1. Definition
What is a Laboratory Centrifuge?

A laboratory centrifuge is an essential piece of equipment used to separate components of a mixture based on their density, size, and viscosity by subjecting them to a high centrifugal force. At its core, it’s a motor-driven device that spins liquid samples at high speeds, causing heavier particles to migrate outward while lighter components remain closer to the center. This process, known as sedimentation, is fundamental to countless scientific, medical, and industrial applications, enabling researchers and technicians to isolate cells, proteins, nucleic acids, and other biological materials with precision and efficiency.
How it Works
The working principle is elegantly simple yet profoundly effective. When a tube containing a heterogeneous mixture is placed in a rotating rotor, centrifugal acceleration forces particles with higher density to sediment along the radial direction (toward the bottom of the tube). The separation occurs because the centrifugal force (measured in Relative Centrifugal Force or “g-force”) mimics an amplified gravitational field. This force is calculated as RCF = 1.118 × r × (RPM/1000)², where ‘r’ is the radius in millimeters. Different particles have different sedimentation rates, allowing for layered separation that can be carefully extracted after the run is complete.
Key Components
- Motor: The heart of the centrifuge, providing the rotational energy. Modern centrifuges use brushless induction motors for smoother operation and longer life.
- Rotor: The rotating unit that holds the sample tubes. Rotors come in various designs:
- Fixed-Angle Rotors: Tubes are held at a fixed angle (typically 45°), ideal for pelleting particles quickly.
- Swinging-Bucket Rotors: Buckets swing outward to a horizontal position during spin, creating a vertical sediment layer, perfect for density gradient separations.
- Vertical Rotors: Tubes are held vertically, offering the shortest pathlength for separation.
- Drive Shaft: Connects the motor to the rotor, transmitting torque.
- Chamber/Casing: A robust, often armored enclosure that contains the rotor and provides containment in case of tube failure.
- Control Panel & User Interface: Allows setting of parameters like speed (RPM), time, temperature, and acceleration/deceleration profiles.
- Braking System: Safely brings the rotor to a stop, often with adjustable deceleration rates to prevent disturbing gradients.
- Refrigeration System (in refrigerated models): Cools the chamber to protect heat-sensitive samples.
- Lid & Safety Lock: Interlocking mechanism prevents operation when the lid is open.
- Imbalance Sensor: Critical safety feature that detects uneven load and automatically stops operation.
2. Uses
Clinical Applications
- Blood Component Separation: Perhaps the most common application. Centrifuges separate whole blood into plasma, serum, buffy coat (white blood cells and platelets), and red blood cells for tests like CBC, chemistry panels, and blood banking.
- Urinalysis: Concentrating urinary sediments for microscopic examination.
- Microbiology: Concentrating pathogens from body fluids (CSF, synovial fluid) to improve diagnostic yield.
- Molecular Diagnostics: Isolating DNA, RNA, or proteins from clinical samples for PCR and genetic testing.
- Therapeutic Applications: Preparing platelet-rich plasma (PRP) for orthopedics or concentrated bone marrow aspirate.
- Cytopathology: Processing liquid-based cytology samples like Pap smears.
Who Uses It
- Medical Laboratory Technologists/Scientists
- Phlebotomists (for plasma/serum preparation)
- Research Scientists in biomedical fields
- Biotechnologists in industrial settings
- Blood Bank Technicians
- Veterinarians in diagnostic labs
Departments/Settings
- Hospital Clinical Laboratories (Core Lab, Chemistry, Hematology, Microbiology)
- Blood Banks and Transfusion Centers
- Research Laboratories (Academic, Pharmaceutical, Biotech)
- Public Health and Reference Laboratories
- Point-of-Care Settings (with smaller, bench-top models)
- Veterinary Diagnostic Clinics
- Forensic Laboratories
3. Technical Specs
Typical Specifications
- Speed Range: From 200 RPM (very low speed) to over 150,000 RPM (ultracentrifuges). Most clinical benchtop models operate between 1,000-15,000 RPM.
- Relative Centrifugal Force (RCF): Expressed in “× g” (gravity). Ranges from a few hundred × g for gentle cell separations to over 1,000,000 × g for viral pelleting.
- Capacity: Measured in number of tubes × volume. Common configurations: 24 × 1.5/2.0 mL, 6 × 50 mL, 4 × 100 mL, or 96-well plate rotors.
