Re: [PSES] One DoCs vs multiple DoCs

2015-11-05 Thread Jon Griver 
I recently participated in a Notified Body audit at a medical device
manufacturer. The manufacturer had a single Declaration of Conformity for
the MDD and RoHS.

The auditor told the manufacturer to separate the Declarations. The reason
given was that the Notified Body's name and number appear 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: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] 
Sent: Friday, 6 November, 2015 06:38
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] One DoCs vs multiple DoCs

The EC Blue Guide says "Where several pieces of Union harmonisation
legislation apply to a product, the manufacturer or the authorised
representative has to provide a single declaration of conformity in respect
of all such Union acts190. It is accepted that the single declaration may be
a dossier made up of relevant individual Declarations of conformity."

-Dave

-Original Message-
From: T.Sato [mailto:vef00...@nifty.ne.jp]
Sent: Thursday, November 05, 2015 5:37 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] One DoCs vs multiple DoCs

On Thu, 5 Nov 2015 19:51:03 +,
  "Kunde, Brian"  wrote:

> With the RoHS Directive kicking in at different times for different
Categories of products, I'm starting to see the RoHS Directive listed on
Declaration of Conformities.  However, I have also noticed many companies
generating two different DoCs; one for Safety and EMC and the other for RoHS
only.
> 
> Can someone explain to me chapter and verse on the EU's position regarding
multiple DoCs?
> 
> Our company's product category will soon be applicable to RoHS and we
would like to know if multiple DoCs are OK to do or not.  I've heard Not,
but then again, I see reputable companies doing it so what's the deal?

Maybe it is under the manufacture's choice.

However, recent directives such as 2014/30/EU and 2014/35/EU says:
"... a single EU declaration of conformity shall be drawn up in respect of
all such Union acts."

Regards,
Tom

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Re: [PSES] One DoCs vs multiple DoCs

2015-11-05 Thread Nyffenegger, Dave 
The EC Blue Guide says "Where several pieces of Union harmonisation legislation 
apply to a product, the manufacturer or the authorised representative
has to provide a single declaration of conformity in respect of all such Union 
acts190. It is accepted that the single declaration may
be a dossier made up of relevant individual Declarations of conformity."

-Dave

-Original Message-
From: T.Sato [mailto:vef00...@nifty.ne.jp] 
Sent: Thursday, November 05, 2015 5:37 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] One DoCs vs multiple DoCs

On Thu, 5 Nov 2015 19:51:03 +,
  "Kunde, Brian"  wrote:

> With the RoHS Directive kicking in at different times for different 
> Categories of products, I'm starting to see the RoHS Directive listed on 
> Declaration of Conformities.  However, I have also noticed many companies 
> generating two different DoCs; one for Safety and EMC and the other for RoHS 
> only.
> 
> Can someone explain to me chapter and verse on the EU's position regarding 
> multiple DoCs?
> 
> Our company's product category will soon be applicable to RoHS and we would 
> like to know if multiple DoCs are OK to do or not.  I've heard Not, but then 
> again, I see reputable companies doing it so what's the deal?

Maybe it is under the manufacture's choice.

However, recent directives such as 2014/30/EU and 2014/35/EU says:
"... a single EU declaration of conformity shall be drawn up in respect of all 
such Union acts."

Regards,
Tom

-

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Re: [PSES] One DoCs vs multiple DoCs

2015-11-05 Thread T.Sato 
On Thu, 5 Nov 2015 19:51:03 +,
  "Kunde, Brian"  wrote:

> With the RoHS Directive kicking in at different times for different 
> Categories of products, I'm starting to see the RoHS Directive listed on 
> Declaration of Conformities.  However, I have also noticed many companies 
> generating two different DoCs; one for Safety and EMC and the other for RoHS 
> only.
> 
> Can someone explain to me chapter and verse on the EU's position regarding 
> multiple DoCs?
> 
> Our company's product category will soon be applicable to RoHS and we would 
> like to know if multiple DoCs are OK to do or not.  I've heard Not, but then 
> again, I see reputable companies doing it so what's the deal?

Maybe it is under the manufacture's choice.

However, recent directives such as 2014/30/EU and 2014/35/EU says:
"... a single EU declaration of conformity shall be drawn up in
respect of all such Union acts."

Regards,
Tom

-

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Re: [PSES] One DoCs vs multiple DoCs

2015-11-05 Thread Rodney Davis 

Correction  directive replaced with declaration... typos.


To keep it simple. You must declare to all applicable directive.


if you feel a number of individual Declarations is easier ( i see no rationale 
but !!!) you can generate a number of Declarations for each Directive.


If you feel it is simpler to issue 1 Declaration referencing all Applicable 
Directives (easier to see the upswing) this approach is also acceptable.


There is no documented restriction on the approach to be taken.


