Re: IEC 61010 requirements

2003-02-19 Thread Ronald R. Wellman

Hello Delphina,

Laboratory equipment can be considered medical devices if you advertise 
them as such or claim that they can be used be physicians to form medical 
opinions. However, most laboratory equipment manufacturers get around this 
by claiming that their products are intended for research use only so they 
don't have to make pre-market approvals to regulatory agencies. How a 
hospital lab uses non-approved devices is not governed by pre-market 
approval regulations because the regulations are not intended to tell 
physicians how to practice medicine.

Therefore, to answer your question concerning the use of an isolation 
transformer, this will depend on whether you need to conform to the leakage 
current requirements of IEC 61010-1 or 60101-1. I suggest that you purchase 
copies of both standards and understand their differences. However, based 
on your equipment description it appears that 61010-1 will be the safety 
standard you will need to use.

Best regards,
Ron Wellman

At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote:

Hi

I am trying to find out safety requirements for devices that control and
monitor equipment in a hospital lab (used for pathology). Does it fall under
the IEC 61010 standard? If so, are there any requirements for use of
isolation transformers in that standard?

Thanks in advance for your response!

-Delphina

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RE: IEC 61010 requirements

2003-02-19 Thread Chris K. Poore
There are no requirements for using an isolation transformer as long as you
can meet the requirements for touch current (leakage current) without one.
These requirements are similiar to 950, and not as stringent as the medical
requirement.
 
Chris Poore
 
 
 

From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of boconn...@t-yuden.com
Sent: Wednesday, February 19, 2003 11:42 AM
To: emc-p...@majordomo.ieee.org
Subject: RE: IEC 61010 requirements



If end-use wiil never see contact w/patient or test subject, and equipment can
be classified as Electrical Test and/or Measurement equipment, and does NOT
fall under the scope of the Med Directive, and can be scoped under the LVD,
then 61010-1 is applicable standard.

Of course, the customer spec can require compliance to the Med Dev Dir. 

Brian 

-Original Message- 
From: Han, Delphina [ mailto:d...@strykerendo.com] 
Sent: Wednesday, February 19, 2003 9:10 AM 
To: emc-p...@majordomo.ieee.org 
Subject: IEC 61010 requirements 



Hi 

I am trying to find out safety requirements for devices that control and 
monitor equipment in a hospital lab (used for pathology). Does it fall under 
the IEC 61010 standard? If so, are there any requirements for use of 
isolation transformers in that standard? 
  




RE: Custom Units in EU

2003-02-19 Thread drcuthbert

I should emphasize that this applies to equipment build by company A for use
by company A only. A label on the equipment stating this is probably a good
idea.

   Dave Cuthbert


From: drcuthbert [mailto:drcuthb...@micron.com]
Sent: Wednesday, February 19, 2003 3:28 PM
To: 'Joe P Martin'; emc-p...@majordomo.ieee.org
Subject: RE: Custom Units in EU



Joe,
I looked into this last year. It appears to me that one can import
non-certified 61010-type equipment for in-house use. But, it technically must
still be able to pass safety, EMC, ESD, surge, and so on. Pretty much like
self certification without the final step or two.

Dave Cuthbert
Micron Technology 


From: Joe P Martin [mailto:marti...@appliedbiosystems.com]
Sent: Wednesday, February 19, 2003 1:49 PM
To: emc-p...@majordomo.ieee.org
Subject: Custom Units in EU



Greetings,

We are planning to manufacture up to 50 units for laboratory use.  Each of
these units will be one of a kind.  These units will be shipped to the EU
to our own laboratory and operated by our personnel.  If I recall correctly
there are exemptions for one of a kind units for EMC, LVD and Machinery
Directives.  However, I was unable to locate this information in the
guidelines to these Directives.  Can members of the group provide me with
specific information regarding the requirements, if any, for one of a kind
units located in the manufacturers facility and operated by employees of
the manufacturer in the EU?

All responses are appreciated.

Regards

Joe Martin
Applied Biosystems
marti...@appliedbiosystems.com



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MRI compatible?

2003-02-19 Thread brent.dew...@us.datex-ohmeda.com

Where can one find the regulations and testing requirements to declare a
device MRI compatible?

Thanks,

Brent DeWitt
Datex-Ohmeda
Louisville, CO



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RE: RE02 cabling problem

2003-02-19 Thread pwell...@csw.l-3com.com

All,

I do not recommend that you use heavy filtering at the chamber egress wall
to control emissions for a couple of reasons:

1) In good faith, you need to duplicate the actual *system* cabling and
loading of the end-target platform equipment or user. With filtered
connectors installed at the chamber egress wall, you certainly have isolated
the exercise equipment emissions away from the Equipment-Under-Test) EUT,
but that is not real world. While you may pass test limit line requirements,
when the product is used in the final application it may either radiate or
be susceptible. While you can always say you met the specification, it isn't
worth losing a customer or degrading your reputation.

2) Filter Connectors can (depending on type and values), present a very low
impedance at the chamber egress wall. This is undoubtedly NOT the end of the
cable (cabling connected to exercise equipment in the Ante Room). This may
cause unforeseen reflections on cables and shields creating worse emissions
or degraded susceptibility (alternate return paths) during testing.

One way to solve your problem is to specify shielded (overbraided) cabling
if you have the ability to. This would have to be something agreed upon
between you and your customer. Be careful of product safety concerns in some
countries with ungrounded power cabling.

The real way to solve the problem is to fix the common mode noise on the
cable by source suppression. Sometimes a painful solution but often the best
in the long run. This is painful if you are out of schedule (many do EMC
testing at the end of their development schedule), working with a difficult
OEM device, or cost is an issue. If you can't source suppress it, you're
back to containing it with the shielded cabling. Be careful about cable
shield pigtails or ferrules and wires. You will almost always have better
success with 360 degree overbraid shielding to EMI backshells.

Philip Ross Wellington
Mgr. Signal Integrity  EMI
L-3 Communications CSW




From: Cortland Richmond [mailto:72146@compuserve.com]
Sent: Wednesday, February 19, 2003 1:25 PM
To: neve...@attbi.com; ieee pstc list
Subject: Re: RE02 cabling problem



I was looking over Dries' post again and note that I overlooked something
important: He says that short shield goes on the *wall plate* -- which I
presume to be the shielded room wall. This doesn't change my recommendation
he test with unshielded wires. But it serves as a reminder that support
equipment must be protected from immunity stresses of its own. I hope there
are filters between the support equipment outside, and signal lines from
the chamber.  


Cortland


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Custom Units in EU

2003-02-19 Thread Joe P Martin

Greetings,

We are planning to manufacture up to 50 units for laboratory use.  Each of
these units will be one of a kind.  These units will be shipped to the EU
to our own laboratory and operated by our personnel.  If I recall correctly
there are exemptions for one of a kind units for EMC, LVD and Machinery
Directives.  However, I was unable to locate this information in the
guidelines to these Directives.  Can members of the group provide me with
specific information regarding the requirements, if any, for one of a kind
units located in the manufacturers facility and operated by employees of
the manufacturer in the EU?

All responses are appreciated.

Regards

Joe Martin
Applied Biosystems
marti...@appliedbiosystems.com



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Re: RE02 cabling problem

2003-02-19 Thread Cortland Richmond

I was looking over Dries' post again and note that I overlooked something
important: He says that short shield goes on the *wall plate* -- which I
presume to be the shielded room wall. This doesn't change my recommendation
he test with unshielded wires. But it serves as a reminder that support
equipment must be protected from immunity stresses of its own. I hope there
are filters between the support equipment outside, and signal lines from
the chamber.  


Cortland


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RE: IEC 61010 requirements

2003-02-19 Thread boconn...@t-yuden.com
If end-use wiil never see contact w/patient or test subject, and equipment can
be classified as Electrical Test and/or Measurement equipment, and does NOT
fall under the scope of the Med Directive, and can be scoped under the LVD,
then 61010-1 is applicable standard.

Of course, the customer spec can require compliance to the Med Dev Dir. 

Brian 

-Original Message- 
From: Han, Delphina [ mailto:d...@strykerendo.com] 
Sent: Wednesday, February 19, 2003 9:10 AM 
To: emc-p...@majordomo.ieee.org 
Subject: IEC 61010 requirements 



Hi 

I am trying to find out safety requirements for devices that control and 
monitor equipment in a hospital lab (used for pathology). Does it fall under 
the IEC 61010 standard? If so, are there any requirements for use of 
isolation transformers in that standard? 
  




IEC 61010 requirements

2003-02-19 Thread Han, Delphina

Hi

I am trying to find out safety requirements for devices that control and
monitor equipment in a hospital lab (used for pathology). Does it fall under
the IEC 61010 standard? If so, are there any requirements for use of
isolation transformers in that standard? 
 
Thanks in advance for your response!

-Delphina


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DRAFT OF NEW EMC DIRECTIVE

2003-02-19 Thread Gordon,Ian

All
I have a copy of the latest draft of the EMC directive (published December
2002) which is with the new holders of the EU presidency for implementation
although no firm time table is available. I uploaded it to the EMCPSTC
website (well, I tried!). Contact me if you want a copy.
Ian Gordon

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Re: 60950 clauses

2003-02-19 Thread Kim Boll Jensen

Dear Brian

Please indicate where in the standard these references are made, because
it could be that they should have referred to another clause which
exist.

Best regards,

Kim Boll Jensen
Bolls Raadgivning
Denmark
www.bolls.dk

boconn...@t-yuden.com skriver:



 The index of my copy of EN 60950:2000 refers to non-existent clauses
 (e.g., 7.x, 1.2.13.14, etc). Is is safe to assume that these are
 typos ?

 R/S,
 Brian O'Connell
 Taiyo Yuden (USA), Inc.



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Battery Loader for South Africa

2003-02-19 Thread Horst Haug

For a battery loader for the use with toys we would do approval to
IEC60335-2-29 in Europe. Is there a similar standard for South Africa and is
a mark required or the CE-mark sufficient for this country?


Thank you in advance for the answers.

Horst Haug

INNOVA Product Service GmbH
Ampferweg 6
Germany 87677 Stöttwang
Tel: (49) 8345-952727




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Re: Swissair 111 - long winded even by my standards but an interesting article

2003-02-19 Thread Fred Townsend

Scary! I squirmed in my seat as I read the article.  You see I did the
electrical design part of a similar system.  Our system had a critical design
flaw. It was a mechanical error so I was not responsible for the error but it
could have crashed the airplane.  Luckily we did not use a contractor for
certification.  We submitted straight to the FAA.  The FAA spotted the problem
and it was soon fixed.  It makes me wonder what would have happened if we used
a
contractor to certify.

In another vein, did anyone else pick up the error in the article? It related
to
the disk drive.  It probably was the reporter's error.  I see errors of this
kind so frequently when you have a journalist or English major writing about
scientific issues. They are not equipped to do the job.

Fred Townsend

Ken Javor wrote:

 I drove from Huntsville, AL to Ft. Wayne, IN, today  mostly because flying
 is such a pain these days.  Now I'm glad I drove from a safety viewpoint as
 well.

 Seriously,  there is something wrong if gov't oversight is necessary to make
 sure an aircraft is put together right.  I think there is a very simple,
 very old fix for this problem.  Accountability.  They had it back in
 Babylon.  The Code of Hammurabi.  If an architect builds a house, and that
 house collapses and kills the owner, then the architect's life is also
 forfeit...

 on 2/18/03 7:50 PM, Gary McInturff at gary.mcintu...@worldwidepackets.com
 wrote:

 
  http://www.usatoday.com/travel/news/2003/2003-02-17-swissair.htm
 
 
 
 
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 --

 Ken Javor
 EMC Compliance
 Huntsville, Alabama
 256/650-5261

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RE: Satellite receiver

2003-02-19 Thread John Allen

Rob

I think that what you are experiencing is a fairly literal interpretation of
the RTTED by the Turkish authorities (notably the Customs) - one of our own
clients experienced similar problems with satellite equipment recently,
although that did have an up-link transmitter included in the system.

