Re: [PSES] Active Implantable Medical Devices

Kevin From: Grace Lin [mailto:graceli...@gmail.com] Sent: Monday, April 03, 2017 1:35 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Active Implantable Medical Devices Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active

Re: [PSES] Active Implantable Medical Devices

edical Devices Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active implantable medical devices require Notified Body’s involvement per RED? From online search (https://ec.europa.eu/growth/single-market/ce-marking/manufactur

Re: [PSES] Active Implantable Medical Devices

@LISTSERV.IEEE.ORG> Subject: [PSES] Active Implantable Medical Devices Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active implantable medical devices require Notified Body’s involvement per RED? From online search (https://ec.eur

Re: [PSES] Active Implantable Medical Devices

tps://outlook.hslive.net/owa/redir.aspx?C=02be3bf3e3a544d1bdf7b6c99fbd12f5=http%3a%2f%2fwww.sulisconsultants.com%2f> Registered in England and Wales, number 05466247 From: Grace Lin [mailto:graceli...@gmail.com] Sent: 03 April 2017 06:35 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Active Implantable Medical D

Re: [PSES] Active Implantable Medical Devices

Active Implantable Medical Devices DC magnetic fields are outside the scope of ETSI, and fall within that of IEC TC106. Remember that the question was about the RED, and no-one as far as I know, uses DC magnetic fields for radio communication. I might except Gaia, because a very broad defi

Re: [PSES] AW: [PSES] Active Implantable Medical Devices

www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England Sylvae in aeternum manent. -Original Message- From: Dürrer Bernd [mailto:bernd.duer...@wilo.com] Sent: Monday, April 3, 2017 8:37 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] AW: [PSES] Active Implantable Medical Devices Dear Grace

Re: [PSES] Active Implantable Medical Devices

To: John Woodgate <jmw1...@btinternet.com>; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: [PSES] Active Implantable Medical Devices John TC 106 is for human exposure I was thinking of EMC issues - seems a gap here. Andy -Original Message- From: John Woodgate [mailto:jmw1...@btinternet.com]

Re: [PSES] Active Implantable Medical Devices

. -Original Message- From: McCallum, Andy [mailto:andy.mccal...@mottmac.com] Sent: Monday, April 3, 2017 9:23 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Active Implantable Medical Devices Hi Just had a brief scan of the standard and it doesn’t appear to cover immunity to DC Magnetic

Re: [PSES] Active Implantable Medical Devices

] Active Implantable Medical Devices Dear Grace, you can check the status and scheduled publication date (incl. citation in the OJ) of ETSI standards at https://portal.etsi.org/webapp/WorkProgram/SimpleSearch/QueryForm.asp For the 301 489 series standards, click on "EN - European sta

[PSES] AW: [PSES] Active Implantable Medical Devices

. Kind regards, Bernd Von: Grace Lin [mailto:graceli...@gmail.com] Gesendet: Montag, 3. April 2017 07:35 An: EMC-PSTC@LISTSERV.IEEE.ORG Betreff: [PSES] Active Implantable Medical Devices Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do

Re: [PSES] Active Implantable Medical Devices

[PSES] Active Implantable Medical Devices Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active implantable medical devices require Notified Body’s involvement per RED? From online search (https://ec.europa.eu/growth/single-market/ce-m

[PSES] Active Implantable Medical Devices

Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active implantable medical devices require Notified Body’s involvement per RED? From online search ( https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it seems

Re: [PSES] Interpretation for RoHS2 requirement (exemption of medical devices) of CE Marked device under MDD & transfer or ownership but same product

Hi Leo: It seems to me that all you need to do is change the name on the DOCs. Good luck, have a good Thanksgiving, and best regards, Rich - This message is from the IEEE Product Safety Engineering Society

[PSES] Interpretation for RoHS2 requirement (exemption of medical devices) of CE Marked device under MDD & transfer or ownership but same product

and questions. They are producing the same medical device as pre 2014 requirement for RoHS2 exemption for medical devices but a new CE Mark as the co. Name has changed slightly. They still need to be able to sell the same product. See detailed questions below. Any specific guidance you can

