Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

2012-10-13 Thread Steli Loznen
Right. Use the clause 4.5 of the standard and give a rationale in the Risk 
Management file.

Steli Loznen, M.Sc.,SM-IEEE
Q.A. and Certification Manager
Convener of IEC/TC62/SC62A/WG17
I.T.L (Product Testing) Ltd.
1, Bat Sheva St., POB 87
LOD 71100, ISRAEL
Tel: 972-8-9153100
Fax: 972-8-9153101
Mobile: 972-54-7245794
E-mail: st...@itl.co.il<mailto:st...@itl.co.il>
www.itl.co.il<http://www.itl.co.il>
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From: Momcilovic, Nick (GE Healthcare) [mailto:nick.momcilo...@ge.com]
Sent: Thursday, October 11, 2012 7:05 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

The data must be able to be displayed in SI units but it does not prohibit the 
equipment to display other units of measure.  At least that is my understanding 
of this requirement.

Regards,
Nick Momcilovic

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carl Newton
Sent: Thursday, October 11, 2012 8:56 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: AAMI version of 60601-1 3rd ed - requirement for SI Units

Group,

Does anyone have experience with the AAMI version of 60601-1, 3rd edition and 
clause 7.4.3?  This clause requires that measurement parameters be in SI units. 
I'm working on a therapeutic exercise device which requires patients to enter 
weight as a step in the setup process.  American patients will be befuddled if 
required to enter kg.  Anyone aware of a loophole?  I'm working with the EN 
edition.

Thanks,

Carl
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Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

2012-10-12 Thread Carl Newton
Thanks very much to all of you who responded.  I now have a path to pursue.

Carl

On Thu, Oct 11, 2012 at 9:55 AM, Carl Newton  wrote:

> Group,
>
> Does anyone have experience with the AAMI version of 60601-1, 3rd edition
> and clause 7.4.3?  This clause requires that measurement parameters be in
> SI units. I'm working on a therapeutic exercise device which requires
> patients to enter weight as a step in the setup process.  American patients
> will be befuddled if required to enter kg.  Anyone aware of a loophole?
>  I'm working with the EN edition.
>
> Thanks,
>
> Carl
>

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Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

2012-10-11 Thread Momcilovic, Nick (GE Healthcare)
The data must be able to be displayed in SI units but it does not prohibit the 
equipment to display other units of measure.  At least that is my understanding 
of this requirement.

Regards,
Nick Momcilovic

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carl Newton
Sent: Thursday, October 11, 2012 8:56 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: AAMI version of 60601-1 3rd ed - requirement for SI Units

Group,

Does anyone have experience with the AAMI version of 60601-1, 3rd edition and 
clause 7.4.3?  This clause requires that measurement parameters be in SI units. 
I'm working on a therapeutic exercise device which requires patients to enter 
weight as a step in the setup process.  American patients will be befuddled if 
required to enter kg.  Anyone aware of a loophole?  I'm working with the EN 
edition.

Thanks,

Carl
-


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Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

2012-10-11 Thread Wiseman, Joshua E
Carl,

What if it is addressed in your RMF?  Considering it is ANSI/AAMI instead of 
IEC/EN, and the intended market, I would think this would be an area you could 
use the RMF and address it that way.  If needed you could possible address this 
using Clause 4.5 (although, this might be a bit of a stretch here.)  I would 
also check with your NB or safety lab that you use and see what they have to 
say.

Regards,
Josh

Joshua Wiseman
Taylor Company
A division of Carrier Commercial Refrigeration, Inc

From: Carl Newton [mailto:emcl...@gmail.com]
Sent: Thursday, October 11, 2012 8:56 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

Group,

Does anyone have experience with the AAMI version of 60601-1, 3rd edition and 
clause 7.4.3?  This clause requires that measurement parameters be in SI units. 
I'm working on a therapeutic exercise device which requires patients to enter 
weight as a step in the setup process.  American patients will be befuddled if 
required to enter kg.  Anyone aware of a loophole?  I'm working with the EN 
edition.

Thanks,

Carl
-


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Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

2012-10-11 Thread John Woodgate
In message 
, 
dated Thu, 11 Oct 2012, Carl Newton  writes:



American patients will be befuddled if required to enter kg.


So would many British patients!
--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

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[PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units

2012-10-11 Thread Carl Newton
Group,

Does anyone have experience with the AAMI version of 60601-1, 3rd edition
and clause 7.4.3?  This clause requires that measurement parameters be in
SI units. I'm working on a therapeutic exercise device which requires
patients to enter weight as a step in the setup process.  American patients
will be befuddled if required to enter kg.  Anyone aware of a loophole?
 I'm working with the EN edition.

Thanks,

Carl

-

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