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Medical device sterilization packaging (MDSP) overview

The authority of the international standards MDSP update based on ISO 11607 (Note: is the 2006 version, EN868 series has been integrated into thelatest version of ISO11607 to GB19633-2005, the standard has not yet had time to update) analysis and understanding, still can be divided into the beginning of MDSP packaging and ancillary packaging two parts, only but the new standard provides a clear unified appellation, the initial package called'sterile barrier system (Sterile Barrier System, hereinafter referred to as SBS)',and 'will become affiliated packaging protective packaging (ProtectivePackaging)', and very carefully defined as' preformed sterile barrier system indidn't realize SBS function before packing products and materials (PerformedSterile Barrier System, hereinafter referred to as the PSBS, because the concept and the concept of SBS is the latest version of ISO 11607 isproposed, so the translation is not what uniform or authoritative name, thesecorresponding Chinese names are the author's own translation)'. The term SBS concept has been more obvious that it is what kind of packaging system:direct and medical equipment products contact and aseptic packaging systemmicrobial barrier barrier, is the core part of MDSP; and Protective Packaging is mainly about the storage process of product in its life cycle within the protective, convenience, can be some of the packaging design traceability and packaging costs, related to the carton, plastic bags, labels, bar code,printing, pallets and containers etc..

Although the cartons and other protective packaging strength is not enoughwill also affect the implementation of SBS functionality (Note: if Pouch SBSpackaging carton damage cause inside crush failure), and the label is focus on another MDSP pay great attention to the problem of traceability (Note: the country has to the food, drug and industry medical specialized documentspromulgated relevant label requirements; the new label of radio frequency identification technology -RFID America related industry like a raging fire inthe popular), but considering the limited space, this paper only discussesMDSP SBS (including PSBS).

SBS common industrial production in the main bag type (Pouch&Bag), forming - filling - sealing type (Form-Fill-Seal, hereinafter referred to as FFS) and hardplastic box cover material type (Tray+Lid) three. Disinfection with SBS in the hospital may have a reel bag (Reel Bag)

The bag type SBS according to the common classification and paper plastic bag (Paper-Poly Pouch) (Paper Bag), paper bags, plastic bags (Poly Bag),Tyvek-Pouch, Header Bag, Vent Bag (header bag) (window bags), behind the three at home because of no standard translation so to name but Englishbrackets given in the reference Chinese translation. Here the paper arebreathable medical packaging paper good (Medical-Grade Paper), plastic filmused in many species, mainly LDPE, HDPE, PET/PE, PA/PE, and Liner TearFilm (special line very innovative easy tear film, several big companies onlyinternational industry leading, used in the Vent Bag). Bag products used inMDSP is very wide, from the syringe, the most low-end catheter, disposable appliance to high-end implantable device can be used, the cost with the use ofmaterials and packaging purposes vary greatly.

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