overclocking options to see what affects the
emissions.
Best Wishes,
Jon Griver
On Fri, 2020-11-27 at 17:49 -0600, DEREK WALTON wrote:
Hi Folks,
I’m working on a product containing a Raspberry PI as the main controller. I
see two very strong emissions at about 240 MHz and 480
comply with ISO 13485:2003, EN ISO 13485:2012 and ISO
13485:2016, together with whatever other regulatory requirements you need.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Designer's Guide to IEC 60601-1
From: Stephen Whalen [mailto:scwha...@bellsouth.net]
Sent
ar on the MDD
Declaration, and if the RoHS Declaration was included in the same
Declaration, then it may be assumed that the Notified Body was involved in
the supervision of the manufacturer's compliance with RoHS, which it is not.
Jon Griver
www.601help.com
-Original Message-
From: N
likely to
have more stringent requirements for the proof of clinical efficacy.
You will find all the requirements on the FDA’s site. I would start here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm
Regards,
Jon Griver
http://www.601help.com
The
tinuity test of clause 18. In this case additional
earthing arrangements, beyond a hinge, are not required.
Jon Griver
http://www.601help.com
The Medical Device Designers Guide to IEC 60601-1
From: "Crabb, John"
To: "Ned Devine" ; "IEEE EMC/Product Safety (IEEE,
EMC/Pro
Corrective
Action proposal to amend your current calibration procedures in order to
reduce calibration costs, without in any way compromising quality or ISO 9001
compliance. This should bring the problem to the attention of Quality
Assurance and bypass the interests of the your Metrology department
60601-1, which just specifies the
marking which is required adjacent to the terminal, but does not specify the
form of the terminal itself, or when it should be used.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Designer's Guide to IEC 60601-1
This message is from the IEE
it "intended by their manufacturer to be used
for in vitro diagnostic examination", then it falls under the IVD. If not,
and the same model is also sold for non-medical use, then its LVD.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Developer's Guide to IEC 60601-1
onnection caused the
enclosure to be earthed at
a potential different from that of other equipment to which the patient may be
connected.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Developers Guide to IEC 60601-1
This message is from the IEEE EMC Society Product Safety
Technica
pplies are not designed to be
in direct conductive
connection with the patient. Additional insulation is usually required.
5. Red or yellow indicators must not be used for the ON/OFF switch. Green is
usually used.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Designer's Guide
t
at the transformer,
except at the load end?
I am interested in both US and UK terms.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Developers Guide to IEC 60601-1
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.
Visit ou
the LVD, specifying
IEC 60601-1 as the applied standard. You can present your comparison table to
anyone who questions
this, demonstrating the engineering basis for your declaration.
Regards,
Jon Griver
http://www.601help.com
On 25 Feb 2003 at 13:40, boconn...@t-yuden.com wrote:
>
>
er day, I called a surgeon and he happened to be in the operating
room with his cellphone
> performing an operation. Does that make his cellular comply with IEC 601-1?
> Peter
>
> Jon Griver wrote:
>
> Delphina,
>
> It's not only an issue of intended
h other medical
instruments with which he is in contact. This could be particularly nasty if
there is a fault in
the PC's earth wire.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Developers Guide to IEC 60601-1
On 20 Feb 2003 at 12:38, Han, Delphina wrote:
>
> H
would
probably be acceptable if the instrument is based on a PC.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Developers Guide to IEC 60601-1
Hello Greg,
I have to disagree with your interpretation. There are many in vitro
devices that are classified as medical equipment and
Brent,
Can you clarify your question? What exactly do you mean by MRI compatible? An
accessory to an MRI
device? Please give some more details.
Regards,
Jon Griver
http://www.601help.com
The Medical Device Developers Guide to IEC 60601-1
Subject:MRI compatible?
To
.html for Japan
>
> Any help/direction would be appreciated.
>
> Thanks,
>
> Mike Cantwell
>
>
Regards,
Jon Griver
www.601help.com
The Medical Device Developer's Guide to IEC 60601-1
---
This message is from the IEEE EMC So
Paul,
I posted this a few days ago, but it only refers to regulatory requirements
for medical equipment:
http://www.ita.doc.gov/td/mdequip/regulations.html
As it's the site of the US Department of Commerce, it may also have
regulatory requirements in any fields.
Regards,
Jon Grive
your production tests are not suitable.
There are obviously also legal liability issues involved. You should have a
written engineering justification for the tests chosen, as well as written
traceable records of production testing performed.
Regards,
Jon Griver
www.601help.com
The Medical Device De
Peter,
An excellent place to start your search is:
http://www.ita.doc.gov/td/mdequip/regulations.html
which is the US Department of Commerce site, giving information on the
medical device requirements for many countries.
