Bowl,round,stainless steel,4L

General Description:
Bowl, round, stainless steel, 4 litres.

Intended use:
Basic container for nursing and surgical care.

Technical Specifications:
Container, round.
Smooth surface.
Internal diameter: approx. 300 mm.
Height: approx. 100 mm.
Capacity: approx. 4 litres.
Thickness: approx. 0.8 mm.
Material: Austenitic stainless steel.
Austenitic stainless steel composition: 18 - 20% chromium, 8 - 10% nickel.
Reusable.

Environmental conditions:
Storage and transport conditions: 1°C to 40°C.
Humidity: 30% RH to 75% RH.

Note: Do not use a stainless steel container to hold a chlorine solution, as this may damage the stainless steel; use a plastic container.

Safety process:
This item must be cleaned, disinfected after each use. It can be sterilized in a steam sterilizer when necessary.

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

Regulation & conformity requirements:
EU Medical Devices Directive 93/42/ECC, Class I

Compliance to safety & product performance standards:
ISO 14971:2007 Medical devices - Application of risk management to medical devices.

Nomenclature:
GMDN code: General-purpose bowl, reusable (42893)
UMDNS code: Bowls (15561)

Packaging and labelling:
Primary packaging: Unit of use.
One (1) round bowl protected by adhesive plastic film

Secondary packaging: Protected unit
10 (ten) bowls in a pack.

Component of a kit:
S9902218 - Midwifery kit, 2 - equipment.