Separator Gel Blood Collection Tubes: Efficient Plasma Separation

In the intricate world of clinical diagnostics, the quality of a blood sample is paramount. It serves as the foundation for accurate test results, guiding critical medical decisions. At the heart of this crucial pre-analytical phase lies the blood collection tube, and among its most advanced iterations is the separator gel blood collection tube. This innovative device fundamentally transforms sample processing, ensuring optimal specimen integrity for a wide range of laboratory analyses.

The Evolving Landscape of Blood Collection: Trends and Innovations

The medical diagnostics industry is in a perpetual state of advancement, driven by the need for faster, more accurate, and more reliable test results. Key trends influencing blood collection technology include:

• Automation and Efficiency: Laboratories are increasingly relying on automated systems for sample handling, processing, and analysis. Blood collection tubes must be compatible with these high-throughput platforms to maximize efficiency and minimize manual errors.
• Enhanced Sample Quality: The focus on pre-analytical variables has intensified. Factors like hemolysis, clotting, and analyte degradation can significantly impact diagnostic accuracy. Advanced tube designs, particularly those incorporating gel separators, are crucial in mitigating these issues.
• Specialized Diagnostics: The rise of molecular diagnostics, proteomics, and personalized medicine demands pristine samples. Tubes designed for specific tests, such as those optimized for cell-free DNA (cfDNA) or sensitive immunological assays, are becoming more prevalent.
• Safety and Compliance: Strict regulatory frameworks (e.g., FDA, ISO) and occupational safety standards drive the development of safer collection devices, including those that reduce needle-stick injuries and biological exposure.

The separator gel blood collection tube directly addresses many of these trends. By providing a stable barrier between cellular components and serum/plasma, it significantly improves sample quality, reduces turnaround time, and enhances the reliability of diagnostic outcomes.

Understanding the Gel Separator-Sodium Citrate Tube: Technology and Parameters

Our flagship product, the Gel Separator-Sodium Citrate Tube, is engineered for superior performance in coagulation studies. This tube combines the precision of sodium citrate as an anticoagulant with the efficiency of a high-quality gel separator. The typical Gel Separator-Sodium Citrate Tube is designed for the collection and transportation of venous blood specimens for coagulation tests. The tube contains a buffered tri-sodium citrate solution, which acts as an anticoagulant by binding to calcium ions in the blood, thereby preventing coagulation.

Technical Parameters and Specifications:

The efficacy of a separator gel blood collection tube hinges on its precise technical specifications. These parameters ensure consistency, reliability, and compatibility with various analytical platforms.

• Tube Material: Typically made from medical-grade polyethylene terephthalate (PET) or polypropylene (PP). PET offers excellent barrier properties, preventing gas exchange (e.g., CO2 loss) that can alter pH and affect analytes, while PP is known for its robustness and cost-effectiveness.
• Anticoagulant: Sodium Citrate (3.2% or 3.8%) is the standard for coagulation tests. The precise ratio of blood to anticoagulant (1:9 for 3.2% citrate) is critical for accurate results, as deviations can lead to false readings (e.g., prolonged PT/aPTT if too much citrate, or clotting if too little).
• Separator Gel: The gel is an inert, thixotropic polymer with a specific gravity typically between 1.04 and 1.06 g/mL, which is intermediate to that of blood cells (1.08-1.09 g/mL) and plasma/serum (1.025-1.035 g/mL). Upon centrifugation, the gel forms a stable barrier between the cellular components (red blood cells, white blood cells, platelets) at the bottom and the plasma/serum at the top. This barrier prevents metabolic exchange between cells and plasma, preserving analyte stability.
• Draw Volume Accuracy: Critical for maintaining the correct blood-to-additive ratio. Our tubes are manufactured with precision to ensure an exact draw volume, typically indicated on the tube label (e.g., 2.7 mL, 4.5 mL).
• Tube Dimensions: Standardized dimensions (e.g., 13x75mm, 13x100mm) ensure compatibility with automated processing equipment.
• Vacuum Stability: The vacuum within the tube is precisely calibrated to draw the correct blood volume and maintained through an airtight seal until use.
• Sterilization: Sterilized by gamma irradiation to ensure a sterile internal environment, meeting ISO 11137 standards for sterility assurance level (SAL).

