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Non-Sterile Single Use Surgical Scissors Blunt/Blunt CVD 150mm

Article: Number BTBC4155
General Description: Surgical Scissors Blunt/Blunt CVD
Size:  150mm

 

UDI – DI:
EMDN Code:
Classification – Rule: Class I (non-sterile) according to Rule 5 Annex IX MDR 2017/745

Justification: Single use-Invasive Through Natural Orifice, Transient use

Technical Specification

Application / Intended Use:
Raw materials: Stainless steel AISI 420
Surface: Matt Finish/Mirror
Standard Reference: ASTM F899-11 & ISO 7153-1
Environment: Harmless
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.

Instruction For Use