Specification builder · Tier C
Balloon catheter inflation, leak, burst pressure, compliance and deflation-time tester with 37 deg C water bath (ISO 10555-4)
A hydraulic test instrument that fills a catheter balloon with water at 37 deg C and raises the pressure step by step to measure leakage, burst pressure, diameter growth (compliance) and deflation time. It is bought by drug and medical-device testing laboratories, balloon catheter manufacturers and university biomedical departments to check angioplasty and other balloon catheters against ISO 10555-4. It is a laboratory test instrument, not a medical device.
What this equipment will do
- Sample types: balloon dilatation catheters, such as angioplasty balloons (compliant, semi-compliant and non-compliant), tested immersed in a 37 deg C water bath (ISO 10555-4).
- Sample types: balloon-expandable stent delivery systems, tested with the stent mounted on the balloon (ISO 25539-2). (with the optional module)
- Sample types: compliant occlusion, retention and other large-volume, low-pressure balloons (0 to 7 bar, 150 mL or more). (with the optional module)
- Rated burst pressure: step-and-hold inflation until the balloon bursts, with the burst pressure recorded automatically (ISO 10555-4 Annex A).
- Fatigue and freedom from leakage: repeated inflation and deflation cycles and leak checks at a held pressure (ISO 10555-4 Annex B).
- Statistical check that the rated burst pressure printed on the label is met (99.9% of balloons with 95% confidence). (with the optional module)
- Compliance: balloon diameter measured at each pressure step to give the diameter-versus-pressure table and chart that can be compared with the label (ISO 10555-4 Annex D). (with the optional module)
- Deflation time: time for the inflated balloon to deflate (ISO 10555-4 Annex C), timed automatically or with the syringe and 0.1 s timer kit. (with the optional module)
- Liquid leakage under pressure of catheter hubs, connectors and shafts, and static burst pressure of catheter shafts (ISO 10555-1). (with the optional module)
- Testing at least 4 samples or lumens in sequence without re-plumbing. (with the optional module)
Not covered: Kink resistance and bending stiffness of catheter shafts need the catheter kink resistance and flexibility tester (EN 13868).; Peak tensile force of catheter shafts, joints and hub bonds (ISO 10555-1) needs a universal testing machine with catheter fixtures.; Full ISO 80369-20 testing of the catheter's luer hub (unscrewing, overriding, separation) needs the digital torque tester for medical connectors.; Sterility, bacterial endotoxins, particulate matter and biocompatibility need the microbiology, chemistry and biological testing laboratories.
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Standards this specification draws on
- ISO 10555-4:2023 Defines the balloon dilatation catheter tests the tester must perform: rated burst pressure (Annex A), fatigue / freedom from leakage (Annex B), deflation time (Annex C) and diameter-versus-pressure compliance (Annex D).
- ISO 10555-1:2023 General intravascular catheter requirements, including liquid leakage under pressure and static burst tests done on the same hydraulic tester.
- ISO 25539-2:2020 Vascular stent standard; relevant where balloon-expandable stent systems are tested (stent diameter versus pressure, burst and deflation with stent mounted).
- FDA guidance: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (2010) Lists the balloon bench tests (rated burst pressure, fatigue, compliance, inflation/deflation time) regulators expect, useful for checking imported product claims.
- IEC 61010-1 Basic electrical safety of laboratory equipment; the tester combines mains power, a heated water bath and pressurised water on one bench.
- IEC 61326-1:2020 EMC requirements for laboratory measurement equipment, so readings are not disturbed by nearby equipment.
- ISO/IEC 17025:2017 Competence of testing and calibration laboratories; requires traceable calibration of pressure, temperature and diameter.
- EURAMET Calibration Guide No. 17 Recognised guideline for calibrating electronic pressure gauges and transducers, used to judge the pressure calibration certificate.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; applies where electronic burst-test records support batch release.
- 21 CFR Part 820 US FDA Quality Management System Regulation (aligned with ISO 13485 from 2 Feb 2026); sets expectations for test equipment control at device manufacturers exporting to the US.
Common mistakes in tenders for this equipment
- Copying the top pressure range from one brochure (e.g. 5000 psi) when the lab tests balloons below 30 atm: it locks the tender to one maker and worsens accuracy where it matters.
- Buying a burst tester without a 37 deg C bath and balloon fixtures, so tests are done at room temperature and are not to ISO 10555-4.
- Leaving out diameter measurement, so the compliance chart on the balloon label can never be checked.
- Forgetting inflation-port adaptors, sealing plugs, guidewire mandrels and a de-airing kit for the catheter sizes actually received; the tester then sits idle or gives false leaks.
- Accepting a supplier calibration sheet without ISO/IEC 17025 accreditation, measurement uncertainty or multi-point pressure data, which an accreditation assessor or a challenged manufacturer will reject.
- Testing too few balloons and calling the result a rated burst pressure check: the claim is statistical, so the tender should include the statistics tool and training.
- Ignoring after-sales service: most balloon-tester makers have no engineer in Pakistan, so response time, spare seals, a spare transducer path and remote support must be written into the contract.
- Requiring DRAP medical device registration for the tester itself; it is a laboratory instrument and the demand only excludes genuine bidders.