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  • 1.  Medical Device Plastics Testing Standards

    Posted 11-Aug-2020 09:20
    Hi everyone,

    We have some Class I medical devices (EU) that are comprised of plastic material.

    Does anyone have any suggestions on plastics standards to test to (i.e. drop, pressure, etc.)?

    I've been reviewing the following standards, which would be great to cite in our GSPR, but not a requirement, correct?

    ISO 527-1:2019 Plastics - Determination of tensile properties
    ISO 458-1:1985 Determination of stiffness in torsion of flexible materials
    ISO 75-1:2020 Plastics - Determination of temperature deflection under load 
    etc.

    Thank you,

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    April Komplin
    United States
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  • 2.  RE: Medical Device Plastics Testing Standards

    Posted 12-Aug-2020 05:32
    April,

    There are a few standards out there for materials, depending on your device may apply some of these standards.  Keep in mind some of these standards are for the "blank" or raw materials and not for the finished device.  My suggestion is contacting a material specialist or working with your supplier of these materials to obtain the necessary testing (what I have done in the past getting a materials specialist).  The one comment I wanted to give you is: if you are citing standards in your GSPR, make sure there is testing information available supporting those requirements.  When you say great to cite in GSPR, but not a requirement - the requirement depends more on if you are using these standards supporting the safety and performance of your device.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Medical Device Plastics Testing Standards

    Posted 12-Aug-2020 12:22

    April - whereas your message does not provide a lot of information about your devices, we find the below reference very useful. With kindest regards, 


    VDI 2017 - Medical Grade Plastics (MGP) - July 2019 (bilingual German/English)

    [VDI = Verein Deutscher Ingenieure, the German Association of Engineers]



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    Ary Saaman
    Director, Regulatory Affairs
    Lausanne
    Switzerland
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    Original Message


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