- Temperature Control: Refrigerated models typically range from -20°C to +40°C.
- Noise Level: Typically 50-65 dB, with quieter models being preferred for shared lab spaces.
- Dimensions: Benchtop models: ~30-50 cm width, 50-70 cm depth, 30-40 cm height. Floor models are larger.
- Weight: Benchtop: 20-80 kg; Floor-standing: 100-300 kg.
Variants & Sizes
- Microcentrifuges (Microfuges): Small, compact, for 0.2-2.0 mL tubes. Often non-refrigerated. Max RCF ~21,000-30,000 × g.
- Clinical Benchtop Centrifuges: The workhorse of hospital labs. Moderate speed (up to 6,000 RPM), often with sealed rotors for biohazard safety.
- High-Speed Refrigerated Centrifuges: For more demanding separations (up to 25,000 RPM, 100,000 × g). Used for subcellular organelles, protein precipitates.
- Ultracentrifuges: Analytical and preparative models reaching over 100,000 RPM and >1,000,000 × g. For viruses, lipoproteins, membrane fractions.
- Cell Washers: Specialized for washing red blood cells in transfusion medicine.
- Blood Bank Centrifuges: Often large-capacity with swing-out rotors and specific programs for blood component preparation.
- Floor-Standing Models: Higher capacity and force for large-volume processing.
Materials & Features
- Rotor Materials: Aluminum (lightweight, affordable), titanium (stronger, corrosion-resistant, for ultrahigh speeds), or carbon fiber (advanced, for ultracentrifuges).
- Chamber: Stainless steel interiors for easy cleaning and corrosion resistance.
- Advanced Features: Programmable memory, imbalance detection, rotor recognition (prevents overspeed), low-speed balancing, condensate-free operation, user access logs, quiet operation technology, and compatibility with various tube types (conical, PCR strips, plates).
- Technological Innovations: Brushless direct drive motors, non-contact infrared temperature control, vacuum-insulated chambers (for ultracentrifuges to reduce friction), touchscreen interfaces, connectivity (USB, Ethernet for data export), and automated rotor identification.
Notable Models
- Eppendorf 5430/5430 R: Popular microcentrifuge with versatile rotor options.
- Thermo Scientific Sorvall ST 8/ST 16: Reliable benchtop clinical centrifuge series.
- Beckman Coulter Allegra X-15R: High-performance refrigerated benchtop model.
- Hettich Rotina 380/380 R: Well-regarded for its robust build and value.
- Sigma 4-16KS: Versatile refrigerated centrifuge for research.
- Beckman Coulter Optima XE / Preparative Ultracentrifuges: Industry standard for high-speed and ultracentrifugation.
4. Benefits & Risks
Advantages
- Efficiency: Rapidly separates components that would take days by gravity alone.
- Precision & Reproducibility: Provides consistent, reliable results critical for diagnostics and research.
- Versatility: With appropriate rotors and adapters, can process a vast array of sample types and volumes.
- Sample Integrity: Refrigerated models maintain biological activity of sensitive samples.
- Automation: Reduces hands-on time and potential for human error compared to manual methods.
- Scalability: From microliter research samples to large-volume blood bag processing.
Limitations
- Shear Forces: High g-forces can damage delicate cells or molecules.
- Heat Generation: Friction can heat samples; refrigeration mitigates but doesn’t eliminate this for all models.
- Aerosol Generation: Risk of creating infectious aerosols if tubes break or seals fail.
- Limited by Sample Density: Cannot separate particles with very similar densities without density gradient media.
- Cost of Consumables: Specific certified tubes and rotors can be expensive.
Safety Concerns & Warnings
- Rotor Failure/Catastrophic Imbalance: The most severe risk. Can turn the centrifuge into a high-energy projectile. Caused by improper loading, using cracked rotors, or exceeding speed limits.
- Aerosol Exposure: Primary hazard when processing infectious samples. Always use sealed rotors (buckets with O-rings) or sealed tubes.
- Tube Breakage: Can spread contamination and damage the rotor.
- Noise-Induced Hearing Loss: Prolonged exposure to older, louder models.
- Mechanical Injury: From moving parts, especially when servicing.
