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  • 1.  Testing standards applied

    Posted 26-Jan-2021 15:23
    Hello,
    I am looking for guidance on what regulatory testing standards (besides Bio compatibility- 10993) can be followed when applying a coating to a plastic component used in a device. Would an ASTM standard like D3359 Tape adhesion test apply?
    Thanks!

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    Chris Schweitzer
    Brookfield WI
    United States
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  • 2.  RE: Testing standards applied

    Posted 26-Jan-2021 18:33
    This will depend heavily on the intended use of the device; many device-specific standards exist, such as for implants, that could be germane.  In general, I would take a look at ASTM D3002-07 Standard Guide for Evaluation of Coatings Applied to Plastics.  Though that was withdrawn in 2016 for administrative reasons, I believe it still contains a wealth of good information, including cross-references to related ASTM standards such as D3359.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Ridgway, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: Testing standards applied

    Posted 27-Jan-2021 02:02
    Hello Chris,

    Applicable standards really depends on the medical device, composition, and intended use.  There are some general recognised standards like ISO 14971 or ISO 10993 which could be used for many different types of medical devices, then you have specific standards from ISO, IEC, or ASTM which could apply depending on the device type.  Typically these standards in the purpose or scope statement at the beginning provide information on where they could be used.  If still unsure, might be best to contacting a testing laboratory or an expert to complete a review of standards or testing applications which would apply.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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