RE: [PSES] Medical devices and Israel

...@itl.co.il http://www.itl.co.il From: peter merguerian [mailto:pmerguerian2...@yahoo.com] Sent: Tuesday, December 08, 2009 6:37 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Medical devices and Israel Derek, Do you have the harmonized tariff code? The Standards Institution

Re: Medical devices and Israel

have for safety and emc Thanks, Peter --- On Mon, 12/7/09, Derek Walton lfresea...@aol.com wrote: From: Derek Walton lfresea...@aol.com Subject: Medical devices and Israel To: IEEE EMC SAFETY PSTC emc-p...@ieee.org Date: Monday, December 7, 2009, 2:34 PM

Medical devices and Israel

Hi folks, A while back I tested a light box that goes on the wall of a Dr's office. It's used for showing X-Ray films. I was asked to perform testing to EN60601-2, which we did. I have been asked to produce an EMC Certificate, but I must have missed where the requirements for this came from.

New EMC Standard for Medical Devices in Japan

Group, Thanks for the replies but does anyone have a pulse on when the new EMC Standard for Medical Devices will be published for Japan. JIS T 0601-X-X ? Has anyone seen a draft version of this? Regards, Jeff Collins Compliance Reliability Consultant Alcon Surgical Labs

Re: JIS EMC standards: EMC requirements for Medical Devices in Japan

On Thu, 11 Oct 2007 06:28:30 -0700 (PDT), jeff collins jeffcollin...@yahoo.com wrote: Does anyone have any current information regarding EMC requirements for Medical Devices in Japan? JIS T 0601-1-2:2002 (corresponds to IEC 60601-1-2 ed.1) is still current, although IEC 60601-1-2 ed.2

JIS EMC standards: EMC requirements for Medical Devices in Japan

Dear List Members, Does anyone have any current information regarding EMC requirements for Medical Devices in Japan? Regards, Jeff Collins Compliance Reliability Consultant Alcon Surgical Labs - This message is from the IEEE

RE: CSA requirements for medical devices

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Paolo Peruzzi Sent: Wednesday, April 26, 2006 5:25 AM To: emc-p...@ieee.org Subject: CSA requirements for medical devices Dear all, I've been asked to make some modification on a CE marked medical device in order to make it compliant

Re: CSA requirements for medical devices

If no success with CSA talk with Global Advantage in Toronto. email ga...@globaladvantage.ca Regards: Kevin Keegan Senior Associate KES Associates 1 Stonecroft Terrace Kanata, Ontario Canada K2K 2V1 Tel: 613-592-0820 Email: kkee...@kesandassociates.com Web: http://www.kesandassociates.com

Re: CSA requirements for medical devices

In message 2006042207.m77...@elen.it, dated Wed, 26 Apr 2006, Paolo Peruzzi standa...@elen.it writes I've been asked to make some modification on a CE marked medical device in order to make it compliant with CSA requirements. Some modifications concern non-combustible enclosure and a

CSA requirements for medical devices

Dear all, I've been asked to make some modification on a CE marked medical device in order to make it compliant with CSA requirements. Some modifications concern non-combustible enclosure and a dedicated ground point. So I'm a little confused, cause I thought I had to simply follow the last

wireless in medical devices

Hi all, could anybody tell me if there are particular restrictions in the use of a wireless kit in medical devices not for data transfer but for remote control and activation? I'd like to know in particular if, for european market, it would be sufficient to certify the system according to MD

[Fwd: canadian requirements for medical devices]

Paulo, 1. Your approval to ISO 13485 must be by a Notified Body or other registrar which is accredited by the Canadian Medical Devices Conformity Assessment System (CMDCAS) 2. The Canadian Medical Device Regulations are available at: http://laws.justice.gc.ca/en/f-27/sor-98-282/text.html 3

canadian requirements for medical devices

version of 13485 (and it already has), and we shall apply the medical devices canadian directive If it's correct, where can I find such a directive? And what about technical standards? I know only 601-1 deviations. Is there a sort of harmonized standards list like fo EU MDD? thanks in advance

Re: Medical devices and voltage dip testing

I read in !emc-pstc that Pat Lawler pat.law...@verizon.net wrote (in 20040429172618.kxjh10678.out004.verizon@outgoing.verizon.net) about 'Medical devices and voltage dip testing' on Thu, 29 Apr 2004: EN60601-1-2:2001 (EMC requirements for general medical devices) requires various voltage dip

