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iso-16371-computed-radiography-testing
Non-Destructive Testing ASTM E1065 Time-of-Flight Diffraction (TOFD)ASTM E120 Non-Destructive Testing TerminologyASTM E1306 Leak TestingASTM E1316 Standard Terminology for NDTASTM E1316 Terminology for NDTASTM E1316 Terminology for NDTASTM E1317 Radiographic Testing Acceptance CriteriaASTM E1417 Liquid Penetrant Inspection ProceduresASTM E1417 Liquid Penetrant TestingASTM E1418 Magnetic Particle Testing ProceduresASTM E1444 Magnetic Particle InspectionASTM E1444 Magnetic Particle TestingASTM E165 Radiographic Testing of WeldsASTM E1742 Eddy Current TestingASTM E213 Ultrasonic Testing for Flaw DetectionASTM E213 Ultrasonic Testing of WeldsASTM E2293 Computed Tomography TestingASTM E2375 Ultrasonic Thickness MeasurementASTM E2597 Ultrasonic Shear Wave TestingASTM E2706 Digital RadiographyASTM E2706 Digital Radiography TestingASTM E2736 Phased Array Ultrasonic Testing of CompositesASTM E2737 Phased Array Ultrasonic TestingASTM E2738 Computed RadiographyASTM E2738 Computed Radiography TestingASTM E2865 Acoustic Emission MonitoringASTM E2865 Acoustic Emission Testing of StructuresASTM E2867 Acoustic Emission TestingASTM E309 Visual TestingASTM E709 Radiographic Film QualityASTM E709 Radiographic Film Quality IndicatorsASTM E797 Thermographic TestingISO 10675 Radiographic AcceptanceISO 10863 Shear Wave Ultrasonic TestingISO 10863 TOFD TechniqueISO 12713 Acoustic EmissionISO 12713 Acoustic Emission of StructuresISO 12713 Acoustic Emission TestingISO 15549 Eddy Current TestingISO 16371 Computed RadiographyISO 16371 Digital RadiographyISO 16371 Digital Radiography TestingISO 17635 Thickness MeasurementISO 17640 Ultrasonic Flaw DetectionISO 17640 Ultrasonic Testing of WeldsISO 17658 Industrial Computed TomographyISO 18436 Infrared ThermographyISO 19232 Radiographic Film QualityISO 19232 Radiographic Quality ControlISO 20485 Leak TestingISO 22232 Phased Array Ultrasonic TestingISO 22232 Ultrasonic Testing of CompositesISO 3057 Visual TestingISO 3452 Liquid Penetrant InspectionISO 3452 Liquid Penetrant TestingISO 5579 Radiographic TestingISO 9712 Certification and QualificationISO 9712 NDT TerminologyISO 9712 Personnel CertificationISO 9712 Qualification and Certification of NDT PersonnelISO 9934 Magnetic Particle InspectionISO 9934 Magnetic Particle TestingISO 9934 Magnetic Particle Testing Procedures

ISO 16371 Computed Radiography Testing: Eurolabs Laboratory Testing Service

Computed radiography (CR) is a digital imaging technique used in various industries, including medical, industrial, and scientific research. The ISO 16371 standard specifies the requirements for computed radiography testing laboratories to ensure that they can provide reliable and accurate results.

The ISO 16371 standard is part of the family of standards for computed radiography, which includes:

  • ISO 18562-1:2017 (Medical devices -- Non-invasive vascular access systems -- Part 1: Requirements)

  • ISO 11929-2:2016 (Radiation protection -- Spectra and dose assessment -- Part 2: Dose assessment)

  • ASTM E2584-10 (Standard Practice for Computed Radiography)

    • The legal and regulatory framework surrounding computed radiography testing is governed by various national and international standards, including:

  • EU Medical Devices Regulation (EU) 2017/745

  • US FDA Quality System Regulation (21 CFR Part 820)

  • International Electrotechnical Commission (IEC) 60601-2-41:2009

    • The ISO 16371 standard requires that testing laboratories meet specific requirements, including:

  • Equipment and instruments used for computed radiography testing must be calibrated and validated in accordance with the manufacturers instructions

  • Testing personnel must have appropriate training and experience in computed radiography testing

  • Sample preparation procedures must be followed to ensure accurate and reliable results

  • Test results must be documented and reported in a clear and concise manner

    • Eurolab is committed to providing high-quality laboratory testing services that meet or exceed the requirements of ISO 16371. Our experienced technicians and state-of-the-art equipment enable us to provide accurate and reliable test results.

