Comprehensive Guide to ISO 20387 Biobanking Laboratory Testing Service Provided by Eurolab
Standard-Related Information
ISO 20387 is a global standard for biobanking, which provides guidelines for the collection, processing, storage, and distribution of biological materials. The standard aims to ensure the quality, safety, and integrity of biological samples, while also promoting transparency and accountability throughout the entire biobanking process.
Relevant Standards and Regulations
International and National Standards
The International Organization for Standardization (ISO) develops and publishes international standards, which are adopted by countries worldwide. In addition to ISO 20387, several other standards govern biobanking, including ASTM E2985-18 and EN 15224:2017A1:2020.
Standard Development Organizations
Standard development organizations (SDOs), such as ISO and ASTM, play a crucial role in establishing and maintaining global standards. These organizations bring together experts from various industries to develop and update standards, ensuring they remain relevant and effective.
Evolution of Standards
Standards evolve over time to address emerging issues, new technologies, or changes in regulatory requirements. As a result, existing standards may be revised or replaced by newer versions, reflecting the latest scientific knowledge and best practices.
Standard Numbers and Scope
The following table provides an overview of relevant standard numbers and their scope:
Standard Number Title
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ISO 20387:2018 Biobanking General requirements for biobanks
ASTM E2985-18 Standard Guide for Biobanking
EN 15224:2017A1:2020 Quality Management Systems Requirements for organizations providing laboratory services
Standard Compliance Requirements
Compliance with these standards is essential for laboratories, institutions, and companies involved in biobanking. Failure to meet standard requirements can result in compromised sample quality, compromised data integrity, and even legal consequences.
Standard-Related Costs
Implementing standard-compliant procedures and systems may involve initial investments, such as training personnel, purchasing equipment, or modifying laboratory layouts. However, these costs are outweighed by the benefits of ensuring high-quality samples, maintaining regulatory compliance, and protecting patient safety.
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Standard Requirements and Needs
Why is ISO 20387 Biobanking Testing Required?
Biobanking involves the collection, processing, storage, and distribution of biological materials for research, clinical trials, and other purposes. Ensuring the quality, integrity, and consistency of these samples is crucial to maintaining data reliability, minimizing errors, and ensuring patient safety.
Business and Technical Reasons for Conducting ISO 20387 Biobanking Testing
Conducting ISO 20387 biobanking testing ensures:
Consequences of Not Performing ISO 20387 Biobanking Testing
Failure to conduct ISO 20387 biobanking testing can result in:
Industries and Sectors Requiring ISO 20387 Biobanking Testing
Biobanking is essential for various industries, including:
Risk Factors and Safety Implications
ISO 20387 biobanking testing identifies potential risks associated with biological samples, such as contamination, degradation, or damage. By addressing these risks through standard-compliant procedures, laboratories can minimize the likelihood of adverse events.
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Test Conditions and Methodology
Step-by-Step Explanation of Test Conduct
Conducting ISO 20387 biobanking testing involves several steps:
1. Sample collection and preparation
2. Testing and analysis
3. Data collection and recording
4. Quality control measures
5. Reporting and documentation
Testing Equipment and Instruments
Eurolab uses state-of-the-art equipment and instruments, such as:
Testing Environment Requirements
The testing environment must meet specific requirements, including:
Sample Preparation Procedures
Proper sample preparation is essential to ensure accurate testing results. This includes:
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Reporting and Documentation
Standard-Compliant Reporting
Eurolab provides standard-compliant reports, which include:
Documentation and Record-Keeping
Accurate documentation and record-keeping are critical for maintaining standard compliance. This includes maintaining:
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Conclusion
ISO 20387 biobanking testing is a crucial component of ensuring high-quality biological samples, reliable research results, and patient safety. By following standard-compliant procedures, laboratories can maintain regulatory compliance, minimize risks, and protect patients.
Eurolabs experienced team provides expert guidance on implementing ISO 20387 biobanking testing in your laboratory or institution. Contact us today to learn more about our services!