PRECAUTIONS ARE NON-NEGOTIABLE:
- Always balance loads meticulously (mass, not volume) within 0.1 grams.
- Never exceed the maximum speed rating for a specific rotor-tube-adapter combination.
- Inspect rotors and tubes for stress cracks, corrosion, or deformation before each use.
- Always close and lock the lid before starting.
- Wait for the rotor to come to a complete stop before opening.
- Use appropriate personal protective equipment (PPE): lab coat, gloves, and eye protection. Face shields are recommended for high-speed runs.
- Decontaminate the chamber and rotors regularly, especially after spills or processing biohazards.
Contraindications
- Do NOT use with flammable, explosive, or corrosive chemicals unless using specifically designed sealed rotors for chemical resistance.
- Do NOT use standard rotors for pathogenic samples above a certain biosafety level (BSL-2 typically requires sealed rotors/buckets).
- Do NOT operate in explosive atmospheres unless the motor is intrinsically safe.
- Do NOT use tubes that are not rated for the intended RCF.
5. Regulation
Centrifuges are regulated as laboratory equipment, and their classification often depends on intended use and associated risks.
- FDA Class (USA): Typically Class I (general controls) if used as general lab equipment. However, blood bank centrifuges or centrifuges integrated into an in vitro diagnostic (IVD) system may be Class II (special controls). Manufacturers must register and list devices with the FDA.
- EU MDR Class (Europe): Under the Medical Device Regulation (EU 2017/745), laboratory centrifuges are usually Class I, as they are non-invasive and not directly used for diagnosis or monitoring. However, if specifically intended for blood component preparation, they could be up to Class IIb. Compliance requires a CE marking based on a conformity assessment.
- CDSCO Category (India): Regulated under the Medical Device Rules, 2017. Standalone laboratory centrifuges are typically categorized as Class A (low risk). Devices for blood component separation may be classified higher.
- PMDA Notes (Japan): The Pharmaceuticals and Medical Devices Agency regulates centrifuges as general laboratory equipment. They must conform to the Japanese Industrial Standards (JIS) and, if used in a medical context, relevant provisions of the Pharmaceutical and Medical Device Act.
- ISO/IEC Standards:
- ISO 13485: Quality Management Systems for medical device manufacturers.
- IEC 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use. This is the paramount safety standard.
- IEC 61010-2-020: Particular requirements for laboratory centrifuges.
- ISO 21386: Microbeam analysis — Analytical electron microscopy — Method for the determination of energy resolution for electron energy loss spectrum analysis (relevant for some advanced applications).
6. Maintenance
Cleaning & Sterilization
- Daily/Wipe Down: Exterior surfaces with a mild detergent or 70% ethanol.
- Weekly/Post-Spill: Decontaminate the chamber, rotor, and buckets. Never autoclave an entire rotor or chamber. Use appropriate disinfectants (e.g., diluted bleach, quaternary ammonium compounds, accelerated hydrogen peroxide). Rinse with water or ethanol to prevent corrosion.
- Buckets and Adapters: Some plastic components may be autoclavable (check the manual!). Metal parts are typically cleaned with disinfectants.
- Important: Always remove rotors before cleaning the chamber. Dry all components thoroughly to prevent corrosion and microbiological growth.
Reprocessing
For clinical use, “reprocessing” between patient samples typically involves using sealed rotors or buckets. The centrifuge itself isn’t reprocessed between each run unless a spill occurs. The key is containment at the sample level.
Calibration
- Speed/RPM Calibration: Should be performed annually or per manufacturer’s recommendation using a photoelectric or magnetic tachometer.
- Temperature Calibration: For refrigerated models, using a calibrated thermometer placed in the center of a dummy load. Performed annually.
- Timer Calibration: Checked against a certified stopwatch.
- Documentation: All calibration activities must be documented as part of the lab’s quality management system.
Storage
- Rotors: Store upside down or hung, NOT in the centrifuge chamber. This prevents tension on the rotor arms and allows moisture to evaporate. Keep in a dry place.
- Centrifuge Unit: Store in a clean, dry, level location with adequate ventilation. Unplug during long periods of non-use.
- Environment: Avoid excessive humidity, temperature extremes, and corrosive atmospheres.
7. Procurement Guide
How to Select the Device
- Define Primary Application: Clinical serum separation? High-speed cell biology? DNA extraction? This dictates speed, capacity, and refrigeration needs.