    Computed radiography testing is essential for various industries, including medical, industrial, and scientific research. This type of testing helps ensure that products meet specific requirements and regulations.

    Business reasons for conducting computed radiography testing include:

  • Ensuring compliance with regulatory requirements

  • Meeting industry standards and specifications

  • Verifying product safety and reliability

    • Technical reasons for conducting computed radiography testing include:

  • Evaluating the performance of medical devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs)

  • Testing industrial equipment, such as radiation-hardened electronics

  • Validating scientific research data

    • Consequences of not performing computed radiography testing include:

  • Non-compliance with regulatory requirements

  • Product failure or malfunction due to inadequate testing

  • Inaccurate or unreliable test results

    • Industries and sectors that require this type of testing include:

  • Medical devices

  • Industrial equipment

  • Scientific research

    • Risk factors associated with computed radiography testing include:

  • Incorrect calibration or validation of testing equipment

  • Inadequate training or experience of testing personnel

  • Insufficient documentation or reporting of test results

    • Quality assurance and quality control aspects of computed radiography testing involve:

  • Regular maintenance and calibration of testing equipment

  • Verification of testing personnels qualifications and experience

  • Review and approval of test reports by a qualified expert

    • This type of testing contributes to product safety and reliability by ensuring that products meet specific requirements and regulations.

    Competitive advantages of having this testing performed include:

  • Improved market positioning through compliance with regulatory requirements

  • Enhanced customer confidence and trust in product quality

  • Reduced risk of product failure or malfunction due to inadequate testing

    • Cost-benefit analysis of performing computed radiography testing indicates that the benefits far outweigh the costs, including:

  • Reduced risk of non-compliance with regulatory requirements

  • Improved product safety and reliability

  • Enhanced market positioning and customer confidence

    • Computed radiography testing involves a series of steps to ensure accurate and reliable test results.

    Step-by-step explanation of the test procedure:

    1. Sample preparation: Samples must be prepared according to the manufacturers instructions.

    2. Testing equipment calibration: The testing equipment must be calibrated and validated in accordance with the manufacturers instructions.

    3. Testing personnel training: Testing personnel must have appropriate training and experience in computed radiography testing.

    4. Test execution: The test is executed according to the manufacturers instructions, using a certified radiation source.

    5. Data analysis: The test data is analyzed to determine the performance of the product.

    Testing equipment used includes:

  • Computed radiography units

  • Radiation sources (e.g., X-ray tubes)

  • Detectors (e.g., phosphor screens)

    • Testing environment requirements include:

  • Temperature control

  • Humidity control

  • Pressure control

    • Sample preparation procedures involve:

  • Cleaning and disinfecting the sample

  • Applying a radiation-hardened coating to the sample (if necessary)

    • Measurement and analysis methods used in computed radiography testing include:

  • Spectral analysis

  • Dose assessment

  • Image quality evaluation

    • Calibration and validation procedures for testing equipment involve:

  • Manufacturers instructions

  • Regular maintenance and calibration of testing equipment

  • Verification of testing personnels qualifications and experience

    • The test report must be documented in a clear and concise manner, including:

  • A summary of the test procedure

  • Test results, including spectral analysis and dose assessment data

  • Image quality evaluation results

  • Any observations or comments made during testing

    • Eurolab is committed to providing high-quality laboratory testing services that meet or exceed the requirements of ISO 16371. Our experienced technicians and state-of-the-art equipment enable us to provide accurate and reliable test results.

    Eurolab is accredited by a recognized national or international accreditation body, such as:

  • International Organization for Standardization (ISO)

  • American Association for Laboratory Accreditation (A2LA)

  • National Accreditation Board (NAB)

    • Our laboratory meets the requirements of ISO 17025:2017 (General requirements for the competence of testing and calibration laboratories).

    We are committed to maintaining our accreditation status through regular audits and assessments.

    Conclusion

    Computed radiography testing is essential for various industries, including medical, industrial, and scientific research. This type of testing helps ensure that products meet specific requirements and regulations. Eurolabs laboratory testing services meet or exceed the requirements of ISO 16371, providing high-quality results to our clients.

    We are committed to maintaining our accreditation status through regular audits and assessments.

    References

  • ISO 18562-1:2017 (Medical devices -- Non-invasive vascular access systems -- Part 1: Requirements)

  • ISO 11929-2:2016 (Radiation protection -- Spectra and dose assessment -- Part 2: Dose assessment)

  • ASTM E2584-10 (Standard Practice for Computed Radiography)

    • Contact Eurolab for more information on our laboratory testing services and how we can help you meet your regulatory requirements.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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