Here's a comparison table illustrating key parameters of different types of separator gel blood collection tube and related variants:

Tube Type	Anticoagulant/Additive	Gel Type	Typical Application	Key Advantages	Gel Specific Gravity (Approx.)	Sample Type After Centrifugation
Separator Gel Blood Collection Tube (Sodium Citrate)	Sodium Citrate (3.2% or 3.8%)	Thixotropic Polymer Gel	Coagulation Studies (PT, aPTT, Fibrinogen, D-dimer)	Preserves coagulation factors, prevents re-mixing, suitable for prolonged storage of plasma. Critical for accurate INR.	1.04 - 1.06 g/mL	Citrated Plasma
Lithium Heparin Tube with Gel Separator	Lithium Heparin	Thixotropic Polymer Gel	Clinical Chemistry, Therapeutic Drug Monitoring, Immunoassays	Rapid plasma separation, prevents clotting, preserves analytes without affecting enzymes or electrolytes.	1.04 - 1.06 g/mL	Heparinized Plasma
Serum Separator Tube (SST)	Clot Activator (Silica particles)	Thixotropic Polymer Gel	Clinical Chemistry, Serology, Immunology, Blood Banking	Accelerates clotting, provides stable serum barrier for general chemistry tests. Most common for routine chemistry.	1.04 - 1.06 g/mL	Serum
EDTA Plasma Separator Tube	EDTA (K2 or K3)	Thixotropic Polymer Gel	Molecular Diagnostics (e.g., HIV viral load), PCR, plasma-based genetic testing	Prevents cellular contamination of plasma, preserves nucleic acids. Not for calcium or coagulation tests.	1.04 - 1.06 g/mL	EDTA Plasma
Blood Green Plasma Separator Tube	Lithium Heparin	Thixotropic Polymer Gel	General Chemistry, Emergency Panels	Often used for rapid processing and STAT tests due to its green cap coding. Provides heparinized plasma.	1.04 - 1.06 g/mL	Heparinized Plasma

Application Scenarios: Where Performance Matters Most

The Gel Separator-Sodium Citrate Tube finds indispensable application across various healthcare settings:

• Hospital Clinical Laboratories: For routine and specialized coagulation panels for inpatients and outpatients. The stability offered by the gel barrier is crucial for samples that may experience delays in testing.
• Reference Laboratories: Handling high volumes of samples from multiple collection sites. The consistent quality and ease of processing facilitated by the gel tube are critical for efficiency and accuracy.
• Research Institutions: Where precise and reproducible coagulation assays are needed for clinical trials and pathophysiological studies.
• Blood Banks: For specific donor screening tests requiring plasma, although full cross-matching typically uses whole blood.

In these scenarios, the ability of the separator gel blood collection tube to create a clean separation of plasma/serum from cellular components significantly reduces the risk of cellular contamination and metabolic exchange, ensuring the integrity of delicate analytes for up to 48 hours post-collection under recommended storage conditions (typically 2-8°C). This stability is a massive advantage for laboratories, especially those with high sample volumes or remote collection points.

The Meticulous Craftsmanship: Manufacturing Process of Gel Separator Blood Collection Tubes

The manufacturing of a high-quality separator gel blood collection tube is a complex process demanding precision, sterile environments, and adherence to stringent quality control standards. It ensures that each tube consistently performs its critical function.

Manufacturing Process Overview:

1. Tube Molding:
   • Material Selection: High-grade medical PET or PP resin is chosen for its clarity, chemical inertness, and gas barrier properties. PET is preferred for its superior vacuum retention.
   • Injection Molding/Extrusion Blow Molding: Plastic pellets are melted and injected into precision molds (injection molding for PET) or extruded and blown into tube shapes (extrusion blow molding for PP). This process ensures uniform wall thickness and precise dimensions crucial for vacuum integrity.

     Key Node: Dimensional accuracy (length, diameter, wall thickness) is constantly monitored using optical sensors and calipers to meet ISO 6710 standards.

