Dear Sir or Madam,

According to the ISO 10993-7: 1995 the section 4.3.1 is determined the EtO dose for Permanent contact devices:

Permanent contact devices: The average daily dose of EtO to patient shall not exceed 0.1mg/day. In addition, the max EtO dose shall not exceed 20mg in the first 24h .

In addition attached EtO limit table explains the EtO limit and gives the formula for calculation method.

(Formula; ppm x weigth of device(g)=micrograms of residue( mg or microgram)

If I use this formula for our product, the result of EtO limit range is very different bcs of the EtO dose is determined 0.1mg/day and 20mg/24h.

Weight of the our product is not between 80gr-800gr so we have to found the limit using formula or we can choose directly 20ppm?

If we have to use formula which dose (0.1mg or 20mg) we have to choose?

Product: Stent
Weight: 3.5gr

According to table the Device for contacting blood (ex vivo);

Our product weight is not between 80-800 gr so we have to found the limit according to formula or we can choose 250ppm directly?

Product: Tubset
Weight: 2000gr=2kg

Thank you for your interest,

Best regards,
Ozlem CEYHAN
Quality Assurance Manager

Dear Ozlem Ceyhan

It is obvious you do have already a broad knowledge of ETO Sterilization. If you intend to manufacture and sell ready to use sterile Stents you do have to contact a Notified Body (Test-laboratory) which is able to give a law - binding answers and assistance for the registration for CE-Marking.
If you "have to" resterilize" Stents for your hospital the information source can only be the manufacturer of the original Stents.
Don't miss to visit www.devicelink.com/rc/sterilization/articles.html a profound Sterilization Resource Center for industry. There you find a Help Desk e.g. the articles "Where to Go for ETO Info" and "Optimizing ETO Sterilization".

Good luck and kind regards
Josy Holdener