Re: [PSES] A question about FDA language and interlocking devices

Doug, These type of interlock switches are new to me. They are used in industrial applications where they protect the user from a very hazardous condition. These switches usually have what is called a Positive Mechanical Action or Certified Direct Opening mechanism which forces a Normally

Re: [PSES] A question about FDA language and interlocking devices

EN ISO 14119 Safety of machinery - Interlocking devices associated with guards - Principles for design and selection has good information to refer to for safety interlocks. Compliance with this standard is required for machinery under the Machinery Directive for CE marking. While there may

Re: [PSES] A question about FDA language and interlocking devices

That seems to make more sense. I don’t know anything about X-ray requirements but the FDA requirements laser interlocks are not specific, only referring to “interlocks”. -Dave From: MIKE SHERMAN [mailto:msherma...@comcast.net] Sent: Tuesday, February 05, 2019 12:27 PM To:

Re: [PSES] A question about FDA language and interlocking devices

Please see test below: “Safety Interlocks [21 CFR 1020.40(c)(4)(i)]:Each door of a cabinet x-ray system shall have a minimum of two safety interlocks. One, but not both of the required interlocks shall be such that door opening results in physical disconnection of the energy supply circuit to

Re: [PSES] A question about FDA language and interlocking devices

I see another probably more likely interpretation of "knife edge and finger stock" in this context. Look up a knife edge fuse on the internet. Presumably the socket the fuse seats in would be the finger stock. Mike Sherman Graco Inc. > On February 5, 2019 at 2:34 PM "Schmidt, Mark" wrote: >

Re: [PSES] Johnson City NY - crazy street lights

Interesting indeed,The thing that probably should surprise me and does not is that as we get more sophisticated in our technology the more ways that technology can fail. I can't help but remember the old copy machine in our offices that had nothing more a zoom control, number of copies and a big

Re: [PSES] [BULK] [PSES] Economical operator name & postal address onEEEproducts

Dear Brian & Scott, Thanks for your excellent guides for this matter!! Currently we act as a manufacturer because the product has our own brand although the products are manufactured in China or other third countries outside EU. The technical files are located at our branch offices outside EU

Re: [PSES] Johnson City NY - crazy street lights

This is true, but I don't see it as cynical 'planned obsolescence'; it's a two-edged sword: 'We want to give the public all the benefits of advancing technology, so there is no point in designing for a life of even 10 years'. Like my grandfather's garden fork, which is about 100 years old and

Re: [PSES] UK Gov Using The UKCA Mark

Hello Glyn, There’s no requirement for a lab to be accredited or listed when performing sDoC testing for the FCC (similar to the old Verification requirements). So, it should not affect sDoC testing at all. There is a requirement for a test lab to be accredited and listed for testing

Re: [PSES] UK Gov Using The UKCA Mark

I don't know. Maybe the UK has an MRA with the US, independent of any EU-US MRA. Best wishes John Woodgate OOO-Own Opinions Only J M Woodgate and Associates www.woodjohn.uk Rayleigh, Essex UK On 2019-02-05 10:40, Payne, Glyn wrote: Hi John, Won’t the lack of a MRA with the US effect the FCC

Re: [PSES] UK Gov Using The UKCA Mark

Hi John, Won’t the lack of a MRA with the US effect the FCC SDoC route when getting emission scans done in labs that are accredited by UKAS? Regards, Glyn Payne Validation and Compliance Engineer Solid State Logic - UK Headquarters www.solidstatelogic.com Facebook :

Re: [PSES] UK Gov Using The UKCA Mark

I fully agree on the Ken's concern. How can the manufactures change the logos and relevant documents of the goods arrive in the UK post Brexit of 30/03/2019? UK will suffer short of goods in next few months. Does UK plan to cope with it? Regards, Scott On Tue, 5 Feb 2019 at 01:51, Kapur,

Re: [PSES] UK Gov Using The UKCA Mark

Goods arriving in the UK should not be in trouble. UK recognizes the CE Mark on March 29 and there is no reason to stop recognizing it on March 30.  Goods leaving the UK for the EU are in a different position IF a UK-only Notified Body is involved in determining compliance. For many products,

Re: [PSES] UK Gov Using The UKCA Mark

Anyone with a test site that meets the requirements of ANSI C63.4.:) Michael. From: Charlie Blackham [mailto:char...@sulisconsultants.com] Sent: 05 February 2019 10:52 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] UK Gov Using The UKCA Mark Glyn For sDoC... there is no

