Bernd
Further:
the European medical directive (93/42/EEC) and UK regulations for medical
devices (BS EN 60601-1-2) instruct manufacturers that they should minimise the
risk from foreseeable environmental conditions such as magnetic fields and
external electrical influences.
BS EN 45502-2-2, harmonised standard under the AIMD, test 27.7 exposes
pacemakers to fields up to 50 mT for 1 minute, the device operating normally
once the field is removed.
BS EN 50527-1 Procedure for risk assessment of AIMD gives a Static field limit
of 1mT stating exposure to fields in excess of this may influence the operation
AIMD. Prolonged exposure is not advised but short term transient conditions may
be tolerated.
There are approximately 250,000 people fitted with pacemakers in the UK (2010)
BS ISO 14117:2012 Active implantable medical devices specifies static DC
magnetic field testing at 50 mT.
-----Original Message-----
From: McCallum, Andy [mailto:[email protected]]
Sent: 06 July 2018 10:27
To: [email protected]
Subject: Re: [PSES] EN62311 - Human Exposure to Electromagnetic Fields
Hi Bernd
It’s a mess but at this time no one seems to want to address the limit. If the
public exposure limit is 400mT then all equipment including pacemakers should
operate at this level or higher.
Some progress was made towards the slightly older ICNIRP limit of 40mT
BS ISO 14117:2012
4.7 Protection from static magnetic fields of flux density up to 50 mT
4.7.1 General considerations
The DUT shall not remain functionally affected after exposure to static
magnetic fields of flux density of up to 50 mT.
4.7.2 Pacemakers and CRT-P devices
Test equipment: use a field coil that is capable of generating a uniform
magnetic field of flux density of up to
50 mT ± 5 mT in the region to be occupied by the DUT.
Test procedure: the required field flux density shall be generated before
placing the DUT in the field. Then the DUT shall be slowly placed in the centre
of the test coil. After at least 15 s of exposure to the magnetic field, the
DUT shall be slowly removed from the field.
https://emea01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.rbht.nhs.uk%2Fabout%2Fnews-events%2Farchive%2Fpacemaker%2F&data=01%7C01%7CAndy.McCallum%40mottmac.com%7C8ab8be52e7fd4abf03ec08d5e322bb23%7Ca2bed0c459574f73b0c2a811407590fb%7C0&sdata=4JPlio918VOy7yMaqcyNb9pvdfBuWRR4KZTscTWw1dQ%3D&reserved=0
The easiest was around it is to actually contact the manufacturer and try and
get some form of reassurance from them.
Regards
Andy
-----Original Message-----
From: Dürrer Bernd [mailto:[email protected]]
Sent: 06 July 2018 09:53
To: McCallum, Andy <[email protected]>; [email protected]
Subject: AW: [PSES] EN62311 - Human Exposure to Electromagnetic Fields
Hello Andy,
Thank you for pointing out the ICNIRP limits: Actually, I recently had a
request concerning a service technician with a pacemaker and exposure to static
magnetic fields when handling permanent magnet rotors.
However, when I check ICNIRP resources, I do not find any publication to
justify higher limits. On the contrary, the “ICNIRP GUIDELINES ON LIMITS OF
EXPOSURE TO STATIC MAGNETIC FIELDS”
(https://emea01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.icnirp.org%2Fcms%2Fupload%2Fpublications%2FICNIRPstatgdl.pdf&data=01%7C01%7CAndy.McCallum%40mottmac.com%7C15d40e00326b4219a4df08d5e31ddb08%7Ca2bed0c459574f73b0c2a811407590fb%7C0&sdata=GtqO0ps18xjo1yE6siOKfeeYPdNzy4Ws7Tv6OcFLzmM%3D&reserved=0)
contain the statement:
“Electromagnetic interference from low-intensity static magnetic fields has
been observed to affect the operation of pacemakers, particularly those with
magnetic switches, and other types of medical electronic devices, including
cardiac defibrillators, hormone infusion pumps (e.g., for insulin),
neuromuscular stimulation devices (e.g., for the sphincter muscle of the
bladder), neurostimulators, and electronically operated prosthetic devices
(e.g., for the limbs and inner ear). In general, the operation of these devices
is not adversely affected by static magnetic fields below 0.5 mT."
