{"id":19093,"date":"2025-12-12T09:53:36","date_gmt":"2025-12-12T09:53:36","guid":{"rendered":"https:\/\/www.eviewconnect.com\/?p=19093"},"modified":"2025-12-31T09:00:17","modified_gmt":"2025-12-31T09:00:17","slug":"key-certifications-and-cellular-requirements-for-4g-5g-mpers-devices-in-the-eu-us-and-australia","status":"publish","type":"post","link":"https:\/\/www.eviewconnect.com\/ja\/key-certifications-and-cellular-requirements-for-4g-5g-mpers-devices-in-the-eu-us-and-australia\/","title":{"rendered":"EU\u3001\u7c73\u56fd\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306b\u304a\u3051\u308b4G\/5G mPERS\u30c7\u30d0\u30a4\u30b9\u306e\u4e3b\u8981\u8a8d\u8a3c\u304a\u3088\u3073\u30bb\u30eb\u30e9\u30fc\u8981\u4ef6"},"content":{"rendered":"<div class=\"scrolling-article-view\" data-v-cac51986=\"\">\n<h1 data-v-cac51986=\"\"><img decoding=\"async\" style=\"font-size: 16px;\" data-src=\"https:\/\/statics.mylandingpages.co\/static\/aaanxdmf26c522mpaaafaxasccsw4p5r\/image\/4d34f7b2692640339d7ee7b75941fa83.webp\" alt=\"Key Certifications and Cellular Requirements for 4G\/5G mPERS Devices in the EU, US and Australia\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" \/><\/h1>\n<\/div>\n<div id=\"scrolling-view\" class=\"scrolling-article-view\" data-v-cac51986=\"\">\n<p>\u8a8d\u8a3c\u3068\u30e2\u30d0\u30a4\u30eb\u901a\u4fe1\u306e\u30cb\u30fc\u30ba\u306f\u3001\u4ee5\u4e0b\u306b\u3068\u3063\u3066\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\uff1a\u00a0<a href=\"https:\/\/www.eviewconnect.com\/ja\/mpers\/\">\u30a8\u30e0\u30d1\u30fc\u30b9<\/a>\u00a0\u30c7\u30d0\u30a4\u30b9\u3002\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u7279\u306b\u7279\u5225\u306a\u914d\u616e\u3092\u5fc5\u8981\u3068\u3059\u308b\u4eba\u3005\u306b\u3068\u3063\u3066\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u5b89\u5168\u6027\u3068\u52b9\u7387\u6027\u3092\u7dad\u6301\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u898f\u5236\u306f\u5730\u57df\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001EU\u306f\u305d\u306e\u8a8d\u8a3c\u898f\u5247\u306b\u304a\u3044\u3066\u5feb\u9069\u6027\u3092\u91cd\u8996\u3057\u3066\u3044\u308b\u4e00\u65b9\u3067\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306f\u512a\u5148\u3057\u3066\u3044\u307e\u3059\u00a0<a href=\"https:\/\/www.presentationeze.com\/presentations\/medical-device-validation\/medical-device-validation-full-details\/medical-devices-regulated-australia\/differences-australian-essential-principles-eu-essential-requirements\/\" target=\"_blank\" rel=\"noopener\">\u30e6\u30fc\u30b6\u30fc\u6559\u80b2\u3068\u30ea\u30b9\u30af\u7279\u5b9a<\/a>.<\/p>\n<blockquote><p>mPERS\u30d9\u30f3\u30c0\u30fc\u3092\u9078\u5b9a\u3059\u308b\u969b\u306b\u306f\u3001\u4f4d\u7f6e\u60c5\u5831\u6280\u8853\u306e\u91cd\u8981\u6027\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u88fd\u9020\u696d\u8005\u306f\u3001\u81ea\u793e\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u4e3b\u8981\u306a\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<a href=\"https:\/\/www.securitysales.com\/insights\/pers-personal-emergency-response-systems-offerings\/83478\/\" target=\"_blank\" rel=\"noopener\">4G\u6e96\u62e0<\/a>, 3G\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306e\u9806\u6b21\u5ec3\u6b62\u306b\u4f34\u3044\u3001\u5730\u57df\u3054\u3068\u306e\u7570\u306a\u308b\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u74b0\u5883\u304c\u3001\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3055\u3089\u306a\u308b\u8ab2\u984c\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><\/blockquote>\n<div class=\"table-wrapper\"><table>\n<thead>\n<tr>\n<th>\u5730\u57df<\/th>\n<th>\u8a8d\u5b9a\u8981\u4ef6<\/th>\n<th>\u8aac\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2<\/td>\n<td>\u57fa\u672c\u539f\u5247<\/td>\n<td>\u30e6\u30fc\u30b6\u30fc\u7814\u4fee\u3068\u30ea\u30b9\u30af\u8b58\u5225\u306e\u30eb\u30fc\u30eb\u306b\u3064\u3044\u3066\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002.<\/td>\n<\/tr>\n<tr>\n<td>EU<\/td>\n<td>\u5fc5\u9808\u8981\u4ef6<\/td>\n<td>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306e\u898f\u5236\u306b\u4f3c\u3066\u3044\u308b\u304c\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u5feb\u9069\u6027\u3092\u3088\u308a\u91cd\u8996\u3057\u3066\u3044\u308b\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u4e21\u65b9<\/td>\n<td>CE\u8a3c\u660e\u66f8<\/td>\n<td>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u7533\u8acb\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u5229\u7528\u3067\u304d\u307e\u3059\u3002.<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<h2>\u4e3b\u306a\u30dd\u30a4\u30f3\u30c8<\/h2>\n<ul>\n<li>mPERS\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u7279\u5225\u306a\u8a8d\u8a3c\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u4fe1\u983c\u3068\u5e02\u5834\u53c2\u5165\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u3002.<\/li>\n<li>EU\u3067\u306f\u3001CE\u30de\u30fc\u30af\u306e\u53d6\u5f97\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u304c\u5b89\u5168\u6027\u3001\u5065\u5eb7\u3001\u304a\u3088\u3073\u74b0\u5883\u306b\u95a2\u3059\u308b\u898f\u5247\u306b\u5f93\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/li>\n<li>\u30a2\u30e1\u30ea\u30ab\u3067\u306f\u3001FCC\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068UL\u8a8d\u8a3c\u304c\u91cd\u8981\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u8a8d\u8a3c\u306b\u3088\u308a\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3001\u901a\u4fe1\u898f\u683c\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u8a3c\u660e\u3055\u308c\u307e\u3059\u3002.