2. Additive Dispensing (Gel and Anticoagulant):
   • Gel Dispensing: A precise amount of thixotropic separator gel is dispensed into the bottom of the tube. The gel is formulated to be inert and stable, preventing interference with diagnostic assays. Viscosity control is critical to ensure proper dispensing and future barrier formation.
   • Anticoagulant/Clot Activator Dispensing: For our Gel Separator-Sodium Citrate Tube, a specific volume of pre-calibrated liquid sodium citrate solution is accurately dispensed. For other tubes, dry anticoagulants (e.g., EDTA, Lithium Heparin) or clot activators (e.g., silica particles) are sprayed or dispensed as fine powders.
   • Drying (for liquid additives): If liquid additives are used (like sodium citrate), a controlled drying process (e.g., vacuum drying or warm air circulation) may follow to remove excess moisture without degrading the additive.

     Key Node: Automated volumetric pumps and spray nozzles ensure precise and consistent additive quantities, directly impacting the blood-to-additive ratio and thus test accuracy.

3. Capping and Vacuum Sealing:
   • Stopper Insertion: High-quality butyl rubber stoppers, designed for optimal sealing and needle puncture integrity, are automatically inserted. The stopper material is selected to prevent leaching of contaminants into the sample.
   • Vacuum Creation: A precisely controlled vacuum is drawn inside the tube immediately before or during stopper insertion. This vacuum dictates the exact blood draw volume, ensuring the critical blood-to-additive ratio.

     Key Node: Vacuum pressure is continuously monitored. Any deviation results in rejection of the tube. This is a critical factor for ensuring accurate fill volumes in clinical settings.

4. Labeling and Packaging:
   • Automated labeling machines apply clear, durable labels containing product information, expiration dates, and lot numbers.
   • Tubes are then packaged into racks and boxes, often in sterile, tamper-evident packaging.
5. Sterilization:
   • The packaged tubes are sterilized, most commonly through gamma irradiation. This method ensures a high Sterility Assurance Level (SAL) without compromising the integrity of the tube materials or additives.

     Key Node: Dosimetry checks are performed to ensure adequate radiation exposure for sterilization while preventing material degradation. Compliance with ISO 11137 is paramount.

6. Quality Control and Inspection:
   • Throughout the entire process, rigorous quality control checks are performed. This includes visual inspection for defects, dimensional checks, vacuum retention tests, gel integrity tests, and anticoagulant concentration verification.

     Key Node: Automated vision systems identify imperfections, while analytical tests confirm additive potency and tube performance according to ISO 6710 (single-use container111s for human blood collection) and CLSI (Clinical and Laboratory Standards Institute) guidelines.

This meticulous process ensures that each separator gel blood collection tube leaving our facility meets the highest global standards for medical devices, guaranteeing reliability and consistency for critical diagnostic applications. The typical service life of these tubes, referring to their shelf life, is generally 12 to 24 months from the date of manufacture, provided they are stored under recommended conditions (typically 4-25°C, away from direct sunlight).

Technical Advantages and Industry Impact

The separator gel blood collection tube offers significant advantages that resonate across the healthcare continuum, from phlebotomy to laboratory analysis and ultimately, patient care.

Enhanced Sample Integrity:

• Stable Barrier: The gel barrier, formed after centrifugation, physically separates plasma/serum from cellular components. This prevents further metabolic activity of cells that can alter analyte concentrations (e.g., glucose consumption, potassium release from red blood cells, changes in coagulation factor activity).
• Reduced Analyte Degradation: By isolating the plasma/serum, the gel minimizes contact with cellular enzymes and components that can degrade sensitive analytes, leading to more accurate and reliable test results. This is particularly crucial for tests like potassium, phosphorus, lactate dehydrogenase (LDH), and coagulation factors.
• Prevention of Re-mixing: Unlike traditional tubes where gentle handling is required to prevent re-mixing after centrifugation, the gel barrier offers a robust separation, allowing for easier transport and storage of samples without compromising integrity.

Operational Efficiency and Cost Savings:

• Elimination of Aliquoting: In many cases, the separated plasma/serum can be directly used for testing, eliminating the need for manual pipetting or aliquoting into secondary tubes. This reduces pre-analytical errors, saves time, and lowers consumable costs.
• Improved Laboratory Workflow: The consistent and clean separation provided by gel tubes streamlines laboratory operations, particularly in automated systems. Faster processing means quicker turnaround times for patient results.
• Reduced Specimen Rejection Rates: Enhanced sample quality due to the gel barrier leads to fewer rejected specimens caused by hemolysis or cellular contamination, saving resources and avoiding patient re-draws.

