Big News!!!

IEC published ahead of schedule 6 of the 8 standards from the IEC 60601 Amendments Project. These standards are in Consolidated format meaning the latest edition plus amendments are all consolidated together. IEC notes this as a CSV. On 22 July 5 standards that published were: IEC 60601-1-6 Ed. 3.2, IEC 60601-1-9 Ed. 1.2, IEC 60601-1-10 Ed. 1.2, IEC 60601-1-11 Ed. 2.1, IEC 60601-1-12 Ed. 1.1. On 23 July 2020 IEC 60601-1-8 Ed. 2.2 was also published https://bit.ly/2Bui5mK
The other IEC 60601 Amendments (2 standards) still to be published include — IEC 60601-1 (ed. 3.2), IEC 60601-1-2 (Ed. 4.1) and maybe published as early as the end of this month (rumor has it but looking more likely) but it could be til Sept time range too.

Join us for a webinar on July 29, 9AM PT (Noon ET) for a live Zoom conversation on the IEC 60601 Amendments Updates (the 8 standards being published now & soon) with Leo Eisner the “IEC 60601 Guy” of Eisner Safety Consultants and Rob Packard of Medical Device Academy.

To sign up for this Zoom conversation click here. This Zoom Conversation is being hosted by Rob Packard of Medical Device Academy.

Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. Read the below infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.

This is a newly released standard as of 19 June 2014.  Are you ready to use this standard for your emergency medical services equipment (i.e. equipment used in and around ambulances and at locations where emergency medical services would be needed like a crash site.  The breadth of medical electrical equipment that this will cover is a wide swath and so manufacturers should start thinking about designing their products for these more rugged requirements.  Some of the testing is similar to the Home Use Environment Standard (IEC 60601-1-11) as that was a base for some of the development of this standard (IEC 60601-1-12). The scope of the standards is for Medical Electrical Equipment (MEE) & Medical Electrical Systems (MES) which are intended, as indicated by the IFU by their manufacturer, for use in the Emergency Medical Services (EMS) Environment.

The definition of EMS Environment per the standard is:

• actual conditions and settings, in which OPERATORS interact with the ME EQUIPMENT or ME SYSTEM, in and around the scene of an emergency outside of a professional healthcare facility where a PATIENT can be given medical care, basic or advanced life support as well as during professional transport to a professional healthcare facility or between professional healthcare facilities

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.

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