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    60D, Declaration of Conformity

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    parazitu38
    This document is a Declaration of Conformity for a Contec Medical Systems Co., Ltd pulse oximeter (Model CMS60D) to the EU Medical Device Directive 93/42/EEC. It states that the device meets the requirements of the directive and applicable harmonized standards, including IEC 60601-1 for basic safety and essential performance of medical electrical equipment and ISO 80601-2-61 for pulse oximeters. Testing was performed by TÜV SÜD Product Service GmbH and the device has an EC Certificate number of G1 050972 0050 Rev.02. European representation is provided by Shanghai International Holding Corp. GmbH.

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    60D, Declaration of Conformity

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    parazitu38
    628 views2 pages
    This document is a Declaration of Conformity for a Contec Medical Systems Co., Ltd pulse oximeter (Model CMS60D) to the EU Medical Device Directive 93/42/EEC. It states that the device meets the requirements of the directive and applicable harmonized standards, including IEC 60601-1 for basic safety and essential performance of medical electrical equipment and ISO 80601-2-61 for pulse oximeters. Testing was performed by TÜV SÜD Product Service GmbH and the device has an EC Certificate number of G1 050972 0050 Rev.02. European representation is provided by Shanghai International Holding Corp. GmbH.

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    60D,Declaration of Conformity

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    This document is a Declaration of Conformity for a Contec Medical Systems Co., Ltd pulse oximeter (Model CMS60D) to the EU Medical Device Directive 93/42/EEC. It states that the device meets the requirements of the directive and applicable harmonized standards, including IEC 60601-1 for basic safety and essential performance of medical electrical equipment and ISO 80601-2-61 for pulse oximeters. Testing was performed by TÜV SÜD Product Service GmbH and the device has an EC Certificate number of G1 050972 0050 Rev.02. European representation is provided by Shanghai International Holding Corp. GmbH.

    Copyright:

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

    60D, Declaration of Conformity

    Uploaded by

    parazitu38
    This document is a Declaration of Conformity for a Contec Medical Systems Co., Ltd pulse oximeter (Model CMS60D) to the EU Medical Device Directive 93/42/EEC. It states that the device meets the requirements of the directive and applicable harmonized standards, including IEC 60601-1 for basic safety and essential performance of medical electrical equipment and ISO 80601-2-61 for pulse oximeters. Testing was performed by TÜV SÜD Product Service GmbH and the device has an EC Certificate number of G1 050972 0050 Rev.02. European representation is provided by Shanghai International Holding Corp. GmbH.

    Copyright:

    © All Rights Reserved
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    of 2

    DECLARATION OF CONFORMITY

    TO COUNCIL DIRECTIVE 93/42/EEC


    CONCERNING MEDICAL DEVICES
    CONTEC MEDICAL SYSTEMS CO., LTD
    No.112 Qinhuang West Street, Economic ＆Technical
    MANUFACTURER: Development Zone, Qinhuangdao, Hebei Province,
    PEOPLE’S REPUBLIC OF CHINA
    MEDICAL DEVICE: Pulse Oximeter, CMS60D
    CLASSIFICATION - ANNEX IX: Class Ⅱb, Rule 10

    CONFORMITY ASSESSMENT ROUTE: Annex Ⅱexcluding chapter 4


    WE, （CONTEC MEDICAL SYSTEMS CO., LTD） HEREWITH DECLARE THAT THE STATED
    MEDICAL DEVICES. MEET THE TRANSPOSITION INTO NATIONAL LAW, THE PROVISIONS OF
    COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES;
    INCLUDING, AT 21 MARCH 2010, THE AMENDMENTS BY COUNCIL DIRECTIVE 2007/47/EEC
    ALL SUPPORTING DOCUMENTATION IS RETAINED AT THE PREMISES OF THE MANUFACTURE.

    STANDARDS APPLIED: SEE ATTACHED LIST OF


    (HARMONISED - EN) STANDARDS FOR WHICH
    DOCUMENTED EVIDENCE OF COMPLIANCE CAN BE PROVIDED.

    TÜV SÜD PRODUCT SERVICE GMBH


    NOTIFIED BODY:
    RIDLERSTR 65, D-80339 M NCHEN, GERMANY

    IDENTIFICATION NUMBER:
    0123

    (EC) CERTIFICATE(S): G1 050972 0050 Rev.02

    Shanghai International Holding Corp. GmbH(Europe)


    EUROPEAN REPRESENTATIVE: Eiffestrasse 80, 20537 Hamburg Germany

    START OF CE-MARKING: 2009-07-23 (Date or Lot or serial number)

    PLACE, DATE OF DECLARATION: QINHUANGDAO, 2019-07-23

    President
    SIGNATURE:

    TF-CE081104.3-09 Ver: L
    Page 1 of 2
    DECLARATION OF CONFORMITY
    TO COUNCIL DIRECTIVE 93/42/EEC
    CONCERNING MEDICAL DEVICES
    Appendix: list of (harmonised - EN) standards
    No. Serial Number Title and Description
    Medical electrical equipment - Part 1: General requirements for
    1 IEC 60601-1:2012
    basic safety and essential performance
    Medical electrical equipment - Part 1-2: General requirements for
    2 IEC60601-1-2:2014 basic safety and essential performance - Collateral standard:
    Electromagnetic compatibility - Requirements and tests
    EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for
    3 basic safety and essential performance - Collateral standard:
    (IEC 60601-1-6:2010) Usability
    Medical electrical equipment - Part 1-8: General requirements for
    EN 60601-1-8:2007 basic safety essential performance- Collateral standard: General
    4
    (IEC 60601-1-8:2006) requirements, tests and guidance for alarm systems in medical
    electrical equipment and medicacl electrical systems
    Medical electrical equipment —Part 2-61:Particular requirements
    5 ISO 80601-2-61:2011 for basic safety and essential performance of pulse oximeter
    equipment
    Medical electrical equipment –Part 1-11: General requirements
    EN 60601-1-11:2010 for basic safety and essential performance –Collateral Standard:
    6
    (IEC 60601-1-11:2010) Requirements for medical electrical equipment and medical
    electrical systems used in the home healthcare environment
    EN 62366:2008 Medical devices - Application of usability engineering to medical
    7
    (IEC 62366:2007) devices
    EN 62304:2006 Medical device software - Software life-cycle processes
    8
    (IEC 62304:2006)

    TF-CE081104.3-09 Ver: L
    Page 2 of 2

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