- Assess Sample Volume & Throughput: How many samples per run? What tube sizes (microtubes, 15 mL, 50 mL, blood bags)?
- Evaluate Space Constraints: Benchtop vs. floor-standing.
- Consider User Skill Level: Simple interfaces for high-turnover staff; programmable features for specialized labs.
- Noise Level: Critical in open-plan labs.
- Budget: Include initial cost, expected lifespan (often 7-10 years), cost of consumables (tubes, rotors), and service contracts.
Quality Factors
- Build Quality & Stability: Heavy, vibration-dampening construction.
- Rotor Options & Availability: A wide range of certified rotors from the manufacturer and third parties indicates a versatile platform.
- Safety Features: Imbalance detection, rotor recognition, lid lock, robust containment.
- Brand Reputation & Service Support: Availability of local technical support and spare parts.
- Energy Efficiency: Especially important for constantly running refrigerated models.
Certifications
- CE Marking (for Europe, indicating compliance with EU directives, now MDR).
- FDA Listed (for the USA).
- IEC 61010-1 Safety Certification (from a recognized body like UL, TÜV, CSA).
- ISO 13485 Certification of the manufacturer.
Compatibility
- Ensure rotor types are available for your specific tube racks, plates, or blood bag systems.
- Check if the device can integrate with laboratory information systems (LIS) if data logging is required.
- Verify electrical requirements (voltage, frequency) match your facility.
Typical Pricing Range
- Basic Microcentrifuge: $500 – $2,000
- Standard Clinical Benchtop Centrifuge: $3,000 – $8,000
- High-Speed Refrigerated Benchtop: $10,000 – $25,000
- Floor-Standing High-Capacity/High-Speed: $20,000 – $50,000
- Preparative Ultracentrifuge: $50,000 – $150,000+
Note: Prices are highly variable based on features, brand, and region.
8. Top 10 Manufacturers (Worldwide)
- Thermo Fisher Scientific (USA)
- Brands: Thermo Scientific, Sorvall, Heraeus.
- Profile: Global life science giant offering the broadest portfolio, from basic to ultracentrifuges.
- Notable Lines: Sorvall ST and Lynx series, Heraeus Fresco series, Megafuge, Ultrafuge.
- Eppendorf (Germany)
- Profile: A leader in laboratory consumables and instruments, renowned for premium quality, ergonomics, and quiet operation.
- Notable Lines: Centrifuge 5425/5430 series, 5804/5810 series (refrigerated).
- Beckman Coulter, Life Sciences Division (USA)
- Profile: A Danaher company, historically the gold standard in ultracentrifugation and high-performance centrifuges.
- Notable Lines: Allegra series (benchtop), Avanti series (floor-standing), Optima series (ultracentrifuges).
- Sartorius (Germany)
- Profile: Major player in bioprocessing and laboratory equipment, following strategic acquisitions.
- Notable Lines: Labacent series (formerly from Sigma-Aldrich).
- Andreas Hettich GmbH & Co. KG (Germany)
- Profile: A family-owned company specializing exclusively in centrifugation technology, known for robust and reliable devices.
- Notable Lines: Rotina, ROTOFIX, MIKRO series.
- Kubota Corporation (Japan)
- Profile: A significant manufacturer with a strong presence in clinical and industrial centrifuges.
- Notable Lines: Numerous models for clinical and research use.
- NuAire (USA)
- Profile: Known for laboratory safety equipment, including biosafety cabinets and reliable, value-oriented centrifuges.
- Notable Lines: C-series benchtop centrifuges.
- DRM-Descartes (Italy)
- Profile: Specialized manufacturer of microhematocrit centrifuges and small clinical centrifuges.
- Notable Lines: Microhematocrit centrifuges used worldwide.
- Plastronics (India)
- Profile: A leading Indian manufacturer, producing a wide range of centrifuges for domestic and export markets, known for cost-effectiveness.
- Notable Lines: Various clinical and research models.
- DLAB Scientific Co., Ltd. (China)
- Profile: A growing global manufacturer offering a comprehensive range of centrifuges at competitive prices, increasing in quality and market share.
- Notable Lines: D2012 plus, D3024 models.
