{"id":3512,"date":"2013-10-26T21:46:58","date_gmt":"2013-10-26T21:46:58","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3512"},"modified":"2013-10-26T21:46:58","modified_gmt":"2013-10-26T21:46:58","slug":"iec-60601-medical-electrical-equipment-classifications-faqs","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/10\/26\/iec-60601-medical-electrical-equipment-classifications-faqs\/","title":{"rendered":"IEC 60601 Medical Electrical Equipment Classifications: FAQ\u2019s"},"content":{"rendered":"<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog.\u00a0<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Why do I need to classify my product for IEC 60601-1, 3<\/strong><strong><sup>rd<\/sup><\/strong><strong>\u00a0ed.?<\/strong>\u00a0\u2013 The standard says you have to classify<em>\u201c<\/em>\u2026ME EQUIPMENT, or parts thereof, including applied parts\u2026<em>\u201d<\/em>\u00a0as noted in sub-clause 6.1 of IEC 60601-1, 3<sup>rd<\/sup> ed or 3<sup>rd<\/sup> ed. with Amendment 1 of the standard.. But a more practical reason you would want to classify your products that fall under the scope of IEC 60601-1 (<a title=\"Link for previous blog by Leo Eisner regarding the scope of IEC 60601\" href=\"http:\/\/bit.ly\/60601scope\">http:\/\/bit.ly\/60601scope<\/a>) is it is a helpful tool in identifying the requirements that apply to the device, and helps us in determining the test plan for the product to be tested.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">This blog discusses the following FAQ\u2019s:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>What are the various classifications that are used in IEC 60601-1, edition 3.1?<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>What is an applied part?\u00a0<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>What are the classifications for Protection Against Electric Shock?\u00a0<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Power Sources \u2013 External Class I, External Class II or Internal<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Applied Parts \u2013 B, BF, CF (also defibrillation-proof)<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Why do we have classifications for protection against electric shock?<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>What are the classifications for protection against harmful ingress of water or particulate matter?<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Why do we have classifications for protection against harmful ingress of water or particulate matter?<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>What are the classifications for methods of sterilization?<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Why do we have classification for the suitability in an oxygen rich environment?<\/strong><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>What are the classifications for modes of operation?<\/strong><\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog.\u00a0 Why do I need to classify my product for IEC 60601-1, 3rd\u00a0ed.?\u00a0\u2013 The standard says you have to classify\u201c\u2026ME EQUIPMENT, or parts thereof, including applied parts\u2026\u201d\u00a0as<\/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":[61,15,16,403,54,41,404,163,1126,74,499,63,64,27,93,89,91,13,218,53,94,22,330,174,149,5],"class_list":["post-3512","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-a1","tag-aami","tag-aami-es60601-1","tag-amendment-1","tag-ansiaami-es60601-1","tag-applied-parts","tag-cdrh","tag-classification","tag-en60601","tag-en60601-1","tag-escnews","tag-home-healthcare-environments","tag-home-use-environment","tag-home-use-med-dvcs","tag-iec","tag-iec-60601-1","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-devices","tag-risk-management"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3512","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=3512"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3512\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3512"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3512"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3512"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}