Testing Medical

Medical

  • Overview

    Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

    • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
    • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
    • Investigation, replacement or modification of the anatomy or of a physiological process,
    • Control of conception,

    and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

  • Medical electrical equipment (Active medical devices)

    Medical device which is operated by electrical energy is included in active medical device. For medical devices every region and/or countries have conformity assessment procedures and only when the device fulfills regulatory requirements it can be placed on the market.
    In case of medical device, test of product is included in the conformity assessment procedure and through the test manufacturer verify that products are fulfilling the requirements of international standards or national standards.
    For the test, we use standards which are published by region or country. ISO and IEC are international standard and EN is European Standard. Korea, Japan and China have their own national standards such as KS, JIS and GB

  • Standardization body for medical devices

    Classification Standardization body Standard
    International Standard IEC ISO IEC, ISO Standards
    Regional Standard CENELEC CEN EN Standards
    National Standard KATS KS
    National Standard MFDS Standard and specification of MFDS
    Association Standard Specific Association ex) NEMA


    Main standards which are applied to medical electrical equipment and correlation of these standards are as follows.



    Publication status of IEC 60601-1 standard is as follow

    Standard No Title of the standard
    IEC 601-1:1977 Ed1.0 Safety of medical electrical equipment - Part 1: General requirements
    IEC 60601-1:1988 Ed2.0 Medical electrical equipment - Part 1: General requirements for safety
    Amendment 1: 1991
    Amendment 2: 1995
    IEC 60601-1:2005 Ed3.0 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    Amendment 1: 2012
    IEC 60601-1:2012 Ed3.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1: 2005 + Amendment 1: 2012


    Required documents for the testing of medical electrical equipment and conformity assessment procedures are as following steps.

    1. Preparation of test sample and documents
    시험을 위한 서류
    Manual, Marking Accompaning document, Markings
    Design conformity
    • Applied Part (AP)
    • Accessible Parts
    • Insulation Diagram
    • Essential Performance
    • Expected Service Life
    • List of critical components
    • Support systems
    • Batteries
    Usability Usability
    Software validation Software Documents (PEMS)
    Risk management Risk Management files
    2. Perform test at the testing laboratory according to the harmonized standards
    3. Issue of test reports at the testing laboratory
    4. Submit documents for the conformity assessment to the certification body
    • EC DOC
    • Essential Requirements Checklist
    • Instruction for Use
    • Draft Labels & Packaging
    • Test Reports
    • Software Documents
    • Usability Document
    • Clinical Evaluation Report
    • Risk Management Report
    • Agreement of EU representative
    • Applied Standard List
    • Classification of medical device
    5. Certification body issue certificate when product fulfills the essential requirements

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