CE Mark for Surgical Gowns & Surgical Drapes

[soydanceran]

need information about CE Mark for Surgical Gowns & Surgical Drapes
After my research I thought that they are in Class 1 (rule 1- either dont touch patient or contact only intact Skin) and i shoul do self decleration. But I cant be sure about that.

Please help me about their classes
Thanx for all your kindly replay.

[Gert Sorensen]

I would agree with you that it is a class one product. However - IMO - you need to consider the user as well as the patient. At least for the gowns I think you need to consider skin contact for the user. How long do they wear them for? You also need to consider the fact that it may be considered long term contact even though they change gowns, due to the fact that they will still be in contact with the fabric day after day after day. I think you need to investigate intended use and design your reactivity tests to that, as part of the documentation that you will need for the CE-mark.

[soydanceran]

Originally Posted by Gert Sorensen

your reactivity tests to that, as part of the documentation

would give me more info about that. what kinds of tests. with respect to EN 13795 or for some other docoments?
Thanks

[Gert Sorensen]

Originally Posted by soydanceran

would give me more info about that. what kinds of tests. with respect to EN 13795 or for some other docoments?
Thanks

Medical devices that comes into skin contact has to comply with the requirements set forth in the ISO 10993 series. Be aware that there are some requirements to animal protection that you need to consider (it is the manufacturers responsibility). A competent test laboratory can help you navigate this field at a "low" cost.

[soydanceran]

Thanks for promt replay

And Do I need Clinical Data, Risk Analysis and ISO 13485.
We have ISO 9001

[soydanceran]

I found the test laboratoryand I know what was the tests are.

However It is important that "do I need ISO 13485 for Surgical Gowns & Surgical Drapes"

Please send any interpretation

[Gert Sorensen]

I am guessing here, but I pressume that at least the gowns are supplied sterile?

For 1S products you need to follow this route:



This site makes CE-marking of medical devices easier to understand:

http://www.dgm-nb.org/veje_til_ce/ce_medicin.shtml

[GStough]

Originally Posted by soydanceran

However It is important that "do I need ISO 13485 for Surgical Gowns & Surgical Drapes"

Please send any interpretation

I would say "yes", especially since you already have ISO 9001 registration, it shouldn't be too far a stretch to obtain ISO 13485 registration, as well.

Slightly
Prior to my current position, I spent 13 years with a manufacturer of surgical gowns, surgical drapes & wrappers, and other healthcare textiles. It's nice to see input here from someone else in that same industry. Welcome to the Cove!