<\/li>\n<li>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u306f\u3001RCM\u30de\u30fc\u30af\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u73fe\u5730\u898f\u5247\u3078\u306e\u9069\u5408\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u306e\u30de\u30fc\u30af\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u304c\u5b89\u5168\u6027\u304a\u3088\u3073\u96fb\u6c17\u901a\u4fe1\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/li>\n<li>\u30eb\u30fc\u30eb\u306e\u66f4\u65b0\u60c5\u5831\u3092\u5b9a\u671f\u7684\u306b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6700\u65b0\u60c5\u5831\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u7dad\u6301\u3068\u30d3\u30b8\u30cd\u30b9\u306e\u4fdd\u8b77\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002.<\/li>\n<\/ul>\n<h2>EU\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/h2>\n<p><img decoding=\"async\" data-src=\"https:\/\/statics.mylandingpages.co\/static\/aaanxdmf26c522mpaaafaxasccsw4p5r\/image\/4c170ad9c4df4dfcbf02aad1fac13cd1.webp\" alt=\"EU Compliance\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" \/><\/p>\n<p>\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u3067\u306f\u3001mPERS\u30c7\u30d0\u30a4\u30b9\u304c\u7279\u5b9a\u306e\u8a8d\u8a3c\u306b\u5f93\u3046\u3053\u3068\u304c\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u8a8d\u8a3c\u306f\u3001\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u78ba\u5b9f\u306a\u52d5\u4f5c\u3092\u4fdd\u8a3c\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u4fe1\u983c\u3092\u7372\u5f97\u3057\u3001\u5e02\u5834\u3078\u306e\u53c2\u5165\u3092\u8a31\u53ef\u3055\u308c\u308b\u4e0a\u3067\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002.<\/p>\n<h3>CE\u30de\u30fc\u30af<\/h3>\n<p>\u30b6\u00a0<strong>CE\u30de\u30fc\u30af<\/strong>\u00a0\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u304cEU\u306e\u5b89\u5168\u6027\u3001\u5065\u5eb7\u3001\u74b0\u5883\u306b\u95a2\u3059\u308b\u898f\u5236\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30de\u30fc\u30af\u306f\u3001EU\u3067\u8ca9\u58f2\u3055\u308c\u308b\u591a\u304f\u306e\u88fd\u54c1\u306b\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u624b\u9806\u3092\u5b9f\u884c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ol>\n<li><strong>\u9069\u7528\u3055\u308c\u308b\u6307\u4ee4\u3092\u7279\u5b9a\u3059\u308b<\/strong>\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u3069\u306eEU\u898f\u5247\u304c\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002mPERS\uff08\u79fb\u52d5\u578b\u500b\u4eba\u7dca\u6025\u901a\u5831\u30b7\u30b9\u30c6\u30e0\uff09\u30c7\u30d0\u30a4\u30b9\u306e\u5834\u5408\u3001\u901a\u5e38\u306f\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR\uff09\u3068\u7121\u7dda\u6a5f\u5668\u6307\u4ee4\uff08RED\uff09\u304c\u95a2\u4fc2\u3057\u307e\u3059\u3002.<\/li>\n<li><strong>\u9069\u5408\u6027\u8a55\u4fa1\u3092\u5b9f\u65bd\u3059\u308b<\/strong>\u3053\u306e\u8a55\u4fa1\u3067\u306f\u3001\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u95a2\u9023\u3059\u308b\u898f\u5247\u306e\u4e3b\u8981\u306a\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u306f\u3001\u627f\u8a8d\u5be9\u67fb\u6a5f\u95a2\uff08\u30ce\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\uff09\u3068\u9023\u643a\u3059\u308b\u5fc5\u8981\u304c\u751f\u3058\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/li>\n<li><strong>\u6280\u8853\u6587\u66f8\u306e\u7de8\u7e82<\/strong>\u8a2d\u8a08\u8a73\u7d30\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3001\u304a\u3088\u3073\u30c6\u30b9\u30c8\u7d50\u679c\u3092\u542b\u3080\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002.<\/li>\n<li><strong>CE\u30de\u30fc\u30af\u3092\u8868\u793a\u3059\u308b<\/strong>\u8a55\u4fa1\u3068\u6587\u66f8\u5316\u3092\u7d42\u3048\u305f\u3089\u3001\u30c7\u30d0\u30a4\u30b9\u306bCE\u30de\u30fc\u30af\u3092\u8cbc\u4ed8\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/li>\n<\/ol>\n<h3>RED\u6307\u4ee4<\/h3>\n<p>\u30b6\u00a0<strong>\u7121\u7dda\u6a5f\u5668\u6307\u4ee4 (RED)<\/strong>\u00a0\u7121\u7dda\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u96fb\u78c1\u4e21\u7acb\u6027\uff08EMC\uff09\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u6307\u4ee4\u306b\u3088\u308a\u3001mPERS\u30c7\u30d0\u30a4\u30b9\u304c\u4ed6\u306e\u6a5f\u5668\u306b\u5e72\u6e09\u3059\u308b\u3053\u3068\u306a\u304f\u6b63\u5e38\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002\u4e3b\u306a\u8981\u4ef6\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\uff1a<\/p>\n<ul>\n<li><strong>\u5b89\u5168\u8981\u4ef6<\/strong>\u304a\u5ba2\u69d8\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u3084\u4ed6\u306e\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u5371\u967a\u306a\u3082\u306e\u3067\u3042\u3063\u3066\u306f\u306a\u308a\u307e\u305b\u3093\u3002.<\/li>\n<li><strong>EMC\u8981\u4ef6<\/strong>\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u96fb\u78c1\u5e72\u6e09\u3092\u5f15\u304d\u8d77\u3053\u3057\u305f\u308a\u3001\u305d\u306e\u5f71\u97ff\u3092\u53d7\u3051\u305f\u308a\u305b\u305a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<li><strong>\u96fb\u6ce2\u306e\u52b9\u7387\u7684\u5229\u7528<\/strong>\u304a\u4f7f\u3044\u306e\u6a5f\u5668\u306f\u3001\u6df7\u96d1\u3092\u907f\u3051\u3001\u826f\u597d\u306a\u901a\u4fe1\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u96fb\u6ce2\u3092\u8ce2\u304f\u5229\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/li>\n<\/ul>\n<h3>EN\u898f\u683c<\/h3>\n<p>\u4ee5\u4e0b\u00a0<a href=\"https:\/\/measurlabs.com\/blog\/eu-mdr-medical-device-regulation\/\" target=\"_blank\" rel=\"noopener\"><strong>EN\u898f\u683c<\/strong><\/a>\u00a0mPERS\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u304a\u3044\u3066\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u898f\u683c\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u8a2d\u8a08\u3068\u30c6\u30b9\u30c8\u306e\u3055\u307e\u3056\u307e\u306a\u5074\u9762\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002mPERS\u30c7\u30d0\u30a4\u30b9\u306b\u95a2\u9023\u3059\u308b\u91cd\u8981\u306aEN\u898f\u683c\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<div class=\"table-wrapper\"><table>\n<thead>\n<tr>\n<th><strong>\u6a19\u6e96<\/strong><\/th>\n<th><strong>\u30c8\u30d4\u30c3\u30af<\/strong><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>EN ISO 10993-10<\/td>\n<td>\u76ae\u819a\u611f\u4f5c\u6027<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 10993-17<\/td>\n<td>\u6bd2\u6027\u5b66\u7684\u30ea\u30b9\u30af\u8a55\u4fa1<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 10993-18<\/td>\n<td>\u5316\u5b66\u7279\u6027\u8a55\u4fa1<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 10993-23<\/td>\n<td>\u76ae\u819a\u523a\u6fc0\u6027\u304a\u3088\u3073\u76ae\u5185\u53cd\u5fdc\u6027<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 11737-1<\/td>\n<td>\u5fae\u751f\u7269\u306e\u5b58\u5728<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 11737-2<\/td>\n<td>\u6ec5\u83cc\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 17664-1<\/td>\n<td>\u6e96\u9ad8\u6c34\u6e96\u304a\u3088\u3073\u9ad8\u6c34\u6e96\u533b\u7642\u6a5f\u5668\u306e\u518d\u51e6\u7406<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 17664-2<\/td>\n<td>\u975e\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u5668\u5177\u306e\u518d\u51e6\u7406<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 11607-1<\/td>\n<td>\u6ec5\u83cc\u30d0\u30ea\u30a2\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u5305\u88c5\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u4ef6<\/td>\n<\/tr>\n<tr>\n<td>EN ISO 11607-2<\/td>\n<td>\u6210\u5f62\u3001\u30b7\u30fc\u30eb\u3001\u304a\u3088\u3073\u7d44\u7acb\u30d7\u30ed\u30bb\u30b9\u306e\u59a5\u5f53\u6027\u78ba\u8a8d<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>\u3053\u308c\u3089\u306e\u57fa\u6e96\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u3001\u30e6\u30fc\u30b6\u30fc\u306b\u3068\u3063\u3066\u5feb\u9069\u306b\u52d5\u4f5c\u3059\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<h2>\u7c73\u56fd\u306e\u898f\u5236<\/h2>\n<p><img decoding=\"async\" data-src=\"https:\/\/statics.mylandingpages.co\/static\/aaanxdmf26c522mpaaafaxasccsw4p5r\/image\/c5dd6a0f2e484b9380cda9fbd3f474a2.webp\" alt=\"US Regulations\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" \/><\/p>\n<p>\u7c73\u56fd\u3067\u306f\u3001mPERS\u30c7\u30d0\u30a4\u30b9\u306f\u7279\u5b9a\u306e\u898f\u5247\u3084\u8a8d\u8a3c\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u305f\u3081\u306b\u91cd\u8981\u3067\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u3084\u958b\u767a\u8005\u306f\u3001\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u305f\u3081\u306b\u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u7406\u89e3\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n<h3>FCC \u6e96\u62e0<\/h3>\n<p>\u30b6\u00a0<strong>\u9023\u90a6\u901a\u4fe1\u59d4\u54e1\u4f1a\uff08FCC\uff09<\/strong>\u00a0\u7c73\u56fd\u306b\u304a\u3051\u308b\u96fb\u6c17\u901a\u4fe1\u3092\u7ba1\u8f44\u3057\u3066\u3044\u307e\u3059\u3002mPERS\u30c7\u30d0\u30a4\u30b9\u306eFCC\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u624b\u9806\u3092\u5b9f\u884c\u3057\u307e\u3059\uff1a<\/p>\n<ol>\n<li><a href=\"https:\/\/www.fcc.gov\/engineering-technology\/laboratory-division\/general\/equipment-authorization\" target=\"_blank\" rel=\"noopener\">\u3069\u306eFCC\u898f\u5247\u304c\u9069\u7528\u3055\u308c\u308b\u304b\u8abf\u3079\u308b<\/a>\u00a0\u3042\u306a\u305f\u306e\u88fd\u54c1\u306b\u3002.<\/li>\n<li>\u88fd\u54c1\u306b\u5fc5\u8981\u306a\u6a5f\u5668\u8a8d\u53ef\u624b\u7d9a\u304d\u3092\u7279\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<li>\u8a8d\u5b9a\u8a66\u9a13\u6240\u3067\u9069\u5408\u6027\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3002.<\/li>\n<li>\u5fc5\u8981\u306a\u627f\u8a8d\u3092\u5f97\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<li>\u88fd\u54c1\u306b\u5fc5\u8981\u306a\u60c5\u5831\u3092\u8868\u793a\u3057\u3001\u30e6\u30fc\u30b6\u30fc\u30de\u30cb\u30e5\u30a2\u30eb\u306b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u8a73\u7d30\u3092\u8a18\u8f09\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u95a2\u3059\u308b\u8a18\u9332\u3092\u4fdd\u7ba1\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<li>\u3053\u308c\u3089\u306e\u624b\u9806\u3092\u5b8c\u4e86\u3059\u308c\u3070\u3001\u88fd\u54c1\u306e\u88fd\u9020\u3001\u8f38\u5165\u3001\u304a\u3088\u3073\u8ca9\u58f2\u3092\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/li>\n<\/ol>\n<p>\u3053\u308c\u3089\u306e\u624b\u9806\u3092\u5b9f\u884c\u3059\u308b\u3053\u3068\u3067\u3001\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u7c73\u56fd\u306e\u901a\u4fe1\u74b0\u5883\u306b\u304a\u3051\u308b\u7a3c\u50cd\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u5b9f\u306b\u3067\u304d\u307e\u3059\u3002.