The "ICNIRP GUIDELINES FOR LIMITING EXPOSURE TO TIME-VARYING ELECTRIC AND
MAGNETIC FIELDS (1 Hz TO 100 kHz)"
(https://emea01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.icnirp.org%2Fcms%2Fupload%2Fpublications%2FICNIRPLFgdl.pdf&data=01%7C01%7CAndy.McCallum%40mottmac.com%7C15d40e00326b4219a4df08d5e31ddb08%7Ca2bed0c459574f73b0c2a811407590fb%7C0&sdata=TKolfMPIxVlXj8Gu%2FcuYTd2jpKm2TQpJJY8R%2B4ihA3k%3D&reserved=0)
contain the following statement:
"Compliance with the present guidelines may not necessarily preclude
interference with, or effects on, medical devices such as metallic prostheses,
cardiac pacemakers and implanted defibrillators and cochlear implants.
Interference with pacemakers may occur at levels below the recommended
reference levels. Advice on avoiding these problems is beyond the scope of the
present document but is available elsewhere (IEC 2005b)." (IEC2005b refers to
IEC 60601-1-2)
Kind regards,
Bernd
Von: McCallum, Andy <[email protected]>
Gesendet: Freitag, 6. Juli 2018 09:41
An: Dürrer Bernd <[email protected]>; [email protected]
Betreff: RE: [PSES] EN62311 - Human Exposure to Electromagnetic Fields
Bernd
Pacemakers have DC static magnetic field limits as low as 0.5mT as mentioned in
the EU EMF directive. Which is a level encountered in many environments not
least DC Trams and railways. The fact that we don’t see people with pacemakers
staggering around the underground suggests this limit has been set far too low
(most likely when pacemakers where first introduced). The ICNIRP public
exposure limit is 400mT which is much more realistic and only encountered
rarely.
Contacted a number of UK government agencies regarding this and the most honest
verbal response was we will get rid of that limit after Brexit.
Also note a number of pacemakers are now available which are safe to wear in
MRI scanners operating at 7Teslas.
Andy
From: Dürrer Bernd [mailto:[email protected]]
Sent: 06 July 2018 08:24
To: mailto:[email protected]
Subject: [PSES] AW: [PSES] EN62311 - Human Exposure to Electromagnetic Fields
Hi Doug,
I assume that due to your good health you don’t have a pacemaker or any other
electronic medical implants that might be affected by EM field exposure. As
protection and shielding options for such implants are limited (except by the
surrounding tissue), the remaining other option to reduce the risk of
malfunction is to limit EM fields.
Stay in the best of health and have a nice weekend,
Bernd
Von: Doug Smith <mailto:[email protected]>
Gesendet: Donnerstag, 5. Juli 2018 20:56
An: mailto:[email protected]
Betreff: Re: [PSES] EN62311 - Human Exposure to Electromagnetic Fields
Hi Michael and the group,
With the exception tissue heating generated by some sources at very high
frequencies, I wonder if the EM field exposure worries today are a bit
overblown. I started my experiments in high voltage (100,000+ Volts, and NOT
static electricity) around age 13 and by age 14 was regularly immersing myself
in 10,000+V/m, 300 kHz fields. It was fun, heating up screw driver blades from
induction heating, lighting incandescent light bulbs (as well as fluorescent
tubes) without wires, and more. About 600 Watts of RF energy was concentrated
in the relatively small space I was in and I was uninjured! My kids all have
two arms, two legs, and one head and I am still here almost 60 years later and
healthier than 90% of adults of any age from 18 on. Some of my friends say this
explains a lot about me (frying brain cells) though.