Safety and Compliance:

• Closed System: The sealed nature of the tube (post-collection) minimizes exposure to biohazardous materials for laboratory personnel, enhancing safety.
• Standardization: Adherence to international standards (e.g., ISO 6710, CLSI guidelines) ensures global compatibility and reliability, facilitating international diagnostic practices and research.

For example, in a high-volume hospital laboratory processing hundreds of coagulation panels daily, the use of Gel Separator-Sodium Citrate Tubes can reduce the average pre-analytical processing time per sample by 15-20% and lower re-draw rates related to sample quality by up to 10%, translating to significant operational savings and improved patient care outcomes.

Comparing Manufacturers: The Pursuit of Excellence

When selecting a supplier for separator gel blood collection tube and related products, laboratories and healthcare providers must look beyond mere pricing. Key differentiators among manufacturers include consistency, innovation, quality assurance, and customer support.

Key Factors for Comparison:

• Manufacturing Consistency: Top-tier manufacturers utilize highly automated, controlled environments (e.g., ISO Class 7 or 8 cleanrooms) to ensure batch-to-batch consistency in tube dimensions, vacuum levels, additive concentrations, and gel properties. Inconsistent gel viscosity, for instance, can lead to incomplete barrier formation.
• Gel Performance: The quality of the separator gel is paramount. Leading manufacturers invest heavily in R&D to develop gels that are truly inert (non-interfering with analytes), stable across a range of temperatures, and form a robust, impenetrable barrier after centrifugation, preventing 'gel-fall' or 'gel-stick' issues. Our Gel Separator-Sodium Citrate Tube utilizes a proprietary gel formulation optimized for coagulation studies.
• Anticoagulant Purity and Ratio: The purity of sodium citrate (or other anticoagulants) and the precision of its dispensing directly impact test results. Reputable manufacturers ensure pharmaceutical-grade purity and stringent control over the blood-to-additive ratio.
• Certifications and Compliance: Adherence to international standards such as ISO 13485 (Quality Management System for Medical Devices), FDA 510(k) clearance (for US market), and CE marking (for EU market) is non-negotiable. These certifications are a testament to a manufacturer's commitment to quality and safety.
• Research & Development and Innovation: Manufacturers who continuously invest in R&D are more likely to offer advanced solutions, such as tubes optimized for specific sensitive assays or improved safety features.
• Global Supply Chain and Support: A robust global supply chain ensures timely delivery, while comprehensive customer support (technical assistance, training) is vital for seamless integration into laboratory workflows.

We pride ourselves on exceeding these benchmarks. Our manufacturing facilities are ISO 13485 certified, and our products adhere to the strictest global regulatory requirements. We provide extensive technical support and collaborate with leading diagnostic companies to ensure compatibility and optimal performance of our Gel Separator-Sodium Citrate Tube within diverse laboratory ecosystems.

Customized Solutions and Tailored Approaches

Recognizing that healthcare systems and research protocols vary widely, we offer customized solutions for blood collection tubes. While our standard Gel Separator-Sodium Citrate Tube meets most needs, we can adapt to specific requirements for high-volume orders or specialized research.

Customization Options May Include:

• Specific Draw Volumes: Beyond standard volumes, we can manufacture tubes with precise fill volumes to meet unique research or clinical requirements.
• Alternative Labeling: Custom barcodes, hospital-specific labels, or private branding options are available to integrate seamlessly into existing inventory and tracking systems.
• Bulk Packaging: For large laboratories or distribution centers, tubes can be packaged in bulk or specific configurations to optimize handling and storage.
• Additives: While the primary focus is sodium citrate, discussions can be had regarding specific formulations or concentrations for specialized research applications, always ensuring compliance and stability.

Our team of technical experts works closely with clients to understand their specific challenges and design a solution that integrates flawlessly with their operations, ensuring maximal efficiency and data integrity.

Real-World Impact: Application Cases and Customer Success

The practical benefits of the separator gel blood collection tube are best illustrated through its application in various clinical and research settings.

Case Study 1: Large Academic Medical Center

Challenge: A major university hospital laboratory struggled with sample integrity issues for coagulation tests, particularly for samples arriving from off-site clinics, leading to frequent re-draws and delayed patient diagnoses. Hemolysis and cellular contamination were common, impacting PT and aPTT results.

