Re: [PSES] 60601-1 drop dead date - June 2012 for EU

[Charlie Blackham]

Gary

Harmonised Standards do give a presumption of conformity..but...non-harmonised 
standard do not give a presumption of non-conformity.

You are required to demonstrate compliance with the "Essential Requirements of 
the Directive" not with "harmonised standards". Just because a standard has 
been superseded doesn't necessarily mean that you can't use it to support a DoC.

Regards
Charlie


From: McInturff, Gary [mailto:gary.mcintu...@esterline.com]
Sent: 02 April 2012 19:49
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] 60601-1 drop dead date - June 2012 for EU

Just checking to make sure I understand.
For Europe the 60601-1 medical standard transitions from 2nd to 3rd edition. It 
does the same in the US next June.
So after June 1s we can't ship to the EU but
  What about products that are in our customers warehouses in the EU at 
that time? Do they have to be recalled or can they be used until the warehouse 
is empty?
They are in EU but can they cross boarders?
We are just looking at our inventory split. We have completed the 60601-2 3rd 
edition for the products being currently produced, but the customer has some 
volume of them in EU in their possession. As those are depleted their stocks 
will be current edition units will be shipped to fill the inventory.
They haven't mentioned anything about them just yet, but I'm trying to 
anticipate the question.

Thanks

Gary McInturff
Reliability/Compliance Engineer








Esterline Interface Technologies

Featuring
ADVANCED INPUT, MEMTRON, and LRE MEDICAL products



600 W. Wilbur Avenue
Coeur d'Alene, ID  83815-9496
Office:208-635-8306
Cell:  509 868 2279
Toll Free: 800-444-5923 X 1238
gary.mcintu...@esterline.com


www.esterline.com/interfacetechnologies

Technology, Innovation, Performance...



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Re: [PSES] 60601-1 drop dead date - June 2012 for EU

[Momcilovic, Nick (GE Healthcare)]

See section 2.3 of the " Guide to the implementation of directives based
on the New Approach and the Global Approach" for guidance on "placing on
the market".  Here is a link:
http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-g
uide/guidepublic_en.pdf

Couple other things to point out:

The 01-Jun-2012 60601-1 date in the EU is only for products not covered
by a particular (-2-xx) standard.  If a particular standard exists, it
takes precedence and drives the deadline in the EU.  Some are before the
01-Jun-2012 date and some are after.  You can see the dates in the OJ
here:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-st
andards/medical-devices/

In the EU the date applies to any product "placed on the market" after
that date, whereas the 60601-1 implementation dates for the US & Canada
are based on new product registrations submitted (not for existing
products).  US is 30-Jun-2013 for all products under the scope of
60601-1 (not based on the particular standard).  Canada was 01-Jun-2012,
but recently came out with some guidance, which clarified the date.  The
date is either 01-Jun-2012 or 3 years following the date the 2-xx
particular standard was published, whichever is later.

Nick

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of
McInturff, Gary
Sent: Monday, April 02, 2012 2:51 PM
To: 'John Woodgate'; 'EMC-PSTC@LISTSERV.IEEE.ORG'
Subject: RE: [PSES] 60601-1 drop dead date - June 2012 for EU

John and Brian,
Thanks for the input. I do appreciate it.

Gary

-Original Message-
From: John Woodgate [mailto:j...@jmwa.demon.co.uk]
Sent: Monday, April 02, 2012 12:21 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] 60601-1 drop dead date - June 2012 for EU

In message
,
dated Mon, 2 Apr 2012, "McInturff, Gary" 
writes:

>What about products that are in our customers warehouses in the EU at 
>that time? Do they have to be recalled or can they be used until the 
>warehouse is empty?

If they are in *customers* warehouses, they have a 'reasonable time' to
clear stocks. What is 'reasonable' depends on the type of product.

>They are in EU but can they cross boarders?

Yes.
--
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK If
'QWERTY' is an English keyboard, what language is 'WYSIWYG' for?

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Re: [PSES] 60601-1 drop dead date - June 2012 for EU

[McInturff, Gary]

John and Brian,
Thanks for the input. I do appreciate it.

Gary

-Original Message-
From: John Woodgate [mailto:j...@jmwa.demon.co.uk] 
Sent: Monday, April 02, 2012 12:21 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] 60601-1 drop dead date - June 2012 for EU

In message 
, 
dated Mon, 2 Apr 2012, "McInturff, Gary"  
writes:

>What about products that are in our customers warehouses in the EU at 
>that time? Do they have to be recalled or can they be used until the 
>warehouse is empty?

If they are in *customers* warehouses, they have a 'reasonable time' to 
clear stocks. What is 'reasonable' depends on the type of product.

>They are in EU but can they cross boarders?

Yes.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
If 'QWERTY' is an English keyboard, what language is 'WYSIWYG' for?

-

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Re: [PSES] 60601-1 drop dead date - June 2012 for EU

[John Woodgate]

In message 
, 
dated Mon, 2 Apr 2012, "McInturff, Gary"  
writes:


What about products that are in our customers warehouses in the EU at 
that time? Do they have to be recalled or can they be used until the 
warehouse is empty?


If they are in *customers* warehouses, they have a 'reasonable time' to 
clear stocks. What is 'reasonable' depends on the type of product.



They are in EU but can they cross boarders?


Yes.
--
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
If 'QWERTY' is an English keyboard, what language is 'WYSIWYG' for?

-

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Re: [PSES] 60601-1 drop dead date - June 2012 for EU

[Brian Oconnell]

Gary,

We are both 'laying in the same ditch'.

You need to look at the legal definitions for 'placing on the market'.

If the customers accepted shipment into their warehouse, and you have
invoiced them - it is their problem. If it is a contract warehouse, then
your employer is probably on the hook for it.

Where the product is not changed, but the CB report has been updated so that
there is a basis for presumption of conformity to 3d edition, then the only
task is to open the boxes and replace affected docs.

Brian

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of McInturff,
Gary
Sent: Monday, April 02, 2012 11:49 AM
To: 'EMC-PSTC@LISTSERV.IEEE.ORG'
Subject: 60601-1 drop dead date - June 2012 for EU

Just checking to make sure I understand.
For Europe the 60601-1 medical standard transitions from 2nd to 3rd edition.
It does the same in the US next June. 
So after June 1s we can't ship to the EU but
  What about products that are in our customers warehouses in the EU
at that time? Do they have to be recalled or can they be used until the
warehouse is empty?
They are in EU but can they cross boarders?
We are just looking at our inventory split. We have completed the 60601-2
3rd edition for the products being currently produced, but the customer has
some volume of them in EU in their possession. As those are depleted their
stocks will be current edition units will be shipped to fill the inventory. 
They haven't mentioned anything about them just yet, but I'm trying to
anticipate the question.
 
Thanks
 
Gary McInturff
Reliability/Compliance Engineer  

 
 
Esterline Interface TechnologiesFeaturing
ADVANCED INPUT, MEMTRON, and LRE MEDICAL products 
600 W. Wilbur Avenue
Coeur d'Alene, ID  83815-9496
Office:208-635-8306
Cell:  509 868 2279
Toll Free: 800-444-5923 X 1238
gary.mcintu...@esterline.com
 
 
www.esterline.com/interfacetechnologies
 
Technology, Innovation, Performance...

 
 
-


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