1. ntroduction

{Company Name} for advanced medical industries has been manufactured a range of single Use {Product Name}. This Products are manufactured according to the requirements of MOD 93/42/EEC as amended by 2007/47/EC.

As per manufacturing process of {Product Name}; {Product Name} undergo the packaging and cartooning process at production room, and packaging area.

With regards to the requirements of MOD  93/42/EEC as amended by 2007/47/EC Annex I   Essential requirements concerning the risk associated with the shipment; Storage; transportation of the product;  {Company Name} has decided to validate Shipment, Storage, and transportation processes in order to make sure that all risks have been reduced, controlled and eliminated accordingly.

Shipment validation for {Product Name} is executed according to the requirements of ASTM D 4169-01 Performance Testing of Shipping Containers and Systems".

2.  Objective

This document is issued in order to determine   the ability of {Product Name}to withstand the hazards that may occur during Shipment, Storage, and Transportation process such as loading, unloading, stacking, sorting, or palletizing, and to demonstrate compliance with MOD 93/42/EEC as amended  by 2007/47/EC Annex I "Essential requirements"

 

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