dd\u30fc\u30c8\uff1a<\/strong> \u6b63\u5f0f\u306a\u8a66\u9a13\u306e\u524d\u306b\u3001\u5185\u90e8\u8a2d\u8a08\u691c\u8a3c\u3092\u5b9f\u65bd\u3057\u3066\u6f5c\u5728\u7684\u306a\u4e0d\u9069\u5408\u3092\u65e9\u671f\u306b\u7279\u5b9a\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u8a66\u9a13\u4e0d\u5408\u683c\u3001\u518d\u8a2d\u8a08\u8981\u4ef6\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u9045\u5ef6\u306e\u30ea\u30b9\u30af\u304c\u8efd\u6e1b\u3055\u308c\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u8a8d\u5b9a\u8a66\u9a13\u306e\u8abf\u6574\uff1a<\/strong> \u5f53\u793e\u306f\u3001EMC\u3001\u96fb\u6c17\u7684\u5b89\u5168\u6027\u3001RoHS\u5206\u6790\u306a\u3069\u3001\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u8a66\u9a13\u306b\u3064\u3044\u3066\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u7b2c\u4e09\u8005\u8a66\u9a13\u6a5f\u95a2\u3068\u9023\u643a\u3057\u3066\u3044\u307e\u3059\u3002\u4e3b\u8981\u306a\u8a66\u9a13\u6a5f\u95a2\u3068\u306e\u95a2\u4fc2\u306b\u3088\u308a\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u52a0\u901f\u3055\u308c\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u9867\u5ba2\u306b\u3068\u3063\u3066\u6709\u5229\u306a\u4fa1\u683c\u8a2d\u5b9a\u304c\u5b9f\u73fe\u3057\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30e9\u30a4\u30d6\u30e9\u30ea\uff1a<\/strong> \u5f53\u793e\u306f\u3001\u6a19\u6e96\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306eRoHS\u304a\u3088\u3073REACH\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6587\u66f8\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u7dad\u6301\u3057\u3066\u304a\u308a\u3001\u65b0\u88fd\u54c1\u5c0e\u5165\u6642\u306e\u6587\u66f8\u5316\u4f5c\u696d\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u30e9\u30d9\u30eb\u8868\u793a\u30b5\u30dd\u30fc\u30c8\uff1a<\/strong> \u5f53\u793e\u306e\u30c1\u30fc\u30e0\u306f\u3001\u591a\u8a00\u8a9e\u306e\u4f7f\u7528\u8aac\u660e\u66f8\u3001CE\u30de\u30fc\u30af\u914d\u7f6e\u4ed5\u69d8\u3001\u8f38\u5165\u696d\u8005\u60c5\u5831\u8981\u4ef6\u306a\u3069\u3001EU\u306e\u30e9\u30d9\u30eb\u8868\u793a\u8981\u4ef6\u3092\u7406\u89e3\u3057\u3066\u3044\u307e\u3059\u3002.<\/li>\r\n        <li><strong>\u5de5\u5834\u76e3\u67fb\u6587\u66f8\uff1a<\/strong> \u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u691c\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u30d6\u30e9\u30f3\u30c9\u5411\u3051\u306b\u3001ISO 13485\u8a3c\u660e\u66f8\u3001\u65bd\u8a2d\u5199\u771f\u3001\u751f\u7523\u80fd\u529b\u30c7\u30fc\u30bf\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u6982\u8981\u3092\u542b\u3080\u5305\u62ec\u7684\u306a\u76e3\u67fb\u6587\u66f8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002.<\/li>\r\n      <\/ul>\r\n\r\n      <p>\u7d4c\u9a13\u8c4a\u5bcc\u306aOEM\u30e1\u30fc\u30ab\u30fc\u3068\u5f53\u521d\u304b\u3089\u63d0\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u30aa\u30fc\u30e9\u30eb\u30b1\u30a2\u30d6\u30e9\u30f3\u30c9\u306fEU\u5e02\u5834\u53c2\u5165\u306b\u304b\u304b\u308b\u6642\u9593\u3001\u30b3\u30b9\u30c8\u3001\u8907\u96d1\u3055\u3092\u5927\u5e45\u306b\u524a\u6e1b\u3067\u304d\u307e\u3059\u3002\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3078\u306e\u5f53\u793e\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u8a73\u7d30\u306f\u3001 <a href=\"https:\/\/staging.relish-tech.com\/jp\/%e8%aa%8d%e8%a8%bc\/\">\u8a8d\u8a3c\u30da\u30fc\u30b8<\/a> \u3092\u3054\u89a7\u3044\u305f\u3060\u304f\u304b\u3001\u76f4\u63a5\u30c1\u30fc\u30e0\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002.