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  • Certificate Sterility Statement Dekra Steril

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    marius patulea
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    The document is a statement from DEKRA Certification B.V. declaring that Parter Sterilization Services' quality management system for ethylene oxide sterilization services complies with the requirements of EN ISO 11135:2014. DEKRA Certification B.V. serves as the Notified Body for medical devices and has determined Parter Sterilization Services' quality management system meets applicable standards. The statement is dated February 25, 2021 and signed by J.A. van Vugt, Principal Certification Manager of DEKRA Certification.

    Original Description:

    STERILITATEA CERCEILOR STUDEX ESTE DOVEDITS

    Original Title

    202103_Certificate Sterility Statement Dekra Steril

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    The document is a statement from DEKRA Certification B.V. declaring that Parter Sterilization Services' quality management system for ethylene oxide sterilization services complies with the requirements of EN ISO 11135:2014. DEKRA Certification B.V. serves as the Notified Body for medical devices and has determined Parter Sterilization Services' quality management system meets applicable standards. The statement is dated February 25, 2021 and signed by J.A. van Vugt, Principal Certification Manager of DEKRA Certification.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    36 views1 page

    Certificate Sterility Statement Dekra Steril

    Uploaded by

    marius patulea
    The document is a statement from DEKRA Certification B.V. declaring that Parter Sterilization Services' quality management system for ethylene oxide sterilization services complies with the requirements of EN ISO 11135:2014. DEKRA Certification B.V. serves as the Notified Body for medical devices and has determined Parter Sterilization Services' quality management system meets applicable standards. The statement is dated February 25, 2021 and signed by J.A. van Vugt, Principal Certification Manager of DEKRA Certification.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    of 1

    REPNBSQD.

    2R0 / Confidential MED

    DEKRA Certification B.V.


    STATEMENT

    Date: February 25, 2021

    Manufacturer: Parter Sterilization Services


    A Division of Parter Medical Products
    17115 Kingsview Avenue
    Carson, CA 90746
    USA

    To Whom It May Concern,

    DEKRA Certification B.V. in its capacity of Notified Body for Medical Devices declares the
    following:

    The Quality Management System of the above mentioned manufacturer is in compliance with
    the provision of Ethylene Oxide sterilization services fulfilling applicable quality management
    system requirements within EN ISO 11135:2014

    DEKRA Certification B.V.

    ¦
    J.A. van Vugt
    Principal Certification Manager DEKRA Certification
    MEAN-P-MED215 rev1

    DEKRA Certification B.V., Meander 1051, 6825 MJ Arnhem, P.O. Box 5185, 6802 ED Arnhem, The Netherlands
    T +31 88 96 83009, F +31 88 96 83100, medical.nl@dekra.com, https.//www.dekra-product-safety.com
    Registered Arnhem 09085396

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