Solution: The laboratory transitioned entirely to our Gel Separator-Sodium Citrate Tubes for all coagulation samples. The robust gel barrier ensured stable plasma separation even after extended transport times.

Outcome: Within six months, the lab reported a 30% reduction in pre-analytical sample rejections related to coagulation studies. Turnaround time for these critical tests improved by an average of 1.5 hours, directly impacting patient management and reducing hospital stays for certain conditions. Laboratory personnel reported increased confidence in results and reduced manual handling errors, significantly enhancing their overall experience.

Case Study 2: Regional Reference Laboratory Network

Challenge: A network of reference laboratories received samples from hundreds of collection sites, requiring high-throughput processing. Manual aliquoting of plasma for coagulation testing was a significant bottleneck, prone to human error, and increased biohazard exposure risks for technicians.

Solution: By adopting our Gel Separator-Sodium Citrate Tubes, the laboratory could directly load centrifuged tubes onto automated analyzers without the need for manual aliquoting. The secure gel barrier allowed for direct pouring or aspiration of plasma.

Outcome: This led to a 25% increase in daily sample throughput for coagulation tests and a 50% decrease in manual aliquoting steps, significantly improving operational efficiency and reducing potential exposure. The lab also noted a reduction in consumable costs associated with secondary aliquoting tubes.

Case Study 3: Pharmaceutical Clinical Trial

Challenge: A global pharmaceutical company conducting a multi-center clinical trial required highly consistent and stable coagulation samples for pharmacodynamic studies of a new anticoagulant drug. Variation in sample quality across sites could compromise trial data integrity.

Solution: The company mandated the exclusive use of our Gel Separator-Sodium Citrate Tubes across all trial sites. Our commitment to strict manufacturing consistency and quality control provided the necessary uniformity.

Outcome: The trial successfully collected high-quality, reproducible coagulation samples from all sites, ensuring the integrity of the study data. The stable plasma yielded by the gel tubes was critical for accurate drug level monitoring and assessment of coagulation parameters, directly contributing to the successful progression of the drug candidate through clinical development. This demonstrated our product's ability to perform reliably even under the rigorous demands of clinical research.

These cases exemplify how the strategic implementation of our Gel Separator-Sodium Citrate Tube transcends mere product supply; it represents a partnership in elevating diagnostic precision and operational excellence.

Frequently Asked Questions (FAQ)

To further enhance understanding and address common queries regarding the separator gel blood collection tube, we've compiled a list of frequently asked questions:

Q1: What is the primary material used for your Gel Separator-Sodium Citrate Tubes?

A1: Our tubes are primarily manufactured from medical-grade polyethylene terephthalate (PET), known for its excellent vacuum retention, clarity, and chemical inertness, ensuring sample integrity and compatibility with laboratory instruments. The stopper is typically made from high-quality butyl rubber.

Q2: How does the gel separator function in the tube?

A2: The gel is a thixotropic, inert polymer. After blood collection, the tube is centrifuged. During centrifugation, the gel, having a specific gravity intermediate to that of blood cells and plasma, moves to form a stable physical barrier between the heavier cellular components (which settle at the bottom) and the lighter plasma/serum (which remains at the top). This barrier prevents cellular metabolism from affecting analyte concentrations in the plasma/serum.

Q3: What specific industry standards do your tubes comply with?

A3: Our manufacturing processes and products adhere to rigorous international standards, including ISO 13485 (Quality Management System for Medical Devices), ISO 6710 (Single-use container111s for human venous blood specimen collection), and relevant CLSI (Clinical and Laboratory Standards Institute) guidelines. We also comply with FDA regulations for the US market and hold CE marking for the European Union.

Q4: What is the typical shelf life of the Gel Separator-Sodium Citrate Tube?

A4: When stored under recommended conditions (typically 4-25°C, away from direct sunlight), our Gel Separator-Sodium Citrate Tubes have a shelf life of 12 to 24 months from the date of manufacture. The exact expiry date is printed on each tube and packaging.

Q5: Can these tubes be used for molecular diagnostic tests?

A5: While the Gel Separator-Sodium Citrate Tube is primarily designed for coagulation studies, a specific variant, the EDTA plasma separator tube, is often preferred for molecular diagnostic tests requiring plasma (e.g., cell-free DNA, PCR) because EDTA is an excellent anticoagulant for preserving nucleic acid integrity. Please consult test protocols and instrument manufacturer recommendations.