<\/p>\r\n\r\n      <!-- OEM Sourcing Essentials -->\r\n      <div class=\"info-box\">\r\n        <strong>EU\u5e02\u5834\u53c2\u5165\u306e\u305f\u3081\u306eOEM\u8abf\u9054\u306e\u8981\u70b9<\/strong>\r\n        <ul style=\"margin: 8px 0 0 20px;\">\r\n          <li><strong>MOQ\uff1a<\/strong> SKU\u3042\u305f\u308a500\u30e6\u30cb\u30c3\u30c8\u304b\u3089\u306e\u3054\u6ce8\u6587\u3067CE\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30b5\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b<\/li>\r\n          <li><strong>\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0<\/strong> \u4e8b\u524d\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30b5\u30f3\u30d7\u30eb\u306b4\uff5e6\u9031\u9593\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u6e96\u5099\u306b8\uff5e12\u9031\u9593\u3001CE\u6587\u66f8\u5b8c\u6210\u5f8c\u306e\u672c\u751f\u7523\u306b60\uff5e120\u65e5<\/li>\r\n          <li><strong>QC\u57fa\u6e96\uff1a<\/strong> ISO 13485\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u51fa\u8377\u524dAQL 1.5\/2.5\u691c\u67fb\u3001\u51fa\u8377\u524d\u306eCE\u6587\u66f8\u30ec\u30d3\u30e5\u30fc<\/li>\r\n          <li><strong>\u8cc7\u683c\uff1a<\/strong> ISO 13485\u3001FDA 21 CFR Part 820\u3001CE MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6587\u66f8\u3001RoHS\/REACH\u8a66\u9a13\u3001EMC\u304a\u3088\u3073\u96fb\u6c17\u7684\u5b89\u5168\u6027\u8a66\u9a13\u306e\u8abf\u6574<\/li>\r\n        <\/ul>\r\n      <\/div>\r\n\r\n      <h2>\u30aa\u30fc\u30e9\u30eb\u30b1\u30a2\u6a5f\u5668\u306eEU\u5e02\u5834\u53c2\u5165\u306b\u304a\u3051\u308b\u4e00\u822c\u7684\u306a\u843d\u3068\u3057\u7a74<\/h2>\r\n\r\n      <p>CE\u30de\u30fc\u30ad\u30f3\u30b0\u8981\u4ef6\u306f\u4e00\u898b\u7c21\u5358\u305d\u3046\u306b\u898b\u3048\u307e\u3059\u304c\u3001\u591a\u304f\u306e\u30aa\u30fc\u30e9\u30eb\u30b1\u30a2\u30d6\u30e9\u30f3\u30c9\u306f\u5e02\u5834\u53c2\u5165\u3092\u9045\u3089\u305b\u3001\u30b3\u30b9\u30c8\u3092\u81a8\u3089\u307e\u305b\u308b\u969c\u5bb3\u306b\u76f4\u9762\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u4e00\u822c\u7684\u306a\u843d\u3068\u3057\u7a74\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u7a4d\u6975\u7684\u306a\u7de9\u548c\u6226\u7565\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\r\n\r\n      <ul>\r\n        <li><strong>\u4e0d\u5b8c\u5168\u306a\u6280\u8853\u30d5\u30a1\u30a4\u30eb\uff1a<\/strong> \u8a66\u9a13\u6a5f\u95a2\u306f\u5b8c\u5168\u306a\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306a\u3057\u3067\u306f\u8a66\u9a13\u3092\u958b\u59cb\u3067\u304d\u307e\u305b\u3093\u3002\u6587\u66f8\u6e96\u5099\u6642\u9593\u3092\u904e\u5c0f\u8a55\u4fa1\u3059\u308b\u30d6\u30e9\u30f3\u30c9\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u671f\u9593\u306e\u5ef6\u9577\u306b\u76f4\u9762\u3057\u307e\u3059\u3002\u8a66\u9a13\u958b\u59cb\u524d\u306b\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u4f5c\u6210\u306b4\uff5e8\u9031\u9593\u3092\u5272\u308a\u5f53\u3066\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\r\n        <li><strong>\u898f\u683c\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u66f4\u65b0\uff1a<\/strong> \u6574\u5408\u898f\u683c\u306f\u5b9a\u671f\u7684\u306b\u66f4\u65b0\u3055\u308c\u3001\u53e4\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u9069\u5408\u6027\u306e\u63a8\u5b9a\u3092\u5931\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u53e4\u3044\u898f\u683c\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u4e0d\u9069\u5408\u306a\u5ba3\u8a00\u306b\u306a\u308a\u307e\u3059\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u958b\u59cb\u6642\u306b\u73fe\u5728\u306e\u898f\u683c\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u78ba\u8a8d\u3057\u3001\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u4e2d\u306b\u66f4\u65b0\u3092\u76e3\u8996\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\r\n        <li><strong>\u30d0\u30c3\u30c6\u30ea\u30fc\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u30ae\u30e3\u30c3\u30d7\uff1a<\/strong> \u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u30d0\u30c3\u30c6\u30ea\u30fc\u306f\u3001\u8f38\u9001\u8a66\u9a13\u306e\u305f\u3081\u306eUN 38.3\u3092\u542b\u3080\u7279\u5b9a\u306e\u898f\u5236\u306e\u5bfe\u8c61\u3067\u3059\u3002\u591a\u304f\u306e\u30d6\u30e9\u30f3\u30c9\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u5f8c\u671f\u307e\u3067\u30d0\u30c3\u30c6\u30ea\u30fc\u56fa\u6709\u306e\u8981\u4ef6\u3092\u898b\u843d\u3068\u3057\u307e\u3059\u3002\u30d0\u30c3\u30c6\u30ea\u30fc\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6587\u66f8\u304c\u6700\u521d\u304b\u3089\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002. <a href=\"https:\/\/staging.relish-tech.com\/jp\/%e5%95%86%e5%93%81%e3%82%ab%e3%83%86%e3%82%b4%e3%83%aa%e3%83%bc\/%e9%9b%bb%e5%8b%95%e6%ad%af%e3%83%96%e3%83%a9%e3%82%b7\/\">\u5f53\u793e\u306e\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u88fd\u54c1\u30e9\u30a4\u30f3\u30ca\u30c3\u30d7\u3092\u898b\u308b<\/a> Relish Tech\u304c\u6a19\u6e96\u30e2\u30c7\u30eb\u5168\u4f53\u3067\u30d0\u30c3\u30c6\u30ea\u30fc\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u3069\u306e\u3088\u3046\u306b\u7ba1\u7406\u3057\u3066\u3044\u308b\u304b\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002.<\/li>\r\n        <li><strong>\u4e0d\u5341\u5206\u306aEMC\u4e8b\u524d\u8a66\u9a13\uff1a<\/strong> EMC\u8a66\u9a13\u306f\u3001\u9045\u5ef6\u3084\u4e88\u671f\u305b\u306c\u518d\u8a2d\u8a08\u306e\u539f\u56e0\u3068\u306a\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u6b63\u5f0f\u306a\u8a66\u9a13\u306e\u524d\u306b\u3001\u4e8b\u524d\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9EMC\u8a66\u9a13\u307e\u305f\u306f\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30ec\u30d3\u30e5\u30fc\u306b\u6295\u8cc7\u3059\u308b\u3053\u3068\u3067\u3001\u521d\u56de\u4e0d\u5408\u683c\u306e\u30ea\u30b9\u30af\u304c\u8efd\u6e1b\u3055\u308c\u307e\u3059\u3002.<\/li>\r\n        <li><strong>RoHS\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u9a5a\u304d\uff1a<\/strong> \u6b21\u7ea7\u4f9b\u5e94\u5546\u6709\u65f6\u4f1a\u63d0\u4f9b\u4e0d\u6b63\u786e\u7684RoHS\u58f0\u660e\uff0c\u5bfc\u81f4\u5408\u89c4\u6587\u4ef6\u5ba1\u6838\u5931\u8d25\u3002\u5e94\u5728\u91c7\u8d2d\u89c4\u8303\u4e2d\u660e\u786eRoHS\u5408\u89c4\u8981\u6c42\uff0c\u5e76\u901a\u8fc7\u968f\u673a\u62bd\u6837\u9a8c\u8bc1\u4f9b\u5e94\u5546\u58f0\u660e\u3002.<\/li>\r\n        <li><strong>\u6807\u7b7e\u672c\u5730\u5316\uff1a<\/strong> \u6b27\u76df\u8981\u6c42\u5728\u4ea7\u54c1\u9500\u552e\u7684\u6bcf\u4e2a\u6210\u5458\u56fd\u7684\u5b98\u65b9\u8bed\u8a00\u4e2d\u63d0\u4f9b\u4f7f\u7528\u8bf4\u660e\u3002\u4e00\u4e9b\u54c1\u724c\u4f4e\u4f30\u4e86\u591a\u8bed\u8a00\u6587\u6863\u7684\u6210\u672c\u548c\u590d\u6742\u6027\u3002.