RE: Medical devices and voltage dip testing

Brent DeWitt wrote: that in the CDV (not law yet) of 1st amendment to 60601-1-2 we have changed essential performance from a defined term to an undefined term due to the instability of IEC 60601-1 , which is still at the CDV stage. My _personal_ opinion as a representative (and only that), is

RE: Medical devices and voltage dip testing

To: ieee pstc list Subject: Re: Medical devices and voltage dip testing Pat Lawler posted: If a product is rated for 100-240Vac operation, this means test levels like 40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 cycles). The performance criteria makes this especially difficult

Re: Medical devices and voltage dip testing

Pat Lawler posted: If a product is rated for 100-240Vac operation, this means test levels like 40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 cycles). The performance criteria makes this especially difficult - The system shall provide essential performance. Do not forget that, in

Re: Medical devices and voltage dip testing

Hi Pat: If a product is rated for 100-240Vac operation, this means test levels like 40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 cycles). The performance criteria makes this especially difficult - The system shall provide essential performance. This

Medical devices and voltage dip testing

EN60601-1-2:2001 (EMC requirements for general medical devices) requires various voltage dip tests at the extremes of the rated input voltage range. If a product is rated for 100-240Vac operation, this means test levels like 40Vac for 100ms (100Vac/50Hz nominal input, 60% dip for 5 cycles

RE: PVC in Medical Devices

:51 AM To: emc-p...@majordomo.ieee.org Subject: PVC in Medical Devices Are there formal requirements requiring that PVC (Poly Vinyl Chloride) NOT be used in medical device materials? If so, what are they called, and can there be exceptions to these rules. From my understanding, there are only

PVC in Medical Devices

Are there formal requirements requiring that PVC (Poly Vinyl Chloride) NOT be used in medical device materials? If so, what are they called, and can there be exceptions to these rules. From my understanding, there are only informal ones that medical device manufacturers should adhere to for

Medical devices

Hi all Can some one send me a copy of CCA 227-7 Rotine tests for medical equipment, or point me to a downloadeable fil. Best regards, Kim Boll Jensen Bolls Rådgivning Hyacintvej 6 DK-3660 Stenløse Tlf.: 48 18 35 66 Fax: 48 18 35 30 Mobil: 22 99 69 91 E-mail: k...@bolls.dk web:

RE: RTTE for Medical Devices?

To: emc-p...@majordomo.ieee.org Subject: RTTE for Medical Devices? Hi All, I would appreciate your thoughts on the following scenario: Company A designs a medical product that incorporates a wireless device, lets say, a wireless PCI card. The wireless card is manufactured by Company B

RTTE for Medical Devices?

Hi All, I would appreciate your thoughts on the following scenario: Company A designs a medical product that incorporates a wireless device, let’s say, a wireless PCI card. The wireless card is manufactured by Company B and has been evaluated to the RTTE directive and thus CE-marked. This

RE: Medical Devices Environmental Requirements

Mobile: + 972-(0)54-838175 http://www.itl.co.il http://www.i-spec.com -Original Message- From: Mandel, Joel [mailto:joel_man...@adc.com] Sent: Tuesday, November 05, 2002 6:43 PM To: 'emc-p...@majordomo.ieee.org' Subject: Medical Devices Environmental Requirements Hi All Can anybody

Re: Medical Devices Environmental Requirements

...@majordomo.ieee.org Sent: Tuesday, November 05, 2002 8:03 PM Subject: RE: Medical Devices Environmental Requirements Have you checked 60601-1? Jim -Original Message- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Naftali Shani Sent

RE: Medical Devices Environmental Requirements

' Subject: Medical Devices Environmental Requirements Hi All Can anybody help me out with Environmental testing requirement/Standards (Temp,Vibration) for medical devices? Thank You Joel Mandel Reliability Dept ADC Israel --- This message is from the IEEE EMC

RE: Medical Devices Environmental Requirements

Have you checked 60601-1? Jim -Original Message- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Naftali Shani Sent: Tuesday, November 05, 2002 1:27 PM To: 'Mandel, Joel'; 'emc-p...@majordomo.ieee.org' Subject: RE: Medical Devices