Rodney Davis




From: Kunde, Brian 
Sent: Thursday, November 5, 2015 2:51 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] One DoCs vs multiple DoCs


Greetings, experts.



With the RoHS Directive kicking in at different times for different Categories 
of products, I'm starting to see the RoHS Directive listed on Declaration of 
Conformities.  However, I have also noticed many companies generating two 
different DoCs; one for Safety and EMC and the other for RoHS only.



Can someone explain to me chapter and verse on the EU's position regarding 
multiple DoCs?



Our company's product category will soon be applicable to RoHS and we would 
like to know if multiple DoCs are OK to do or not.  I've heard Not, but then 
again, I see reputable companies doing it so what's the deal?



Thanks to all.



The Other Brian






LECO Corporation Notice: This communication may contain confidential 
information intended for the named recipient(s) only. If you received this by 
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Re: [PSES] One DoCs vs multiple DoCs

2015-11-05 Thread Rodney Davis 
To keep it simple. You must declare to all applicable directive.


if you feel a number of individual Directives is easier ( i see no rationale 
but !!!) you can generate a number of Directives.


If you feel it is simpler to issue 1 directive referencing all Applicable 
Directives (easier to see the upswing) this approach is also acceptable.


There in no documented restriction on the approach taken.


Rodney Davis




From: Kunde, Brian 
Sent: Thursday, November 5, 2015 2:51 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] One DoCs vs multiple DoCs


Greetings, experts.



With the RoHS Directive kicking in at different times for different Categories 
of products, I'm starting to see the RoHS Directive listed on Declaration of 
Conformities.  However, I have also noticed many companies generating two 
different DoCs; one for Safety and EMC and the other for RoHS only.



Can someone explain to me chapter and verse on the EU's position regarding 
multiple DoCs?



Our company's product category will soon be applicable to RoHS and we would 
like to know if multiple DoCs are OK to do or not.  I've heard Not, but then 
again, I see reputable companies doing it so what's the deal?



Thanks to all.



The Other Brian






LECO Corporation Notice: This communication may contain confidential 
information intended for the named recipient(s) only. If you received this by 
mistake, please destroy it and notify us of the error. Thank you.
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[PSES] One DoCs vs multiple DoCs

2015-11-05 Thread Kunde, Brian 
Greetings, experts.

With the RoHS Directive kicking in at different times for different Categories 
of products, I'm starting to see the RoHS Directive listed on Declaration of 
Conformities.  However, I have also noticed many companies generating two 
different DoCs; one for Safety and EMC and the other for RoHS only.

Can someone explain to me chapter and verse on the EU's position regarding 
multiple DoCs?

Our company's product category will soon be applicable to RoHS and we would 
like to know if multiple DoCs are OK to do or not.  I've heard Not, but then 
again, I see reputable companies doing it so what's the deal?

Thanks to all.

The Other Brian



LECO Corporation Notice: This communication may contain confidential 
information intended for the named recipient(s) only. If you received this by 
mistake, please destroy it and notify us of the error. Thank you.

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Re: [PSES] Cd exemption for art material

2015-11-05 Thread John Allen 
Brian 

 

Having now read the eur-lex text, I would have thought that the most likely
people to be affected by the cadmium in paints would be the artists who use
those paints -is that what you are alluding to below?

 

If so, then, again, I would have thought that the Swedish proposal should
then have been drafted to address that issue - Thus if "history" then showed
that artists and their direct associates do/do not appear not to have
suffered any long term effects from cadmium in their materials, then that
would be a good reason for accepting/rejecting that proposal.

 

By contrast the actual Swedish proposal took a tortuous route to actually
achieving very little - and presumably at some actual cost for the
investigations and reports etc.

 

Relatively good to see that the REACH bodies do take a risk assessment
approach where the material in question is a minor contributor to an
environmental issue, and not just the "definitive" "if it can then it will
cause a real problem" approach.

 

Might be a pity that the powers-that-be behind ROHS/ROHS2 did not take a
similar approach?

 

John Allen

W. London, UK.

 

-Original Message-
From: Brian O'Connell [mailto:oconne...@tamuracorp.com] 
Sent: 05 November 2015 17:51
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Cd exemption for art material

 

 

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52015XC1028(01
)&from=EN

 

The chemical principle of local concentration vs equilibria, and likelihood
for direct exposure to users, seems to have been ignored.

 

 

Brian

Sr Janitorial Assistant For the Vulcan Science Academy

 

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[PSES] Cd exemption for art material

2015-11-05 Thread Brian O'Connell 
http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52015XC1028(01)&from=EN

The chemical principle of local concentration vs equilibria, and likelihood for 
direct exposure to users, seems to have been ignored.


Brian
Sr Janitorial Assistant For the Vulcan Science Academy

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