{"id":3161,"date":"2013-02-21T06:24:26","date_gmt":"2013-02-21T06:24:26","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3161"},"modified":"2013-02-21T06:24:26","modified_gmt":"2013-02-21T06:24:26","slug":"iec-tr-62348-2012-added-in-assessment-of-impact-of-most-significant-changes-of-iec-60601-1-2005-amendment-1","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/02\/21\/iec-tr-62348-2012-added-in-assessment-of-impact-of-most-significant-changes-of-iec-60601-1-2005-amendment-1\/","title":{"rendered":"IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1"},"content":{"rendered":"

A very useful document was recently released to be a summary of the significant and moderate changes made to IEC 60601-1:2005 based on Amendment 1 (A1) of IEC 60601-1.\u00a0 This is an excellent resource (IEC TR 62348:2012, published 12 Dec \u201912 and ANSI\/AAMI\/IEC TIR 62348:2012, published 31 Dec \u201912 by AAMI & 23 Dec \u201912 by ANSI) and should be purchased if you ever plan to use IEC 60601-1 3rd<\/sup> ed. or 3rd<\/sup> ed + A1.\u00a0 <\/span><\/p>\n

Either way this is a great resource and is useful to get a grip on the breadth of changes made for A1 and also if you are still getting your feet wet with 3rd<\/sup> ed. of IEC 60601-1 (many companies are still just starting along this process) there are still items that were in 1st ed. of IEC 62348 that are still of great resource to you. \u00a0<\/span><\/p>\n

With the release of A1 of IEC 60601-1 on July 13, \u201812<\/a><\/strong> (consolidated edition 3.1 published Aug 20, \u201912<\/a><\/strong>) & the US National Version ANSI\/AAMI ES 60601-1:2005\/A1:2012 there were a significant number of changes made to the 60601-1, 3rd<\/sup> edition.\u00a0 There were 182 identified issues and a total of 496 discrete changes to the 3rd<\/sup> ed. of 60601-1, which included some significant changes, moderate changes, and some minor typos, as well.\u00a0 Each of the 496 changes that A1 made were accessed by the developers of the standard to determine the impact on the users of 60601-1.\u00a0 Many of the changes are only editorial corrections or clarifications so many of the changes (413 changes) were accessed as having minimal or no impact on the application of the standard.\u00a0 But there were 83 changes that were accessed as having a moderate to significant impact on the users of the standard.\u00a0 So, IEC TR 62348 \u201cAssessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition\u201d<\/em> (here forward will only refer to IEC version as ANSI\/AAMI\/IEC TIR 62348:12 is the same as no technical changes to the document, just US national version introductory page changes) was updated for the 2nd<\/sup> edition to add in the Assessment of the impact of these 83 changes, as noted in the title of the standard, and still keep the comparison between 2nd<\/sup> to 3rd<\/sup> ed. of IEC 60601-1.\u00a0 The A1 assessment portion of the Technical Report is split into 2 parts based on the Significant (Table 1) or Moderate (Table 2) Impact on the users of the standard.\u00a0 This assessment is based on the likelihood that some alterations to the design documentation, testing, the product itself, or its accompanying documents will be required because of the change to a requirement in the A1.\u00a0 Further within each table the impact is sliced a bit thinner by considering if the issue will Impact many users or impact only particular users like a mechanical requirement that a chunk of devices may not be impacted by.\u00a0 As these assessments are subjective users of the standard (IEC 60601-1:05 + A1:12) are highly encouraged to review the contents of the A1 and determine its impact on the sections that are relevant to their products. \u00a0\u00a0The easiest way to read the A1 document is the consolidated A1 by IEC as the changes that can be shown are identified in a different color.\u00a0 The IEC version of the consolidated version (edition 3.1) of IEC 60601-1:2005 + A1:2012 standard can be obtained thru TechStreet<\/a><\/strong>.\u00a0 For the AAMI pdf go to the AAMI standards store<\/a><\/strong> and for the print version click here<\/a><\/strong>.<\/span><\/p>\n

The first edition of IEC TR 62348 was originally set up to compare 2nd<\/sup> to 3rd<\/sup> ed. of IEC 60601-1 so for those going from 2nd<\/sup> to 3rd<\/sup> ed. the document was accessible to any that wanted to learn what type of changes were made and what clauses changed, stayed the same or similar, were new or disappeared.\u00a0 Also, this document used to be free on the IEC website.\u00a0 As of the 2nd<\/sup> edition publication the document isn\u2019t free anymore.\u00a0 You can purchase the 2nd<\/sup> ed. of IEC TR 62348:212 or AAMI\/IEC TIR 62348:12 from various sources such as TechStreet<\/a><\/strong> or AAMI<\/a><\/strong>.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

A very useful document was recently released to be a summary of the significant and moderate changes made to IEC 60601-1:2005 based on Amendment 1 (A1) of IEC 60601-1.\u00a0 This is an excellent resource (IEC TR 62348:2012, published 12 Dec<\/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":[61,15,16,403,54,919,920,921,922,41,47,923,404,924,55,925,926,163,927,654,928,173,27,13,218,842,414,929,930,931,932,933,934,935,936,937,938,939,416,53,94,899,22,330,174,175,149,861,940,620,621],"class_list":["post-3161","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-es-60601-1-2005a1-2012","tag-aami-es-60601-105a112","tag-aami-es-60601-12005-a12012","tag-aami-es-60601-12005a12012","tag-aami-es60601-1","tag-aami-es60601-1c1","tag-aamiiec-tir-6234812","tag-amendment-1","tag-amendment-1-to-iec-60601-12005","tag-ansi","tag-ansi-aamiiec","tag-ansiaami-es-60601-12005a12012","tag-ansiaami-es60601-1","tag-ansiaamiiec-tir-623482012","tag-consolidated-edition","tag-es-60601-12005-a12012","tag-esc","tag-escnews","tag-iec","tag-iec-60601-1","tag-iec-60601-1-a1","tag-iec-60601-1-3rd-ed","tag-iec-tr-62348","tag-iec-tr-62348-2nd-ed","tag-iec-tr-62348-2nd-edition","tag-iec-tr-6234812","tag-iec-tr-623482012","tag-iec-tr62348","tag-iec-tr62348-2012","tag-iec-tr62348-2nd-ed","tag-iec-tr62348-2nd-edition","tag-iec-tr6234812","tag-iec-tr623482012","tag-iec60601","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-international-electrotechnical-commission","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-medical-electrical-equipment","tag-moderate-changes","tag-moderate-impact","tag-significant-impact"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3161","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=3161"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3161\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3161"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3161"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3161"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}