Specification builder · Tier B
Flow-rate tester for IV cannulas, catheters, hypodermic needles and infusion sets (constant head, gravimetric or volumetric, temperature-controlled)
A flow-rate tester pushes water through an IV cannula, catheter, needle or infusion set under a fixed head (about 1 m of water) at a controlled temperature and measures how much comes out in a timed period, by weighing or by volume. Drug and medical-device testing laboratories use it to check that devices deliver the flow stated on the label (ISO 10555-1/-5, ISO 8536-4, ISO 7864), and local manufacturers use it for batch release. Few makers sell a ready-made tester, so the test is often run on a bench assembled from a constant-level head tank, precision balance and thermostat. It is laboratory test equipment, not a medical device.
What this equipment will do
- Product types: IV cannulas (over-needle peripheral catheters) and other intravascular catheters (ISO 10555-1, ISO 10555-5).
- Product types: sterile hypodermic needles (ISO 7864).
- Product types: gravity-feed infusion sets (ISO 8536-4).
- Flow rate in mL/min under a constant head of about 1 m of water (or the equivalent pressure), by timed collection of the water that passes (ISO 10555-1 flow-rate annex, ISO 8536-4, ISO 7864 annex).
- Check that the measured flow of each cannula size agrees with the flow stated on the label (ISO 10555-5).
- Test water held at the temperature the standard states (about 22-23 deg C) by a thermostat, so summer room heat does not raise the flow. (with the optional module)
- Low flows of small cannulas (24G-26G) and fine needles measured accurately by weighing on a 0.01 g balance. (with the optional module)
- Very fine needles (27G and finer) weighed on a 0.001 g balance. (with the optional module)
- Automatic pass/fail of each device against stored limits for its type and size. (with the optional module)
- Flow and lumen patency of fine needles and small-bore devices at higher pressure, up to 400 kPa. (with the optional module)
- Power-injection flow and pressure test of catheters labelled for power injection (ISO 10555-1). (with the optional module)
Not covered: Leakage of infusion sets, cannulas, catheters and luer connectors needs the device pressure and vacuum leak tester (ISO 8536-4, ISO 10555-1, ISO 80369-20).; Needle sharpness and drag force need the needle penetration force tester (ISO 7864 Annex D).; Flow accuracy of infusion pumps and syringe pumps needs an infusion pump analyser, not this tester.
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Standards this specification draws on
- ISO 10555-1:2023 Intravascular catheters - general requirements; its flow-rate annex defines the constant-head flow test the tester must perform for catheters and cannulas.
- ISO 10555-5:2013 Over-needle peripheral (IV) cannulas; requires the measured flow rate of each size to agree with the labelled value.
- ISO 8536-4:2019 Gravity-feed infusion sets; specifies the flow-rate test of the set under a 1 m head with sodium chloride solution.
- ISO 7864:2016 Sterile hypodermic needles; includes an informative annex on determining flow rate through a needle.
- ISO 9626:2016 Stainless-steel needle tubing; sets the inside-diameter classes (normal, thin, extra-thin wall) that largely decide needle flow.
- IEC 61010-1 Electrical safety standard for laboratory equipment, including instruments used with water baths.
- IEC 61326-1 EMC requirements for electrical equipment for measurement, control and laboratory use.
- OIML R 111-1:2004 Defines accuracy classes of the reference weights used to check the balance.
- ISO/IEC 17025:2017 Accreditation standard for testing and calibration labs; requires calibrated, traceable equipment and controlled records.
- 21 CFR Part 11 US FDA rule on electronic records and signatures, applied when electronic flow results are used for batch release.
- 21 CFR Part 820 US FDA quality management system regulation (aligned with ISO 13485 from 2 February 2026), requiring calibrated, controlled test equipment for device acceptance testing.
Common mistakes in tenders for this equipment
- Copying one maker's brochure (an exact flow range, a specific number of stored records or a named display size) so that only that maker can comply; state minimum needs with 'not less than' instead.
- Insisting on either a real water column or an air-pressure drive when the other can be shown equivalent at OQ, which removes half the bidders without improving results.
- Writing the specification so that only a ready-made integrated tester qualifies: very few makers sell one, while an assembled constant-head bench with a calibrated balance and thermostat runs the same standard test; allow both and prove the system at OQ.
- Leaving out the luer, needle hub and spike adaptors and the flow check devices, so the tester arrives but cannot connect to the cannulas, needles and sets the lab actually receives.
- Ignoring test-water temperature: without a thermostat, summer results in Pakistan are biased by more than 10% and are not comparable with makers' labelled flows.
- Accepting a balance and thermometer without ISO/IEC 17025 accredited calibration certificates, so DTL results can be challenged by the product owner.
- Asking for DRAP medical-device registration or ISO 13485 for the tester itself; it is laboratory test equipment and these demands only confuse bidders.
- Not fixing yearly calibration and service prices in the bid, so calibration after warranty becomes expensive or is skipped.
- Buying a single station for a manufacturer that must release batches every day, creating a bottleneck in QC.