9. Top 10 Exporting Countries (Latest Year – Based on HS Code 8421.19)
Data is illustrative, based on trends from international trade databases.
- Germany: The global leader in high-end centrifuge exports, home to Eppendorf, Hettich, and Sartorius. Known for precision engineering.
- United States: Major exporter of high-performance and ultracentrifuges (Thermo Fisher, Beckman Coulter).
- China: Largest volume exporter of cost-effective benchtop and clinical centrifuges, rapidly improving in technology.
- Japan: Exporter of high-quality, reliable devices (Kubota, Hitachi).
- Italy: Significant exporter, especially of specialized centrifuges (DRM-Descartes).
- United Kingdom: Exports niche and high-specification devices.
- Switzerland: Home to precision instrument manufacturers with centrifuge lines.
- India: Growing export market for affordable clinical and lab centrifuges.
- France: Exports from subsidiaries of global groups and specialized manufacturers.
- South Korea: Exporter of increasingly competitive laboratory equipment.
10. Market Trends
Current Global Trends
- Consolidation: Larger life science companies acquiring specialized centrifuge manufacturers.
- Demand Growth in Emerging Markets: Rapid expansion of healthcare and biotech infrastructure in Asia-Pacific and Latin America driving sales.
- Point-of-Care Testing (POCT): Increased demand for small, robust, quiet centrifuges for decentralized testing.
- Automation & Integration: Centrifuges are increasingly being integrated into automated liquid handling and sample preparation workstations.
New Technologies
- Non-Contact Drive Systems: Reducing mechanical wear and vibration.
- Micro-Centrifugation in Diagnostics: Centrifugal microfluidic “lab-on-a-disc” platforms for integrated sample-to-answer testing.
- Advanced Materials: Use of carbon fiber and composites for lighter, stronger rotors.
- Connectivity & IoT: Smart centrifuges with remote monitoring, predictive maintenance alerts, and usage tracking for compliance.
Demand Drivers
- Rising Diagnostic Test Volumes: Aging populations and increased disease screening.
- Biotechnology & Pharmaceutical R&D Growth: Drug discovery and biologics production require extensive centrifugation.
- Advancements in Genomics & Proteomics: Techniques like NGS and mass spectrometry rely on high-quality sample prep.
- Stringent Regulatory Standards: Driving replacement of older, non-compliant equipment.
Future Insights
- “Greener” Centrifuges: Emphasis on energy efficiency and recyclable materials.
- Enhanced User Safety & Ergonomics: Further refinement of containment, noise reduction, and intuitive interfaces.
- Modularity: Devices that can be easily upgraded or adapted for different workflows.
- AI Integration: Potential for adaptive run profiles based on sample type and desired outcome.
11. Training
Required Competency
Operators must be trained to:
- Understand basic centrifugation principles (RPM vs. RCF).
- Select the correct rotor, tube, and adapter for the application.
- Load and balance samples correctly.
- Program run parameters (speed, time, temperature, acceleration/deceleration).
- Perform routine cleaning, maintenance, and visual inspections.
- Recognize and respond to alarms, imbalances, and spills.
- Follow all biosafety protocols for infectious samples.
Common User Errors
- Improper Balancing: The most common and dangerous error. Loads must be symmetrically balanced by mass.
- Using the Wrong Tube: Using a tube not rated for the intended speed, leading to collapse or breakage.
- Overfilling Tubes: Leaving insufficient headspace can cause leakage and imbalance.
- Mismatching Rotors & Lids: Using a rotor without its specific lid or bucket seals.
- Ignoring Maintenance Schedules: Not cleaning spills or inspecting for wear and corrosion.
- Forcing the Lid Open: Attempting to open before the rotor has completely stopped.
Best-Practice Tips
- Create a Standard Operating Procedure (SOP) for each type of centrifugation protocol.
- Keep a rotor logbook to track usage hours for each rotor (critical for preventive maintenance).
- Balance using a calibrated scale, not by volume or eye.
- Use the slowest speed and shortest time necessary for adequate separation to preserve sample integrity and extend equipment life.
- Always use the lid or bucket covers, even during a short spin.
- Centrifuge infectious materials only in sealed rotors or safety cups and open them in a biosafety cabinet if possible.
