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    37572_E

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    crisjuro97
    PFGT

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    37572_E

    Uploaded by

    crisjuro97
    15 views2 pages
    PFGT

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    © © All Rights Reserved

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    PFGT

    Copyright:

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

    37572_E

    Uploaded by

    crisjuro97
    PFGT

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    P/N 37572 Rev E

    Part Type 210


    ECN87361
    MATERIAL SPECIFICATION FORM

    Part Name: Tube Pebax 0.114” ID 0.003” Wall 6.25” L, OTS

    SECTION 1 – DISTRIBUTOR/SUPPLIER INFORMATION SECTION 2 – MANUFACTURER INFORMATION

    NAME P/N NAME P/N

    Any per ASL By Description Any per ASL By Description

    SECTION 3 – PART DESCRIPTION

    Is the component off-the-shelf (OTS)? ☒ Yes ☐ No

    Single lumen, straight Pebax tubing

    3.1 Material: Pebax, 7033-SA01 or Pebax, 7033-SA01 MED


    3.2 Colorant: N/A, Natural
    3.3 Length: 6.25 ± 0.13 inch N/A
    3.4 Inner Diameter: 0.114 ± 0.001 inch
    3.5 Wall Thickness: 0.0030 ± 0.0005 inch
    3.6 Must meet acceptance criteria per inspection techniques detailed in
    inspection section
    3.7 Certificate of conformance required for each lot
    3.8 Materials must be compliant to QCI P/N 108027.

    SECTION 4 – SPECIAL HANDLING OR STORAGE REQUIREMENTS

    4.1 Double Bag Parts and Ship in Straight Lengths. Package to prevent damage and prevent
    contamination during shipment, handling, and storage.
    4.2 Label inner bag with Supplier Name, Supplier Lot Number, ArthroCare Part Number, Arthrocare
    Revision, and Quantity.
    4.3 Package and Label multiple material lots separately.

    SECTION 5 – INSPECTION REQUIREMENTS

    FIRST ARTICLE INSPECTION (FAI) INCOMING INSPECTION

    • Verify Materials are compliant to QCI P/N 108027. • Certificate of Conformance required per each lot.
    Certificate of conformance to include the following
    information:
    o Supplier Name, Supplier Lot Number,
    Customer Part Number, Customer Revision,
    and Quantity.
    o Material per this specification.
    o Colorant per this specification
    o Dimensional requirements per this
    specification.
    • Verify material compliance to QCI P/N 108027.
    • Sampling Plan: ANSI/ASQC Z1.4 or Equivalent.
    Single Normal, Level 1 AQL = 1.0

    Form P/N 01171 Rev C | ECN82001 Page 1 of 2


    P/N 37572 Rev E
    Part Type 210
    ECN87361
    MATERIAL SPECIFICATION FORM
    o Dimensional: The following inspection
    technique is only applicable to Arthrocare
     Equipment that has an asterisk (*)
    must have:
    • Accuracy at least one-eighth
    (1/8th) of the specification
    tolerance range.
    • Resolution that can
    discriminate at least one-
    tenth (1/10th) of the
    specification tolerance
    range.
     Inner Diameter: Verify ∅0.113 inch
    minus gauge pin, Class ZZ or higher
    accuracy, fits into each end of tube
    to a minimum depth of 1 inch.
     Inner Diameter: Verify ∅0.115 inch
    plus gauge pin, Class ZZ or higher
    accuracy, cannot be inserted into
    either end of the tube to a depth
    greater than 1 inch.
     Wall Thickness: Use a micrometer*
    with ratchet stop (use 1 click) and a
    best fit pin gauge inserted into the
    inner diameter. Wall thickness =
    (micrometer measurement - best fit
    pin gauge)/2
     Length: Measure with appropriate
    equipment*
    o Visual: Inspection to be performed at 12-18”
    using room lighting with no magnification.
     No cuts, scratches, tears, or
    embedded material.

    Form P/N 01171 Rev C | ECN82001 Page 2 of 2

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