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    Philips M3015A

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    Paulina
    This document declares that various Philips medical monitoring devices and modules, including the IntelliVue MP2, MP5, MP20, and MX800, are in conformity with European medical device directives and standards for safety and electromagnetic compatibility. The devices have been tested and certified by the Notified Body VDE Testing & Certification Institute to meet the appropriate requirements. Hauke Schik, Director of Quality & Regulatory Affairs at Philips Medizin Systeme Boblingen GmbH, signs the declaration.

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    Philips M3015A

    Uploaded by

    Paulina
    55 views1 page
    This document declares that various Philips medical monitoring devices and modules, including the IntelliVue MP2, MP5, MP20, and MX800, are in conformity with European medical device directives and standards for safety and electromagnetic compatibility. The devices have been tested and certified by the Notified Body VDE Testing & Certification Institute to meet the appropriate requirements. Hauke Schik, Director of Quality & Regulatory Affairs at Philips Medizin Systeme Boblingen GmbH, signs the declaration.

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    This document declares that various Philips medical monitoring devices and modules, including the IntelliVue MP2, MP5, MP20, and MX800, are in conformity with European medical device directives and standards for safety and electromagnetic compatibility. The devices have been tested and certified by the Notified Body VDE Testing & Certification Institute to meet the appropriate requirements. Hauke Schik, Director of Quality & Regulatory Affairs at Philips Medizin Systeme Boblingen GmbH, signs the declaration.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    55 views1 page

    Philips M3015A

    Uploaded by

    Paulina
    This document declares that various Philips medical monitoring devices and modules, including the IntelliVue MP2, MP5, MP20, and MX800, are in conformity with European medical device directives and standards for safety and electromagnetic compatibility. The devices have been tested and certified by the Notified Body VDE Testing & Certification Institute to meet the appropriate requirements. Hauke Schik, Director of Quality & Regulatory Affairs at Philips Medizin Systeme Boblingen GmbH, signs the declaration.

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    of 1

    PHILIPS

    0366 DECLARATION OF CONFORMITY Philips Medizin Systeme


    Boblingen GmbH
    Hewlett-Packard Str.2
    71034 Boblingen
    Germany
    Declares under our sole responsibility that the product:
    Product Name: lntelliVue MP2, MP5 , MP5 T, MP5 SC, MP20, MP30, MP40, MP50,
    MP60, MP70, MP80, MP90, MX800
    and lntelliVue Multi-Measurement Module X2
    Product Model Number or Designator: M8102A, M8105 A, M8105 AT, M8105 AS, M8001A, M8002A,
    M8003A, M8004A, M8005 A, M8007A, M8008A, M8010A, 865240,
    and M3002A
    Including the components: M8023A, M8048A, M8025 A, M8026A, M8027A, M8045 A, M8016A,
    865297
    And measurement modules: M3001A, M3012A, M3014A, M3015A, M3015B, M3016A
    Plug-In modules: M10068, M1011A, M1012A, M1014A, M1019A, M10208, M1021A,
    M1027A, M1029A, M1032A, M1034A, M1116B, 865115
    Starting Revision: SW Revision: H.1
    Device Classification: lib, Rule 10
    Global Medical Device Nomenclature Code (GMDN): 36872 (M8102A, M8105A, M8105AT, M8105AS,
    M8001A, M8002A, M8003A, M8004A, M3002A); 33586 (M8005A, M8007A, M8008A, M8010A, M8016A,
    865240); 42528 (M8048A); 36553 (M3001A, M3002A, M3012A, M3014A, M3015A, M3016A); 36554
    (M1020B); 41221 (M8025A); 36861 (M8026A); 35508 (M8045A), 36550 (M1006B), 15200 (M1011A,
    M1021A), 36561 (M1012A), 15965 (M1014A), 36898 (M1019A), 37323 (M1027A), 36562 (M1029A), 36862
    (M1032A, M1034A, 865115), 36534 (865297)
    Product Options/Accessories: All, except patient connected accessories
    To which this Declaration relates is in conformity with the provisions of Council
    Directive: 93/42/EEC (Medical Devices Directive).
    The Manufacturer is certified by the Notified Body listed below to EN ISO 13485 and Annex I I-Section 3.2 of
    the Medical Device Directive (Certificate Number 0366/MDD/659100-11).
    Name/Address of Notified Body: VDE Testing & Certification Institute,
    Merianstr. 28, D-63069 Offenbach/Main, Germany

    Supplementary Information:
    The products above have been tested in typical configuration s of Philips M edizin S ysteme, Agilent Technologies and Hewlett-Packard
    patient monitor_s, telemetry systems and defibrillators as described in the manufacturers accompanying documents.
    The products listed a bove are fully compliant with standards listed below. Addition ally the pr oducts listed above have been designed,
    manufactured, tested, and foun d to be compatibl e with devices and accessories described b y the manufacturer in the devices
    accompanying documentation:

    EN 60601-1:1990 + A1:1993 + A 2:1995 Medical ele ctrical equipment - Part 1: General requirements
    for basic safety and essential performance
    EN 60601-1-2: 2001 + A1:2006 Medical ele ctrical equipment - Part 1-2: General requirements

    f_ � '
    for safety and essential performance - Collateral standard:
    Electromagnetic compatibility, requirements and tests

    Signature Date: 5-May-2011

    Printed Name: Hauke Schik Place of Issue: Boblingen


    Title: Director Quality & Regulatory Affairs

    (Form No. A-Q2920-00316-F4 Rev. D)


    Document Identification No.: A-M8005-97007 Revision No.: R.05.00 Page 1 of 1

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