<\/li>\r\n        <li><strong>\u4e0a\u5e02\u540e\u76d1\u7ba1\u758f\u5ffd\uff1a<\/strong> \u8bb8\u591a\u54c1\u724c\u53ea\u5173\u6ce8\u521d\u59cb\u8ba4\u8bc1\uff0c\u800c\u5ffd\u89c6\u4e86\u6301\u7eed\u7684\u4e0a\u5e02\u540e\u76d1\u7ba1\u8981\u6c42\u3002\u5e94\u5728\u8fdb\u5165\u5e02\u573a\u524d\u5efa\u7acb\u76d1\u7ba1\u4f53\u7cfb\uff0c\u4ee5\u907f\u514d\u5408\u89c4\u6f0f\u6d1e\u3002.<\/li>\r\n      <\/ul>\r\n\r\n      <div class=\"takeaways\">\r\n        <h3>\u8981\u70b9<\/h3>\r\n        <ul>\r\n          <li>CE\u6807\u5fd7\u662f\u5728\u6b27\u76df\u9500\u552e\u7535\u52a8\u7259\u5237\u7684\u6cd5\u5f8b\u8981\u6c42\u2014\u2014\u4e0d\u5408\u89c4\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u53ec\u56de\u3001\u7f5a\u6b3e\u548c\u5211\u4e8b\u8d23\u4efb\u3002.<\/li>\r\n          <li>\u591a\u9879\u6b27\u76df\u6307\u4ee4\u9002\u7528\u4e8e\u7535\u52a8\u7259\u5237\uff1aMDR\uff08\u82e5\u58f0\u79f0\u6cbb\u7597\u529f\u6548\uff09\u3001EMC\u3001\u4f4e\u7535\u538b\u548cRoHS\u3002\u5728\u5f00\u59cb\u8ba4\u8bc1\u524d\uff0c\u9700\u786e\u5b9a\u6240\u6709\u9002\u7528\u8981\u6c42\u3002.<\/li>\r\n          <li>I\u7c7b\u7535\u52a8\u7259\u5237\u901a\u5e38\u53ef\u9075\u5faa\u81ea\u6211\u58f0\u660e\u8def\u5f84\uff1b\u9ad8\u98ce\u9669\u4ea7\u54c1\u9700\u8981\u516c\u544a\u673a\u6784\u53c2\u4e0e\u3002.<\/li>\r\n          <li>\u4ece\u4ea7\u54c1\u8bbe\u8ba1\u521d\u671f\u89c4\u5212CE\u8ba4\u8bc1\uff0c\u4e0e\u4e8b\u540e\u8ffd\u6eaf\u5408\u89c4\u76f8\u6bd4\uff0c\u53ef\u964d\u4f4e\u6210\u672c\u5e76\u7f29\u77ed\u65f6\u95f4\u3002.<\/li>\r\n          <li>UKCA\u6807\u5fd7\u662f\u4e0eCE\u6807\u5fd7\u4e0d\u540c\u7684\u72ec\u7acb\u8981\u6c42\u2014\u2014\u82e5\u540c\u65f6\u7784\u51c6\u6b27\u76df\u548c\u82f1\u56fd\u5e02\u573a\uff0c\u9700\u89c4\u5212\u53cc\u91cd\u5408\u89c4\u3002.<\/li>\r\n          <li>\u4e0e\u7ecf\u9a8c\u4e30\u5bcc\u7684\u6b27\u76df\u5408\u89c4OEM\u5236\u9020\u5546\u5408\u4f5c\uff0c\u53ef\u7b80\u5316\u6587\u6863\u3001\u6d4b\u8bd5\u534f\u8c03\u548c\u76d1\u7ba1\u63d0\u4ea4\u6d41\u7a0b\u3002.<\/li>\r\n        <\/ul>\r\n      <\/div>\r\n\r\n      <!-- Mid-article CTA -->\r\n      <div class=\"cta-section\">\r\n        <h2>\u4e3a\u60a8\u7684\u7535\u52a8\u7259\u5237\u83b7\u53d6\u514d\u8d39\u5408\u89c4\u8bc4\u4f30<\/h2>\r\n        <p>\u4e0d\u786e\u5b9a\u54ea\u4e9b\u6307\u4ee4\u9002\u7528\u4e8e\u60a8\u7684\u4ea7\u54c1\u6216\u54ea\u79cd\u8ba4\u8bc1\u8def\u5f84\u9002\u5408\u60a8\u7684\u4e1a\u52a1\uff1fRelish Tech\u4e3a\u63a2\u7d22\u6b27\u76df\u5e02\u573a\u51c6\u5165\u7684\u53e3\u8154\u62a4\u7406\u54c1\u724c\u63d0\u4f9b\u514d\u8d39\u521d\u6b65\u5408\u89c4\u8bc4\u4f30\u3002.<\/p>\r\n        <a href=\"https:\/\/staging.relish-tech.com\/jp\/%e3%82%b3%e3%83%b3%e3%82%bf%e3%82%af%e3%83%88\/\" class=\"cta-btn\">\u7533\u8bf7\u5408\u89c4\u8bc4\u4f30<\/a>\r\n      <\/div>\r\n\r\n      <!-- CTA -->\r\n      <div class=\"cta-section\">\r\n        <h2>\u51c6\u5907\u8fdb\u5165\u6b27\u76df\u5e02\u573a\uff1f<\/h2>\r\n        <p>Relish Tech\u5df2\u5e2e\u52a9\u6570\u767e\u4e2a\u53e3\u8154\u62a4\u7406\u54c1\u724c\u83b7\u5f97CE\u8ba4\u8bc1\u5e76\u6210\u529f\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u3002\u6211\u4eec\u7ecf\u9a8c\u4e30\u5bcc\u7684\u6cd5\u89c4\u4e8b\u52a1\u56e2\u961f\u53ef\u6307\u5bfc\u60a8\u5b8c\u6210\u6574\u4e2a\u5408\u89c4\u6d41\u7a0b\u3002.<\/p>\r\n        <a href=\"https:\/\/staging.relish-tech.com\/jp\/%e3%82%b3%e3%83%b3%e3%82%bf%e3%82%af%e3%83%88\/\" class=\"cta-btn\">\u8054\u7cfb\u6211\u4eec\u7684\u56e2\u961f<\/a>\r\n      <\/div>\r\n\r\n      <!-- Related Articles -->\r\n      <div class=\"related\">\r\n        <h3>\u95a2\u9023\u8a18\u4e8b<\/h3>\r\n        <div class=\"related-grid\">\r\n          <a href=\"https:\/\/staging.relish-tech.com\/jp\/blog\/amazon-fba-%e3%82%aa%e3%83%bc%e3%83%a9%e3%83%ab%e3%82%b1%e3%82%a2%e3%83%96%e3%83%a9%e3%83%b3%e3%83%89\/\" class=\"related-link\">\u6253\u9020\u4e9a\u9a6c\u900aFBA\u53e3\u8154\u62a4\u7406\u54c1\u724c<\/a>\r\n          <a href=\"https:\/\/staging.relish-tech.com\/jp\/blog\/%e4%b8%ad%e5%9b%bd%e3%81%8b%e3%82%89%e3%81%ae%e3%82%aa%e3%83%bc%e3%83%a9%e3%83%ab%e3%82%b1%e3%82%a2%e8%a3%bd%e5%93%81%e8%aa%bf%e9%81%94\/\" class=\"related-link\">\u4e2d\u56fd\u304b\u3089\u306e\u30aa\u30fc\u30e9\u30eb\u30b1\u30a2\u8abf\u9054<\/a>\r\n          <a href=\"https:\/\/staging.relish-tech.com\/jp\/%e8%aa%8d%e8%a8%bc\/\" class=\"related-link\">\u8a8d\u5b9a\u8cc7\u683c<\/a>\r\n        <\/div>\r\n      <\/div>\r\n\r\n      <!-- FAQ -->\r\n      <div class=\"faq-section\">\r\n        <h2>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\r\n\r\n        <div class=\"faq-item\">\r\n          <div class=\"faq-q\">CE\u8a8d\u8a3c\u3068FDA\u8a8d\u53ef\u306e\u9055\u3044\u306f\u4f55\u3067\u3059\u304b\uff1f<\/div>\r\n          <div class=\"faq-a\">CE\u8a8d\u8a3c\u306f\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u3067\u8ca9\u58f2\u3055\u308c\u308b\u88fd\u54c1\u306b\u5fc5\u8981\u3067\u3042\u308a\u3001EU\u306e\u5065\u5eb7\u3001\u5b89\u5168\u3001\u74b0\u5883\u8981\u4ef6\u3078\u306e\u9069\u5408\u3092\u793a\u3057\u307e\u3059\u3002FDA\u8a8d\u53ef\u306f\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u304c\u7ba1\u8f44\u3059\u308b\u7c73\u56fd\u5e02\u5834\u306e\u8981\u4ef6\u3067\u3059\u3002\u4e21\u8005\u306f\u305d\u308c\u305e\u308c\u306e\u5e02\u5834\u3067\u5fc5\u9808\u3067\u3059\u304c\u3001\u7570\u306a\u308b\u898f\u5236\u67a0\u7d44\u307f\u3001\u8a66\u9a13\u57fa\u6e96\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306b\u5f93\u3044\u307e\u3059\u3002\u88fd\u54c1\u306f\u8ca9\u58f2\u5730\u57df\u306b\u5fdc\u3058\u3066\u4e21\u65b9\u306e\u8a8d\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/div>\r\n        <\/div>\r\n\r\n        <div class=\"faq-item\">\r\n          <div class=\"faq-q\">\u901a\u8fc7\u516c\u544a\u673a\u6784\u83b7\u5f97CE\u8ba4\u8bc1\u9700\u8981\u591a\u957f\u65f6\u95f4\uff1f<\/div>\r\n          <div class=\"faq-a\">\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u6d41\u7a0b\u901a\u5e38\u9700\u89813\u81f36\u4e2a\u6708\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u4ea7\u54c1\u590d\u6742\u6027\u3001\u6280\u672f\u6587\u4ef6\u7684\u5b8c\u6574\u6027\u4ee5\u53ca\u516c\u544a\u673a\u6784\u5f53\u524d\u7684\u5de5\u4f5c\u91cf\u3002\u6839\u636eMDR 2017\/745\u8981\u6c42\u8fdb\u884c\u4e34\u5e8a\u8bc4\u4f30\u7684\u4ea7\u54c1\u53ef\u80fd\u9700\u8981\u66f4\u957f\u65f6\u95f4\u3002\u63d0\u4ea4\u524d\u7684\u51c6\u5907\u5de5\u4f5c\u2014\u2014\u5305\u62ec\u6d4b\u8bd5\u3001\u6280\u672f\u6587\u6863\u7f16\u5236\u548c\u5dee\u8ddd\u5206\u6790\u2014\u2014\u53ef\u80fd\u989d\u5916\u589e\u52a02\u81f34\u4e2a\u6708\u3002\u5efa\u8bae\u4e3a\u7535\u52a8\u7259\u5237\u4ece\u542f\u52a8\u5230CE\u6807\u5fd7\u52a0\u8d34\u89c4\u5212\u603b\u8ba16\u81f312\u4e2a\u6708\u7684\u65f6\u95f4\u7ebf\u3002.