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Related Topic Tags
dehp - di(2-ethylhexyl) phthalate, european union, european union regulations and standards, labeling content, labeling requirements, labels and labeling (general), medical devices (general)
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Old 21st June 2012, 03:28 PM
zmimshen zmimshen is offline
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Question What Specific Tests are Required to Label a Device as being DEHP Free

Hi all,
Are there any specific tests that are required in order to label a device as being DEHP Free?
Our NB asked why we didn't add this to the labeling but I have only been able to find a requirement to indicate the presence of DEHP and not the absence of it.

Any thoughts?

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Old 21st June 2012, 05:53 PM
PaulGr PaulGr is offline
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Re: What Specific Tests are Required to Label a Device as being DEHP Free

Hi,

It's the same for me. I am not aware of any requirement to identify the absence of a specific substance on the label. For phthalates, the MDD (Annex I, 7.5) only requires the phthalates symbol when the device contains phthalates...

For commercial reasons, it can help to identify what's not in the device. Like the 'latex free' symbols which is also - as far as I know - not required by any regulation.
Thanks to PaulGr for your informative Post and/or Attachment!
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Old 21st June 2012, 10:57 PM
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Re: What Specific Tests are Required to Label a Device as being DEHP Free

futher info that you can find out in REACH regulation and also can be inquire ralated consultative bodies
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Old 22nd June 2012, 02:06 AM
Ronen E Ronen E is offline
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Re: What Specific Tests are Required to Label a Device as being DEHP Free

Quote:
In Reply to Parent Post by zmimshen View Post

Hi all,
Are there any specific tests that are required in order to label a device as being DEHP Free?
Our NB asked why we didn't add this to the labeling but I have only been able to find a requirement to indicate the presence of DEHP and not the absence of it.

Any thoughts?
It's not about testing. You (or the manufacturer) should have full knowledge of what has been put into the device! DEHP is commonly used as a PVC plasticizer -- in such a case the supplier is ought to tell the customer whether they use DEHP or another type of plasticizer in their formulation (if they refuse, I wouldn't buy from them!).
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Old 22nd June 2012, 05:10 AM
PaulGr PaulGr is offline
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Re: What Specific Tests are Required to Label a Device as being DEHP Free

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In Reply to Parent Post by Ronen E View Post

It's not about testing. You (or the manufacturer) should have full knowledge of what has been put into the device! DEHP is commonly used as a PVC plasticizer -- in such a case the supplier is ought to tell the customer whether they use DEHP or another type of plasticizer in their formulation (if they refuse, I wouldn't buy from them!).
Well, testing can be an option. In the past, I have organized phthalate testing for those parts where we could not get the required information through the supply chain. Testing was performed by an external lab and for every sample we got a sheet specifying the contents and percentages.
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Old 22nd June 2012, 05:13 PM
Ronen E Ronen E is offline
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Re: What Specific Tests are Required to Label a Device as being DEHP Free

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In Reply to Parent Post by PaulGr View Post

Well, testing can be an option. In the past, I have organized phthalate testing for those parts where we could not get the required information through the supply chain. Testing was performed by an external lab and for every sample we got a sheet specifying the contents and percentages.
IMHO, a supplier that can't / won't tell you whether or not you get DEHP in the product is not one you want to work with, if you have a choice. In that sort of relationship (for whatever reason), who knows what else might be in the product? Or even if what they do tell you is trustworthy. You can't test for "everything" and it also doesn't make sense. Someone created this product so for sure someone knows what has intentionally gone into it.

We're not talking about some exotic contaminant here. We're talking about DEHP -- a mainstream, long recognized concern in the industry.
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