<\/p>\n<h3>UL\u8a8d\u8a3c<\/h3>\n<p><strong>\u30a2\u30f3\u30c0\u30fc\u30e9\u30a4\u30bf\u30fc\u30ba\u30fb\u30e9\u30dc\u30e9\u30c8\u30ea\u30fc\u30ba<\/strong>\u00a0mPERS\u30c7\u30d0\u30a4\u30b9\u306b\u3068\u3063\u3066\u3082\u3001\u8a8d\u8a3c\u306f\u91cd\u8981\u3067\u3059\u3002\u3053\u306e\u8a8d\u8a3c\u306f\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002UL\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u304c\u6d88\u8cbb\u8005\u306b\u3068\u3063\u3066\u5b89\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u53b3\u3057\u3044\u30c6\u30b9\u30c8\u3092\u53d7\u3051\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002UL\u8a8d\u8a3c\u306b\u95a2\u3059\u308b\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/p>\n<ul>\n<li>UL\u306f\u96fb\u6c17\u7684\u5b89\u5168\u6027\u3001\u706b\u707d\u30ea\u30b9\u30af\u3001\u74b0\u5883\u5f71\u97ff\u306b\u3064\u3044\u3066\u6a5f\u5668\u306e\u8a66\u9a13\u3092\u884c\u3044\u307e\u3059\u3002.<\/li>\n<li>\u8a8d\u8a3c\u306f\u3001\u88fd\u54c1\u304c\u9ad8\u3044\u5b89\u5168\u6027\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u6d88\u8cbb\u8005\u306b\u793a\u3057\u307e\u3059\u3002.<\/li>\n<li>\u305d\u308c\u306f\u30d6\u30e9\u30f3\u30c9\u306e\u8a55\u5224\u3092\u9ad8\u3081\u3001\u6d88\u8cbb\u8005\u306e\u4fe1\u983c\u3092\u7bc9\u304f\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/li>\n<\/ul>\n<p>mPERS\u30c7\u30d0\u30a4\u30b9\u306eUL\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306b\u5b89\u5168\u6027\u3068\u4fe1\u983c\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u3001\u5927\u304d\u306a\u30e1\u30ea\u30c3\u30c8\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n<h3>FDA\u898f\u5236<\/h3>\n<p>\u30b6\u00a0<strong>\u98df\u54c1\u533b\u85ac\u54c1\u5c40<\/strong>\u00a0mPERS\u6a5f\u5668\u3092\u542b\u3081\u3001\u7c73\u56fd\u5185\u306e\u533b\u7642\u6a5f\u5668\u3092\u898f\u5236\u3057\u3066\u3044\u307e\u3059\u3002FDA\u306e\u533b\u7642\u6a5f\u5668\u30fb\u653e\u5c04\u7dda\u5065\u5eb7\u30bb\u30f3\u30bf\u30fc\uff08CDRH\uff09\u306f\u3001\u3053\u308c\u3089\u306e\u88fd\u54c1\u304c\u8ca9\u58f2\u3055\u308c\u308b\u524d\u306b\u3001\u305d\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5be9\u67fb\u3057\u307e\u3059\u3002FDA\u306e\u898f\u5236\u304c\u304a\u5ba2\u69d8\u306e\u6a5f\u5668\u306b\u3069\u306e\u3088\u3046\u306b\u5f71\u97ff\u3059\u308b\u304b\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/p>\n<div class=\"table-wrapper\"><table>\n<thead>\n<tr>\n<th>\u30bd\u30fc\u30b9<\/th>\n<th>\u8aac\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u6982\u8981<\/td>\n<td><a href=\"https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/overview-device-regulation\" target=\"_blank\" rel=\"noopener\">FDA\u306f\u3001\u4ee5\u4e0b\u306e\u4f01\u696d\u3092\u898f\u5236\u3057\u3066\u3044\u307e\u3059\uff1a<\/a>, \u3001\u533b\u7642\u6a5f\u5668\u306e\u518d\u5305\u88c5\u3001\u518d\u30e9\u30d9\u30eb\u8868\u793a\u3001\u307e\u305f\u306f\u8f38\u5165\u3092\u884c\u3044\u3001\u8ca9\u58f2\u524d\u306b\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u30c7\u30d0\u30a4\u30b9\u306e\u8abf\u67fb\u65b9\u6cd5\u3068\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u306e\u65b9\u6cd5<\/td>\n<td>\u533b\u7642\u6a5f\u5668\u306fFD&amp;C\u6cd5\u304a\u3088\u307321 CFR\u306e\u898f\u5247\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u3053\u308c\u3089\u306f\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u3001\u8a2d\u8a08\u3084\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u306e\u8a08\u753b\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u7c73\u56fd\u533b\u7642\u6a5f\u5668\u5e02\u5834\u3078\u306e\u53c2\u5165<\/td>\n<td>\u7570\u306a\u308b\u898f\u5236\u30d1\u30b9\u306b\u306f\u7570\u306a\u308b\u6587\u66f8\u3068\u8a66\u9a13\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u30e1\u30fc\u30ab\u30fc\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3068\u30b3\u30b9\u30c8\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002.<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>FDA\u306e\u898f\u5236\u3092\u9075\u5b88\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u5fb9\u5e95\u7684\u306a\u30c6\u30b9\u30c8\u3068\u6587\u66f8\u5316\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u3088\u308a\u3001mPERS\u30c7\u30d0\u30a4\u30b9\u306e\u30e6\u30fc\u30b6\u30fc\u306b\u5bfe\u3059\u308b\u5b89\u5168\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3001\u533b\u7642\u6a5f\u5668\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<p>\u3053\u308c\u3089\u306e\u7c73\u56fd\u898f\u5236\u3092\u7406\u89e3\u3057\u9075\u5b88\u3059\u308b\u3053\u3068\u3067\u3001mPERS\u30c7\u30d0\u30a4\u30b9\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u74b0\u5883\u3092\u6b63\u5e38\u306b\u5207\u308a\u629c\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u77e5\u8b58\u306f\u3001\u6cd5\u7684\u8981\u4ef6\u3092\u6e80\u305f\u3059\u306e\u306b\u5f79\u7acb\u3061\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u9ad8\u3081\u307e\u3059\u3002.