Bowl,stainless steel,180ml

General Description:
Bowl, round, 180 ml, smooth surface.

Intended use:
Basic container for nursing and surgical care.

Technical specifications:
Contaner, round.
Smooth surface.
Inner diameter: approx. 75-85 mm.
Height: approx. 36-48 mm.
Capacity: approx. 170 to 190ml.
Thickness: approx. 0.75-0.85mm.
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:
S9906621 - IEHK2006,kit,basic unit
S9906626 - IEHK2006,kit,suppl.2-equipment
S9910001 - Surg.inst.,basic surgery/SET
S9910002 - Surg.inst.,curettage/SET