Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone, 

For regulatory professionals dealing with IEC 60601-1 and who are new to the medical electrical equipment, what is the best way to familiarize with the standard other than reading?  Are there helpful webcasts or white papers that can provide a reader's digest version of this standard, especially for the non-engineers? 

Thank you.

I have found greenlight guru to be very helpful when learning the basics with 60601-1 standards. Here is a link that states 15 steps to getting approval for IEC 60601-1: (https://www.greenlight.guru/blog/iec-60601-1-steps).

What I would do first is read the standard, see which areas apply and familiarize yourself with the collateral standards. Here is a website that mentions a bit about the collateral standards: https://www.mddionline.com/collateral-standards-iec-60601-1 . Not all of the general standard and collateral standard will apply to your device but it will be a nice foundation knowing exactly what areas to reference. 

If you have some money to spare and want more in depth knowledge from experts, Intertek and UL  have training's they offer a few times a year in different locations in the US (https://news.ul.com/events/designing-compliance-iec-60601-1-3rd-edition-1). Intertek also has some good information on their website including white papers and a webinar (http://www.intertek.com/medical/regulatory-requirements/iec-60601-1/) . I will say this, if you are using UL to get get 60601-1 certified than use their training (likewise with Intertek). 

The general standard can be overwhelming but just carve out some time here and there to review piece by piece and you'll become familiar. 

Hope this helps,


------------------------------
April Corella
Temecula CA
United States
------------------------------

Original Message:
Sent: 06-Feb-2019 11:29
From: Anonymous Member
Subject: IEC 60601-1

This message was posted by a user wishing to remain anonymous

Hello everyone,

For regulatory professionals dealing with IEC 60601-1 and who are new to the medical electrical equipment, what is the best way to familiarize with the standard other than reading?  Are there helpful webcasts or white papers that can provide a reader's digest version of this standard, especially for the non-engineers?

Thank you.

As April mentioned there are lots of helpful information out there that boils the hundred page standard down to something that is useful for a lay-person to use.  We also have some experts in this forum like Leo Eisner eisnersafety.com who are experts in those standards that have published information - if you search this forum for IEC 60601-1 there are some links provided to helpful information.  I would also recommend to search on IEC 60601-1 version "3.1" differences as from version 3.0 to 3.1 there were some meaningful changes that are quite important.  And of course, you can contact your testing laboratory that you may be using for the safety testing as they usually have much helpful information, checklists, and guides to follow for compliance.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 07-Feb-2019 11:48
From: April Corella
Subject: IEC 60601-1

I have found greenlight guru to be very helpful when learning the basics with 60601-1 standards. Here is a link that states 15 steps to getting approval for IEC 60601-1: (https://www.greenlight.guru/blog/iec-60601-1-steps).

What I would do first is read the standard, see which areas apply and familiarize yourself with the collateral standards. Here is a website that mentions a bit about the collateral standards: https://www.mddionline.com/collateral-standards-iec-60601-1 . Not all of the general standard and collateral standard will apply to your device but it will be a nice foundation knowing exactly what areas to reference.

If you have some money to spare and want more in depth knowledge from experts, Intertek and UL  have training's they offer a few times a year in different locations in the US (https://news.ul.com/events/designing-compliance-iec-60601-1-3rd-edition-1). Intertek also has some good information on their website including white papers and a webinar (http://www.intertek.com/medical/regulatory-requirements/iec-60601-1/) . I will say this, if you are using UL to get get 60601-1 certified than use their training (likewise with Intertek).

The general standard can be overwhelming but just carve out some time here and there to review piece by piece and you'll become familiar.

Hope this helps,


------------------------------
April Corella
Temecula CA
United States

Original Message:
Sent: 06-Feb-2019 11:29
From: Anonymous Member
Subject: IEC 60601-1

This message was posted by a user wishing to remain anonymous

Hello everyone,

For regulatory professionals dealing with IEC 60601-1 and who are new to the medical electrical equipment, what is the best way to familiarize with the standard other than reading?  Are there helpful webcasts or white papers that can provide a reader's digest version of this standard, especially for the non-engineers?

Thank you.

Great information April.

Anonymous, Leo Eisner is Mr. IEC 60601-1... 

 For great consulting on this you can contact him at Eisner Safety Consultants.  


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 07-Feb-2019 11:48
From: April Corella
Subject: IEC 60601-1

I have found greenlight guru to be very helpful when learning the basics with 60601-1 standards. Here is a link that states 15 steps to getting approval for IEC 60601-1: (https://www.greenlight.guru/blog/iec-60601-1-steps).

What I would do first is read the standard, see which areas apply and familiarize yourself with the collateral standards. Here is a website that mentions a bit about the collateral standards: https://www.mddionline.com/collateral-standards-iec-60601-1 . Not all of the general standard and collateral standard will apply to your device but it will be a nice foundation knowing exactly what areas to reference.

If you have some money to spare and want more in depth knowledge from experts, Intertek and UL  have training's they offer a few times a year in different locations in the US (https://news.ul.com/events/designing-compliance-iec-60601-1-3rd-edition-1). Intertek also has some good information on their website including white papers and a webinar (http://www.intertek.com/medical/regulatory-requirements/iec-60601-1/) . I will say this, if you are using UL to get get 60601-1 certified than use their training (likewise with Intertek).

The general standard can be overwhelming but just carve out some time here and there to review piece by piece and you'll become familiar.

Hope this helps,


------------------------------
April Corella
Temecula CA
United States

Original Message:
Sent: 06-Feb-2019 11:29
From: Anonymous Member
Subject: IEC 60601-1

This message was posted by a user wishing to remain anonymous

Hello everyone,

For regulatory professionals dealing with IEC 60601-1 and who are new to the medical electrical equipment, what is the best way to familiarize with the standard other than reading?  Are there helpful webcasts or white papers that can provide a reader's digest version of this standard, especially for the non-engineers?

Thank you.

First Thank you to Ginger & Richard for those nice words. 

My site has some additional resources not mentioned yet.


------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 06-Feb-2019 11:29
From: Anonymous Member
Subject: IEC 60601-1

This message was posted by a user wishing to remain anonymous

Hello everyone,

For regulatory professionals dealing with IEC 60601-1 and who are new to the medical electrical equipment, what is the best way to familiarize with the standard other than reading?  Are there helpful webcasts or white papers that can provide a reader's digest version of this standard, especially for the non-engineers?

Thank you.