Chapter 1 - Product Description; Intended Use; Mode Of Operation - MELAG MELAstore-Box 100 Consignes D'utilisation

Chapter 1 - Product description

Chapter 1 - Product description

Intended use

The sterile container is validated for steam sterilization in a sterilizer in accordance with DIN EN 13060,
EN 285/ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993 and EN 554/ISO 13683. Medical devices
can be sterilized, stored and transported in the sterile container. The sterile container can also be used for
transporting medical devices back to the decontamination centre after use.

Mode of operation

The sterile container is conform to DIN 58953-9 and EN ISO 11607-1 requirements. Sterile containers with
perforated lids and closed container bottoms are validated for steam sterilization in a sterilizer in
accordance with EN 285 and DIN EN 13060 in fractionated vacuum process.
PLEASE NOTE
The suitability of any specific process must be validated at the site of application.
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