<\/p>\n<h2>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u898f\u683c<\/h2>\n<p>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u306f\u3001mPERS\u30c7\u30d0\u30a4\u30b9\u304c\u73fe\u5730\u898f\u683c\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u304c\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u304c\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u901a\u4fe1\u30e1\u30c7\u30a3\u30a2\u5e81\uff08ACMA\uff09\u3084\u305d\u306e\u4ed6\u306e\u91cd\u8981\u306a\u7d44\u7e54\u306b\u3088\u3063\u3066\u5b9a\u3081\u3089\u308c\u305f\u898f\u5247\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n<h3>ACMA \u9069\u5408\u6027<\/h3>\n<p>mPERS \u30c7\u30d0\u30a4\u30b9\u306e ACMA \u9069\u5408\u6027\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u624b\u9806\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002<\/p>\n<div class=\"table-wrapper\"><table>\n<thead>\n<tr>\n<th>\u30b9\u30c6\u30c3\u30d7<\/th>\n<th>\u8aac\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>\u5fc5\u305a\uff5e\u3092\u6e80\u305f\u3057\u3066\u304f\u3060\u3055\u3044\u00a0<a href=\"https:\/\/incompliancemag.com\/cellular-approvals-and-rcm-certification-in-australia\/\" target=\"_blank\" rel=\"noopener\">\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30de\u30fc\u30af\uff08RCM\uff09\u898f\u5247<\/a>, \u3053\u308c\u3089\u306fACMA\u3068ERAC\u306b\u3088\u3063\u3066\u5171\u6709\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>ACMA\u306eTLN\uff1a\u96fb\u6c17\u901a\u4fe1\uff08\u9867\u5ba2\u6a5f\u5668\u304a\u3088\u3073\u9867\u5ba2\u914d\u7dda\u306e\u30e9\u30d9\u30eb\u8868\u793a\u306b\u95a2\u3059\u308b\u901a\u77e5\uff092015\u5e74\uff082018\u5e74\u96fb\u6c17\u901a\u4fe1\uff08\u79fb\u52d5\u4f53\u6a5f\u5668\u30a8\u30a2\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\uff09\u6280\u8853\u57fa\u6e96\u306e\u9075\u5b88\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u3082\u306e\uff09\u306b\u5f93\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>AS\/CA S042.1\u304a\u3088\u3073AS\/CA S042.4\u306e\u78ba\u8a8d\u306b\u5fc5\u8981\u306a\u66f8\u985e\u3092\u53ce\u96c6\u3059\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u7dca\u6025\u30b5\u30fc\u30d3\u30b9\u30a2\u30af\u30bb\u30b9\u306b\u95a2\u3059\u308b\u30c6\u30b9\u30c8\u3084\u3001\u88fd\u9020\u8005\u9069\u5408\u5ba3\u8a00\u66f8\uff08DoC\uff09\u304c\u542b\u307e\u308c\u308b\u3002.<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>EMC\u3001\u96fb\u6c17\u901a\u4fe1\u3001\u96fb\u6c17\u5b89\u5168\u6027\u3001\u7121\u7dda\u901a\u4fe1\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u6280\u8853\u898f\u5247\u3092\u5fc5\u305a\u9075\u5b88\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>\u3053\u308c\u3089\u306e\u624b\u9806\u3092\u5b9f\u884c\u3059\u308b\u3053\u3068\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u9069\u5207\u306b\u7ba1\u7406\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n<h3>RCM\u30de\u30fc\u30af<\/h3>\n<p>RCM\u30de\u30fc\u30af\u306f\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306e\u5b89\u5168\u304a\u3088\u3073\u96fb\u6c17\u901a\u4fe1\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u4e0a\u3067\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002mPERS\u30c7\u30d0\u30a4\u30b9\u3067RCM\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e\u4e3b\u306a\u8981\u4ef6\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n<div class=\"table-wrapper\"><table>\n<thead>\n<tr>\n<th>\u8981\u4ef6<\/th>\n<th>\u8aac\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u8a8d\u8a3c<\/td>\n<td>\u3042\u306a\u305f\u306b\u306f\u5fc5\u8981\u3067\u3059\u00a0<a href=\"https:\/\/www.csiassoc.com\/australia.html\" target=\"_blank\" rel=\"noopener\">\u53d7\u3051\u5165\u308c\u53ef\u80fd\u306aFCC\u307e\u305f\u306fCE\u30ec\u30dd\u30fc\u30c8<\/a>.<\/td>\n<\/tr>\n<tr>\n<td>\u30c6\u30b9\u30c8<\/td>\n<td>\u30c6\u30b9\u30c8\u30ec\u30dd\u30fc\u30c8\u306f\u3001ILAC-MRA\u307e\u305f\u306f\u8a8d\u5b9a\u3055\u308c\u305f\u6a5f\u95a2\u306b\u3088\u308b\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306e\u898f\u683c\u306b\u9069\u5408\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u8ffd\u52a0\u306e\u30c6\u30b9\u30c8\u304c\u5fc5\u8981\u306b\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d5\u30a9\u30eb\u30c0<\/td>\n<td>ACMA\u306b\u767b\u9332\u3055\u308c\u305f\u73fe\u5730\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30fb\u30d5\u30a9\u30eb\u30c0\u30fb\u30db\u30eb\u30c0\u30fc\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u30ed\u30fc\u30ab\u30eb\u30a4\u30f3\u30dd\u30fc\u30bf\u30fc<\/td>\n<td>\u30a4\u30f3\u30dd\u30fc\u30bf\u30fc\/\u30c7\u30a3\u30b9\u30c8ributor\u304c\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u56fd\u5185\u3067\u88fd\u54c1\u3092\u8ca9\u58f2\u3059\u308b\u5834\u5408\u3001\u73fe\u5730\u306e\u30a4\u30f3\u30dd\u30fc\u30bf\u30fc\u306e\u8a73\u7d30\u60c5\u5831\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u96fb\u6c60\u306e\u9069\u5408\u6027<\/td>\n<td>\u30dc\u30bf\u30f3\u96fb\u6c60\uff08\u30b3\u30a4\u30f3\u96fb\u6c60\uff09\u3092\u4f7f\u7528\u3059\u308b\u88fd\u54c1\u306b\u306f\u3001\u9069\u5408\u6027\u8a66\u9a13\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u30c1\u30e3\u30a4\u30eb\u30c9\u30ec\u30b8\u30b9\u30bf\u30f3\u30c8\u5305\u88c5\uff08\u5b50\u4f9b\u304c\u958b\u3051\u306b\u304f\u3044\u5305\u88c5\uff09\u3092\u63a1\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9650<\/td>\n<td>\u88fd\u54c1\u304c\u5909\u66f4\u3055\u308c\u306a\u3044\u9650\u308a\u3001\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9593\u306f5\u5e74\u9593\u3067\u3059\u3002.