|Basic UDI Code:|
|UDI – DI:|
|Classification – Rule:|
|Application / Intended Use:|
|Raw materials:||Stainless steel AISI 410|
|Standard Reference:||ASTM F899-11 & ISO 7153-1|
|Bio-burden per Non-Sterile Device CFU/Device||≤100 CFU|
|Bio-burden per Sterile Device CFU/Device|
|Biocompatible material according to subject standards:||EN ISO 10993-10:2010 (Intradermal Reactivity Test), EN ISO 10993-11:2017 (Acute Systemic Toxicity Test), EN ISO 10993-11:2017 (Material Mediated Pyrogens Test), EN ISO 10993-10:2010 (Skin Sensitization Test), EN ISO 10993-5:2009 (In Vitro Cytotoxicity Test)|
|ETO Sterilisable as per subject limits:||Concentration ETO: 600 ± 50mg/l
Temperature: 54°C – 55°C
Exposure time: 6 Hours
Humidity: 60-70% RH minimum
|Shelf life:||Shelf life is 5 years for Sterile and 2 years for non-sterile items|
|Etching/Marking:||Beauty Teck can provide the Etching/Marking as per client requirement within the MDD/MDR regulation.|
|Colour marking/Identification of single use instrument:||Colour marking or identification of single use instrument should be coloured as per client demand. If client required blue, red or any other colour BTI should provide the colour accordingly.
All colour scheme is compatible with ETO sterilization.
Biocompatibility testing done for Colour instruments after ETO Sterilization.
Coloured instruments are 100% biocompatible and comply ETO sterilization requirements.
|Authorized Representative in the European Union:||CMC MEDICAL DEVICES & DRUGS, S.L
C/ Horacio Lengo n18, C.P 29006
Malaga – Spain