(Fwd) Medical Devices Environmental Requirements

or different environmental requirements. Regards, Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 Hi All Can anybody help me out with Environmental testing requirement/Standards (Temp,Vibration) for medical devices? Thank You Joel Mandel Reliability Dept ADC

RE: Medical Devices Environmental Requirements

-mail: nsh...@catena.com -Original Message- From: Mandel, Joel [mailto:joel_man...@adc.com] Sent: Tuesday, November 05, 2002 11:43 AM To: 'emc-p...@majordomo.ieee.org' Subject:Medical Devices Environmental Requirements Hi All Can anybody help me out with Environmental

Medical Devices Environmental Requirements

Hi All Can anybody help me out with Environmental testing requirement/Standards (Temp,Vibration) for medical devices? Thank You Joel Mandel Reliability Dept ADC Israel --- This message is from the IEEE EMC Society Product Safety Technical Committee emc

RE: Distributors of Medical Devices in Europe

to Article 14, COUNCIL DIRECTIVE 93/42/EEC it indicates informing the competent authorities in that member state. Thus my confusion, I did not concern myself with this issue until recently, when the question was asked, Are there any requirements for European Distributors of Medical Devices . Article 14

Re: Distributors of Medical Devices in Europe

Mark, I assume that you mean Class 1 according to the EU's Medical Devices Directive, and not the FDA classification. Although the principle is the same, i.e. Class 1 is low-risk, the classification method is not identical. The MDD deals with the device rather than the distributor

Distributors of Medical Devices in Europe

Hello Group, Are there any requirements for European Distributors of Medical Devices, i.e. license or registration. The Device in question is a Class 1 device. Thank you. Mark Schmidt Regulatory Compliance X-Rite Incorporated Grandville, MI USA (616) 257 2469 mschm...@xrite.com

(Fwd) Medical devices, current limit

Kim, This type of product may be covered by IEC 60601-2-10, PARTICULAR REQUIREMENTS FOR THE SAFETY OF NERVE AND MUSCLE STIMULATORS, or possibly, IEC 60601-2-14, PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCONVULSIVE THERAPY EQUIPMENT I don't have a copy of these standards, but they

RE: Noise Levels for Household Appliances / Medical Devices

http://www.itl.co.il http://www.i-spec.com -Original Message- From: John Shinn [mailto:john.sh...@sanmina-sci.com] Sent: Wednesday, August 14, 2002 6:53 PM To: 'Peter Merguerian'; 'EMC-PSTC (E-mail) ' Subject: RE: Noise Levels for Household Appliances / Medical Devices Are you talking

Medical devices, current limit

Hi all I have a medical device under EU directive 93/42/EEC. It is a class IIa product and sends some small electrical pulses through the body for treatments. Does anyone know of any limit for the current ? (voltage is generated from battery and is max. 16Vdc) Does anyone have the

Re: Noise Levels for Household Appliances / Medical Devices

I don't think there are mandatory noise limits for these appliances, but directive 86/594/EEC says that if you do declare a noise value for an appliance, you have to use the right test methods and it has to be accurate. Try looking for EN 60704 in the BSI on-line catalogue, and Statutory

RE: Noise Levels for Household Appliances / Medical Devices

for Household Appliances / Medical Devices Dear All, Any recommended European or North American noise levels for household appliances such as massagers? What are the applicable standards? Any recommended European or North American noise levels for medical equipment, such as massagers used

RE: Noise Levels for Household Appliances / Medical Devices

.8277); C 295.7042; F 599.0445 E-mail: nsh...@catena.com -Original Message- From: Peter Merguerian [mailto:pmerguer...@itl.co.il] Sent: Wednesday, August 14, 2002 6:09 AM To: EMC-PSTC (E-mail) Subject: Noise Levels for Household Appliances / Medical Devices Dear All, Any recommended

Noise Levels for Household Appliances / Medical Devices

Dear All, Any recommended European or North American noise levels for household appliances such as massagers? What are the applicable standards? Any recommended European or North American noise levels for medical equipment, such as massagers used by professionals in a therapy center? What are

RE: Medical Devices in Japan and Australia

-emc-p...@majordomo.ieee.org]On Behalf Of Mike Cantwell Sent: Friday, 25 January 2002 6:24 AM To: emc-pstc (E-mail) Subject: Medical Devices in Japan and Australia Does anyone know: 1) Standards for medical devices in Japan and Australia? 2) Approval procedure for medical devices in Japan

