{"id":1715,"date":"2010-07-06T06:00:59","date_gmt":"2010-07-06T06:00:59","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/escnews-6-avail-60601-1-3rd\/"},"modified":"2010-07-06T06:00:59","modified_gmt":"2010-07-06T06:00:59","slug":"eisner-safety-consultants-newsletter-6-now-online","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2010\/07\/06\/eisner-safety-consultants-newsletter-6-now-online\/","title":{"rendered":"Eisner Safety Consultants Newsletter #6 Now Online"},"content":{"rendered":"

Eisner Safety Consultants Newsletter #6 \u2013 published 6\/30\/2010 & covers Recent news on IEC\/EN 60601-1:2005\/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling<\/span> <\/span><\/strong><\/p>\n

<\/span><\/strong><\/p>\n

Download all our newsletters at <\/span>http:\/\/www.EisnerSafety.com\/esc-news\/<\/a><\/span><\/p>\n

Summary:
\n <\/span> <\/strong>This issue is packed full of important updates and useful information. First, we are going to focus on additional updates with regard to IEC\/EN 60601-1:2005\/2006 as there is significant news since the last issue of our newsletter.<\/span><\/p>\n

Next we delve into the MDD Amendment 2007\/47\/EC specifically on the updated Classification MEDDEV and the new Clinical Data requirements. We also would like to remind you when your EU MDD Notified Body is up to reviewing your technical file or design dossier you need to make sure you have addressed the Usability and Clinical Data requirements as they apply to all medical devices under the MDD Amendments. If you need help with these new requirements to the MDD we have a toolkit that will be helpful to you.<\/span><\/p>\n

Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries.<\/span><\/p>\n

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.<\/span><\/p>\n

How to Subscribe:<\/span><\/strong><\/p>\n

If you would like to subscribe to our newsletters please go to the upper left hand corner of any our web pages on the website and enter your e-mail address in the subscribe box.\u00a0 You will receive an e-mail from <\/span>newsletter@EisnerSafety.com<\/span><\/a>.\u00a0 Please click the confirm link to opt-in to the newsletter. If <\/span>newsletter@EisnerSafety.com<\/span><\/a> goes to your junk mail folder please white list our e-mail address so you can enjoy our newsletters<\/span>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Eisner Safety Consultants Newsletter #6 \u2013 published 6\/30\/2010 & covers Recent news on IEC\/EN 60601-1:2005\/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http:\/\/www.EisnerSafety.com\/esc-news\/<\/p>\n","protected":false},"author":3,"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":[26,61,15,16,62,54,41,74,36,63,64,27,9,17,13,53,94,170,12,28,171,32,172,8,114,115,25],"class_list":["post-1715","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-200747ec","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-60601-2-xx-particular-stds","tag-aami","tag-aami-es60601-1","tag-cdrh","tag-cenelec","tag-en60601","tag-en60601-1","tag-escnews","tag-fda","tag-human-factors","tag-iec","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-inductive-coupling","tag-mdd","tag-mdd-amendment","tag-meddev-2-4-1","tag-notified-body","tag-rechargeable-batteries","tag-tuv-america","tag-tuv-product-service","tag-tuv-sud","tag-ul"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1715","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=1715"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1715\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=1715"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=1715"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=1715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}