<\/div>\r\n        <\/div>\r\n\r\n        <div class=\"faq-item\">\r\n          <div class=\"faq-q\">\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306eCE\u8a8d\u8a3c\u306b\u304b\u304b\u308b\u8cbb\u7528\u306f\u3044\u304f\u3089\u3067\u3059\u304b\uff1f<\/div>\r\n          <div class=\"faq-a\">CE\u8a8d\u8a3c\u306e\u8cbb\u7528\u306f\u3001\u88fd\u54c1\u5206\u985e\u3001\u9078\u629e\u3057\u305f\u9069\u5408\u6027\u8a55\u4fa1\u30eb\u30fc\u30c8\u3001\u304a\u3088\u3073\u6307\u5b9a\u6a5f\u95a2\uff08Notified Body\uff09\u306e\u5229\u7528\u6709\u7121\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306e\u5834\u5408\u3001\u8a66\u9a13\uff08EMC\u3001\u96fb\u6c17\u7684\u5b89\u5168\u6027\u3001RoHS\uff09\u306bEUR 5,000\uff5eEUR 25,000\u3001\u5fc5\u8981\u306a\u5834\u5408\u306e\u6307\u5b9a\u6a5f\u95a2\u5be9\u67fb\u306bEUR 5,000\uff5eEUR 30,000\u3001\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306e\u4f5c\u6210\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\u306bEUR 2,000\uff5eEUR 10,000\u306e\u8cbb\u7528\u3092\u898b\u8fbc\u3093\u3067\u304f\u3060\u3055\u3044\u3002\u81ea\u5df1\u5ba3\u8a00\u306f\u4f4e\u30b3\u30b9\u30c8\u3067\u3059\u304c\u3001\u5e02\u5834\u3067\u306e\u4fe1\u983c\u6027\u304c\u5236\u9650\u3055\u308c\u3001\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u304c\u9ad8\u3044\u88fd\u54c1\u306b\u306f\u9069\u3057\u3066\u3044\u307e\u305b\u3093\u3002.<\/div>\r\n        <\/div>\r\n\r\n        <div class=\"faq-item\">\r\n          <div class=\"faq-q\">CE\u8a8d\u8a3c\u306e\u30c6\u30b9\u30c8\u306f\u8ab0\u304c\u5b9f\u65bd\u3057\u307e\u3059\u304b\uff1f<\/div>\r\n          <div class=\"faq-a\">\u6d4b\u8bd5\u5fc5\u987b\u7531\u7ecf\u8ba4\u53ef\u7684\u6d4b\u8bd5\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u3002\u5728\u6b27\u6d32\uff0c\u8bf7\u5bfb\u627e\u7531\u6b27\u6d32\u8ba4\u53ef\u5408\u4f5c\u7ec4\u7ec7\uff08EA\uff09\u591a\u8fb9\u534f\u8bae\u6210\u5458\u7684\u56fd\u5bb6\u8ba4\u53ef\u673a\u6784\u8ba4\u53ef\u7684\u5b9e\u9a8c\u5ba4\u3002\u7535\u52a8\u7259\u5237\u7684\u5e38\u89c1\u6d4b\u8bd5\u62a5\u544a\u5305\u62ecIEC 60335-1\uff08\u5bb6\u7528\u7535\u5668\u5b89\u5168\uff09\u3001IEC 60601-1\uff08\u533b\u7528\u7535\u6c14\u8bbe\u5907\uff0c\u82e5\u5f52\u7c7b\u4e3a\u533b\u7597\u5668\u68b0\uff09\u3001IEC 60601-1-2\uff08\u533b\u7597\u5668\u68b0\u7535\u78c1\u517c\u5bb9\u6027\uff09\u3001EN 55014\uff08\u5bb6\u7528\u7535\u5668\u7535\u78c1\u517c\u5bb9\u6027\uff09\uff0c\u4ee5\u53ca\u7531\u7ecf\u8ba4\u53ef\u7684\u5316\u5b66\u5206\u6790\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u7684RoHS\u6d4b\u8bd5\u3002\u8bb8\u591a\u5236\u9020\u5546\u4f7f\u7528\u7b2c\u4e09\u65b9\u5b9e\u9a8c\u5ba4\uff0c\u5982TUV\u3001SGS\u3001Bureau Veritas\u6216Intertek\u3002.<\/div>\r\n        <\/div>\r\n\r\n        <div class=\"faq-item\">\r\n          <div class=\"faq-q\">CE\u8a8d\u8a3c\u306e\u6709\u52b9\u671f\u9593\u306f\u3069\u306e\u304f\u3089\u3044\u3067\u3059\u304b\uff1f<\/div>\r\n          <div class=\"faq-a\">CE\u8ba4\u8bc1\u672c\u8eab\u6ca1\u6709\u56fa\u5b9a\u7684\u6709\u6548\u671f\uff0c\u4f46\u9700\u8981\u6301\u7eed\u7ef4\u62a4\u3002\u5f53\u4ea7\u54c1\u53d1\u751f\u53d8\u66f4\u65f6\uff0c\u5fc5\u987b\u66f4\u65b0\u7b26\u5408\u6027\u58f0\u660e\u3002\u6839\u636eMDR 2017\/745\uff0c\u7531\u516c\u544a\u673a\u6784\u7b7e\u53d1\u7684CE\u8bc1\u4e66\u901a\u5e38\u6709\u6548\u671f\u4e3a <strong>5\u5e74<\/strong>, \uff0c\u4e4b\u540e\u9700\u8981\u8fdb\u884c\u66f4\u65b0\u5ba1\u6838\u3002\u6b64\u5916\uff0c\u4ea7\u54c1\u3001\u5236\u9020\u5de5\u827a\u6216\u9002\u7528\u6807\u51c6\u7684\u91cd\u5927\u53d8\u66f4\u53ef\u80fd\u9700\u8981\u91cd\u65b0\u8ba4\u8bc1\u3002\u4e0a\u5e02\u540e\u76d1\u7ba1\u6d3b\u52a8\u5fc5\u987b\u5728\u4ea7\u54c1\u7684\u6574\u4e2a\u5e02\u573a\u751f\u547d\u5468\u671f\u5185\u6301\u7eed\u8fdb\u884c\u3002.