5 YEARS FROM DATE OF STERILIZATION STORE 20-25C

3.1 EN ISO 17665-1:2006. Sterilization of health care products – Moist heat

3.2 EN 556-1:2001, Sterilization of medical devices

3.3 EN ISO 11138-3:2006, Sterilization of health care products – Biological indicators

3.4 EN ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods –

3.5 EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices-

3.6 EN ISO 11607-2:2006, Packaging for terminally sterilized medical devices

3.7 EN ISO 13485:2012. Medical devices-Quality management system- 3.8 MDQMT-AG-2007-02, Guideline for Sterilization validation of medical devices

3.8 MDQMT-AG-2007-02, Guideline for Sterilization validation of medical devices

3.9 Korea Pharmacopoeia 8 th, General test method – Sterility test

3.10 EN ISO 10993-1:2009,EN ISO 10993-5 EN ISO 10993-3-12:2012 EN62366:2008

3.11-MIT international testing S.r.I.(NB0068) GMDN CODE:10996 (YO-TF-01-07)

3.12-Sertificate of GMP medical devices manifacturing Practices } \underline{17.03 .2021}}$

3.13 -Full quality assurance system approval EC certificate 22.07.2023 (CE0068)

3.14-Notify body number:0068/QCO-DM/042-2018 via Moscova.11-20017RHO-ITALY

CERTIFICATE OF ANALYSIS

POWER,BASE CUREVE,CENTER THICKNESS, DIAMETER,SURFACE INSPECTION ACCEPT (PASSED)