GBPI GB-BF20010 Synthetic Blood Penetration Tester for Medical Face Masks
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | GB-BF20010 |
| Pressure Test Points | 3 kPa, 5 kPa, 7 kPa, 14 kPa, 20 kPa |
| Specimen Size | 75 mm × 75 mm |
| Pressurized Area | 28.27 cm² |
| Power Supply | AC 220 V, 50 Hz, 100 W |
| Air Pressure Source | Adjustable compressed air up to (20 ± 1) kPa |
| Pressure Display | Analog pressure gauge with manual regulation |
| Test Chamber | Stainless steel penetration test chamber with leak-resistant sealing |
| Support Grid | Square metal retainer mesh, ≥50% open area, deflection ≤5 mm at 20 kPa |
| Clamping Torque | 13.5 N·m |
| Timer | Digital display timer, accuracy ±1 s |
Overview
The GBPI GB-BF20010 Synthetic Blood Penetration Tester is a purpose-built instrument engineered for quantitative evaluation of the resistance of medical face mask materials to synthetic blood penetration under controlled hydrostatic pressure. It operates on the principle of static pressure challenge—applying calibrated, sustained pneumatic pressure to a standardized specimen while exposing it to synthetic blood (formulated per ASTM F1862/F1862M specifications), followed by visual assessment of breakthrough. This method directly simulates potential exposure scenarios encountered during clinical procedures involving high-velocity fluid splashes or prolonged contact with bodily fluids. Designed in strict alignment with GB 19083–2010 “Technical Requirements for Medical Protective Masks”, the system delivers repeatable, operator-independent test conditions essential for regulatory conformance and quality assurance in PPE manufacturing and third-party testing laboratories.
Key Features
- Pneumatic pressure delivery system capable of generating and maintaining precise test pressures of 3 kPa, 5 kPa, 7 kPa, 14 kPa, and 20 kPa—with real-time analog pressure gauge feedback and fine-tuned manual regulation.
- Self-contained compressed air source requiring no external air compressor; operates within (20 ± 1) kPa tolerance across full test range, eliminating dependency on facility-supplied air infrastructure.
- Robust stainless steel test chamber engineered for containment integrity—prevents lateral dispersion of synthetic blood and ensures consistent directional force application to the specimen surface.
- High-strength square metal support grid meeting mechanical stability criteria: ≥50% open area and maximum deflection ≤5 mm under 20 kPa load—ensuring uniform stress distribution and preventing localized deformation artifacts.
- High-torque (13.5 N·m) clamping mechanism guarantees rigid, non-slip fixation of 75 mm × 75 mm specimens over the defined pressurized area of 28.27 cm², minimizing edge leakage and improving inter-laboratory reproducibility.
- Digital timer with ±1 second resolution enables accurate recording of exposure duration—critical for pass/fail determination per GB 19083–2010 Section 4.10.2, where penetration must not occur within specified time thresholds at each pressure level.
Sample Compatibility & Compliance
The GB-BF20010 accommodates flat, non-stretchable mask material specimens cut to 75 mm × 75 mm dimensions—including multi-layer nonwovens (e.g., SMS, SMMS), melt-blown polypropylene, spunbond substrates, and laminated composites used in surgical and N95-type respirators. Its fixed pressurized area (28.27 cm²) conforms to the geometric requirements of GB 19083–2010 and is functionally compatible with international equivalents such as ISO 22609:2004 (Protective clothing — Protection against infectious agents — Test method for resistance of materials to penetration by blood-borne pathogens using synthetic blood). While primarily validated for Chinese national standards, its operational parameters align with the pressure tiers referenced in ASTM F1862 (for surgical masks) and EN 14126:2003 Annex A (for protective clothing), supporting cross-referenced validation protocols in GLP-compliant environments.
Software & Data Management
The GB-BF20010 is a hardware-dedicated, manually operated tester with no embedded microprocessor or digital data logging capability. All test parameters—including applied pressure, exposure duration, and visual pass/fail outcome—are recorded externally by the operator in accordance with documented test protocols. This architecture supports full traceability when integrated into laboratory quality management systems (QMS) compliant with ISO/IEC 17025:2017. Users are advised to pair the instrument with standardized paper-based or LIMS-integrated electronic test records that capture operator ID, calibration status of the pressure gauge, environmental conditions (temperature/humidity), and specimen identification—fulfilling audit readiness requirements for FDA 21 CFR Part 11 (when electronic records are employed) and GB/T 19001–2016 (ISO 9001) documentation controls.
Applications
- Pre-market validation of medical face mask barrier performance prior to registration under China NMPA Class II/III PPE regulations.
- In-process quality control for nonwoven fabric suppliers and mask OEMs verifying batch-to-batch consistency in fluid resistance.
- Third-party conformity assessment for certification bodies issuing CNAS-accredited test reports aligned with GB 19083–2010, ISO 22609, or regional harmonized standards.
- Research and development of novel filtration layers, hydrophobic coatings, or electrospun nanofiber membranes—where comparative penetration onset pressure serves as a key performance indicator.
- Training and proficiency testing in hospital biomedical engineering departments and national metrology institutes focused on PPE safety evaluation.
FAQ
Does the GB-BF20010 comply with ISO 22609 or ASTM F1862?
It is designed to meet the physical test setup requirements of GB 19083–2010, which shares fundamental methodology with ISO 22609 and ASTM F1862. While not pre-certified to those standards, its pressure accuracy, specimen geometry, and exposure protocol enable direct adaptation for use in accredited labs performing those tests.
Is calibration of the pressure gauge required before each test?
Yes—per GB 19083–2010 Clause 5.2, the pressure measurement system shall be verified daily or prior to first use each shift using a traceable reference standard; calibration certificate must be maintained per ISO/IEC 17025 requirements.
Can the instrument test curved or contoured mask forms?
No—it is strictly configured for flat, planar specimens. Three-dimensional mask forms require separate mounting fixtures and are outside the scope of this tester’s validation.
What synthetic blood formulation is recommended?
ASTM F1862-compliant synthetic blood (density ~1.04 g/mL, viscosity ~3.8 cP at 23 °C) is recommended to ensure equivalence with international test protocols and avoid false negatives due to low-viscosity surrogates.
Is maintenance of the stainless steel chamber specified in the manual?
Yes—post-test cleaning with neutral pH detergent and ethanol wipe-down is mandated to prevent residue buildup; quarterly inspection of O-ring integrity and grid flatness is advised to sustain measurement fidelity.
