Adres: UZAYÇAĞI CAD. 82 A-06
Tel 1: 0 (312) 354 09-24
Faks:
Email 1: ozgur.cevik@cinarlabs.com.tr
Email 2: info@cinarlabs.com.tr
Web: http://www.cinarlabs.com/
Medical devices that are distributed sterile must be validated as sterile and remain sterile until the sterile barrier system is damaged or opened. The most critical point for a sterile medical device is to ensure that sterility is maintained.
In order to meet the basic requirements of the European Medical Device Directives and to ensure product safety, packaging process validation studies must be carried out and documented in accordance with ISO 11607 and related test standards.