“Ai sensi delle Nuove Linee guida del Ministero della Salute del 28/03/2013, relative alla pubblicità sanitaria concernente i dispositivi medici, si avvisa l’utente che le informazioni ivi contenute sono esclusivamente rivolte agli operatori professionali”
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Envelopes in paper / polypropylene to envelope the instruments to be sterilized in an autoclave.
They are equipped with sterility detector to be placed upward in the insertion in the autoclave.
Pack of 20pcs or 200pcs.
The envelopes for the self-sealing sterilization are used for steam sterilization (autoclaving) or ethylene oxide individual objects, certifying each other of the sterilization process according to the temperatures applied through the change of color of its indicators for ' ethylene oxide EO the sterilization temperature and '30 ° C - 54 ° C and the change of color color changes from blue to yellow / brown while for the steam sTEAM the sterilization temperature and' 121 ° C - 134 ° C and the Tone color changes from pink to brown.
The indicators change color of a minimum of 100 MM2 area are positioned so as to eventual and possible contamination with the product intended for sterilization.
The self-sealing envelope and 'subject to a single sterilization process and issue of disposable surgical medical device CE Class I in accordance with EUROPEAN DIRECTIVE 93/42 / EEC, and subsequent additional changes such as the European Directive 2007/47 / EEC, disposable why once used must be discarded as absolutely not reusable for a second sterilization cycle.
E 'absolutely forbidden to use if pouch and' damaged.
The self-sealing bags for packaging of instruments to be sterilized are composed of a plastic medical use material called laminated transparent film of green or blue color deriving from a special type of a medical crown polyester film (PET) and polypropylene medical shutterless (CPP) and to medical card (STERIKRAFT).
This card, certified BILLERUD STERIKRAFT S with compliance 'with the standard ISO 11607-1: 2009 and' high-tech, is white in color and is designed to achieve high anti-bacterial protection, excellent functionality 'for medical sterilization, a certified porosity 'and contributes to both the welds sealing is to peel'.
The printing is done with the color change indicators, one for steam and one for STEAM ethylene oxide EO.
All inks used are water based and non-toxic and certified in accordance with ISO 11140. The card is personalized with the printing process set on the welds and in any case outside the main body of the self-sealing envelope in all types and sizes manufactured and put .
The laminate film for its two components both PET and CPP are in compliance with ASTM D882 D1894 D2578 D1505 D2578 D1894 D1003 D882 D1204 D3985 F1249.
It is also produced in a quality system registration system to its suppliers.
The self-sealing envelopes are then certified and produced according to international standards ISO 11140, ISO 11607-1: 2009, ISO 11607-2: 2009, ASTM F1980: 2007, UNI EN ISO 868-2: 2009, UNI EN ISO 868-5: 2006, registration with the Ministry of Health with Italian manufacturer number 5843 and progressive system attributed to DM 112764 / R and classification CND S01010101.