Catheter Balloon Inflation Diameter Tester
The Catheter Balloon Inflation Diameter Tester, also known as a Catheter Cuff Inflated Diameter Tester, is designed to measure the diameter of inflated cuffs on medical devices such as endotracheal tubes and tracheostomy tubes. It uses a controlled positive-pressure inflation method to expand the cuff, remove wrinkles, and minimize unnecessary stretching of the cuff wall before diameter measurement.
Accurate cuff diameter measurement helps medical device manufacturers evaluate dimensional consistency and verify product conformity with applicable specifications. The tester is intended for medical device research, production quality control, and laboratory inspection. Compatibility with other catheter balloons depends on the measurement fixture and applicable test method.
Application
(1) Endotracheal Tubes: Measurement of cuff diameter after inflation under specified pressure conditions.
(2) Tracheostomy Tubes: Evaluation of inflated cuff dimensions for adult and pediatric tube products, subject to fixture compatibility.
(3) Medical Device Manufacturing: Inspection of cuff dimensions during product development and quality control.
(4) Dimensional Consistency Testing: Comparison of inflated cuff dimensions across different specimens or production batches.
(5) Laboratory Verification: Assessment of cuff dimensions against applicable product specifications and testing requirements.
(6) Medical Balloon Products: Potential application to other inflatable medical components, provided the tester has suitable fixtures and a validated measurement method.
The required inflation pressure, stabilization time, measuring positions, and acceptance criteria should be determined according to the relevant product standard and manufacturer specifications.
Standards
(1) ISO 5361:2023, including Amendment 1:2026 — Anaesthetic and respiratory equipment — Tracheal tubes and connectors. This standard addresses tracheal tubes and includes a method for determining cuff diameter. The amendment published in July 2026 should be considered when specifying the applicable edition.
(2) YY/T 0337-2025 — Anaesthetic and respiratory equipment — Tracheal tubes and connectors. This Chinese medical industry standard took effect on October 1, 2026, replacing YY/T 0337.1-2002 and YY/T 0337.2-2002.
(3) ISO 5366:2016 — Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors. This standard covers adult and pediatric tracheostomy tubes and connectors.
(4) YY/T 0338-2023 — Tracheostomy tubes and connectors. This Chinese medical industry standard addresses adult and pediatric tracheostomy tubes and their connectors.
(5) GB/T 15812.1-2005 — Catheters other than intravascular catheters — Part 1: Test methods for common properties. Applicability should be confirmed according to the type of catheter being tested.
Parameters
The following are reference values from the supplied information, not confirmed specifications for a particular model.
| Parameter | Reference Value |
|---|---|
| Product Name | Catheter Balloon Inflation Diameter Tester |
| Testing Principle | Positive-pressure inflation |
| Cuff Inflation Pressure Range | 0–10 kPa (0–1.45 psi), subject to confirmation |
| Pressure Measurement Accuracy | 0.5% FS, subject to confirmation |
| Required Air Supply Pressure | Generally no more than 0.7 MPa, subject to confirmation |
| Air Supply Interface | Ø8 mm polyurethane tubing, as a typical example |
| Main Unit Dimensions | Approximately 300 × 410 × 150 mm |
| Measuring Device Dimensions | Approximately 215 × 215 × 240 mm |
| Weight | Approximately 25 kg |
| Diameter Measurement Range | Not specified |
| Diameter Measurement Accuracy | Not specified |
| Power Supply | Not specified |
Parameter note: The pressure range, accuracy, dimensions, and weight above were presented as typical examples in the supplied material. They must be verified against the actual model. Inflation pressure range and diameter measurement range are different specifications and should not be confused.
Features
(1) Positive-Pressure Inflation: Inflates the cuff under controlled conditions for dimensional evaluation.
(2) Cuff Diameter Measurement: Supports measurement of inflated cuff dimensions after the specified inflation and stabilization conditions.
(3) Controlled Inflation Conditions: Allows testing conditions to be configured according to the applicable method, subject to the actual equipment capabilities.
(4) Medical Device Quality Control: Supports comparison of cuff dimensions with product specifications and relevant acceptance criteria.
(5) Multiple Product Applications: Intended for endotracheal and tracheostomy tube cuffs, with other balloon types subject to fixture compatibility.
(6) Laboratory Testing: Suitable for dimensional inspection and product development in medical device manufacturing laboratories.
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