Specification builder · Tier B
Pressure and vacuum leak tester for single-use infusion and transfusion sets, catheters, cannulas and small-bore connectors (pressure hold, pressure decay and underwater bubble methods)
A pressure and vacuum leak tester applies a controlled air (or water) pressure or vacuum to a single-use device and checks whether it holds, by watching for bubbles under water or by measuring the pressure drop. Drug and device testing laboratories, DRAP labs and local makers of IV sets, cannulas and catheters use it to run the leakage tests of ISO 8536-4, ISO 1135-4, ISO 10555-1 and ISO 80369-20. The right choice depends mainly on the pressure range, whether a vacuum circuit is included and the fixtures supplied.
What this equipment will do
- Product types: single-use gravity infusion sets and transfusion sets (ISO 8536-4, ISO 1135-4).
- Product types: IV cannulas, intravascular catheters and luer (small-bore) connectors, which need test pressures of 300 to 330 kPa (ISO 10555-1, ISO 80369-20). (with the optional module)
- Air leakage under positive pressure: the set pressure (for example 50 kPa for infusion sets) is held for a set time while the device is watched for bubbles under water (ISO 8536-4, ISO 1135-4 leakage test).
- Underwater bubble test at the controlled water temperature of 40 +/- 1 deg C, in a heated immersion tank. (with the optional module)
- Sub-atmospheric (vacuum) leakage: infusion sets at 20 kPa below atmospheric (ISO 8536-4), catheter air leakage during aspiration (ISO 10555-1) and connector subatmospheric air leakage (ISO 80369-20). At high altitude the ISO 10555-1 aspiration test needs an external pressure chamber. (with the optional module)
- Pressure drop over the hold time, recorded with automatic pass/fail. (with the optional module)
- Leak rate of luer connectors by the pressure-decay method, calculated in Pa.m3/s (ISO 80369-20). (with the optional module)
- Liquid (water) leakage under pressure of catheters (ISO 10555-1) and falling-drop liquid leakage of connectors (ISO 80369-20). (with the optional module)
- Luer connectors tested against certified reference connectors (ISO 80369-7, ISO 80369-20). (with the optional module)
- Pressure-rated lines and tubing tested above routine pressures, up to 1,000 kPa. (with the optional module)
- Two or more samples tested at the same time on separate circuits. (with the optional module)
Not covered: Flow rate of infusion sets, cannulas and needles needs the needle and IV set flow-rate tester (ISO 8536-4, ISO 10555-5).; Luer connector stress cracking, pull-off, unscrewing and overriding need the luer connector test system (ISO 80369-20).; Balloon catheter inflation and burst pressure need the catheter balloon inflation and burst tester.; Holes in examination and surgical gloves need the glove water leak tester.
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Standards this specification draws on
- IEC 61010-1 Basic electrical safety standard for laboratory and test equipment.
- IEC 61326-1 EMC requirements for electrical laboratory equipment, so readings are not disturbed by and do not disturb other equipment.
- ISO 8536-4:2019 Infusion sets for single use (gravity feed); its leakage test needs positive air pressure with underwater observation and a sub-atmospheric test, at a controlled temperature.
- ISO 1135-4:2025 Transfusion sets for single use (gravity feed); includes a leakage requirement tested in a similar way to infusion sets.
- ISO 10555-1:2023 Intravascular catheters general requirements; includes liquid leakage under pressure, air leakage under pressure and air leakage during aspiration tests; since 2023 the aspiration test must be run below about 570 m altitude or with an external pressure of about 95 kPa on the sample.
- ISO 80369-20:2024 Common test methods for small-bore connectors, including leakage by pressure decay, falling-drop liquid leakage and subatmospheric-pressure air leakage.
- ISO 80369-7:2021 Defines luer connectors and the reference connectors against which luer leakage is tested.
- ISO/IEC 17025:2017 Accreditation standard for testing labs; requires calibrated equipment with SI traceability and controlled records.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; applies when electronic leak test results support batch release or regulatory decisions.
Common mistakes in tenders for this equipment
- Copying one maker's datasheet (for example an exact 0-600 kPa range, 0.1 Pa resolution or a named channel count) so only that maker can comply; the standards need about 330 kPa, about 88 kPa vacuum and 0.1 kPa resolution, so state minimums with 'not less than'.
- Buying the instrument without the adaptors, sealing plugs, reference luer connectors and heated bubble tank, so the tester cannot run any standard test for months.
- Forgetting the compressed-air supply: many testers need clean dry air at 0.4-0.8 MPa that is not included in the price.
- Accepting a general claim of compliance with ISO 8536-4, ISO 10555-1 or ISO 80369-20 without a clause-by-clause method statement and a demonstration of each test at OQ.
- Ignoring altitude: at Quetta and other high stations the sub-atmospheric and aspiration tests cannot be run as written without an external pressure chamber, so the method must be agreed before purchase.
- Buying a multi-channel production-line leak tester for a testing laboratory that needs flexible single-sample methods, liquid leakage and the bubble method.
- Accepting a factory calibration certificate instead of an ISO/IEC 17025 accredited one with uncertainty, which accreditation assessors will not accept.
- Asking for DRAP medical-device registration or ISO 13485 for the tester itself; it is a laboratory instrument, and the demand only removes competent bidders.