<\/div>\r\n        <\/div>\r\n\r\n        <div class=\"faq-item\">\r\n          <div class=\"faq-q\">CE\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u66f8\u985e\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/div>\r\n          <div class=\"faq-a\">\u7535\u52a8\u7259\u5237\u7684\u6280\u672f\u6587\u4ef6\u5fc5\u987b\u5305\u62ec\uff1a\u4ea7\u54c1\u63cf\u8ff0\u548c\u89c4\u683c\u3001\u8bbe\u8ba1\u56fe\u7eb8\u548c\u5236\u9020\u89c4\u8303\u3001\u98ce\u9669\u5206\u6790\u548c\u8bc4\u4f30\uff08EN ISO 14971\uff09\u3001\u9002\u7528\u6807\u51c6\u6e05\u5355\u548c\u5408\u89c4\u8bc1\u660e\u3001\u6765\u81ea\u8ba4\u53ef\u5b9e\u9a8c\u5ba4\u7684\u6d4b\u8bd5\u62a5\u544a\u3001\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff08\u82e5\u9002\u7528MDR\uff09\u3001\u6b27\u76df\u5b98\u65b9\u8bed\u8a00\u7684\u4f7f\u7528\u8bf4\u660e\u548c\u6807\u7b7e\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u63cf\u8ff0\u3001\u4e0a\u5e02\u540e\u76d1\u7ba1\u8ba1\u5212\uff0c\u4ee5\u53ca\u7b26\u5408\u6027\u58f0\u660e\u3002\u6280\u672f\u6587\u4ef6\u5fc5\u987b\u4fdd\u5b58\u81f3 <strong>10\u5e74<\/strong> \u6700\u540e\u4e00\u6279\u4ea7\u54c1\u6295\u653e\u5e02\u573a\u540e\uff0c\u5e76\u987b\u5728\u5f53\u5c40\u8981\u6c42\u65f6\u63d0\u4f9b\u3002.<\/div>\r\n        <\/div>\r\n\r\n        <div class=\"faq-item\">\r\n          <div class=\"faq-q\">EU\u3067\u8ca9\u58f2\u3055\u308c\u308b\u96fb\u52d5\u6b6f\u30d6\u30e9\u30b7\u306b\u5bfe\u3059\u308bRoHS\u8981\u4ef6\u306f\u4f55\u3067\u3059\u304b\uff1f<\/div>\r\n          <div class=\"faq-a\">RoHS\u6307\u4ee42011\/65\/EU\uff08\u53ca\u5176\u4fee\u6b63\u6848RoHS 3\u3001EU 2015\/863\uff09\u9650\u5236\u7535\u6c14\u548c\u7535\u5b50\u8bbe\u5907\u4e2d\u7684\u5341\u79cd\u6709\u5bb3\u7269\u8d28\uff1a\u94c5\u3001\u6c5e\u3001\u9549\u3001\u516d\u4ef7\u94ec\u3001\u591a\u6eb4\u8054\u82ef\uff08PBB\uff09\u3001\u591a\u6eb4\u4e8c\u82ef\u919a\uff08PBDE\uff09\u3001\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c(2-\u4e59\u57fa\u5df1\u57fa)\u916f\uff08DEHP\uff09\u3001\u90bb\u82ef\u4e8c\u7532\u9178\u4e01\u82c4\u916f\uff08BBP\uff09\u3001\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u4e01\u916f\uff08DBP\uff09\u548c\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c\u5f02\u4e01\u916f\uff08DIBP\uff09\u3002\u7535\u52a8\u7259\u5237\u5c5e\u4e8e\u7b2c11\u7c7b\uff08\u5176\u4ed6\u7c7b\u522b\u672a\u6db5\u76d6\u7684\u4ea7\u54c1\uff09\u3002\u5408\u89c4\u6027\u901a\u8fc7\u6280\u672f\u6587\u6863\u3001\u8ba4\u53ef\u5b9e\u9a8c\u5ba4\u7684\u6d4b\u8bd5\u62a5\u544a\u4ee5\u53ca\u7b26\u5408\u6027\u58f0\u660e\u6765\u8bc1\u660e\u3002\u50cfRelish Tech\u8fd9\u6837\u7684OEM\u5236\u9020\u5546\u901a\u5e38\u6301\u6709RoHS\u6d4b\u8bd5\u62a5\u544a\uff0c\u5e76\u80fd\u63d0\u4f9b\u5408\u89c4\u58f0\u660e\u3002.<\/div>\r\n        <\/div>\r\n      <\/div>\r\n\r\n      <!