Bericah 's Derma Steel Fine Disposable Scalpel - 10 pcs. is a sterile, single-use device designed for surgical procedures requiring precision and safety. Each scalpel is individually packaged in a peel - open pouch made of medical grade paper and polyethylene (PE), ensuring maximum hygiene and protection until use.

The handle is made of ABS , a durable and lightweight material, while the blade is made of medical grade stainless steel , compliant with ISO 7153 - 1:2016 . The minimum hardness of the material is 700 HV on the Vickers scale, ensuring a clean and precise cut. The chemical composition of the steel includes: Carbon (0.60–0.70%), Silicon (≤0.50%), Manganese (≤1%), Chromium (12–13.50%), Phosphorus (≤0.03%), Sulfur (≤0.025%) and Nickel (≤0.50%).

The blade size is clearly marked according to BS 2982 , for easy identification. Sterilization is by irradiation , in compliance with EN ISO - :2015 + A2:2019 .

Classification:

• Class IIa surgical invasive medical device, pursuant to Chapter III of Annex VIII of Regulation (EU) MDR 2017/745 .

Reference regulatory standards:

• UNI CEI EN ISO 14971:2022 – Risk management for medical devices
• EN ISO 11137 - 1:2015 + A2:2019 – Sterilization by radiation
• ISO 11607 - 1:2022 – Requirements for sterile packaging materials and systems
• ISO 7153 - 1:2016 – Materials for surgical instruments
• ISO 15223 - 1:2021 – Symbols and manufacturer's information
• BS 2982 – Specification for materials and packaging for surgical scalpels
• ISO 7740 / EN 27740 – Mounting dimensions for scalpels with detachable blades

The product is manufactured in ISO 9001:2015 and ISO 13485:2016 certified factories, guaranteeing high quality standards.

Pack of 10 pieces .