Specification builder · Tier C
Needle penetration and drag (friction) force tester for hypodermic needles, IV cannulas, pen needles and suture needles
A needle penetration tester pushes a needle through a standard test membrane at a controlled speed and records force against distance. This shows how sharp the point is (penetration force) and how well it is lubricated (drag force). It is bought by drug and device testing laboratories, needle, cannula and syringe makers, and universities.
What this equipment will do
- Product types: sterile hypodermic needles with luer hubs, outside diameter 0.18 to 1.2 mm (ISO 7864).
- Product types: IV cannulas 26G to 14G with the catheter fitted, so the catheter tip transition is measured (ISO 10555-5). (with the optional module)
- Product types: double-ended pen needles (ISO 11608-2), curved and straight suture needles, and bare needle tubing. (with the optional module)
- Penetration force: the highest force as the needle point passes through the standard membrane, showing point sharpness (ISO 7864 Annex D).
- Drag (friction) force: the mean force as the needle shaft slides through the membrane after the point, showing how well it is lubricated (ISO 7864 Annex D).
- Separate force peaks along the point - tip, bevel cutting edges, heel or catheter transition - read automatically from the curve (DIN 13097-4). (with the optional module)
- Repeated penetrations with the same needle (10 or more passes), to see how sharpness and lubrication hold up. (with the optional module)
- Penetration through other media: vial or cartridge stopper material, silicone sheet and a skin-simulant sheet. (with the optional module)
- Needle hub-to-tube bond: force to pull the needle tube out of its hub (ISO 7864). (with the optional module)
- Needle tubing stiffness by three-point bending (ISO 9626 Annex B). (with the optional module)
- Needle tubing resistance to breakage by repeated bending (ISO 9626 Annex C). (with the optional module)
- Video of the needle tip entering the membrane, linked to each point on the force curve. (with the optional module)
Not covered: Syringe plunger forces, leakage and dead space need the syringe performance test system (ISO 7886-1).; Flow rate through needles and IV cannulas needs the needle and IV set flow-rate tester (ISO 7864, ISO 10555-5).; Pull-out of the suture from a surgical needle needs the suture needle attachment tester (USP <871>).; Needle point geometry, bevel angles and fine needle bore need the optical measuring microscope.
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Standards this specification draws on
- ISO 7864:2016 International standard for sterile single-use hypodermic needles; its informative Annex D gives the test method for penetration force and drag force that this instrument performs (a revision, ISO/DIS 7864:2025, is in progress).
- DIN 13097-4:2019-06 German standard on needle point geometry, requirements and testing, widely used by needle makers for penetration-force testing of needle points.
- ISO 9626:2016 Stainless steel needle tubing standard; its stiffness and resistance-to-breakage tests can be run on the same frame with optional fixtures.
- ISO 11608-2:2022 Requirements and test methods for double-ended pen needles; the tester must hold pen needles so their penetration and drag can be measured during design and QC work.
- ISO 10555-5:2013 Current standard for over-needle peripheral intravascular catheters (IV cannulas), with no amendment to the 2013 edition; labs use the tester to compare insertion of the needle and catheter tip transition of these products.
- ISO 7500-1:2018 Calibration and verification of the force-measuring system of testing machines; sets the accuracy class of the load cell.
- IEC 61010-1 Electrical safety standard for laboratory and test equipment.
- IEC 61326-1 EMC requirements for laboratory and measurement equipment, so readings are not disturbed by other equipment.
- 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, used as the benchmark for test software audit trails and e-signatures.
Common mistakes in tenders for this equipment
- Citing a withdrawn or non-existent method: the ASTM method for suture needle penetration (F3014-14) was withdrawn in 2023, and the pen needle and IV cannula product standards do not themselves define a penetration test; specify the ISO 7864:2016 Annex D principle (and DIN 13097-4 if used) and state the membrane and speed in your own method.
- Not specifying the test membrane (material, thickness, hardness, lot certificate) or leaving it out of the bid, so results cannot be compared with the manufacturer's or another lab's figures.
- Asking for a high-capacity load cell (500 N or more) for penetration tests; its error at forces below 1 N is larger than the differences being measured. Specify accuracy in % of reading at the low forces used.
- Copying one dedicated tester's brochure figures (an exact force range, screen size or built-in printer) so that only one model complies; state minimum performance with 'not less than' instead.
- Buying only the luer-hub needle holder and then finding the lab cannot test pen needles, IV cannulas or curved suture needles.
- Accepting a factory calibration sheet instead of an ISO/IEC 17025 accredited force calibration (ISO 7500-1) of each load cell, which accreditation assessors will reject.
- Asking for DRAP medical-device registration for the tester itself; it is laboratory test equipment, so the demand only confuses bidders.
- Requiring Part 11 software for a teaching lab (extra cost) or, the opposite, buying basic software for a lab whose results are used for batch release.