Digerui DKR-NT10-1 Positive Pressure Infusion Set Leak Tester

Overview

The Digerui DKR-NT10-1 Positive Pressure Infusion Set Leak Tester is an ISO 8536-4 and GB 8368-compliant benchtop instrument engineered for deterministic, repeatable detection of micro-leakage in medical infusion sets, IV administration sets, and related single-use fluid delivery components. It operates on the principle of controlled positive pressure application—typically 10–100 kPa—followed by real-time pressure decay monitoring over a user-defined dwell time (e.g., 30–120 seconds). A statistically significant pressure drop exceeding the preset threshold (e.g., ≤0.5 kPa/min) indicates failure due to seal imperfection, tubing porosity, or connector leakage. Designed specifically for quality control laboratories in medical device manufacturing, contract sterilization facilities, and regulatory testing centers, the DKR-NT10-1 delivers traceable, auditable pass/fail results aligned with ISO 13485 quality management system requirements.

Key Features

• Industrial-grade 7-inch capacitive color touchscreen interface with intuitive menu navigation—no keyboard or external PC required for basic operation
• Integrated high-stability pressure generation and sensing module featuring ±0.25% FS accuracy and <0.02 kPa/min zero drift under stabilized conditions
• Programmable test parameters: target pressure (range: 10–100 kPa), dwell time (1–300 s), acceptance threshold (ΔP/time), and number of cycles per sample
• Self-calibrating pressure transducer with automatic zero compensation before each test sequence
• Rugged aluminum alloy chassis with IP54-rated enclosure for resistance to laboratory spills and particulate ingress
• Onboard non-volatile memory storing ≥10,000 test records with timestamp, operator ID, batch number, and result status

Sample Compatibility & Compliance

The DKR-NT10-1 accommodates standard ISO 8536-4 test fixtures and supports direct connection to infusion set Luer lock or screw-type ports via interchangeable pneumatic adapters. Compatible with PVC, polyolefin, thermoplastic elastomer (TPE), and silicone-based tubing configurations up to 2.5 m in length. Test methodology conforms to clause 5.4.2 of ISO 8536-4:2022 (Infusion sets for single use), Annex A of GB 8368–2018 (Chinese national standard for infusion sets), and referenced procedures in USP <1207> Packaging Integrity Evaluation. Instrument validation documentation—including IQ/OQ protocols, as-found/as-left calibration reports, and uncertainty budgets—is provided upon request to support FDA 21 CFR Part 820, EU MDR Annex XIV, and GLP audit readiness.

Software & Data Management

The embedded firmware supports CSV export via USB-A port for offline analysis in Excel or statistical process control (SPC) platforms. Optional PC-based Digerui TestSuite v3.2 software enables remote configuration, automated report generation (PDF/Excel), SPC charting (X̄–R, p-charts), and full 21 CFR Part 11 compliance with electronic signatures, audit trails, and role-based access control (admin/operator/viewer). All data entries—including parameter changes, test starts/stops, and result overrides—are time-stamped and immutably logged. Firmware updates are delivered via signed binary packages with SHA-256 verification to ensure integrity.

Applications

• Final release testing of sterile IV sets prior to packaging and distribution
• In-process verification during assembly line stoppages or material changeovers
• Root cause analysis of field complaints related to fluid leakage or air ingress
• Supplier qualification testing for tubing extruders and connector molders
• Method transfer and equivalence studies between manufacturing sites
• Regulatory submission support (e.g., FDA 510(k), CE Technical File, NMPA registration)

FAQ

What pressure range does the DKR-NT10-1 support for leak testing?
It delivers precise positive pressure from 10 kPa to 100 kPa in 1 kPa increments, with factory calibration traceable to NIM (National Institute of Metrology, China).
Can the instrument be integrated into a MES or LIMS environment?
Yes—via optional RS-232 or Ethernet (TCP/IP) communication modules supporting Modbus RTU or custom ASCII command protocol for bidirectional data exchange.
Is the test method compliant with ASTM F2096 for bubble emission testing?
No—the DKR-NT10-1 performs pressure decay testing per ISO 8536-4; ASTM F2096 is a separate bubble emission method requiring submerged observation and is not supported by this platform.
How often does the system require recalibration?
Annual calibration is recommended; however, daily operational checks using the included reference pressure gauge and leak-free validation kit are mandatory per ISO 17025 Clause 7.7.
Does the unit meet electromagnetic compatibility (EMC) requirements for clinical environments?
Yes—it complies with IEC 61326-1:2013 Class B emissions and immunity specifications, validated per CISPR 11 and EN 61000-4 series standards.