Eisner Safety Consultants» IEC

BS EN 60601-2-43:2010 Med. elec. equip. – X-ray equip. for interventional procedures

eisnersafety — Fri, 23 Jul 2010 23:07:51 +0000

BS EN 60601-2-43:2010 Med. elec. equip. – Particular rqrts – X-ray equip. for interventional procedures Pub. 31-JUL-10 http://ht.ly/2fSOS

BS EN 60601-1-11:2010 Medical electrical equip-Collateral std-Home healthcare environ

eisnersafety — Fri, 23 Jul 2010 21:59:54 +0000

BS EN 60601-1-11:2010 Medical electrical equipment-Collateral standard for use in home healthcare environ Pub 31-JUL-10 http://ht.ly/2fRwW

Eisner Safety Consultants Newsletter #6 Now Online

eisnersafety — Tue, 06 Jul 2010 06:00:59 +0000

Eisner Safety Consultants Newsletter #6 – 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/

Summary:
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.

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.

Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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FDA Formally Recognized AAMI ES60601-1:2005 as Consensus Std 6/10/10

eisnersafety — Wed, 23 Jun 2010 17:32:41 +0000

FDA Formally Recognized AAMI ES60601-1:2005 (National Version of IEC60601-1:2005 = 3rd edition) as Consensus Standard on 6/10/10. The transition period indicated on the FDA Consensus Standard web page for AAMI/ANSI ES 60601-1:2005 says in summary that 2nd edition of IEC 60601-1 will be accepted until June 30,2013 and after that only ANSI/AAMI ES60601-1:2005 will be accepted. The verbatim verbage on the web page is: “FDA recognition of Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance. FDA will accept declarations of conformity, in support of premarket submissions, to Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 until June 30, 2013. After this transitional period, declarations of conformity to Edition 2:1988(A1:1991+A2:1995) of the standard will not be accepted.”

There is additional information, including how collateral and particular standards will be treated and how US National infrastructure requirements enacted as statue (e.g. NFPA 99) will be implemented with this Standard, and how Risk Management will be used with this standard, on the FDA Consensus Standard web page for ANSI/AAMI Es 60601-1:2005 http://ht.ly/22kSQ

Major Regulatory Decisions on IEC60601-1, 3rd ed. (UL White Paper)

eisnersafety — Mon, 14 Jun 2010 17:56:43 +0000

Major Regulatory Decisions on the 3rd ed. of IEC 60601-1 on UL Thought Leadership WebPage http://ht.ly/1YkCB

AAMI News: Online Med Dvc Stan…

eisnersafety — Tue, 16 Mar 2010 19:49:44 +0000

AAMI News: Online Med Dvc Standards Portal Access to Over 2,000 Std’s & Reg’s (AAMI, ANSI, ASTM, DIN, IEC/ISO, FDA) http://ow.ly/1n2Jg

Available at IEC Webstore soon …

leoeisner — Sun, 26 Jul 2009 00:00:11 +0000

Replaced or withdrawn publications available shortly from IEC Webstore

Previously you had to order Replaced or Withdrawn IEC publications thru the IEC Central Office Customer Service Center. This changes should make the purchase of these documents quicker and easier.