...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of drcuthbert
Sent: Monday, February 24, 2003 1:32 PM
To: 'John Woodgate'; emc-p...@majordomo.ieee.org
Subject: RE: IEC 61010 requirements
Maybe he had a special low EMI cell phone? But seriously, a useful product
would
-Original Message-
From: John Woodgate [mailto:j...@jmwa.demon.co.uk]
Sent: Saturday, February 22, 2003 12:05 AM
To: emc-p...@majordomo.ieee.org
Subject: Re: IEC 61010 requirements
I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com
wrote (in 20030221231714.74613.qm
...@majordomo.ieee.org]On Behalf Of drcuthbert
Sent: Monday, February 24, 2003 1:32 PM
To: 'John Woodgate'; emc-p...@majordomo.ieee.org
Subject: RE: IEC 61010 requirements
Maybe he had a special low EMI cell phone? But seriously, a useful product
would be a cell phone detector with an audible alarm
...@majordomo.ieee.org
Subject: Re: IEC 61010 requirements
I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com
wrote (in 20030221231714.74613.qm...@web14806.mail.yahoo.com) about
'IEC 61010 requirements' on Fri, 21 Feb 2003:
The other day, I called a surgeon and he happened
Peter,
Please let me have the name of the surgeon with the cellphone, so I'll be
careful to avoid him!!
Best Wishes,
Jon
On 21 Feb 2003 at 15:17, peter merguerian wrote:
Jon,
I must say that I somewhat disagree with you. A medical equipment as defined
in IEC60601-1 is one
that is for
I read in !emc-pstc that peter merguerian pmerguerian2...@yahoo.com
wrote (in 20030221231714.74613.qm...@web14806.mail.yahoo.com) about
'IEC 61010 requirements' on Fri, 21 Feb 2003:
The other day, I called a surgeon and he happened to be in the
operating room with his cellphone
Delphina,
It's not only an issue of intended use, but also a question of location. With
regard to the example
you give, if a PC for the surgeon's urgent emails is located within the
'patient vicinity', as
defined in IEC 60601-1-1 (within about 6 feet of the patient's bed), then I
believe that
into here!)
Regards
John Allen
From: George Brimlow [mailto:george.brim...@nottingham.ac.uk]
Sent: 20 February 2003 17:40
To: emc-p...@majordomo.ieee.org
Subject: Re: IEC 61010 requirements
Hi,
In response to John Allen's comment, my understanding would be that the
medical electrical
Hello Jon,
Thanks for the clarification. This helps in understanding which safety
standards may be applied to a medical device based on its intended use.
Therefore, it is very important that we understand what a medical device is
versus medical equipment or laboratory equipment, as they are
I read in !emc-pstc that Han, Delphina d...@strykerendo.com wrote (in
4196ec6cef84454d84b90731c905c50e279...@chopin.endo.strykercorp.com)
about 'IEC 61010 requirements' on Thu, 20 Feb 2003:
How about EMC standards? (maybe I should start a new thread...). Will this
PC have to meet IEC 60601-1-2
Hi all,
Thanks for your responses. When I originally asked the question, I was sure
that the particular equipment I was asking about does not fall under the
scope IEC60601, but I wanted to confirm if IEC61010 is the relevant
standard. As you may notice, I have a copy of the IEC60601 standard but
regards
Gregg
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Ronald R. Wellman
Sent: Thursday, February 20, 2003 9:44 AM
To: Gregg Kervill; emc-p...@majordomo.ieee.org
Subject: RE: IEC 61010 requirements
Hello Greg,
I have to disagree with your
: Gregg Kervill [mailto:gr...@test4safety.com]
Sent: 20 February 2003 04:15
To: emc-p...@majordomo.ieee.org
Subject: RE: IEC 61010 requirements
Does it contact a live human - if answer no - it is not medical equipment.
The purpose for the medical device directive is to protect people for harm
Hello all,
There is some confusion between medical devices, in vitro diagnostic devices,
and the scopes of possibly applicable safety standards.
In the US in vitro diagnostic devices are a type of medical device and all
medical devices are subject to applicable FDA regulation. In Europe, there
Hi,
In response to John Allen's comment, my understanding would be that the
medical electrical systems standard (60601-1-1) doesn't really help you
here.
This standard covers the situation where you have a system of either
interconnected electrical medical equipment or a mixed system of
Ron,
Classification of in-vitro devices as medical equipment, requiring regulatory
approval, does not
influence the choice of product safety standard to be used. If it does not
fall within the scope of
IEC 60601-1, and is only used in the lab, then IEC 61010 should be used,
though IEC 60950
...@strykerendo.com; emc-p...@majordomo.ieee.org
Sent: Wednesday, February 19, 2003 5:27 PM
Subject: Re: IEC 61010 requirements
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
Hello Greg,
I have to disagree with your interpretation. There are many in vitro
devices that are classified as medical equipment and are subject to
pre-market approvals in the US, Japan, and EU. There are strict regulations
on labeling products in the US where even advertising is considered
.
These requirements are similiar to 950, and not as stringent as the medical
requirement.
Chris Poore
-Original Message-
From: owner-emc-p...@majordomo.ieee.org
Sent: Wednesday, February 19, 2003 11:42 AM
To: emc-p...@majordomo.ieee.org
Subject: RE: IEC 61010 requirements
If end
dissent?
Mike Harris/Teccom Co./Hayward CA
- Original Message -
From: Ronald R. Wellman rwell...@wellman.com
To: Han, Delphina d...@strykerendo.com; emc-p...@majordomo.ieee.org
Sent: Wednesday, February 19, 2003 5:27 PM
Subject: Re: IEC 61010 requirements
Hello Delphina
)
+44 (0) 1372-367000 (Switchboard)
Fax:+44 (0) 1372-367102 (Fax)
From: Han, Delphina [mailto:d...@strykerendo.com]
Sent: 19 February 2003 17:10
To: emc-p...@majordomo.ieee.org
Subject: IEC 61010 requirements
Hi
I am trying to find out safety requirements for devices that control
Does it contact a live human - if answer no - it is not medical equipment.
The purpose for the medical device directive is to protect people for harm
or infection - being alive would seem to be essential for this.
G
This message is from the IEEE EMC Society Product Safety
Technical Committee
: Wednesday, February 19, 2003 5:27 PM
Subject: Re: IEC 61010 requirements
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
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
...@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
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
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
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