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Medical Sterilization Packaging Standards And Requirements

 Operating room sterile demarcation line

Sterile = free from any living microorganisms (bacteria)
Sterile area
A place where surgery is performed
The place where items used in surgical procedures are placed
Where only sterile items are used
The area defined by a sterile item (an unsterilized cover)
 
The unique functions of medical packaging are:
Must be sterilizable
Bacterial microorganisms must be kept out
Maintain the sterile state of the product
The function of the above package is called: Sterile Barrier System - SBS
Medical packaging is an integral part of medical equipment
Medical device manufacturers must review and approve medical packaging materials.
 
Three-dimensional molding packaging (TFFS)
Hot forming/loading sealing automatic packaging, for example
The underlying membrane
The underlying membrane
PA/PE
PP/PE
PP/PA/PE
PA/PP
EVA/Surlyn/EVA
The top wood grain
Coated/uncoated paper
Coated/row non-coated Tyvek
Easy to peel film (co-extruded/composite).
Typical applications
Suitable for various types of medical instruments, such as syringes, compresses, surgical garments
 
Head bag/window bag
The use of breathable materials, easy to tear film and other materials, such as
Thin film
ULDPE
Metallocene pe
> breathable material
Coated on uncoated Tyvek
Coated reinforced paper
Typical applications
An operating suit, an operating bag
Items of large capacity
 
Three side seal disinfection bag
Loading or heat sealing automatic packaging
material
Coated paper
Tvevk
Paper PE
PET/PE
PET/ easy to peel film
Typical applications
It is more suitable for thin sheet instruments, such as dressings, medicine
With gloves and so on
 
Stereo preformed tray
Typical pallet material
PETG. APET HIPS. P
Typical cover material
Coating Tvek
Coated reinforced paper
Typical applications:
Large and heavy items such as
Implantable device
A pacemaker
Surgical kit

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