> -Original Message-
> From: owner-emc-p...@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 require
>-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
>wrote (in <20
wner-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 be a "cell phone
To: emc-p...@majordomo.ieee.org
Subject: Re: IEC 61010 requirements
I read in !emc-pstc that peter merguerian
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 b
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
I read in !emc-pstc that peter merguerian
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 performing an operation. Does
lto:pmerguerian2...@yahoo.com]
Sent: Friday, February 21, 2003 4:17 PM
To: Jon Griver; emc-p...@majordomo.ieee.org
Subject: RE: IEC 61010 requirements
Jon,
I must say that I somewhat disagree with you. A medical equipment as defined
in IEC60601-1 is one that is for "professional use. The sur
Jon,
I must say that I somewhat disagree with you. A medical equipment as defined
in IEC60601-1 is one that is for "professional use. The surgeon's e-mails PC
can also be used by his son and I do not consider it "professional" in the
sense of the standard.
Let's not exagerate here! A person with
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 i
sed by another thread!
(And system reliability for safety reasons is another area which I am also
not going to get 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
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 de
I read in !emc-pstc that Han, Delphina 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 for medical? Or EN
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
From: 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 f
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
intercon
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 wou
"Han, Delphina" ;
>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 ca
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
nt) without one.
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 requir
inary lab needs. Any dissent?
Mike Harris/Teccom Co./Hayward CA
- Original Message -
From: "Ronald R. Wellman"
To: "Han, Delphina" ;
Sent: Wednesday, February 19, 2003 5:27 PM
Subject: Re: IEC 61010 requirements
>
> Hello Delphina,
>
> Laborator
Hi Folks
The basic answers to the questions of which items of "medical" equipment
are, and are not, required to be compliant to 60601 are given in EN
60601-1-1 "Medical electrical equipment Part 1-1: General requirements for
safety. Collateral standard: Safety requirements for medical electrical
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
My opinion is that unless there are unusual circumstances, an ITE (IEC60950)
certified monitor should satisfy ordinary lab needs. Any dissent?
Mike Harris/Teccom Co./Hayward CA
From: "Ronald R. Wellman"
To: "Han, Delphina" ;
Sent: Wednesday, February 19, 2003 5:27 PM
Su
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
wner-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 cla
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 c
28 matches
Mail list logo