Good Luck
Jon Griver
www.601help.com
The Medical Device Developer&#
general requirements for
batteries.
Regards,
Jon Griver
www.601help.com
The Medical Device Developers Guide to IEC 60601-1
---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.
Visit our web site at
Brian,
Most definitely yes, see http://www.fda.gov/cdrh/emc/
The FDA is concerned with the correct operation of medical equipment, so
immunity requirements are also included.
Regards,
Jon Griver
www.601help.com
The Medical Device Developer's Guide to IEC 60601-1
>
> Do FDA specif
;s accreditation.
I do not believe that a test report produced under EN 45001 accreditation
becomes invalid because this standard has now been superceded.
Best Regards,
Jon Griver
www.i-spec.com
The Engineer's On-line Guide to EN 60950
>
> Hi,
>
> I have a Notified Body test re
t question. Ultrasound equipment does not have to be
certified to Part 18, but the FCC does consider this equipment to be in the
'domain' of Part 18, and can, for instance, demand to inspect the equipment
(under Sec 18.113).
Best Regards,
Jon Griver
http://www.601help.com - The Medic
sections of Part 18 that deal mainly with allowed
frequencies.
Best Regards,
Jon Griver
http://www.601help.com - The Medical Device Developers' Guide to IEC 60601-1
>
> Jon, Ultrasound equipment does us use RF directly to treat or diagnose
> patients. I don't believe Ultraso
found to
cause interference can be stopped from operating.
Medical devices that intentionally use EM radiation are subject to FCC Part
18. This includes ultrasound equipment, diathermy equipment, microwave
therapeutic devices.
Regards,
Jon Griver
http://www.601help.com - The Medical Device
applicable.
Nevetheless, I believe that due diligence requires you to get a written
opinion from an EU MDD Notified Body, or even a Competent Authority (e.g.
the Medical Devices Agency in the UK), rather than depending on free advice
(like this).
Regards
Jon Griver
http://www.601help.com The
ich is not specifically
designed for compliance with the medical standard, is very unlikely to
comply with this standard. Once your product is 'front-ended' by a medical
grade isolation transformer, you can then use other non-medical components
in many cases.
I hope this helps.
Jon Griver
ht
ve
would appear to be the most suitable.
Regards,
Jon Griver
http://www.601help.com
>
>
>
> Actually, I have experienced such a unit at my former chiropractor, and it
> actually felt pretty good to loosen my back before the back adjustment
> session. I was really astonis
n I assume they would be obligatory.
Nevertheless, If you have a good engineering reason why the production test
in the standard is not as good as a different test you wish to perform, and
you document the reasoning, and feel that you have no problem justifying it,
then you should perform your preferred te
alues,
rather than by adding a second earth connection.
Best Wishes,
Jon Griver
http://www.601help.com
The Medical Device Developers' Guide to IEC 60601-1
>
> Group,
>
> This is a general product safety question:
>
> In order to avoid test failures during a sing
UL test, which might miss them.
Presumably if you are selling your medical product in the EU, you have a
Notified Body (unless your product is Group 1). You should agree your
production test plan with them. Be aware that they may insist on the high
current earth continuity test.
Good Luck,
Jo
Dick,
To the best of my knowledge there is no EN standard or guidance on
production tests for medical equipment (There is a standard, EN 50116, for
IT equipment).
Your best bet is to discuss this with your Notified Body and to come to a
mutually acceptable set of tests.
Regards,
Jon Griver
harmonics, but the EU requirement concerns harmonics, not power factor.
Best Wishes,
Jon Griver
Medson Ltd.
>
>
> Dear Colleagues,
>
> I appreciate if you could help me with my problem please. We use
> PC power supply in our control machine for feeding our
> motherboard. The en
gent leakage current, spacings and dielectric
requirements.
Also, depending on the classification of the product, your company may need
to have its Quality System approved by a European Notified Body.
Regards,
Jon Griver
Medson Ltd.
jo...@medson.com
> -Original Message-
> Fro
ishes,
Jon Griver
One comment of Mr Hunter's that stood out in particular was the very last
. . .
" . . . the only ones who benefit from the harmonic current emission
standard
are the European electricity distributors. They "avoid
investments in bolstering their
nsure that you are using the
most updated version.
Best Wishes,
Jon Griver
Medson Ltd.
VP Quality Assurance
>
> Good people of the group:
>
> Are requirements in IEC61326-1 (EMC for lab instruments) similiar
> to/same/much different than CISPR11/16 and/or the "good stuff" i
r these Directives.
