Scalpel blade,ster,disp,no.11

General Description:
Scalpel blade, sterile, disposable, no. 11.

Intended use:
To cut and dissect tissue during surgical incisions.
To be used with: S0745000: Scalpel handle no. 3.

Technical Specifications:
Surgical blade for use with standard scalpel handle no. 3.
Hardness: 50 to 58 HRC.
Blade length: approx. 40 mm.
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel: 0.60-0.70% carbon; 12-14% chromium.
Singe use, disposable.
Sterile.
Sterilisation method: Gamma radiation.

Environmental conditions:
Transport and storage conditions: 10° to 40°C.
Do not expose to direct sunlight, rain or extreme humidity.
Check the integrity of each unit before use. Single use material, supplied in sterile packaging, may only be used if packaging is undamaged.

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

Classification:
EU Medical Devices Directive 93/42/ECC, Class IIa

Compliance to safety & product performance standards:
ISO 7153-1:2016: Surgical instruments - Materials - Part 1: Metals.
ISO 7740:1985: Instruments for surgery - Scalpels with detachable blades - Fitting dimensions.
ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 14971:2007 Medical devices - Application of risk management to medical devices

Nomenclature:
GMDN code: Manual scalpel blade, single-use (37445)
UMDNS code: Blades, (15558)

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

Secondary packaging: Protected unit.
One (1) box of 100 scalpel blades.

Related products:
If required, the following item should be ordered separately:
S0745000 - Scalpel handle, no.3.

Protection of users:
Wear gloves, always apply and remove the blade from the scalpel handle with forceps.
Put the used blades into a sealed container to prevent injuries.
Collect and destroy the sealed containers by incineration in a controlled environment.