Interesting scenerio that you depict. If I had to solve that problem I would
call for a UL Field Inspection and apply the labels in the field. Although Paul
did not mention that alternative in his posting, it is available from UL and I
have taken advantage of it myself in the past on the occasion where we had
several mainframe type computers deployed without a UL mark. The inspector and
I met in the city where the computers were installed (red tagged by the local
electrical inspector I might add), the UL inspector reviewed the construction
against the UL report and we affixed the UL mark on the spot. Of course we had
to pay for his time and travel but it was an immediate and convenient method.
Gabriel Roy
Hughes Network Systems
MD
To: grabowskip @ ul.com ("Paul Grabowski") @ SMTPGW
cc: emc-pstc @ ieee.org @ SMTPGW, medic @ world.std.com @ SMTPGW
From: ghansen @ oecmed.com (Greg Hansen) @ SMTPGW
List-Post: emc-pstc@listserv.ieee.org
Date: 02/19/97 05:42:55 PM
Subject: Re: UL Marks and Repair of Equipment
SMTP Headers: Headers
At 02:09 AM 2/14/97, you wrote:
>I would like to present a defintion of UL Listing which has been used to help
>understand the situation associated with the filed modification or repair of
>Listed equipment before answering your questions.
>
>The UL Listing Mark on a product is the product manufacturer's declaration
>that the product complied with UL requirments at the time it was produced. I
>say that the Listing Mark is the "manufacturer's declaration" since UL
>monitors production of Listed equipment (periodic factory inspection visits
>are conducted), but does not inspect every product. UL evaluates production
>or prototype samples during the product investigation and the manufacturer
>agrees to produce that product in accordance with the UL requirements. Also,
>I say "at the time that it was produced" because neither UL nor the
>manufacturer have control over the product after it is produced and shipped.
>If a product is damaged, repaired, or modified in the filed, neither UL nor
>the manufacturer can state with certainty that the product still complies
>with the UL requirments.
>
>This definition of UL Listing ties in very closely with the second paragraph
>of Section 90-6 of the National Electrical Code. This paragraph states that
>it is the intent of the NEC that the construction of equipment need not be
>inspected, except to detect alterations or damage, if the equipment has been
>Listed. In other words, we interpret Section 90-6 of the NEC as indicating
>that Listed equipment, unless modified or damaged, is considered to meet the
>requirements for Listing in the NEC.
>
>If major modification of a Listed product occurs, UL does not have an
>opportunity to judge the effect of such modification and therefore is not in
>a position to state that the product continues to conform with UL Standards.
>It then becomes a legal question for the modifier of the product in regard to
>any obligations the modifier of the product may have in such a situation. If
>the modification consists of a rebuilding, refurbishing or reconditioning for
>resale, it would appear to be a misrepresentation to represent the product as
>being new.
>
>UL Marks should only be applied at the factory as the declartion by the
>manufacturer that the product meets the requirments. Affixing an identical
>replacement UL Mark on the equipment after the product leaves the factory
>would be a misrepresentation and unaceptable use of the UL Mark.
>
>If enclosure covers or other parts are repaired or replaced, how do you know
>the product still complies with the requirments? For example, the enclosure
>cover may be required to be of a certain plastic to meet flammability
>requirments. Agian it then becomes a legal question for the modifier of the
>product in regard to any obligations the modifier of the product may have in
>such a situation. However, UL does offers a program for evaluating rebuilt
>products.
>
>I hope the above helps.
>
>
>
>
>
>_________________________________________________________________
>
>Paul Grabowski
>Underwriters Laboratories Inc. Voice : (408) 985-2400 x32499
>1655 Scott Blvd. Fax: (408) 296-3256
>Santa Clara, CA 95050 E-mail: grabows...@ul.com
>_________________________________________________________________
>
>
Dear Mr. Grabowski,
I appreciate you response to the question posed for reapplying a UL Listing
label to a system in the field. This question is of concern to many
manufacturers and will probably remain so until an approved method is
created to satisfy this need.
I understand UL's rationale in not allowing replacement of labels in the
field because of the limited legal implications. However, I believe that in
some instances, the implications of this issue are much deeper that UL may
realize.
As an example, my company manufactures a special type of medical X-ray
equipment specifically used for coronary imaging in hospitals. Presently,
it is the only mobile X-ray system that can be used effectively in the
emergency rooms and operating rooms to conduct an immediate angiogram to
locate blocked arteries or other areas of restricted blood flow.
Now, suppose that one of these systems is received at the hospital with the
UL label illegible from shipping damage. Since OSHA requires electrical
equipment in the workplace to be LISTED, our field service engineer
installing the system calls the factory for a replacement label. I inform
him that UL will not allow this label to be applied in the field and
instruct him to repackage the entire system and return it to the factory.
Because of the logistics involved in packaging and shipping such a large
device back to the factory, reprocessing and retesting the equipment at the
factory, and then returning the equipment to the hospital; the hospital will
not have the use of this equipment for approximately 3 weeks. During this
period of time, people will be sent home from this hospital with undetected
arterial blockage, only to later suffer a fatal heart attack.
Now I realize that UL cannot allow manufacturers to replace labels in the
field because they have no controls or methods in place to allow this to be
done properly, but is UL willing to accept the fact that our strict
adherence with their labeling requirements will cost people their lives? On
the other hand, if I was able to send out a label overnight to our field
service engineer and document the reason for label replacement on that
system, the hospital could place the system into use the following day. The
latter scenario would involve some remote risk that something in the system
may have changed since it left the factory, but if our field service
engineer conducts leakage current and ground continuity tests before
replacing the label on the system then the risk would be very minimal.
Now, I understand that UL is in the business of promoting product safety so
I'm sure that you can tell me which is the greater risk: (1) denying the
customer the use of the device for 3 weeks or more during which time
patients die unnecessarily; or (2) replacing the label in the field and
accepting the same risks associated with any other device of that type in
the field?
I am quite sure that many people would not be very understanding if a doctor
informed them that the device which likely could have saved the life of
their loved one was unavailable and the reason that it was unavailable was
because the system had an illegible UL label and had to be returned to the
factory so it could be applied according to UL procedure.
In my opinion, this is an issue that UL needs to look at and provide a
method to satisfy the needs of industry, rather than ignoring the need and
occasionally looking the other direction.
Greg L. Hansen
Regulatory/Quality Engineer
OEC Medical Systems, Inc.
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