<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>RCM\u30de\u30fc\u30af\u306f\u96fb\u6c17\u7684\u5b89\u5168\u6027\u3068\u96fb\u78c1\u4e21\u7acb\u6027\uff08EMC\uff09\u3092\u30ab\u30d0\u30fc\u3057\u3001\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u4f7f\u7528\u8005\u306b\u3068\u3063\u3066\u5b89\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002.<\/p>\n<h3>AS\/CA S042.4<\/h3>\n<p>AS\/CA S042.4\u306f\u3001\u96fb\u6c17\u901a\u4fe1\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3078\u306e\u63a5\u7d9a\u306b\u95a2\u3059\u308b\u898f\u5247\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u898f\u683c\u306f\u3001\u304a\u5ba2\u69d8\u306emPERS\u30c7\u30d0\u30a4\u30b9\u306b\u9069\u7528\u3055\u308c\u3001\u91cd\u8981\u306a\u6280\u8853\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002\u4e3b\u306a\u30dd\u30a4\u30f3\u30c8\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/p>\n<div class=\"table-wrapper\"><table>\n<thead>\n<tr>\n<th>\u8981\u4ef6<\/th>\n<th>\u8aac\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u57fa\u6e96<\/td>\n<td>AS\/CA S042.4: \u96fb\u6c17\u901a\u4fe1\u7db2\u306e\u30a8\u30a2\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3078\u306e\u63a5\u7d9a\u306b\u95a2\u3059\u308b\u8981\u4ef6\u2014\u30d1\u30fc\u30c84\uff1aIMT\u30ab\u30b9\u30bf\u30de\u30fc\u6a5f\u5668<\/td>\n<\/tr>\n<tr>\n<td>\u30c6\u30b9\u30c8\u8981\u4ef6<\/td>\n<td>\u7dca\u6025\u30b5\u30fc\u30d3\u30b9\u3078\u306e\u30a2\u30af\u30bb\u30b9\u306e\u78ba\u8a8d\u3092\u542b\u3081\u30013G\u304a\u3088\u30734G\u6280\u8853\u306e\u6280\u8853\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3<\/td>\n<td>FCC\u304a\u3088\u3073ETSI\u898f\u683c\u306b\u57fa\u3065\u304f\u30bb\u30eb\u30e9\u30fc\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u8a66\u9a13\u5831\u544a\u66f8\u3001\u88fd\u9020\u8005\u9069\u5408\u5ba3\u8a00\u66f8\uff08DoC\uff09\u3001\u304a\u3088\u3073\u653e\u5c04\u30b9\u30d7\u30ea\u30a2\u30b9\u30a8\u30df\u30c3\u30b7\u30e7\u30f3\u306e\u8a66\u9a13\u5831\u544a\u66f8\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002.<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>\u3053\u308c\u3089\u306e\u57fa\u6e96\u306b\u5f93\u3046\u3053\u3068\u3067\u3001mPERS\u6a5f\u5668\u304c\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306e\u30e6\u30fc\u30b6\u30fc\u306b\u3068\u3063\u3066\u9069\u5408\u3057\u3001\u5b89\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u5b9f\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<h2>mPERS\u30c7\u30d0\u30a4\u30b9\u306b\u304a\u3051\u308b\u4e3b\u8981\u306a\u8a8d\u8a3c<\/h2>\n<h3>\u30b0\u30ed\u30fc\u30d0\u30eb\u8a8d\u8a3c\u306e\u6982\u8981<\/h3>\n<p>mPERS\u30c7\u30d0\u30a4\u30b9\u3092\u88fd\u9020\u3059\u308b\u969b\u306b\u306f\u3001\u91cd\u8981\u306a\u8a8d\u8a3c\u306b\u3064\u3044\u3066\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u5730\u57df\u3067\u306e\u898f\u5236\u3092\u9075\u5b88\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u4ee5\u4e0b\u306f\u3001\u00a0<a href=\"http:\/\/multitech.com\/iot-wiki\/device-certifications\/\" target=\"_blank\" rel=\"noopener\">\u4e3b\u8981\u306a\u30b0\u30ed\u30fc\u30d0\u30eb\u8a8d\u8a3c<\/a>:<\/p>\n<ol>\n<li><strong>FCC\u8a8d\u8a3c<\/strong>\u7c73\u56fd\u3067\u8ca9\u58f2\u3055\u308c\u308b\u30c7\u30d0\u30a4\u30b9\u304c\u96fb\u78c1\u59a8\u5bb3\u898f\u5247\u306b\u9069\u5408\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3002.<\/li>\n<li><strong>CE\u30de\u30fc\u30af<\/strong>EEA\u5185\u3067\u8ca9\u58f2\u3055\u308c\u308b\u30c7\u30d0\u30a4\u30b9\u304cEU\u306e\u898f\u5236\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u307e\u3059\u3002.<\/li>\n<li><strong>CB\u30b9\u30ad\u30fc\u30e0<\/strong>\u591a\u304f\u306e\u56fd\u3067\u8cc7\u683c\u304c\u8a8d\u3081\u3089\u308c\u308b\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u306e\u56fd\u969b\u7684\u306a\u30d7\u30ed\u30b0\u30e9\u30e0\u3002.<\/li>\n<li><strong>IC\u8a8d\u8a3c<\/strong>\u6280\u8853\u57fa\u6e96\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u30ab\u30ca\u30c0\u3067\u5fc5\u9808\u3002.<\/li>\n<li><strong>C-\u30c6\u30a3\u30c3\u30af\u30de\u30fc\u30af<\/strong>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u304a\u3088\u3073\u30cb\u30e5\u30fc\u30b8\u30fc\u30e9\u30f3\u30c9\u3067\u306e\u9069\u5408\u6027\u3092\u793a\u3057\u307e\u3059\u3002.<\/li>\n<li><strong>CCC\u30de\u30fc\u30af<\/strong>\u5b89\u5168\u304a\u3088\u3073\u74b0\u5883\u898f\u5236\u306e\u305f\u3081\u4e2d\u56fd\u3067\u5fc5\u8981\u3068\u3055\u308c\u308b\u3002.<\/li>\n<li><strong>GOST-R\u30de\u30fc\u30af<\/strong>\u30ed\u30b7\u30a2\u56fd\u5185\u3067\u306e\u9069\u5408\u6027\u3092\u8a3c\u660e\u3057\u307e\u3059\u3002.<\/li>\n<li><strong>KCC\u8a8d\u8a3c<\/strong>\u5b89\u5168\u6027\u3068\u96fb\u78c1\u4e21\u7acb\u6027\u306e\u305f\u3081\u306b\u97d3\u56fd\u3067\u5fc5\u9808\u3067\u3059\u3002.<\/li>\n<li><strong>MIC\u8a8d\u8a3c<\/strong>\u65e5\u672c\u56fd\u5185\u3067\u96fb\u6c17\u901a\u4fe1\u6a5f\u5668\u306b\u5fc5\u8981\u306a\u3082\u306e\u3002.