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    TDS - Tyvek Sterilization Reel (1073B)

    Uploaded by

    Abdullah Ather
    This technical data sheet provides information on Tyvek sterilization reels used for sterilizing temperature-sensitive medical devices. It describes the intended use, operation conditions, specifications, and packaging of the reels. The reels meet various ISO and EN standards for sterilization packaging and are made of Tyvek material suitable for low-temperature sterilization methods like ethylene oxide and formaldehyde.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    TDS - Tyvek Sterilization Reel (1073B)

    Uploaded by

    Abdullah Ather
    351 views2 pages
    This technical data sheet provides information on Tyvek sterilization reels used for sterilizing temperature-sensitive medical devices. It describes the intended use, operation conditions, specifications, and packaging of the reels. The reels meet various ISO and EN standards for sterilization packaging and are made of Tyvek material suitable for low-temperature sterilization methods like ethylene oxide and formaldehyde.

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    TDS- Tyvek Sterilization Reel (1073B)

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    This technical data sheet provides information on Tyvek sterilization reels used for sterilizing temperature-sensitive medical devices. It describes the intended use, operation conditions, specifications, and packaging of the reels. The reels meet various ISO and EN standards for sterilization packaging and are made of Tyvek material suitable for low-temperature sterilization methods like ethylene oxide and formaldehyde.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    351 views2 pages

    TDS - Tyvek Sterilization Reel (1073B)

    Uploaded by

    Abdullah Ather
    This technical data sheet provides information on Tyvek sterilization reels used for sterilizing temperature-sensitive medical devices. It describes the intended use, operation conditions, specifications, and packaging of the reels. The reels meet various ISO and EN standards for sterilization packaging and are made of Tyvek material suitable for low-temperature sterilization methods like ethylene oxide and formaldehyde.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    TECHNICAL DATA SHEET

    TYVEK STERILIZATION REEL (1073B)

    PRODUCT CODE : TY

    RELATED STANDARDS : PMSSteripack Tyvek Reels are manufactured according to EN 868-


    5 and ISO 11607 standards. The indicator used in the pouch
    production is classified as Class 1 Type Indicator according to the
    ISO 11140-1 standard. PMSSteripack Tyvek Reels meet the
    requirements of 93/42/EEC Medical Device Directive regulations
    S H E E T

    INTENDED USE : The Tyvek Reels are used to sterilze Temperature-sensitive


    medical devices. It is preferred at Low Temperature Sterilization
    regarding to its porous structure. Reels meet the Medical Industry's
    requirement for high quality, hygiene and safety levels.
    PMSSteripack Reels are used for the packing of the Medical
    Devices before sterilization and it maintains the sterility of the
    products after sterilization.
    OPERATION CONDITIONS : PMSSteripack Tyvek Reels are used for ethylene oxide,
    formaldehyde,gas plazma (VH2O2) sterlization.The sterilization
    conditons should be determined by the end user regarding to
    D A T A

    material to be sterilized.

    SPECIFICATIONS :

    PROPERTIES UNIT TYPICAL VALUE

    DELAMINATION N/2.54 cm 2,31


    BASIC WEIGHT g/m² 74,6
    T E C H N I C A L

    POROSITY sec 22
    OPACITY % 92,4

    THICKNESS µm 185
    TYVEK

    SPENCER PUNCTURE J/m 7355

    MULLEN BURST kPa 1227

    HYDROSTATIC HEAD cm H2O 150

    ELMENDORF TEAR, CD mN 3514

    ELMENDORF TEAR, MD mN 3425

    TENSILE STRENGTH,CD N/2.54 cm 208


    TENSILE STRENGTH,MD N/2.54 cm 193
    FREE FROM LEAD AND HEAVY METALS AND TOXIC MATERIALS

    PMS Tıbbi Cihazlar Teknolojisi San. ve Tic. A.Ş


    pms@pmsmedikal.com
    TYVEK STERILIZATION REEL ( 1073 )

    STANDARD OR
    PROPERTIES UNIT TYPICAL VALUE
    TEST METHOD
    LAM.FILM 65 ± 5
    LAMINATED FILM

    THICKNESS μm ISO 534 PE 50 ± 5


    PET 12 ± 2
    F/M 0,30-0,35
    COF ASTM F 1894
    F/F 0,35-0,40
    THERMAL SEAL ºC ASTM F 88 110 ± 5
    S H E E T

    MD 90 min.
    TEAR mN ASTM D 1922
    CD 90 min.
    GLOSS % ASTM D 2457 60 ± 5
    FREE FROM LEAD AND HEAVY METALS AND TOXIC MATERIALS

    PRODUCT SPESIFICATION :
    STANDARD OR
    PROPERTIES UNIT TYPICAL VALUE
    TEST METHOD
    cm < 25 ≥ 25
    ASTM F 88
    D A T A

    SEAL STRENGTH
    Edge Seal (N /15 mm) 3,0 ± 0,5 4,0 ± 0,75
    BUBBLE TEST ASTM F 2096-04 None
    REEL

    PINHOLE DETERMINATION EN 868-5 Annex C None


    DIMENSION CONTROL cm or mm ASTM F 2203-02 Desired dimensions
    LEAKAGE TEST ASTM F 1929-98 None
    Must not break the
    PEEL DIRECTION EN 868-5 Annex E
    particle
    Must return to the
    T E C H N I C A L

    INDICATOR CONTROL ISO 11140-1


    specified color
    INDICATOR

    STERILIZATION METHOD BEFORE STERILIZATION AFTER STERILIZATION

    VH2O2 Red Blue

    PACKAGING : PMSSteripack TYVEK reels are packaged as below.


    Pıeces in Inner
    Product Code Pieces in carton
    Packaging
    05 cm 6 12
    7,5 cm 4 8
    10 cm 3 6
    15 cm 2 4
    20 cm 2 4
    25 cm 1 2
    30 cm 1 2
    35 cm 1 2
    40 cm 1 2

    PMS Tıbbi Cihazlar Teknolojisi San. ve Tic. A.Ş


    pms@pmsmedikal.com
    Rev.02

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