12. FAQs
1. What’s the difference between RPM and RCF?
RPM (Revolutions Per Minute) is the rotational speed. RCF (Relative Centrifugal Force, or “g-force”) is the actual force applied to the sample, which depends on both RPM and the rotor’s radius. RCF is the scientifically relevant parameter. Always specify protocols in RCF when possible.
2. How often should I have my centrifuge calibrated?
Annually, at a minimum, or according to the manufacturer’s recommendation and your lab’s accreditation requirements (e.g., CAP, CLIA).
3. Can I autoclave my centrifuge rotor?
Almost never. The high heat and pressure can weaken the metal, leading to catastrophic failure. Most rotors are cleaned with liquid disinfectants. A few specific plastic buckets may be autoclavable—always consult the user manual.
4. My centrifuge is vibrating and making noise. What should I do?
STOP THE RUN IMMEDIATELY. An unbalanced load or rotor failure is the most likely cause. Check the balance of your tubes. If the problem persists with a properly balanced load, the rotor may be damaged or improperly seated. Do not use it until inspected by qualified personnel.
5. How do I clean a biological spill inside the centrifuge?
Wear appropriate PPE. Stop the run, keep the lid closed for 30-60 minutes to allow aerosols to settle. Carefully clean all surfaces with an appropriate disinfectant (e.g., 1:10 bleach solution, followed by water or ethanol to prevent corrosion). Soak and decontaminate the rotor separately.
6. What is the lifetime of a rotor?
Rotor lifespan is measured in total running hours or years (whichever comes first), as stated by the manufacturer (e.g., 5 years or 20,000 hours for aluminum rotors). Exceeding this is extremely dangerous due to metal fatigue. Keep a usage log.
7. Do I need a refrigerated centrifuge?
If you are separating heat-sensitive samples like proteins, live cells, or RNA, or if your runs are long (>30 minutes), then yes. For quick spins of stable compounds (like serum separation), a non-refrigerated model may suffice.
8. Can I use any brand of tube with my centrifuge?
You can, only if the tube is certified for the maximum RCF your rotor will generate. Using uncertified or low-quality tubes is a major breakage risk. Always use the correct adapter for the tube size.
9. Why won’t the lid of my centrifuge open?
Most modern centrifuges have an interlock that prevents opening while the rotor is spinning. Wait until it comes to a complete stop. If it still won’t open, there may be a vacuum seal (common in ultracentrifuges) or a mechanical fault. Consult the manual; do not force it.
10. How should I dispose of an old centrifuge rotor?
Contact the manufacturer or a certified hazardous materials disposal company. Do not simply throw it in the trash, as it is heavy, may contain hazardous materials, and could be misused.
13. Conclusion
The laboratory centrifuge remains an indispensable pillar of modern science and medicine. Its fundamental principle of applying centrifugal force enables the critical separation steps that underpin diagnostics, research, and biomanufacturing. Selecting the right centrifuge requires a careful assessment of application, throughput, and safety needs. However, the most advanced instrument is only as good as its operator. Rigorous training, meticulous adherence to loading and balancing protocols, and a relentless commitment to preventive maintenance and safety are the non-negotiable cornerstones of effective centrifugation. By understanding its principles, respecting its power, and following best practices, users can ensure this workhorse device delivers reliable, reproducible results safely for years to come, driving discovery and improving patient care.
14. References
- International Electrotechnical Commission (IEC). IEC 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use.
- International Electrotechnical Commission (IEC). IEC 61010-2-020: Particular requirements for laboratory centrifuges.
- Thermo Fisher Scientific. Centrifuge Safety and Maintenance Guide.
- Beckman Coulter Life Sciences. Rotors and Tubes: User Manual.
- World Health Organization (WHO). Laboratory Biosafety Manual, 4th Ed.
- Clinical and Laboratory Standards Institute (CLSI). Quality Management System: Equipment; Approved Guideline (QMS04-A).
- “Centrifugation in Biology and Medicine” – Academic review articles in journals like Analytical Biochemistry and Journal of Biomolecular Techniques.
- Market analysis reports from firms like Grand View Research, MarketsandMarkets™ on “Laboratory Centrifuge Market Size, Share & Trends Analysis.”
- Manufacturer websites and technical documentation from Thermo Fisher Scientific, Eppendorf, Beckman Coulter, and Hettich.
- U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory guidance documents for medical devices.