ISO 18562 Testing Laboratory

In the medical device industry, ISO 18562 testing plays a crucial role in evaluating the safety of gases and particles released by medical devices, ensuring they are safe for patients. However, many companies encounter common mistakes during ISO 18562 testing, which can not only affect the accuracy of test results but also delay the product's market launch. This article will delve into how to avoid these common errors during the ISO 18562 testing process and provide practical advice for related companies.

1. Understand the Basic Requirements of ISO 18562 Testing Standards

   First and foremost, companies must fully understand the basic requirements of the ISO 18562 testing standards. The ISO 18562 standard is divided into four parts:

   - ISO 18562-1: Testing for gases and vapors released by medical devices

   - ISO 18562-2: Testing for particulate matter released by medical devices

   - ISO 18562-3: Testing for volatile organic compounds (VOCs) released by medical devices

   - ISO 18562-4: Evaluation of potentially hazardous substances released during the use of medical devices

   Understanding these basic requirements helps companies adequately prepare for ISO 18562 testing, preventing failures due to a lack of standard knowledge.

2. Choose an Appropriate Testing Laboratory

   Selecting the right testing institution is key to ensuring the reliability of ISO 18562 test results. Companies should choose a qualified and experienced testing laboratory that not only offers professional testing services but also provides technical support and advice. China JJR Laboratory, as a professional medical device technical service platform, offers ISO 18562 test reports that are recognized by major EU certification bodies (such as TUV, SGS, BSI), the U.S. FDA, Australia's TGA, and other international authoritative organizations, making it a trustworthy choice for companies.

   China JJR Laboratory also provides the latest 2024 ISO 18562 standard testing, including:

   - ISO 18562-2:2024

   - ISO 18562-3:2024

   - ISO 18562-4:2024

3. Develop a Detailed ISO 18562 Testing Plan

   Before conducting ISO 18562 testing, companies should develop a detailed testing plan, including defining the purpose, scope, methods, and standards of the tests. A well-detailed testing plan ensures smooth testing processes and helps in timely detection and correction of potential issues, thereby improving the accuracy and reliability of the test.

4. Pay Attention to Sample Preparation and Handling

   Sample preparation and handling are critical factors affecting the results of ISO 18562 testing. Companies should ensure that test samples are representative and consistent, adhering strictly to standard handling and storage requirements. Any deviation from standard sample handling practices can lead to inaccurate test results.

5. Control the Testing Environment

   Controlling the testing environment is crucial for the accuracy of ISO 18562 testing. Companies should ensure that the testing environment meets standard requirements, including temperature, humidity, and air circulation controls. Additionally, regular calibration and maintenance of testing equipment are essential measures to ensure accurate test results.

6. Regular Training and Knowledge Updates

   ISO 18562 standards and testing techniques are continually evolving, so companies should regularly train relevant personnel to ensure they are familiar with the latest standards and testing methods. Continuous knowledge updates and training help companies better handle potential issues during the ISO 18562 testing process, enhancing test accuracy and reliability.

7. Implement Strict Quality Control

   Strict quality control is the foundation for ensuring the reliability of ISO 18562 test results. Companies should establish a comprehensive quality management system to rigorously control and monitor each stage of the testing process, ensuring the accuracy and consistency of ISO 18562 test results.

8. Maintain Good Communication with the Testing Laboratory

   During ISO 18562 testing, companies should maintain good communication with the testing laboratory. Providing timely feedback on any issues encountered during the testing process and working with the laboratory to find solutions helps improve testing efficiency and accuracy. China JJR Laboratory not only provides professional testing services but also offers comprehensive technical support and consulting services, helping companies address various issues encountered during ISO 18562 testing.

9. Effectively Utilize Test Results

   The effective utilization of test results is another important aspect of ISO 18562 testing. Companies should conduct scientific analysis and evaluation based on the test results, identifying potential safety risks in the product and making timely improvements and optimizations to enhance product safety and reliability.

10. Continuous Improvement and Optimization

    ISO 18562 testing is not a one-time task; companies should continually improve and optimize based on test results. This includes improving product design, optimizing production processes, and enhancing product quality. Continuous improvement and optimization enable companies to consistently enhance product safety and market competitiveness.

Conclusion

ISO 18562 testing is an essential step in ensuring the safety of medical devices. Companies should avoid common mistakes during testing to ensure the accuracy and reliability of test results. Choosing a professional testing institution like China JJR Laboratory can provide comprehensive testing services and technical support, helping companies successfully complete ISO 18562 testing and gain recognition from international authoritative organizations.

China JJR Laboratory holds qualifications such as CNAS, CMA, A2LA, IAS, and can operate under the FDA GLP system. As an IEC 17025 accredited laboratory, it provides comprehensive testing services including medical device electrical safety testing, performance testing, and EMC (electromagnetic compatibility) testing. With its professional regulatory registration team and clinical trial team, it offers full support from R&D to clinical registration, aiding companies in passing ISO 18562 testing and enhancing their international competitiveness.

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