Scissors,umbilical cord,b/b,sterile

General Description:
Scissors, umbilical cord, blunt / blunt, sterile

Intended use:
For cutting the umbilical cord after child birth

Technical Specifications:
Umbilical cord scissors
With blunt end blades
Length: 10-14 cm
Material: Martensitic stainless steel (AISI 440 or AISI 410)
Sterile
Single use

Packaging and labelling:
Primary packaging: Unit of use.
One (1) scissors in an individual sterilised peel pack

Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems

Classification:
EU Medical Device Directive 93/42/ECC, Class IIa, Annex IX, Rule 6

Compliance to safety & product performance standards:
EN ISO 7153-1:2016 Surgical instruments. Materials. Metals
EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide.
ISO 11607-1:2006 Packaging for terminally sterilized medical devices.
ISO 11607-2:2006 Packaging for terminally sterilized medical devices.
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices