
B Medical Systems Blood Bank Refrigerator | FDA, AABB & DIN 13277 Standards
Product code: BM-BBR | Brand: B Medical
Blood Bank Refrigerators by B Medical Systems are devices designed to safely store blood and blood products within a temperature range of 2°C to 6°C. Specifically developed for blood transfusion services, blood processing centers, blood banks, and hospitals, our blood bank refrigerators meet the strictest management and regulatory requirements. In addition to complying with DIN 13277 and Önorm K 2030 standards, the equipment is classified as Class IIa medical devices (EU), Class II (FDA), and certified for AABB standard compliance. All models offer high performance in temperature control and energy consumption, and are integrated with remote monitoring solutions, supporting effective management and operation in clinical practice.
International Quality Standards
- Medical Device Classification: Certified MDR (EU) Class IIa and FDA (USA) Class II.
- Advanced Technical Standards: Fully compliant with DIN 13277 (Germany) and Önorm K 2030 (Austria) for pharmaceutical and blood storage.
- AABB Accreditation: Meets the standards of the Association for the Advancement of Blood & Biotherapies, affirming a leading position in the global transfusion medicine sector.
- Quality Management System: Manufactured under ISO 13485 standards, ensuring consistent quality for medical devices.
Superior Advantages in Blood Preservation
Temperature Control and Intelligent Monitoring
The equipment delivers high performance in thermal management, maintaining the integrity of blood components throughout the storage period:
- Temperature Uniformity: The forced-air cooling system ensures all internal compartments are maintained between 2°C and 6°C.
- 24/7 Monitoring: Integrated remote monitoring solutions to track operating conditions in clinical practice.
- Safety Alarms: Visual and audible alarm systems provide immediate notification of temperature excursions or "door ajar" events.
Optimized Design for Clinical Environments
- Energy Efficiency: Advanced refrigeration technology minimizes power consumption while maintaining optimal storage performance.
- Premium Materials: Constructed with stainless steel and antimicrobial coating, providing superior support for infection control within healthcare facilities.
- Security Features: Secure locking mechanisms strictly manage access, ensuring a closed-loop and safe blood storage process.
Một số lưu ý về thuật ngữ chuyên ngành đã sử dụng:
- MDR (EU) Class IIa: "Loại" trong quy định thiết bị y tế quốc tế thường dùng từ Class.
- Blood components: Dịch cho "chế phẩm máu" (bao gồm hồng cầu, tiểu cầu, huyết tương...) chính xác hơn là blood products.
- Temperature excursions: Thuật ngữ chuyên môn để chỉ sự "sai lệch/biến đổi nhiệt độ" ra ngoài ngưỡng cho phép.
- Infection control: Thuật ngữ chuẩn cho "kiểm soát vệ sinh/nhiễm khuẩn" trong bệnh viện.
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Product Description
Reliability
- Forced air cooling system for uniform and stable temperature distribution
- Fast temperature recovery even in case of frequent door openings
- Safety thermostat preventing temperature below freezing
- Extended autonomy in case of power failure
- Audio-visual alarm system with remote transmission via SMS or email
- °B Connected universal software for remote monitoring, reporting, and long-term archiving in combination with a Data Communication Unit

Efficiency
- Natural refrigerant of high cooling efficiency in conformity with US SNAP and EU F-Gas regulations
- Polypropylene cabinets injected with polyurethane foam providing strong thermal insulation
- Sealed gaskets and 4-layer glass window minimizing cold air loss
- Interior automatic LED lighting for lower energy consumption
- One-piece cabinet manufactured with the unique technique of rotational moulding

Convenience
- Smooth cleanable surfaces
- Low-noise appliance
- Low heat emission
- Modular interior equipment
- Organic glass window for better visibility of the refrigerated content
- Easy export of data on USB
- Electronics with easily accessible temperature display
- Gasket heater minimizing condensation
- Lifetime warranty corrosion-free cabinet