<\/li>\n<li><strong>ANATEL\u8a8d\u8a3c<\/strong>\u30d6\u30e9\u30b8\u30eb\u306e\u6280\u8853\u304a\u3088\u3073\u5b89\u5168\u898f\u5247\u3067\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002.<\/li>\n<li><strong>\u53f0\u6e7eNCC\u8a8d\u8a3c<\/strong>\u53f0\u6e7e\u3067\u306e\u7121\u7dda\u5468\u6ce2\u6570\uff08RF\uff09\u653e\u5c04\u8981\u4ef6\u306b\u5fc5\u8981\u3002.<\/li>\n<li><strong>MSIP\u8a8d\u8a3c<\/strong>\u5b89\u5168\u6027\u3068\u96fb\u78c1\u4e21\u7acb\u6027\u306e\u305f\u3081\u306b\u97d3\u56fd\u3067\u5fc5\u9808\u3067\u3059\u3002.<\/li>\n<\/ol>\n<p>\u3053\u308c\u3089\u306e\u8a8d\u8a3c\u306f\u3001\u304a\u4f7f\u3044\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u5b89\u5168\u3067\u3001\u6b63\u5e38\u3067\u3042\u308a\u3001\u4e16\u754c\u4e2d\u306e\u74b0\u5883\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n<h3>\u5730\u57df\u8a8d\u8a3c\u306e\u9055\u3044<\/h3>\n<p>\u5730\u57df\u3054\u3068\u306b\u72ec\u81ea\u306e\u8a8d\u8a3c\u898f\u5247\u304c\u3042\u308b\u305f\u3081\u3001\u5e02\u5834\u53c2\u5165\u304c\u96e3\u3057\u304f\u306a\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u898f\u5247\u3092\u9075\u5b88\u3057\u306a\u3044\u5834\u5408\u306b\u76f4\u9762\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u8ab2\u984c\u306e\u307e\u3068\u3081\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/p>\n<div class=\"table-wrapper\"><table>\n<thead>\n<tr>\n<th>\u30d0\u30ea\u30a2\u30bf\u30a4\u30d7<\/th>\n<th>\u8aac\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u898f\u5236\u67a0\u7d44\u307f<\/td>\n<td>\u5404\u56fd\u306b\u306f\u72ec\u81ea\u306e\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u898f\u5236\u304c\u3042\u308a\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8907\u96d1\u306b\u3057\u3066\u3044\u308b\u3002.<\/td>\n<\/tr>\n<tr>\n<td>\u6cd5\u7684\u7f70\u5247<\/td>\n<td>\u898f\u5247\u306b\u5f93\u308f\u306a\u3044\u3053\u3068\u306f\u3001\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u00a0<a href=\"https:\/\/operonstrategist.com\/top-5-barriers-to-global-market-entry-for-medical-devices\/\" target=\"_blank\" rel=\"noopener\">\u6cd5\u7684\u63aa\u7f6e\u3001\u56de\u53ce\u3001\u7f70\u91d1<\/a>.<\/td>\n<\/tr>\n<tr>\n<td>\u5e02\u5834\u30a2\u30af\u30bb\u30b9<\/td>\n<td>\u5f93\u308f\u306a\u3044\u5834\u5408\u3001\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u304c\u5236\u9650\u3055\u308c\u3001\u7af6\u4e89\u529b\u304c\u640d\u306a\u308f\u308c\u307e\u3059\u3002.<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>\u3053\u308c\u3089\u306e\u554f\u984c\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6ce8\u529b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u898f\u5247\u306b\u5f93\u308f\u306a\u3044\u5834\u5408\u3001\u6cd5\u7684\u306a\u554f\u984c\u3084\u4fe1\u983c\u306e\u5931\u589c\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002mPERS\u30c7\u30d0\u30a4\u30b9\u306b\u9069\u5207\u306a\u8a8d\u8a3c\u3092\u53d6\u5f97\u3055\u305b\u308b\u3053\u3068\u3067\u3001\u5b89\u5168\u6027\u3001\u54c1\u8cea\u3001\u304a\u3088\u3073\u6709\u52b9\u6027\u304c\u78ba\u4fdd\u3055\u308c\u307e\u3059\u3002\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3078\u306e\u3053\u306e\u53d6\u308a\u7d44\u307f\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u3092\u4fdd\u8b77\u3057\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u4fe1\u983c\u6027\u3092\u9ad8\u3081\u307e\u3059\u3002.<\/p>\n<p>\u3053\u308c\u3089\u306e\u91cd\u8981\u306a\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u3067\u3001mPERS\u88fd\u54c1\u3092\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3067\u6210\u529f\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<hr \/>\n<p>\u7d50\u8ad6\u3068\u3057\u3066\u3001\u8a8d\u5b9a\u8cc7\u683c\u3084\u30bb\u30eb\u30e9\u30fc\u8981\u4ef6\u306b\u3064\u3044\u3066\u306e\u77e5\u8b58\u306fmPERS\u30c7\u30d0\u30a4\u30b9\u306b\u304a\u3044\u3066\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u898f\u5247\u306b\u5f93\u3046\u3053\u3068\u3067\u5e02\u5834\u53c2\u5165\u304c\u5bb9\u6613\u306b\u306a\u308a\u3001\u6d88\u8cbb\u8005\u306e\u5b89\u5168\u304c\u5b88\u3089\u308c\u307e\u3059\u3002\u653f\u5e9c\u304b\u3089\u306e\u652f\u63f4\u3092\u53d7\u3051\u308b\u305f\u3081\u306b\u3001\u5e38\u306b\u898f\u5236\u306e\u6700\u65b0\u60c5\u5831\u3092\u78ba\u8a8d\u3059\u3079\u304d\u3067\u3059\u3002\u3053\u306e\u652f\u63f4\u306f\u3001\u9060\u9694\u533b\u7642\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u652f\u3048\u3001\u5e02\u5834\u3092\u6210\u9577\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<p>\u30eb\u30fc\u30eb\u306b\u5f93\u308f\u306a\u3044\u3068\u3001\u4f8b\u3048\u3070\u6b21\u306e\u3088\u3046\u306a\u5927\u304d\u306a\u554f\u984c\u3092\u5f15\u304d\u8d77\u3053\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\uff1a\u00a0<a href=\"https:\/\/advisera.com\/13485academy\/blog\/2017\/11\/02\/what-are-the-consequences-of-noncompliance-with-iso-13485-for-manufacturers-of-medical-devices\/\" target=\"_blank\" rel=\"noopener\">\u6cd5\u7684\u554f\u984c\u3001\u7f70\u91d1<\/a>, \u305d\u3057\u3066\u8cc7\u683c\u3092\u5931\u3046\u3053\u3068\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001\u4ee5\u4e0b\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u691c\u8a0e\u3057\u3066\u304f\u3060\u3055\u3044\uff1a<\/p>\n<ul>\n<li>\u719f\u7df4\u3057\u305f\u30e1\u30fc\u30ab\u30fc\u3068\u5354\u529b\u3059\u308b\u3002.