Specification builder · Tier C
Syringe performance test system for piston forces, leakage, dead space and graduated capacity (ISO 7886-1 to -4; prefilled syringes ISO 11040-4 / -8 optional)
A syringe performance test system is a motorised force frame with syringe fixtures, a leakage apparatus and a weighing set-up that checks whether hypodermic syringes meet ISO 7886-1: plunger forces, air and liquid leakage past the plunger, dead space and accuracy of the graduations. It is bought by drug and device testing laboratories, local syringe manufacturers for batch release, and universities. Prefilled-syringe tests to ISO 11040-4 and -8 can be added for pharmaceutical users.
What this equipment will do
- Syringe types: standard hypodermic syringes 0.5 to 60 mL (ISO 7886-1).
- Syringe types: syringes for syringe pumps (ISO 7886-2), auto-disable syringes for immunization (ISO 7886-3), syringes with re-use prevention (ISO 7886-4) and insulin syringes (ISO 8537). (with the optional module)
- Piston (plunger) forces: force to start the plunger moving and to keep it moving, recorded as a force-distance curve (ISO 7886-1 Annex E).
- Air leakage past the plunger during aspiration (ISO 7886-1 Annex B).
- Liquid leakage past the plunger under pressure (ISO 7886-1 Annex D).
- Dead space: the liquid left in the syringe after full emptying (ISO 7886-1 Annex C).
- Filling and dose accuracy: tolerance on graduated capacity, by weighing water delivered at graduation marks (ISO 7886-1 clause 8).
- Prefilled syringes: break-loose and extrusion force (ISO 11040-8 Annex A). (with the optional module)
- Prefilled syringes: leakage and burst (ISO 11040-8 Annex C). (with the optional module)
- Prefilled syringes: administration time (ISO 11040-8 Annex D). (with the optional module)
- Prefilled syringe components: glass barrel, luer cone and closure tests (ISO 11040-4). (with the optional module)
- Torque on luer-lock syringe tips and caps. (with the optional module)
Not covered: Needles: needle sharpness and penetration force, needle-hub bond and needle stiffness/breakage need the needle penetration tester and force tests (ISO 7864, ISO 9626).; Full ISO 80369-20 luer connector testing (separation, stress cracking, overriding) needs the luer connector test system.; Sterility, bacterial endotoxins, particulate matter, extractables and lubricant (silicone) quantity need the microbiology and chemistry laboratory equipment.
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Standards this specification draws on
- ISO 7886-1:2017 Defines the syringe tests this system must perform: tolerance on graduated capacity (clause 8), air leakage during aspiration (Annex B), dead space (Annex C), liquid leakage under compression (Annex D) and forces to operate the piston (Annex E).
- ISO 7886-2:2020 Requirements for syringes used with power-driven syringe pumps, including piston forces that the fixtures must measure.
- ISO 7886-3:2020 Requirements for auto-disable syringes for fixed-dose immunization, used in EPI programmes in Pakistan.
- ISO 7886-4:2018 Requirements for syringes with re-use prevention feature, required for curative injections in Pakistan.
- ISO 11040-8:2026 Test methods for finished prefilled syringes: break-loose and extrusion force (Annex A), leakage and burst (Annex C), administration time (Annex D).
- ISO 11040-4:2024 Requirements and functional tests for glass-barrel prefilled syringes and subassemblies (luer, needle and closure tests).
- ISO 80369-7:2021 Defines the luer connectors of syringe nozzles and the reference connectors used to connect syringes to test circuits.
- ISO 7500-1:2018 Method and accuracy classes for verifying the force measuring system of the test frame.
- IEC 61010-1 Electrical safety standard for laboratory and test equipment.
- IEC 61326-1 EMC requirements for laboratory and test 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 audit trails and e-signatures in test software.
Common mistakes in tenders for this equipment
- Buying a general force tester and assuming it does 'ISO 7886-1': without the annex fixtures, reservoir, outlet line, barrel inserts and leak apparatus it cannot run the tests.
- Asking only for piston forces and forgetting the leakage (Annexes B and D), dead space (Annex C) and graduated-capacity tests, which need their own apparatus and a balance.
- Specifying one maker's exact force capacity, speed range or travel so only that brand can comply; state minimum needs with 'not less than' instead.
- Accepting a single high-capacity load cell, which cannot measure the small glide forces of 1 mL and insulin syringes accurately.
- Accepting a factory calibration certificate instead of an on-site ISO/IEC 17025 accredited calibration of force, speed and gauges, which accreditation assessors and courts expect.
- Ignoring auto-disable and re-use prevention syringes (ISO 7886-3 and -4), the main syringe types used in Pakistan.
- Adding prefilled-syringe, torque or automation modules 'just in case', which can narrow the field to one or two makers and double the price.
- Asking for DRAP medical-device registration or ISO 13485 for the tester itself: it is laboratory equipment, so this only confuses bidders.