Q6: What are the key advantages of using a gel separator tube over a plain tube?

A6: The main advantages include enhanced sample integrity by preventing metabolic exchange between cells and plasma/serum, eliminating the need for manual aliquoting (saving time and reducing errors), and allowing for prolonged storage of separated plasma/serum without degradation for retesting or batch analysis.

Q7: How do you ensure the precision of the blood-to-additive ratio in your tubes?

A7: We employ highly automated and calibrated dispensing systems for both the anticoagulant and the vacuum. Each tube undergoes rigorous quality checks, including volumetric accuracy assessments and vacuum pressure monitoring, to ensure the precise blood-to-additive ratio (e.g., 1:9 for sodium citrate tubes), which is critical for accurate test results.

Commitment to Trustworthiness and Customer Support

At our core, we believe that trust is built on transparency, reliability, and unwavering support. Our commitment to our customers extends far beyond the sale of a product.

Quality Assurance & Certifications:

Our manufacturing facilities operate under stringent quality management systems certified to ISO 13485, the international standard for medical device quality. This comprehensive system covers every stage, from raw material inspection to final product release. Products like our separator gel blood collection tube undergo exhaustive validation processes, including performance testing against established clinical guidelines (e.g., CLSI H21-A5 for coagulation tubes) and stability studies to ensure consistent quality and shelf life. Our adherence to regulatory bodies such as the FDA (for the U.S. market) and CE marking (for the European Union) further underscores our commitment to global safety and efficacy standards.

Delivery and Logistics:

We understand the critical nature of timely supply in healthcare. Our robust global supply chain and logistics network are designed to ensure efficient and reliable delivery of products worldwide. We work with trusted freight partners and maintain strategic inventory levels to minimize lead times. For standard orders, typical delivery cycles range from 2-4 weeks, depending on destination and order volume. Expedited shipping options are available upon request to meet urgent needs.

Warranty and Post-Sales Support:

All our products, including the Gel Separator-Sodium Citrate Tube, come with a comprehensive warranty against manufacturing defects. Our dedicated customer support team and technical service specialists are readily available to assist with product inquiries, troubleshooting, and any technical challenges that may arise. We provide extensive training resources, user manuals, and online support to ensure that our customers can maximize the utility and performance of our products. Our goal is to build long-term partnerships based on mutual trust and shared success in advancing diagnostic capabilities.

This holistic approach to product quality, operational excellence, and customer care solidifies our position as a reliable and authoritative partner in the medical diagnostics industry.

Industry Insights and Continued Learning

The field of pre-analytical blood sample management is continually evolving with new research and best practices. Staying informed is crucial for optimizing laboratory efficiency and diagnostic accuracy.

For further reading and in-depth understanding of pre-analytical variables and blood collection tube technology, we recommend exploring resources from authoritative organizations:

• Clinical and Laboratory Standards Institute (CLSI): Their guidelines, such as H3-A6 "Collection of Diagnostic Venous Blood Specimens" and H21-A5 "Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays," provide comprehensive recommendations for phlebotomy and sample handling to ensure quality.
• International Organization for Standardization (ISO): Specifically, ISO 6710:2017 "Single-use container111s for human venous blood specimen collection" details the requirements for these devices.
• American Association for Clinical Chemistry (AACC): A leading professional organization for clinical laboratory scientists, offering a wealth of peer-reviewed articles and educational content on laboratory medicine.

These resources, alongside insights from industry forums and academic journals, provide invaluable knowledge for professionals seeking to master the complexities of blood collection and ensure optimal patient outcomes.

References and Further Reading:
1. Lim, Y. K., et al. (2020). Preanalytical Variables Affecting Coagulation Testing: A Review. Journal of Clinical Laboratory Analysis, 34(4), e23145. https://onlinelibrary.wiley.com/doi/full/10.1002/jcla.23145
2. Clinical and Laboratory Standards Institute (CLSI). (2017). Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—Fifth Edition (CLSI document H21-A5). Wayne, PA: Clinical and Laboratory Standards Institute.
3. International Organization for Standardization (ISO). (2017). ISO 6710:2017 - Single-use container111s for human venous blood specimen collection. https://www.iso.org/standard/66663.html