<\/li>\n<li>\u30dd\u30ea\u30b7\u30fc\u3068\u624b\u9806\u306e\u8a73\u7d30\u306a\u8a18\u9332\u3092\u7dad\u6301\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<li>\u5f37\u529b\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<\/ul>\n<p>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6ce8\u529b\u3059\u308b\u3053\u3068\u3067\u3001\u30d3\u30b8\u30cd\u30b9\u3092\u4fdd\u8b77\u3057\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u5b89\u5168\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<h2>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n<h3>mPERS\u30c7\u30d0\u30a4\u30b9\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n<p>mPERS \u30c7\u30d0\u30a4\u30b9\u306f Mobile Personal Emergency Response System\uff08\u643a\u5e2f\u578b\u7dca\u6025\u901a\u5831\u30b7\u30b9\u30c6\u30e0\uff09\u306e\u7565\u3067\u3059\u3002\u7279\u306b\u9ad8\u9f62\u8005\u306e\u5b89\u5168\u3092\u5b88\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002GPS\u8ffd\u8de1\u3001\u8ee2\u5012\u691c\u77e5\u3001SOS\u30a2\u30e9\u30fc\u30c8\u306a\u3069\u306e\u6a5f\u80fd\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002.<\/p>\n<h3>mPERS\u30c7\u30d0\u30a4\u30b9\u306b\u304a\u3044\u3066\u8a8d\u8a3c\u304c\u91cd\u8981\u306a\u306e\u306f\u306a\u305c\u3067\u3059\u304b\uff1f<\/h3>\n<p>\u8a8d\u8a3c\u306fmPERS\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u78ba\u5b9f\u306a\u52d5\u4f5c\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002\u30e6\u30fc\u30b6\u30fc\u306e\u88fd\u54c1\u3078\u306e\u4fe1\u983c\u3092\u9ad8\u3081\u3001\u7570\u306a\u308b\u5e02\u5834\u3067\u306e\u8ca9\u58f2\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002.<\/p>\n<h3>mPERS\u30c7\u30d0\u30a4\u30b9\u304c\u898f\u5236\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u306b\u306f\u3069\u3046\u3059\u308c\u3070\u3088\u3044\u3067\u3059\u304b\uff1f<\/h3>\n<p>\u9069\u5207\u306a\u898f\u5236\u3092\u8abf\u3079\u3001\u5fc5\u8981\u306a\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u3001\u5fc5\u8981\u306a\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u3067\u3001\u30c7\u30d0\u30a4\u30b9\u304c\u898f\u5247\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3067\u304d\u307e\u3059\u3002\u719f\u7df4\u3057\u305f\u88fd\u9020\u696d\u8005\u3068\u5354\u529b\u3059\u308b\u3053\u3068\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n<h3>\u7c73\u56fd\u306b\u304a\u3051\u308bmPERS\u30c7\u30d0\u30a4\u30b9\u306e\u4e3b\u306a\u8a8d\u8a3c\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n<p>\u30a2\u30e1\u30ea\u30ab\u3067\u306f\u3001\u91cd\u8981\u306a\u8a8d\u8a3c\u3068\u3057\u3066FCC\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001UL\u8a8d\u8a3c\u3001FDA\u898f\u5236\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8a8d\u8a3c\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u5b89\u5168\u3067\u3042\u308a\u3001\u52b9\u679c\u7684\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u3059\u3002.<\/p>\n<h3>\u898f\u5236\u306e\u66f4\u65b0\u306f\u3069\u306e\u304f\u3089\u3044\u306e\u983b\u5ea6\u3067\u78ba\u8a8d\u3059\u3079\u304d\u3067\u3059\u304b\uff1f<\/h3>\n<p>\u898f\u5236\u306e\u66f4\u65b0\u60c5\u5831\u306f\u5b9a\u671f\u7684\u306b\u3001\u5c11\u306a\u304f\u3068\u3082\u5e74\u306b1\u56de\u306f\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6700\u65b0\u60c5\u5831\u3092\u628a\u63e1\u3057\u3066\u304a\u304f\u3053\u3068\u3067\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3057\u3001\u5e02\u5834\u306e\u5909\u5316\u306b\u9069\u5fdc\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Certifications and cellular needs are crucial for\u00a0mPERS\u00a0devices. These devices help keep users safe and efficient, especially for those who require extra care. However, regulations vary significantly across different regions. For instance, the EU emphasizes comfort in its certification rules, while Australia prioritizes\u00a0user training and risk identification. Understanding the importance of location-based technology is essential when selecting mPERS vendors. Manufacturers must ensure their devices hold key certifications, such as\u00a04G compliance, as 3G networks are being phased out. The varying network conditions in each region can pose additional challenges for manufacturers. Region Certification Requirement Description Australia Essential Principles Outlines rules for user training and risk identification. EU Essential Requirements Similar to Australia\u2019s [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":19379,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_eb_attr":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-19093","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/posts\/19093","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/comments?post=19093"}],"version-history":[{"count":0,"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/posts\/19093\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/media\/19379"}],"wp:attachment":[{"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/media?parent=19093"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/categories?post=19093"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eviewconnect.com\/ja\/wp-json\/wp\/v2\/tags?post=19093"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}