-- References -->\r\n      <div class=\"references\">\r\n        <h3>\u53c2\u8003\u6587\u732e<\/h3>\r\n        <ol>\r\n          <li>\u6b27\u6d32\u59d4\u5458\u4f1a\u3002\"\u533b\u7597\u5668\u68b0\u6cd5\u89c4 (EU) 2017\/745\u3002\"\u6b27\u76df\u5b98\u65b9\u516c\u62a5\u3002. <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj<\/a><\/li>\r\n          <li>\u6b27\u6d32\u59d4\u5458\u4f1a\u3002\"\u7535\u78c1\u517c\u5bb9\u6027\u6307\u4ee4 2014\/30\/EU\u3002\"\u6b27\u76df\u5b98\u65b9\u516c\u62a5\u3002. <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2014\/30\/oj\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/dir\/2014\/30\/oj<\/a><\/li>\r\n          <li>\u6b27\u6d32\u59d4\u5458\u4f1a\u3002\"\u8bbe\u8ba1\u7528\u4e8e\u7279\u5b9a\u7535\u538b\u8303\u56f4\u5185\u7684\u7535\u6c14\u8bbe\u5907\u6307\u4ee4 2014\/35\/EU\u3002\"\u6b27\u76df\u5b98\u65b9\u516c\u62a5\u3002. <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2014\/35\/oj\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/dir\/2014\/35\/oj<\/a><\/li>\r\n          <li>\u6b27\u6d32\u8bae\u4f1a\u548c\u7406\u4e8b\u4f1a\u3002\"\u5173\u4e8e\u9650\u5236\u5728\u7535\u6c14\u548c\u7535\u5b50\u8bbe\u5907\u4e2d\u4f7f\u7528\u67d0\u4e9b\u6709\u5bb3\u7269\u8d28\u7684\u6307\u4ee4 2011\/65\/EU (RoHS)\u3002\"\u6b27\u76df\u5b98\u65b9\u516c\u62a5\u3002. <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2011\/65\/oj\" target=\"_blank\" rel=\"noopener\">https:\/\/eur-lex.europa.eu\/eli\/dir\/2011\/65\/oj<\/a><\/li>\r\n          <li>\u82f1\u56fd\u6807\u51c6\u534f\u4f1a\u3002\"BS EN ISO 14971:2019 \u533b\u7597\u5668\u68b0\u2014\u2014\u98ce\u9669\u7ba1\u7406\u5728\u533b\u7597\u5668\u68b0\u4e2d\u7684\u5e94\u7528\u3002\"BSI\u6807\u51c6\u6709\u9650\u516c\u53f8\u3002.<\/li>\r\n          <li>\u6b27\u6d32\u59d4\u5458\u4f1a\u3002\"MDCG 2019-16 Rev. 1\uff1aI\u7c7b\u5668\u68b0\u5236\u9020\u5546\u6307\u5bfc\u8bf4\u660e\u3002\"\u6b27\u6d32\u59d4\u5458\u4f1a\u533b\u7597\u5668\u68b0\u534f\u8c03\u5c0f\u7ec4\u3002\u68c0\u7d22\u81ea <a href=\"https:\/\/health.ec.europa.eu\/document\/download_en\" target=\"_blank\" rel=\"noopener\">https:\/\/health.ec.europa.eu\/document\/download_en<\/a><\/li>\r\n          <li>\u836f\u54c1\u548c\u5065\u5eb7\u4ea7\u54c1\u76d1\u7ba1\u5c40\u3002\"\u533b\u7597\u5668\u68b0\uff1a\u82f1\u56fd\u8131\u6b27\u4e0eUKCA\u6807\u5fd7\u3002\"\u82f1\u56fd\u653f\u5e9c\u3002\u68c0\u7d22\u81ea <a href=\"https:\/\/www.gov.uk\/guidance\/medical-devices-mdr-2002\" target=\"_blank\" rel=\"noopener\">https:\/\/www.gov.uk\/guidance\/medical-devices-mdr-2002<\/a><\/li>\r\n        <\/ol>\r\n      <\/div>\r\n\r\n    <\/div>\r\n  <\/article>\r\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":"<p>Article \u00b7 Cluster 6 CE Certification Electric Toothbrushes: EU Market Entry Guide 2026 A comprehensive guide to navigating CE certification [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5482,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[71],"tags":[],"class_list":["post-5662","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-compliance"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/posts\/5662","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/comments?post=5662"}],"version-history":[{"count":5,"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/posts\/5662\/revisions"}],"predecessor-version":[{"id":6398,"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/posts\/5662\/revisions\/6398"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/media\/5482"}],"wp:attachment":[{"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/media?parent=5662"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/categories?post=5662"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/staging.relish-tech.com\/jp\/wp-json\/wp\/v2\/tags?post=5662"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}