I realize this is only one case, but have had a lot of high energy RF exposure
throughout my life. Such as the field in my dorm room from my amateur radio
transmitter being so strong that the fluorescent tubes in the room lit up with
no power and blinked with Morse code. I had to remove the tubes from their
fixtures and cover with towels so my roommate could sleep.
Still here,
Doug
On Thu, 5 Jul 2018 16:27:12 +0100, Michael Derby wrote:
It’s not quite an “unintentional radiator” but if you had a wireless charger
which did not contain any communication (e.g., a dumb charging signal without
handshaking), then it would come within the scope of the EMCD and the LVD (not
the RED), and RF Exposure would therefore be an issue under the LVD.
Michael.
From: McCallum, Andy [mailto:[email protected]]
Sent: 05 July 2018 15:33
To: mailto:[email protected]
Subject: Re: [PSES] EN62311 - Human Exposure to Electromagnetic Fields
Be surprised if any LVD could cause EMF large enough to pose a danger to Human
Health. Intentional transmitters maybe, a rare beast to create those levels
unintentionally at less than 1000V.
Andy
From: John Woodgate [mailto:[email protected]]
Sent: 05 July 2018 10:28
To: mailto:[email protected]
Subject: Re: [PSES] EN62311 - Human Exposure to Electromagnetic Fields
It applies to any LVD product, but there is a flow chart that shows that a
simple assessment is possible if the product has no reasonable likelihood of
producing sufficiently strong EMF.
John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates
https://emea01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.woodjohn.uk&data=01%7C01%7CAndy.McCallum%40mottmac.com%7C3897dc1f76c0406b3a9808d5e259910b%7Ca2bed0c459574f73b0c2a811407590fb%7C0&sdata=vOXyjzMm8FtxrbHRrTRbkgWlhb8gQeuv%2FiISyiAwg24%3D&reserved=0
Rayleigh, Essex UK
On 2018-07-05 10:09, Amund Westin wrote:
EN62311 is listed in OJ and a harmonized LVD standard.
Does EN62311apply to any LVD product or only products containing radio
transmitters?
Best regards
Amund
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Weyers Aufsichtsratsvorsitzender/Chairman of the Supervisory Board:
Prof. Dr. Norbert Wieselhuber
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________________________________
WILO SE
Nortkirchenstrasse 100, 44263 Dortmund
Amtsgericht Dortmund, HRB 21356
https://emea01.safelinks.protection.outlook.com/?url=www.wilo.com&data=01%7C01%7CAndy.McCallum%40mottmac.com%7C15d40e00326b4219a4df08d5e31ddb08%7Ca2bed0c459574f73b0c2a811407590fb%7C0&sdata=KW8uuDiky2Lto6NYtb9aiFvLjWkrGeIs8qp0cQYL55U%3D&reserved=0
Vorstand/Executive Board:
Oliver Hermes (Vorsitzender/Chairman), Carsten Krumm, Georg Weber, Mathias
Weyers Aufsichtsratsvorsitzender/Chairman of the Supervisory Board:
Prof. Dr. Norbert Wieselhuber
Dieses Dokument ist vertraulich zu behandeln. Die Weitergabe sowie
Vervielfaeltigung, Verwertung und Mitteilung seines Inhalts ist nur mit unserer
ausdruecklichen Genehmigung gestattet. Alle Rechte vorbehalten, insbesondere
fuer den Fall der Schutzrechtsanmeldung.
This document has to be treated confidentially. Its contents are not to be
passed on, duplicated, exploited or disclosed without our expressed permission.
All rights reserved, especially the right to apply for protective rights.
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This message is from the IEEE Product Safety Engineering Society emc-pstc
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All emc-pstc postings are archived and searchable on the web at:
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Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used
formats), large files, etc.
Website: http://www.ieee-pses.org/
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