ES 60601-1:2005 – Eisner Safety Consultants

Leo Eisner Presenting @ DesignMed on IEC60601-1-11 Home Healthcare

leoeisner — Fri, 14 Jan 2011 20:38:40 +0000

Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories

When: Feb 10, 2011 (Thursday)

Where: Anaheim Convention Center while you are at the MD&M West Conference

What’s it about: The market for home healthcare equipment is expected to grow exponentially over the coming years, as the delivery of healthcare services shifts from clinical settings to the home. But manufacturers face a series of unique challenges in supplying home healthcare equipment that is both effective and safe. IEC 60601-1-11 “Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Applications” was recently published to address the safety hazards that exist when medical devices are moved into the home. IEC 60601-1-11 is a collateral standard, meaning that it directly references provisions in IEC 60601-1, and is used in conjunction with IEC 60601-1 for the certification of home healthcare equipment. In addition to the publication of the new standard, FDA has launched the Medical Device Home Use Initiative, which is expected to impact the regulatory approvals of medical devices for use in the home. In this presentation, two leading experts in medical device safety, one who participated in the writing of IEC 60601-1-11 and the other working on a sister standard for the emergency medical services type electrical medical devices, will discuss the major considerations all design engineers must consider when designing a medical device that may be marketed for home use.

Learn more: About DesignMed West 2011

Conference Registration: Webpage

ESC @ 74th IEC Gen. Mtg til Oct 16 ’10 – Med Elec Equip Comm’s TC62, SC 62A & 62D

leoeisner — Mon, 11 Oct 2010 00:01:05 +0000

Eisner Safety Consultants is attending the 74th Annual IEC General Meeting in Seattle Washington thru Oct 16, 2010. As a US National Committee member of Technical Committee (TC) 62, Subcommittees (SC) 62A & 62D we are attending the committee meetings that will help medical device manufacturer’s better understand the coming & current standards requirements. We are here so we can help our clients. So, please contact us to help your company through IEC 60601-1, 3rd ed. Gap Analysis and to help your company to stay on top of the ever changing & evolving IEC 60601 series of standards. Go to www.EisnerSafety.com/contact_eisner_safety/ to contact us.

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