Medical Devices in Japan and Australia

Does anyone know: 1) Standards for medical devices in Japan and Australia? 2) Approval procedure for medical devices in Japan and Australia? Any help/direction would be appreciated. Thanks, Mike Cantwell --- This message is from the IEEE EMC Society

RE: Medical devices in Asia

An excellent resource, John. Thank you. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services peter.tar...@sanmina-sci.com -Original Message- From: Jon Griver Sent: Tuesday, January 22, 2002 9:59 PM Peter, An excellent place to start your search

Re: Medical devices in Asia

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's

Medical devices in Asia

All - I have been asked to look into medical device requirements in Asia. This would include Pacific Rim and other Asian countries (the request was not specific, despite a little prodding). I am only beginning my research and would appreciate any pointers you might be able to provide that will

Re: Medical devices radiated immunity

I read in !emc-pstc that Paolo Peruzzi paolo.peru...@esaote.com wrote (in ofb1e46450.bdd89c4b-onc1256b1a.00494...@esaote.com) about 'Medical devices radiated immunity', on Thu, 6 Dec 2001: The second edition of IEC 60601-1-2 (EMC for medical electrical equipments) sets out a radiated immunity

Medical devices radiated immunity

Hi all, The second edition of IEC 60601-1-2 (EMC for medical electrical equipments) sets out a radiated immunity test between 80 MHz and 2.5 GHz. For test methods it refers to IEC 61000-4-3, which covers frequencies up to 2 GHz. So what about the test method? Can you follow the procedure

Medical Devices - another question

So how does one break into the medical device field for a medical device manufacturer? I was recently downsized and all of the compliance jobs in the Northeast seem to be for medical device manufacturers. I have 15+ years of product safety, EMI, etc, but no medical device experience.

RE: Susceptibility level of medical devices (incubator) - urgent!

Cameron [mailto:ral...@igs.net] Sent: Monday, August 27, 2001 5:33 PM To: Antonio Sarolic; emc-p...@majordomo.ieee.org Subject: Re: Susceptibility level of medical devices (incubator) - urgent! Antonio: I would say many incubators were manufactured when there were no concerns

Re: Susceptibility level of medical devices (incubator) - urgent!

: Antonio Sarolic antonio.saro...@fer.hr To: emc-p...@majordomo.ieee.org Sent: Monday, August 27, 2001 11:59 AM Subject: Susceptibility level of medical devices (incubator) - urgent! Hi I need urgent info on susceptibility level of medical electronic devices, especially baby incubators. Can anyone

Susceptibility level of medical devices (incubator) - urgent!

Hi I need urgent info on susceptibility level of medical electronic devices, especially baby incubators. Can anyone confirm if it is 1V/m (according to EU standards)? The EMI source is the GSM BS antenna (900MHz). Thanks very much. Antonio Antonio Sarolic, M.S.E.E. Faculty of Electrical

Re: Medical devices in Japan

the regime is for medical devices in Japan. I don't know anything about this, but if there's anyone out there who can give me a brief idea or possibly even some URLs to look at, I'd be grateful. Anyone in the business of providing consultancy in this area please let me know and I'll likely put

RE: Medical devices in Japan

...@conformance.co.uk] Sent: Tuesday, July 31, 2001 10:02 PM To: emc-p...@majordomo.ieee.org Subject:Medical devices in Japan I've been asked if I know what the regime is for medical devices in Japan. I don't know anything about this, but if there's anyone out there who can give me

RE: Medical devices in Japan

[SMTP:nick.willi...@conformance.co.uk] Sent: Tuesday, July 31, 2001 10:02 PM To: emc-p...@majordomo.ieee.org Subject: Medical devices in Japan I've been asked if I know what the regime is for medical devices in Japan. I don't know anything about

RE: Medical devices in Japan

...@majordomo.ieee.org Subject: Medical devices in Japan I've been asked if I know what the regime is for medical devices in Japan. I don't know anything about this, but if there's anyone out there who can give me a brief idea or possibly even some URLs to look at, I'd be grateful. Anyone

