ISO 5362 Anaesthetic Breathing Bags Leakage Equipment | Anaesthetic and Respiratory Equipment (ISO/TC 121)
The ISO 5362 Anaesthetic Breathing Bags Leakage Equipment (KP-1543A) delivers precise, repeatable leakage rate measurement for anaesthetic reservoir bags in full compliance with ISO 5362 Annex A under ISO/TC 121 Anaesthetic and respiratory equipment standards.
- Standard Compliance: Fully compliant with ISO 5362 Annex A for anaesthesia breathing bag leakage testing (ISO/TC 121)
- Pressure Control: 0โ100 kPa range with high-accuracy ยฑ0.25% FS sensors
- Flow Measurement: 0โ100 ml/min range with ยฑ2.5% FS precision for reliable leakage detection
- Control System: Advanced PLC with 7″ touchscreen interface offering real-time monitoring, automatic sequencing and USB data export
- Test Duration: Fully programmable 0โ9999 s with precise timing control
- Construction: Robust air inlet/outlet ports, high-resolution flow regulating valve and intuitive operator interfaces
- MOQ: 1 set
- Delivery Period: 20 working days
ISO 5362 Anaesthetic Breathing Bags Leakage Equipment
ISO 5362 Compliant Anesthesia Breathing Bags Leakage Tester with 0-100kpa Pressure Range and 0-100ml/min Flow Range
The ISO 5362 Anaesthetic Breathing Bags Leakage Equipment is a specialized medical testing device engineered to accurately determine the leakage rate of anaesthesia breathing bags in accordance with ISO 5362 Annex A. By applying controlled internal pressure and measuring the resulting flow leakage through high-precision sensors, it provides manufacturers and testing laboratories with a reliable, traceable solution to validate the integrity of single-use and reusable reservoir bags used in anaesthetic apparatus and ventilator breathing systems.
Technical Parameters
| Item | Specification | Remark / Notes |
|---|---|---|
| Applicable Standard | ISO 5362 Annex A | ISO/TC 121 Anaesthetic and respiratory equipment |
| Pressure Range | 0โ100 kPa | ยฑ0.25% FS accuracy, traceable calibration |
| Flow Range | 0โ100 ml/min | ยฑ2.5% FS accuracy for precise leakage detection |
| Test Pressure Setting | 3 ยฑ 0.3 kPa (standard) | Adjustable per ISO 5362 Annex A |
| Test Time | 0โ9999 s | Fully programmable |
| Control System | PLC + 7″ Touchscreen | Real-time monitoring, data logging & USB export |
| Power Supply | AC 220V ยฑ10%, 50/60 Hz | Standard laboratory supply |
Professional Construction & Technical Precision
Engineered for high-precision medical laboratory environments, the ISO 5362 Anaesthetic Breathing Bags Leakage Equipment features premium-grade pressure and flow sensors with exceptional long-term stability and repeatability. The advanced PLC control system, combined with a responsive 7-inch touchscreen interface, delivers intuitive parameter setting, real-time data visualization, and automatic test sequencing for consistent results across multiple test cycles.
Precision-machined air connections, a high-resolution flow regulating valve, and dedicated inlet/outlet ports minimize turbulence and ensure leak-free operation. The robust stainless-steel and anodized aluminum construction provides superior corrosion resistance under continuous use, while the compact footprint and USB data export port streamline integration into existing laboratory workflows with minimal maintenance requirements.
Testing Principle
The ISO 5362 Anaesthetic Breathing Bags Leakage Equipment assesses reservoir bag integrity by pressurizing the anaesthesia breathing bag to the specified internal pressure (typically 3 ยฑ 0.3 kPa) and precisely measuring the flow rate required to maintain that pressure. This flow value directly represents the leakage rate in accordance with ISO 5362 Annex A.
The method accurately quantifies any gas escape under tightly controlled conditions, confirming that leakage remains within the standard acceptance limits (โค10 ml/min for bags โค1 L or โค25 ml/min for larger sizes). This rigorous verification ensures the bags meet stringent safety and performance requirements for clinical use in anaesthetic apparatus and respiratory ventilation systems.
Common Error Mitigation
To achieve accurate, repeatable and fully compliant ISO 5362 test results, the following best practices are strongly recommended:
- Verify correct bag connection and airtight sealing before each test to prevent false readings.
- Confirm calibration status of pressure and flow sensors prior to every test series.
- Use only clean, dry compressed air to avoid contamination of high-precision sensors.
- Properly mount and center the breathing bag on the test fixture for uniform pressure distribution.
- Record all critical parameters โ pressure, flow rate, duration and observations โ for complete traceability and regulatory audit compliance.
Primary Use Cases & Business Value
The ISO 5362 Anaesthetic Breathing Bags Leakage Equipment enables manufacturers of anaesthesia breathing bags and respiratory devices to validate leakage performance at the earliest stages of product development. It ensures full compliance with ISO 5362 Annex A, proactively identifies sealing weaknesses, and significantly reduces the risk of field failures, costly recalls and warranty claims.
With reliable, traceable results and minimal operator intervention, the equipment accelerates regulatory certification, shortens time-to-market and strengthens overall quality assurance in the highly regulated medical sector.
Industrial Applications & Lab Scenarios
- Anaesthesia breathing bag manufacturers โ routine leakage validation per ISO 5362
- Medical device testing laboratories โ quality control and type approval testing
- Respiratory equipment producers โ final inspection before market release
- Third-party certification bodies โ formal compliance and audit support
- Quality Control and R&D Departments โ new product development and batch inspection
Strategic Procurement Advantages & Global Support
- High-precision ISO 5362 Annex A testing with traceable ยฑ0.25% FS pressure and ยฑ2.5% FS flow accuracy
- Intuitive PLC touchscreen interface with real-time monitoring and USB data export
- Compact, robust construction optimized for continuous laboratory use
- Manufactured under ISO 9001 quality management with responsive global technical support
- Factory calibration certificate supplied as standard
Compliance & Regulatory Assurance
The ISO 5362 Anaesthetic Breathing Bags Leakage Equipment is engineered and manufactured in strict accordance with ISO 5362:2024 Annex A under the ISO/TC 121 Anaesthetic and respiratory equipment framework. It provides laboratories and manufacturers with a standardized, repeatable platform for verifying reservoir bag performance and meeting stringent regulatory requirements.
- Complimentary Factory Calibration: Each unit is delivered with a comprehensive traceable calibration certificate as standard.
- Third-party ISO 17025 Accreditation: Available upon request to meet stringent laboratory and certification requirements.
- Performance Verification: Regular verification of pressure and flow accuracy is recommended to maintain long-term testing integrity.
Technical Inquiry & Expert Support
Contact our engineering team for custom configurations, integration with other medical testers or specific application requirements. We provide professional technical recommendations and detailed quotations within 24 hours.
The Core Value We Deliver
- Accurate and repeatable ISO 5362-compliant leakage testing for anaesthetic breathing bags
- High-precision pressure and flow measurement with advanced PLC control
- Efficient, user-friendly solution tailored to Anaesthetic and respiratory equipment validation
- Robust construction, full traceability and professional technical support
- Reliable long-term partnership commitment for laboratory success
ISO 5362 Anaesthetic Breathing Bags Leakage tester Detail Display
ISO 5362 Anaesthetic Breathing Bags Leakage Equipment FAQs
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