It sounds like your product falls under the In Vitro Diagnostic Directive,
but check the scope. As an accessory, your product still has to fully comply
with the directive.
Best Wishes,
Jon Griver
Medson Ltd.
VP Quality Assurance
email: jo...@medson.com
> Hi all
>
&g
country
to country.
Hope this helps.
Jon Griver
Medson Ltd.
VP Quality Assurance
> Subject: EMC on Medical Devices?
>
> Looking for a list of standards that apply to EMC on medical
> devices and the
> markets which they apply ( EU, US, and Asia Pacific).
>
> Thanks
>
>
Richard,
DoC is the same except that instead of a list of harmonised standards, you
list the name and address of the Competent Body, and the serial number and
date of the Certificate they issued to you.
Regards,
Jon Griver
VP Quality Assurance
Medson Ltd.
>
> I have seen s
tter than testing for weeks or months with a
faulty lead.
Your Quality Manager would be quite pleased if you detect a failure and have
to redo a day's testing. He will be able to demonstrate to his auditors how
your Quality System picks up and corrects a potentially serious problem. :-)
Re
e his 'due diligence' with regard to
the safety of the product. In this case it may be a safety test report with
most paragraphs marked as 'Not Applicable', but that may be the difference
between being found criminally negligent, or just liable for damages.
Regards,
Jon Griver
i-Spec.
As an ex-programmer, I can say that Y3K shouldn't be a problem. But we
really do have to be concerned about Y10K when we move from 4 digit to 5
digit years :)
Jon Griver
i-Spec.com
The On-Line Compliance Guide
http://www.i-spec.com
>Y3K preparedness seminar
>For those who t
do go the TCF route, your DoC should include the name of the
Competent Body that assessed your TCF, together with the number and date of
issue of the certificate the Competent Body issued.
Regards,
Jon Griver
i-Spec.com Ltd.
jgri...@i-spec.com
i-Spec, The Online Guide to Compliance
http://www.i-
ious version of this document is available at http://www.rcic.com
The wording and section number are different from those quoted above. Maybe
someone on the list can give an address for the latest version of this
document.
I hope this is helpful.
Jon Griver
i-Spec.com Ltd.
i-Spec IT - The Online Guid
Ron,
Be very careful with this subject. There is a feedback loop between the
remote transmitter and the cell phone. A reduction in the efficiency of the
cell phone antenna will cause the cell phone to transmit at higher power,
defeating the intention.
Regards,
Jon Griver
i-Spec IT - The IEC
t
of our way of life. I use a cell phone, though as little as possible,
knowing that there is a possible risk, in the same way as I know I risk my
life every time I get in my car.
Jon Griver
i-Spec IT - The IEC 60950 Compliance Guide
http://www.i-spec.com
>From: geor...@lexmark.com
>
&g
lusion of a product group within the scope of an EN standard does
not necessarily imply that compliance with that standard is mandatory.
Jon Griver
ITL (Product Testing) Ltd
http://www.itl.co.il
-
This message is coming from the emc-pstc discussion list.
To cancel your subscrip
s not apply the medical
devices, so EN 61000-3-2 does not apply.
Jon Griver
ITL (Product Testing) Ltd.
http://www.itl.co.il
At 14:25 18/06/99 -0400, you wrote:
>
>Pat:
>61000-3-2 is a horizontal standard and it applies to all products unless
>specifically excluded by 61000-3-2.
ctive, not the EMC Directive. So if harmonics are not mentioned in EN
>60601-1-2, then it is not required.
>
>
>Jon Griver
>ITL (Product Testing) Ltd.
>http://www.itl.co.il
>
>
>
>>
>>
>>I was asked the following question, and wasn't sure about t
equired.
Application to the Ministry of Communications can only be made by local
importer/distributor to ensure local support for product.
For further information try:
http://www.itl.co.il
Regards,
Jon Griver
ITL (Product Testing) Ltd.
Tel: +972-3-5339022
Fax: +972-3-5339019
email: stand...@itl.co.il
y specific conclusions on this subject, but I would be
interested to hear the opinions of other maling list members.
Jon Griver
ITL (Product Testing) Ltd.
i...@shani.net
he body, particularly with internal body
parts, e.g. via endoscopes, intracardiac probes, etc.
The isolation concepts used in IEC 950, IEC 1010 and IEC 65 are sufficiently
different from those required for medical equipment to make a unified
standard not feasible in this case.
Jon Griver
ITL (Product Testing) Ltd.
i...@shani.net
The Medical Devices Directive does not have any specific
requirements for Power Factor Correction. The EMC standard for
medical equipment, EN60601-1-2, does not call out any limitations on
harmonics, a related issue.
Jon Griver
i...@shani.net
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