I suspect that the interpretation results from the fact the external network
in question is your Virtual Private Network (VPN) since this may be
interpreted as meaning that your receiver is NOT considered excluded from
the RTTED under Item 4 of Annex I Equipment not covered by this Directive
as referred to in Article 1 (4), i.e.: 4. Receive only radio equipment
intended to be used solely for the reception of sound and TV broadcasting
services. and because it's use falls with the scope of Article 3(3),
(whereas a similar domestic receiver would be considered to be excluded).

Nevertheless I think you might still be able your RTTED declaration using
just the EMCD  LVD evidence by virtue of the provisions of Article 3,
notably Article 3(1).

Our experience to-date suggests that you may also need the ANNEX II
Technical Documentation files to back up your submission.

Please contact me off-line if you need further assistance.

John Allen
Technical Consultant
Safety and Risk Management
ERA Technology Ltd
Cleeve Rd
Leatherhead
Surrey KT22 7SA
Tel:+44 (0) 1372-367025 (Direct)
+44 (0) 1372-367000 (Switchboard)
Fax:+44 (0) 1372-367102 (Fax)










From: Rob Humphrey [mailto:rob.humph...@reuters.com]
Sent: 18 February 2003 13:59
To: emc-p...@majordomo.ieee.org
Subject: Satellite receiver



Group, 

Grateful for your views...

I have been asked by the Turkish authorities to prove compliance to RTTE
directive, 1999/5 for a satellite receiver,
The unit sits between a satellite dish and our private network, it extracts
IP content from DVB Mpeg2 stream and delivers it via fast ethernet
Onto our network.

I already comply to EMC directive and LVD directive, I don't believe that
the RTTE directive applies.

Thanks in advance for your response.

Rob.




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Northeast Product Safety Society Meeting Next Week on Wednesday, February 26

2003-02-19 Thread Matt Campanella


There will be a Northeast Product Safety Society meeting on Wednesday,
February 26th, at EMC Corporation's Customer Briefing Center at 42 South
Street in Hopkinton, MA.  A social hour with light refreshments will
begin at 7:00 PM and the technical meeting will start at 7:30 PM.  David
W. Simmerer, former Director of Product Reliability at Olson
Manufacturing Company, will present this month’s topic on Failure Mode
and Effects Analysis.

David’s presentation will provide an overview of FMEA and it’s
methodology with an example analysis using a Ford car door.  He will
illustrate FMEA application with past experiences such as brain shunts
for JJ in Switzerland, Otis Elevator, and some actual hospital process
FMEA's that have done to prevent patient mix-up of diagnosis and
prescriptions and stealing of infants, etc.  David will condense what is
normally a two or three day seminar into 1 hour, and still leave time
for QA and discussions afterwards.  If you have never taken part in a
FMEA this will be a new insight for you, and if you have, then this can
provide some refresher information.

David W. Simmerer is a management consultant with over 40 years of
experience in all areas of quality improvement.  David is a former
Director of Product Reliability and Human Resources at Olson
Manufacturing Company.  David studied mechanical engineering and
graduated from the WPI School of Industrial Management.  He is past
chairperson of the American Society for Quality, Worcester Section.
David, a certified quality engineer, teaches in the areas of quality
improvement and management.  Over the past years, David has conducted
customized In-House Training for many National and International
corporations.

The 2003 NPSS meeting schedule is available on the NPSS website at
http://www.nepss.org/meetings/NPSS2003Calendar.htm.

Further information about the Northeast Product Safety Society and how
to become a member is available at http://www.nepss.org.  You can also
contact one of the NPSS officers via links at
http://www.nepss.org/secretary/officers03.html.

Directions:
From Route 495 North or South take exit 21B to South Street.
At the first traffic light, turn left (Note: This is on South direction
side of Route 495).
EMC Corporation is the second driveway on the right.


Matt Campanella
   NPSS Secretary

Compliance Engineer
Motorola, Inc.
Broadband Communications Sector
3 Highwood Drive East
Tewksbury, MA 01876

(978) 858-2303   Direct
(978) 858-2300   Main
(978) 858-2399   Fax

matthew.campane...@motorola.com  email






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