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  • List of Harmonized Standards: File No.: CE-01-04-1 Version: A/0

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    Andrew Amz
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    This document is a technical file for a disposable medical mask. It includes information such as the manufacturer details, document revision history, applicable regulations and standards for medical devices in the EU that the mask complies with. The regulations listed include the Medical Device Regulation and clinical evaluation guidelines. The standards cover areas such as quality management, risk management, labeling and biological safety evaluation.

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    4.1_List_of_Harmonized_standards

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    This document is a technical file for a disposable medical mask. It includes information such as the manufacturer details, document revision history, applicable regulations and standards for medical devices in the EU that the mask complies with. The regulations listed include the Medical Device Regulation and clinical evaluation guidelines. The standards cover areas such as quality management, risk management, labeling and biological safety evaluation.

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    26 views3 pages

    List of Harmonized Standards: File No.: CE-01-04-1 Version: A/0

    Uploaded by

    Andrew Amz
    This document is a technical file for a disposable medical mask. It includes information such as the manufacturer details, document revision history, applicable regulations and standards for medical devices in the EU that the mask complies with. The regulations listed include the Medical Device Regulation and clinical evaluation guidelines. The standards cover areas such as quality management, risk management, labeling and biological safety evaluation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 3

    Technical File File No.

    CE-01-04-1
    Disposable Medical Mask Version A/0 Page 1of 3

    List of Harmonized
    standards
    According to Medical Device Regulation (EU) 2017/745

    File No.: CE-01-04-1

    Version: A/0

    Product: Disposable Medical Mask

    Model: Flat ear type

    Baoding Yinhong Yuhe medical device manufacturing Co., Ltd


    Nanlongshan village, Dawangdian Industrial Park, Xushui District, Baoding City, Hebei Province,
    China

    1
    Technical File File No. CE-01-04-1
    Disposable Medical Mask Version A/0 Page 2of 3

    Document Revision History


    REV ECN DESCRIPTION ORIGINATOR DATE
    A/0 - Initial 2020-04-09

    2
    Technical File File No. CE-01-04-1
    Disposable Medical Mask Version A/0 Page 3of 3

    1. Regulation
    No. Regulation

    European Parliament and of the Council of 5 April 2017 on


    medical devices, amending Directive 2001/83/EC, Regulation
    1 Regulation (EU) 2017/745
    (EC) No 178/2002 and Regulation (EC) No 1223/2009 and
    repealing Council Directives 90/385/EEC and 93/42/EEC
    Vigilance report form for field safety corrective action report
    2 MEDDEV 2 12-1 Rev:8
    Form Manufacturer’s Field Safety Corrective Action Report
    MEDDEV. 2.7.1 Rev.4 (2016) Clinical evaluation: A guide for manufacturers and notified
    3
    bodies
    4 MEDDEV2.12/2 rev2(2012) Guidelines on post market clinical follow up

    2. Standards
    No. Standards

    Medical devices – Quality management systems – Requirements


    1 EN ISO 13485: 2016
    for regulatory purposes

    Medical devices - Application of risk management to medical


    2 EN ISO 14971:2012
    devices

    3 EN 1041:2008+A1: 2013 Information supplied by the manufacturer of medical devices

    4 EN ISO 15223-1:2016 Symbols for use in the labeling of medical devices


    EN 62366-1:2015 Medical devices - Application of usability engineering to medical
    5
    devices
    Biological evaluation of medical devices -- Part 1: Evaluation and
    6 EN ISO 10993-1:2018
    testing within a risk management process
    Biological evaluation of medical devices - Part 5: Cytotoxicity
    7 EN ISO 10993-5-2009
    test - In vitro method
    Biological Evaluation of Medical Device-Part 10: stimulation and
    8 EN ISO 10993-10:2013
    allergic reaction

    9 EN 14683:2019+AC: 2019 Medical face masks-Requirements and test methods

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