Re: [PSES] Confusion about IEC 60601-1-11 Power Cord Requirements and Functional vs Protective Earth Terminals

[Leonard (Leo) Eisner]

Hi Matthew,

You should read Annex A, clause 6 of IEC 60601-1-11 to understand the class II 
requirement is that many households around the world don’t have reliable 
grounds is why the standard requires class II for household medical devices 
unless the device is PERMANENTLY INSTALLED and then it can be class I.

Also, note that the APPLIED PARTS need to be floating BF or CF (F stands for 
floating and so would not be able to be grounded.

I would suggest you sell two different versions a professional version and home 
medical version.

Best, 

  

  Leonard (Leo) Eisner, P.E.
  The “IEC 60601 Guy”
  Principal Regulatory & Compliance Consultant, Eisner Safety Consultants
  Mobile: (503) 709-8328
  Email: l...@eisnersafety.com
  Website: www.EisnerSafety.com
 
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> On Oct 18, 2022, at 12:36 PM, John E Allen 
> <09cc677f395b-dmarc-requ...@listserv.ieee.org> wrote:
> 
> A comment from my “impressions only” as to why the requirement exists:
>  
> In many parts of the World, a majority of power outlets in household 
> locations do not include a protective earth/ground contact – and thus any 
> such connection in connected equipment might induce a false sense of 
> “security” in the users, and thus it was “prohibited” by the standard and 
> replaced by the Class II/external supply requirement.  (Anyone who has 
> travelled widely should appreciate that reason!)
>  
> John.E.Allen
> W.London, UK.
>  
>  
> From: Richard Nute mailto:ri...@ieee.org>> 
> Sent: 18 October 2022 20:21
> To: EMC-PSTC@LISTSERV.IEEE.ORG 
> Subject: Re: [PSES] Confusion about IEC 60601-1-11 Power Cord Requirements 
> and Functional vs Protective Earth Terminals
> To why 
>  
> Hi Matthew:
>  
> According to IEC 60601-1 Sub-clause 6.2:
>  
> ME EQUIPMENT energized from an external electrical power source shall be 
> classified as
> CLASS I ME EQUIPMENT or CLASS II ME EQUIPMENT
>  
> Its okay to have Class I equipment with Class II construction throughout.  
> However, you are likely to find it unacceptable to authorities to use a 
> protective earth cord without an internal connection.  I suggest you run a PE 
> wire from the appliance inlet to the metal tank or some other metal in the 
> equipment – even though it is not needed as the equipment is double-insulated 
> throughout.
>  
> Best regards,
> Rich
>  
>  
>  
> From: Matthew D. Varas mailto:m...@wrmed.com>> 
> Sent: Tuesday, October 18, 2022 9:53 AM
> To: EMC-PSTC@LISTSERV.IEEE.ORG 
> Subject: [PSES] Confusion about IEC 60601-1-11 Power Cord Requirements and 
> Functional vs Protective Earth Terminals
>  
> Hello, 
>  
> We are converting a product to comply with 60601-1-11 for home use and I was 
> hoping to get some clarification on the power cord requirements. 
>  
> The device is a mains-powered heating tank which uses snap-action thermostats 
> to control mains power through the internal heating pad. It is currently 
> intended for professional healthcare environments and has a metal tank that 
> is treated as an applied part. A three-prong power cord is used to provide a 
> protective earth connection as a MOP which, as I understand it, is not 
> allowable per clause 6 of 60601-1-11 (“shall be class II or internally 
> powered” and “shall not have a functional earth terminal”). 
>  
> The sales and marketing folks do not want to switch to a two-prong cord out 
> of concern that it will look unprofessional when used in a professional 
> healthcare environment, regardless of the fact that it will be redesigned to 
> be double insulated through other MOP’s. In trying to respond to them a 
> coworker and I are in disagreement about how to interpret clause 6 and could 
> use some help. Does this mean that :
>  
> The power cord must be two prong, or
> The power cord can be three prong but can have the earth terminal not 
> connected internally
> If it were to not be connected internally, I assume that a C18 connector on 
> the device (while still using the three-prong cord) would be the correct 
> path, however I interpret this to mean option 1 is correct. 
>  
>  
> Which leads to the second related part of my question: 
> I am unclear on the differences between a functional earth terminal and a 
> protective 

Re: [PSES] IEC 62368-1 ES3/PS3 cold impact test

[Boštjan Glavič]

Hi Christopher,

This is applicable for outdoor product. IP test follows cold impact test.

Best regards,
Boštjan



From: Don Gies <0e5e843b011c-dmarc-requ...@listserv.ieee.org>
Sent: Friday, October 21, 2022 2:04 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] IEC 62368-1 ES3/PS3 cold impact test

CAUTION: This email originated from outside of our organisation. Do not click 
links or open attachments unless you recognise the sender and know the content 
is safe.

Christopher,

Per Annex Y.6, you have to consider performing the cold impact tests on 
polymeric outdoor enclosures housing class 3 energy sources.

Best regards,

Don Gies



Internal
From: Chris 
<0133def26cf0-dmarc-requ...@listserv.ieee.org>
Sent: Thursday, October 20, 2022 5:43 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] IEC 62368-1 ES3/PS3 cold impact test


[External email: Use caution with links and attachments]




Folks,

When do we need to do IEC 62368-1 ES3/PS3 cold impact test as per IEC 62368-1 
Third edition.

I was told if EUT is powered by ES3/PS3 then it is required.

any insight will be helpful

Thanks in advance

Christopher

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