Re: [PSES] UK Gov Using The UKCA Mark

Thanks Michael. From: Michael Derby Reply-To: Michael Derby Date: Tuesday, 5 February 2019 at 11:14 To: Subject: Re: [PSES] UK Gov Using The UKCA Mark UK-USA talks happened very quickly after the referendum, so they are quite advanced I think. Michael. From: John Woodgate

Re: [PSES] UK Gov Using The UKCA Mark

UK-USA talks happened very quickly after the referendum, so they are quite advanced I think. Michael. From: John Woodgate [mailto:j...@woodjohn.uk] Sent: 05 February 2019 11:06 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] UK Gov Using The UKCA Mark I don't know. Maybe the UK

Re: [PSES] [BULK] [PSES] Economical operator name & postal address on EEEproducts

Dear Brian, Thanks for your useful info! Must the responsible person be in EU/EEA countries? Otherwise the responsible person will fall into the importers or authorized resprentatives who is in EU/EEA countries? Regards, Scott Scott, The short answer to your question is, the name and

Re: [PSES] [BULK] [PSES] Economical operator name & postal address on EEEproducts

The responsibilities of importers and authorized representative specified in Directives and Regulations are insufficient to qualify as 'responsible person', because the 'responsible person' has to know that no changes have been made to the product that would affect its compliance. In other

Re: [PSES] UK Gov Using The UKCA Mark

Glyn For sDoC... there is no requirement to be accredited, nor listed on the FCC website. So, anyone can do sDoC testing. Regards Charlie Charlie Blackham Sulis Consultants Ltd Tel: +44 (0)7946 624317 Web:

Re: [PSES] UK Gov Using The UKCA Mark

Hi Ian, That’s correct. In the past, the FCC logo was mandatory if you followed the old DoC route, and forbidden if you did not follow the old DoC route. Many people got that wrong. So nowadays, if you follow the sDoC route, the logo is now optional for you. Thanks, Michael.

Re: [PSES] Economical operator name & postal address on EEEproducts

Scott, Go to this link: https://ec.europa.eu/growth/content/%E2%80%98blue-guide%E2%80%99-implementation-eu-product-rules-0_en At the bottom of the page, click on “BLUE GUIDE 2016”. It should download the document in .pdf format. Go to page 30 which should be section 3.1 on “MANUFACTURER”.

Re: [PSES] UK Gov Using The UKCA Mark

Hello Michael. Am I right in believing that you can now affix the FCC logo to products when using the sDoc scheme? Kind regards; Ian McBurney Lead Compliance Engineer Allen & Heath Ltd. Kernick Industrial estate, Penryn, Cornwall. TR10 9LU. UK. Tel: 01326 372070 Email:

Re: [PSES] UK Gov Using The UKCA Mark

Correct. Mommas kitchen is not acceptable place to test SDOC requirements are listed in KDB896810D01 SDoC v01r01. There are also general requirements for any testing of unintentional devices that must be met. For example” While an accredited lab is not required. Section 15.31(a)(4) reminds the

Re: [PSES] A question about FDA language and interlocking devices

Hello Doug, I have only a limited amount of knowledge in this area, and I hope another listserv member can either correct me or provide more detail. I also believe Mike Sherman may be correct on the knife edge/finger stock description. The CDRH at the FDA is generally very conservative and

Re: [PSES] UK Gov Using The UKCA Mark

Not exactly correct – unintentional radiators, regardless if they are SDOC or certified, are to be tested using C63.4_2014. C63.4 requires the site must meet the site requirements of C63.4 and requires that antennas used for measurements must be calibrated to C63.5 (latest edition). Thanks

[PSES] A question about FDA language and interlocking devices

Colleagues, I had a question come my way yesterday that I need a little help with. Here’s the question: > I have a customer that produces X-ray equipment. The FDA requires that the > door that gives access to the X-ray source must have an interlock with a > ‘knife-edge and finger stock’ type

Re: [PSES] A question about FDA language and interlocking devices

Doug -- "knife-edge and finger stock" sounds more like the gasketing around the door to keep the radiation inside. I think you'll find similar gasketing on doors to EMC chambers. I've not heard of this term applied to interlock switches. Mike Sherman Graco Inc. > On February 5, 2019 at

Re: [PSES] [BULK] [PSES] Economical operator name & postal address on EEEproducts

Hi Scott, I echo Brian's recommendation to read the relevant sections of the Blue Guide (2016 version is the latest I believe). You can download it here . See section 4.2 on Traceability. It has

Re: [PSES] Economical operator name & postal address on EEEproducts

Nice summary. From: Kunde, Brian [mailto:brian_ku...@lecotc.com] Sent: Tuesday, February 05, 2019 10:46 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Economical operator name & postal address on EEEproducts Scott, Go to this link: