Emergency Medical Devices Environment – Eisner Safety Consultants

Conf. on IEC 60601-1-11 & Proposed IEC 60601-1-12 (Home Health Care & Emerg Med Srvcs Environ Stds)

leoeisner — Wed, 16 Feb 2011 08:07:33 +0000

Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively

Presenter: Leo Eisner of Eisner Safety Consultants

When: March 3, 2011 (Thursday), 8:30 – 9:30AM (Pacific), 11:30AM – 12:30PM (Eastern)

Where: At your office or conference room (No travel required)

What’s it about: Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS). Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.

In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.

Cost & Registration: Fx Conferences registration page for this event. Cost is normally $249.00 but with the Eisner Safety Consultants special discount you pay only $199.00. When checking out use the $50.00 discount code AF2009EIS.

Our Events Listing Page has events we are presenting at and also there is a listing of industry events that may interest you.

EU Interpretative Doc on Placing Med Dev’s on Mrkt

leoeisner — Wed, 01 Dec 2010 19:43:29 +0000

On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this applies to are Active Implantables Medical Devices 90/385/EEC, Medical Devices 93/42/EEC, and the InVitro Diagnostic Medical Devices 98/76/EC. Additionally, the biocidal products directive 98/8/EC is also referenced in this document.

This document refers to the EU Directive on accreditation and market surveillance relating to the marketing of products which is EC/765/2008. EC/765/2008 is relied on for the term “making available’.

The interpretative document may be viewed by clicking EU Interpretative Document – Placing Medical Devices on the Market.

To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the EUROPA webpage that has the Medical Device Directives Interpretative Documents.

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)