Medical devices in Japan

I've been asked if I know what the regime is for medical devices in Japan. I don't know anything about this, but if there's anyone out there who can give me a brief idea or possibly even some URLs to look at, I'd be grateful. Anyone in the business of providing consultancy in this area

RE: Serial Number Format - Medical Devices

To: IEEE EMC-PSTC E-Mail Forum (E-mail) Subject: Serial Number Format - Medical Devices A question to the group: Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label must bear the following particulars: (l), year of manufacture for active devices other than those covered by (e

Re: Serial Number Format - Medical Devices

At 06:55 +0100 26/6/2001, John Woodgate wrote: 36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail, Dick Grobner dick.grob...@medgraph.com inimitably wrote: Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label must bear the following particulars: (l), year of manufacture

Re: Serial Number Format - Medical Devices

I'd say both are probably right. I've never done medical. But, I have run into this type of thing when I was doing ISO-9001 as a lead auditor. Critical words for interpretation are This indication may be included ... It specifically says *may* which means either *you can* or *you don't

Re: Serial Number Format - Medical Devices

36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail, Dick Grobner dick.grob...@medgraph.com inimitably wrote: Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label must bear the following particulars: (l), year of manufacture for active devices other than those covered by (e).

RE: Production Line Test Requirements - Medical Devices

[mailto:jo...@medson.com] Sent: Tuesday, May 22, 2001 9:06 AM To: Dick Grobner Cc: emc-p...@majordomo.ieee.org Subject: RE: Production Line Test Requirements - Medical Devices Dick, This is the situation as I understand it. Please note that a few years ago I did factory inspections for TUV

RE: Production Line Test Requirements - Medical Devices

Ltd -Original Message- From: Dick Grobner [mailto:dick.grob...@medgraph.com] Sent: Monday, May 21, 2001 18:23 To: 'Jon Griver' Cc: IEEE EMC-PSTC E-Mail Forum (E-mail) Subject: RE: Production Line Test Requirements - Medical Devices Jon Thx for the info, however, I re-checked

Re: Production Line Test Requirements - Medical Devices

200105212113.oaa14...@epgc196.sdd.hp.com, Rich Nute ri...@sdd.hp.com inimitably wrote: Yes, for one strand. No, for five strands. I agree with what you say. In Europe, the PEC within equipment may be 16/0.2, so the possibility of the connection being reduced to one or two strands is, in one

Re: Production Line Test Requirements - Medical Devices

Hi John: Because continuity at low current does not ensure that the protective circuit will carry a large fault current - it might be 'hanging on by one strand'. Yes, for one strand. No, for five strands. Some years ago, I did some experiments on what problems the 25-amp test

Re: Production Line Test Requirements - Medical Devices

36BDBCA75E0FD411A80100104B93ABF202C2C079@MGCMAIL, Dick Grobner dick.grob...@medgraph.com inimitably wrote: Why wouldn't a simple continuity tests as defined by UL be appropriate from equipment coming off of the production line (assuring that the protective earth circuit in intake)? Because

RE: Production Line Test Requirements - Medical Devices

Hi Dick, The requirement for using 10 to 25 Amps comes from the test house. It is their mark. If you want to use it, they can require you to do anything they want. Is it fair, no. Does the requirement make engineering sense, no (I believe that Rich Nute did an article on how this requirement

RE: Production Line Test Requirements - Medical Devices

)? Appreciate your feedback Jon! thanks again. Does anyone else on this forum have any input - would appreciate it. -Original Message- From: Jon Griver [mailto:jo...@medson.com] Sent: Monday, May 21, 2001 9:16 AM To: Dick Grobner Subject: RE: Production Line Test Requirements - Medical Devices

FW: Production Line Test Requirements - Medical Devices

Medson Ltd. Good Day Everyone Question I have - Does anyone out there know if an EN standard or guidance document exists that deals with production line test requirements of finished medical devices. Reading in EN60601-1 it states that the test (ground resistance, high potential, etc.) are type

Production Line Test Requirements - Medical Devices

Good Day Everyone Question I have - Does anyone out there know if an EN standard or guidance document exists that deals with production line test requirements of finished medical devices. Reading in EN60601-1 it states that the test (ground resistance, high potential, etc.) are type test only

