ES 60601-1 – Eisner Safety Consultants

Several Test Labs Awaiting Approval for AAMI ES 60601-1, ed. 3.1 under OSHA NRTL Program

leoeisner — Mon, 30 Jun 2014 20:13:09 +0000

Several NRTLs, who are currently recognized for UL 60601-1, have applied to OSHA to add ANSI AAMI ES60601 + Amendment 1 to their scope of recognition. OSHA is currently reviewing these applications and anticipates the final recognition for these NRTLs to be granted in late summer.

Some of the NRTL’s have completed the technical review process and demonstrated that they have the capability to test and certify to the AAMI standard. For these NRTLs, the preliminary Federal Register notice has been drafted and OSHA is expecting to see these in the Federal Register in the near future (could be a couple weeks or a month or two).

As this is an expansion of their scope these NRTL’s are subject to a 15 day notice and comment period where members of the public will have an opportunity to comment on OSHA’s intent to recognize these organizations for the AAMI Standard. At the conclusion of the 15 day comment period, OSHA will draft a second and final notice, addressing any comments OSHA receives from the public, and announce OSHA’s final decision in the Federal Register. Once these second FR notices are published, the NRTLs named in the notice will be considered recognized for the AAMI standard.

So, once the NRTL’s are Recognized for the AAMI ES 60601-1, for 3^rd + Amendment 1 these NRTL’s will finally be authorized to allow their clients, after passing the applicable testing for their product(s), to place a US NRTL Test Mark on their client product(s).

If you need additional support for AAMI ES 60601-1 or IEC 3rd edition + A1 email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Great Resource – Current/Draft IEC 60601/80601 Series of Stds & Test Rprts Now Available

leoeisner — Wed, 17 Jul 2013 06:09:24 +0000

We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.

We also set-up pages to do the same for checking on the status of the IEC 80601 series of current & draft standards, which are standards that are jointly developed between IEC & ISO, and TRFs of the current 806012 series standards. These later standards are called either IEC 80601-X-Y standards or ISO 80601-X-Y standards. The lead organization gets their organization initials in the standards identifier.

This is a great resource to be able to stay up to date on the standards that are being developed, the updates to current standards and to ensure your standards library is up to date as required under ISO 13485 and also under most medical device regulatory national schemes. If your organization needs help keeping track of current &/or developing standards our organization can help you develop a system or we can do this work for your organization’s standards and external documents library. Please feel free to contact us about this at Leo@EisnerSafety.com or 503-244-6151.

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

NWIP – Collateral Std IEC60601-1-XX Emergency Med Srvcs

leoeisner — Mon, 25 Oct 2010 22:21:11 +0000

A New Work Item Proposal for Medical Electrical Equipment & Medical Electrical Systems used in the Emergency Medical Services Environment will be submitted to ISO by the end of November 2010. This proposed standard follows the structure of the Collateral Standard IEC 60601-1-11 Medical Equipment and Medical Systems for Home Use that was published April 2010. Even though this proposed standard follows the structure of 60601-1-11 there are differences such as the environmental exposure of the device (temperature, liquid & particulate exposure, etc.) and the type of operators (professional use – EMT’s vs non-professional use – patients), among other issues. Note, that both of the Collateral Standards (Proposed & 60601-1-11) are aligned with 3rd ed. of IEC 60601-1 (published in 2005). So, if a device has an intended use that is for air &/or land ambulances and you have only tested to 2nd ed. of IEC 60601-1 you will have to move up to 3rd ed. to add this new standard when it is published. As this is not a published standard and will probably take about 3 years to publish the final document may not include all these items but it is likely to follow the IEC 60601-1-11 formatting as these two types of medical products have some similarities as well.

Please feel free to contact us on this matter if you would like some assistance in learning more about this proposed standard as it applies to your products.

Leo@EisnerSafety.com
503-244-6151 (USA)

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