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View Full Version : EN 13795 Surgical Drapes and Covers...any other makers of plastic-film drapes...


MIREGMGR
8th April 2009, 10:43 PM
...and equipment covers working to integrate this newly harmonized standard into your compliance stance, and confused because the specified test standards are all textiles-only, even though the scope of EN 13795 itself encompasses woven-textile-multiple-use, non-woven-textile-single-use, and plastic-film-single-use equipment covers...?

One wonders how the drafting committee for such a standard could generate such a document if it included expertise from all of the major technologies it would encompass...or why such a committee would be set up without having such an all-encompassing membership.

Maybe I'm becoming even more cynical, but perhaps the committee membership included quite a few individuals who were employed by woven/non-woven material makers/drape sellers, and they had a collective memory lapse and forgot to include a compliance path for the competing technologies. :rolleyes:

Of course, one then has to wonder how the resulting final draft managed to get through all the subsequent approval layers without being understood.

Oops.

MIREGMGR
9th April 2009, 12:53 PM
We've been inquiring among regulatory organizations with which we interact in regard to our European marketing.

Amusingly, a principal from our Authorized Representative has independently arrived at the conclusion that it appears the developing committee may have included disproportionate representation from manufacturers/sellers of textile drape products, and may not have included effective representation of the end user perspective, with an interest in having the resultant standard be inclusive of all the technologies that end users historically have chosen to use.

A question for those participants here with more knowledge of the EU "system" than I have: is there a venue or pathway for a complaint about this standard's content?

Roland Cooke
9th April 2009, 10:00 PM
We've been inquiring among regulatory organizations with which we interact in regard to our European marketing.

Amusingly, a principal from our Authorized Representative has independently arrived at the conclusion that it appears the developing committee may have included disproportionate representation from manufacturers/sellers of textile drape products, and may not have included effective representation of the end user perspective, with an interest in having the resultant standard be inclusive of all the technologies that end users historically have chosen to use.

A question for those participants here with more knowledge of the EU "system" than I have: is there a venue or pathway for a complaint about this standard's content?


Did the committee turn down proffered representation from the end user community, or were there no volunteers? Big difference.

It's highly unlikely the committe was convened in secret, so if the latter above, the end user community only has itself to blame.
They should work with the committee to fast-track a revision, i.e. rather than waiting the full five years.

If there is evidence the standard was inappropriately prepared, I'm sure there must be some kind of appeals process, maybe check out the CEN website.

MIREGMGR
10th April 2009, 12:31 AM
Did the committee turn down proffered representation from the end user community, or were there no volunteers? Big difference.

It's highly unlikely the committe was convened in secret, so if the latter above, the end user community only has itself to blame.

Yes, understood.

Actually, of course, it's not the end user community that is damaged by this...it's the manufacturers of products other than those that the standard is structured to favor. Your point remains generally valid, of course.

But, the whole standards concept is damaged by this sort of thing. The concept depends on a shared perception that standards always represent enlightened thinking and best practices. Standards would be much less powerful if it became commonly perceived that they might be drafted to serve the interests of those who did the drafting.

At this point, of course, I don't know that that is what occurred. So far I have only the content of the final standard to go by.

Roland Cooke
10th April 2009, 01:37 AM
It's certainly worth getting in touch with the "left-out" companies, see if you can get a group together. Much better to do it that way, than be one lone voice whining in the wilderness.

Also, it may have been that "Evil Manufacturer Group #1" did "quietly drive the creation of a new standard, and that there was inadequate effort made to get a consensus from across the board. The convenors from the Standards organizations are unlikely to be specialists in the specific subject, they are technical administrators.

And I'm sure this isn't the first time this kind of thing has happened, so I am sure they have a process for redress.

One of the ways to "fight" it, is to run a negative media campaign against the standard, but that has plenty of downsides as I am sure you would agree.