Re: [PSES] FCC requirements for fixed installations?

2017-03-28 Thread T.Sato 
On Tue, 28 Mar 2017 21:37:41 +0200,
  Michael Loerzer  wrote:

> in comparison to the EU EMC Directive art. 19 and annex I no. 2 "essential
> requirements for fixed installations" has US FCC similar regulations to show
> compliance?

For Part 15 devices, exemption specified in 47 CFR 15.103 may apply,
although still subjected to the general conditions of operation.

For Part 18 devices, there are no such exemption.

Regards,
Tom

-- 
Tomonori Sato  
URL: http://t-sato.in.coocan.jp

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[PSES] FCC requirements for fixed installations?

2017-03-28 Thread Michael Loerzer 
Hello,

 

in comparison to the EU EMC Directive art. 19 and annex I no. 2 "essential
requirements for fixed installations" has US FCC similar regulations to show
compliance?

 

Michael


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Re: [PSES] Radiated RF electromagnetic fields immunity test on ambulatory electrocardiographic system

2017-03-28 Thread Brian O'Connell 
Agree, difficult to determine. This is a particular standard so the 
requirements of the standard 'over-rule' test requirements that not same in 
some, but not all, other standards.

Essential performance is defined by the scoped standards and the manufacturer's 
analysis that defines what conditions would result in an "unacceptable risk". 
Where a resultant degradation of performance makes the equipment "no longer 
suitable for intended use", then essential performance requirements are not 
met. And ' essential performance' drives your test matrix, and thus the design 
of Type Tests.

The authorities or bodies doing the product assessment should be consulted (or 
insulted) after you have performed your analysis and completed a type test 
design, but before the type testing.

Brian


From: ce-test, qualified testing bv - Gert Gremmen [mailto:g.grem...@cetest.nl] 
Sent: Tuesday, March 28, 2017 11:57 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Radiated RF electromagnetic fields immunity test on 
ambulatory electrocardiographic system


You did not mention the product , but I assume that

IEC 60601-2-47:2012 concerns the basic safety and essential performance of 
AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS

so you probably considering such a device.


I believe that if it is required to test essential performance, and for thorough
the specific type of equipment a patient signal is required,  a simulator is 
what you need to fulfil due diligence.
Especially if the device software autonomously draws any pertinent conclusions 
from the measured signals
and the signals are not for  visual monitoring only.

A classical cardiographic device is basically a DM oscilloscope with a high 
(assisted) CM suppression:
any device that can generate a large CM  and extremely small DM voltage 
simultaneously will do.

In no way the testing for the integrity of stored data can be the only 
compliance criterion here.

That said and concluded: I am not fully sure what your device is up to...

Gert Gremmen



Van: Silvia Diaz Monnier [mailto:silvi...@inti.gob.ar] 
Verzonden: dinsdag 28 maart 2017 20:12
Aan: EMC-PSTC@LISTSERV.IEEE.ORG
Onderwerp: [PSES] Radiated RF electromagnetic fields immunity test on 
ambulatory electrocardiographic system

Hi,

the Radiated RF electromagnetic fields immunity test according to IEC 
60601-2-47:2012, 202.6.2.3, makes an addition to IEC 60601-1-2:2007. This 
addition requires to check that there is no loss of any stored data. But 
collateral IEC 60601-1-2:2007, on 6.2.1.10 also requires to verify the 
essential performance is not affected by noise on a waveform in which the noise 
could interfere the diagnosis, treatment or monitoring.

Test setup of IEC 60601-2-47 for that test do not require to simulate the 
patient signal. Is that correct? 
If so, why 2-47 makes an addition instead of a replacement.
If not, why the test setup do not require to use a patient signal simulator to 
check essential performance as other particular standards IEC 60601-2-25 or IEC 
60601-2-27.

That is, taking into account both standards, is it neccesary to check both 
essential performance and the no loss of storaged data? Or only the no loss of 
any stored data.

Thanks for your help.
Best regards,
Silvia

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Re: [PSES] Radiated RF electromagnetic fields immunity test on ambulatory electrocardiographic system

2017-03-28 Thread ce-test, qualified testing bv - Gert Gremmen 
 

You did not mention the product , but I assume that

 

IEC 60601-2-47:2012 concerns the basic safety and essential performance
of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS

 

so you probably considering such a device.

 

 

I believe that if it is required to test essential performance, and for
thorough

the specific type of equipment a patient signal is required,  a
simulator is what you need to fulfil due diligence.

Especially if the device software autonomously draws any pertinent
conclusions from the measured signals

and the signals are not for  visual monitoring only.

 

A classical cardiographic device is basically a DM oscilloscope with a
high (assisted) CM suppression:

any device that can generate a large CM  and extremely small DM voltage
simultaneously will do.

 

In no way the testing for the integrity of stored data can be the only
compliance criterion here.

 

That said and concluded: I am not fully sure what your device is up
to...

 

Gert Gremmen

 

 

 

Van: Silvia Diaz Monnier [mailto:silvi...@inti.gob.ar] 
Verzonden: dinsdag 28 maart 2017 20:12
Aan: EMC-PSTC@LISTSERV.IEEE.ORG
Onderwerp: [PSES] Radiated RF electromagnetic fields immunity test on
ambulatory electrocardiographic system

 

Hi,

 

the Radiated RF electromagnetic fields immunity test according to IEC
60601-2-47:2012, 202.6.2.3, makes an addition to IEC 60601-1-2:2007.
This addition requires to check that there is no loss of any stored
data. But collateral IEC 60601-1-2:2007, on 6.2.1.10 also requires to
verify the essential performance is not affected by noise on a waveform
in which the noise could interfere the diagnosis, treatment or
monitoring.

 

Test setup of IEC 60601-2-47 for that test do not require to simulate
the patient signal. Is that correct? 

If so, why 2-47 makes an addition instead of a replacement.

If not, why the test setup do not require to use a patient signal
simulator to check essential performance as other particular standards
IEC 60601-2-25 or IEC 60601-2-27.

 

That is, taking into account both standards, is it neccesary to check
both essential performance and the no loss of storaged data? Or only the
no loss of any stored data.

 

Thanks for your help.

Best regards,

Silvia

 

 

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[PSES] Radiated RF electromagnetic fields immunity test on ambulatory electrocardiographic system

2017-03-28 Thread Silvia Diaz Monnier 
Hi,

 

the Radiated RF electromagnetic fields immunity test according to IEC
60601-2-47:2012, 202.6.2.3, makes an addition to IEC 60601-1-2:2007. This
addition requires to check that there is no loss of any stored data. But
collateral IEC 60601-1-2:2007, on 6.2.1.10 also requires to verify the
essential performance is not affected by noise on a waveform in which the
noise could interfere the diagnosis, treatment or monitoring.

 

Test setup of IEC 60601-2-47 for that test do not require to simulate the
patient signal. Is that correct? 

If so, why 2-47 makes an addition instead of a replacement.

If not, why the test setup do not require to use a patient signal simulator
to check essential performance as other particular standards IEC 60601-2-25
or IEC 60601-2-27.

 

That is, taking into account both standards, is it neccesary to check both
essential performance and the no loss of storaged data? Or only the no loss
of any stored data.

 

Thanks for your help.

Best regards,

Silvia

 

 


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