{"id":3492,"date":"2013-10-02T10:51:56","date_gmt":"2013-10-02T10:51:56","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3492"},"modified":"2013-10-02T10:51:56","modified_gmt":"2013-10-02T10:51:56","slug":"iec-60601-1-3rd-edition","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/10\/02\/iec-60601-1-3rd-edition\/","title":{"rendered":"What is the Scope of IEC 60601-1:2005 (3rd edition)?"},"content":{"rendered":"<p><strong><a style=\"font-family: arial, helvetica, sans-serif; font-size: small;\" href=\"http:\/\/bit.ly\/MedDvcAcadIEC60601-12005\" target=\"_blank\" rel=\"noopener noreferrer\">This blog<\/a><\/strong><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"> will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product. \u00a0Definitions, third-party testing, etc. discussed.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">One of the first questions clients ask before a project starts is,\u00a0<em>\u201cDoes this medical<\/em>\u00a0<em>electrical product fall under IEC 60601-1?\u201d<\/em>\u00a0Another common question clients ask is whether IEC 60601-1 applies to battery operated medical devices. To answer these questions, we must review and understand the scope (sub-clause 1.1) of IEC 60601-1 to determine if and how the IEC 60601-1 Standard applies to a medical electrical product.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">This blog discusses the following points:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Definitions<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Examples within Scope of IEC 60601-1:2005<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Examples not within Scope of IEC 60601-1:2005<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">IEC 60601 &amp; ISO 13485<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Third-Party Testing<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product. \u00a0Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is,\u00a0\u201cDoes this medical\u00a0electrical product fall<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[1094,61,15,16,403,54,41,47,404,163,36,92,63,64,27,185,9,91,13,218,53,94,95,213,4,22,330,266,174,175,149,861,1118,5,423,424,1119,1120],"class_list":["post-3492","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-3rd-edition","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-a1","tag-aami","tag-aami-es60601-1","tag-aami-es60601-1c1","tag-amendment-1","tag-ansiaami-es60601-1","tag-cenelec","tag-collateral-standard","tag-en60601","tag-en60601-1","tag-escnews","tag-eu","tag-fda","tag-home-use-med-dvcs","tag-iec","tag-iec-60601-1","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-11","tag-iso-13485","tag-iso-14971","tag-medical","tag-medical-device","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-medical-electrical-equipment","tag-medical-equipment","tag-risk-management","tag-risk-management-file","tag-rmf","tag-standard","tag-stnadards"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3492","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=3492"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3492\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3492"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3492"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3492"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}