FW: Medical devices

the right answer! -Original Message- From: k...@i-data.com [mailto:k...@i-data.com] Sent: Wednesday, January 17, 2001 2:13 AM To: emc-p...@majordomo.ieee.org Subject: Medical devices Hi all Can some one give me links to information regarding EU Medical Devices directive. My

FW: Medical devices

Kim, Check out http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re flist.html From that page you can get to both the In Vitro Diagnostic Medical Devices Directive and the Medical Devices Directive, as well as the Harmonised Standards for these Directives. It sounds

Medical devices

Hi all Can some one give me links to information regarding EU Medical Devices directive. My problem is to define the requirement for the following situation: A manufacturer is making an add-on device for another company's medical device and the total equipment is CE approved without involving

RE: EMC on Medical Devices?

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 Regards, David Spencer

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 Regards, David Spencer --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc

RE: EMC for medical devices

-Original Message- From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]On Behalf Of Chris Duprés Sent: Wednesday, January 26, 2000 3:51 PM To: Kevin Newland Cc: emc-pstc Subject: EMC for medical devices Hi Kevin. You asked: 1-What are the immunity standards used

EMC for medical devices

Hi Kevin. You asked: 1-What are the immunity standards used in Europe for medical devices? I think you'll find that the IEC601 covers all the EMC requirements as well. Sorry, can't help with US requirements. Chris Dupres Surrey, UK. - This message is coming from the emc-pstc

FW: EMC for medical devices

-Original Message- From: Dick Grobner Sent: Wednesday, January 26, 2000 11:19 AM To: 'Kevin Newland' Subject: RE: EMC for medical devices Europe is EN 60601-1-2 In 1996 - for the US - it was the FDA's draft document entitled Reviewers Guidance for Premarket Notification Submissions

EMC for medical devices

Hello All, Could someone let me know the answer to the following questions please: 1-What are the immunity standards used in Europe for medical devices? 2-What EMC standards is used in US/Canada for medical devices? The product in question is approved for safety to IEC601-1. Thank you

Medical devices lab in Italy

Hi Everyone I have a client that wishes to have a Class I medical device tested in Italy, since our own lab can not assist at present. Can anybody suggest a lab or two that could possibly help for testing under the MDD ? Thanks, Lizette de Vries-Venter SENIOR ENGINEER Division of Electronics

Brazil approval of medical devices

Does anybody out of there know which are the steps to be taken in order to get the approval for a medical device to be sold in Brazil? Do they recognize international standards as IEC 60601-1 and family? What is the relevant law? Which are the Notified Bodies for medical devices? Thanks

RE: Medical Devices in Hyperbaric Chamber

At 12:16 PM 11/24/98 -0800, ed.pr...@cubic.com wrote: Massimo: Further complicating the issue is that the Apollo 1 fire ocurred with a partial pressure O2 rich environment. My guess(!) is that a 1ATM O2 rich environment would be even more hazardous. Maybe you can find some hints on this via NASA

Re: Medical Devices in Hyperbaric Chamber

1) In a high-pressure atmosphere, convection cooling of power devices should be OK. 2) Corona/voltage breakdown through the air would happen at a lower voltage level. These are based on the idea that there's little convection/corona in vacuum environments. As others have indicated, the gas in

Medical Devices in Hyperbaric Chamber

A distributors of ours asks us about the suitability of our ECG device for use into a Hyperbaric Chamber. Does anybody know any reference safety standard for medical devices in hyperbaric chamber? Are the environmental conditions similar to those in presence of a flammable anaesthetic mixture

RE: Medical Devices in Hyperbaric Chamber

/HP-ColSprings,mimegw3/dd.HPMEXT1=regr...@esaote.com Subject: Medical Devices in Hyperbaric Chamber A distributors of ours asks us about the suitability of our ECG device for use into a Hyperbaric Chamber. Does anybody know any reference safety standard for medical devices in hyperbaric chamber

RE: Medical Devices in Hyperbaric Chamber

From: dave_osb...@hp-waltham-om3.om.hp.com Subject: RE: Medical Devices in Hyperbaric Chamber Date: Tue, 24 Nov 1998 11:13:10 -0500 To: regr...@esaote.com Cc: emc-p...@ieee.org Hello Massimo, The use of devices in oxygen enriched environments is not a trivial

  1   2   >