Indications 
Single-use scalpel for laparoscopic surgery

Matériaux utilisés 
Blade: SF100 stainless steel (carbon, chrome, silicon sulfur, manganese, phosphorus, nickel) Handle: ABS

Étiquetage 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

dispositif médical 

• MD class : IIA
• MD notified body : 2797
• EU directive/regulation : Règlement UE
• annexe : VIII

stérile 

• stérile : yes
• sterilization method : ethylene oxide

conformité 

• Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
• Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized medical devices;
• Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
• Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1
• Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1
• Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements