Tray,instr,ss,310x195x60mm,w/cover

General Description:
Tray,instr,ss,310x195x60mm,w/cover

Intended use:
Tray for medical and surgical instruments.

Technical specifications:
Tray, instruments.
Seamless tray with cover.
Rectangular with rounded corners, smooth surface.
Length: approx. 300-320.mm.
Width: approx. 185-205.mm.
Height: approx. 55-65.mm.
Thickness: approx. 0.75-0.85.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 30°C.
Humidity: 30% RH to 70% 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: Instrument tray, reusable (12143)
UMDNS code: Trays, Instrument (12143)

Packaging, labelling instructions:
Primary packaging: Unit of use.
One (1) instrument tray with cover protected by adhesive plastic film.

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