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IS 9165 · ISO 7864 · ISO 9626 · Model NTM-200NServo-motorized benchtop testing system for hypodermic needle quality control — sharpness, bending strength, and hub pull-force in a single compact platform compliant with IS 9165, ISO 7864 & ISO 9626.
Applicable Standards
Needle Testing Machine
Quality Control for Hypodermic Needles — IS 9165 · ISO 7864 · ISO 9626
Hypodermic needle quality directly affects patient safety and comfort. A needle that is too blunt causes unnecessary pain and tissue trauma; one that is too brittle may break during use. Hub-to-tube bond failure can lead to leakage or separation inside a patient — making controlled mechanical testing of every needle batch a mandatory quality step.
The NTM-200N is a compact, servo-motorized benchtop testing machine that performs the three critical mechanical tests specified by IS 9165 (Part 1) and international standards: sharpness (puncture) testing, three-point bending, and hub pull-force testing — all from a single platform with 0.1 N force resolution.
Controlled by an on-board microcontroller and linked to a PC via USB, the NTM-200N enables manufacturers to log every test result, generate traceable QC reports, and demonstrate compliance with IS 9165, ISO 7864, and ISO 9626 during audits and regulatory submissions.
Test Capabilities
The NTM-200N covers all three mechanical tests required for hypodermic needle quality control under IS 9165 and ISO standards.
IS 9165-1:1992 Cl. 7.5 / ISO 7864
The pointed end of the hypodermic needle is pushed perpendicularly into a 0.025 mm aluminium foil or stretched membrane at a controlled speed. The peak piercing force is measured in Newtons and verified to be below the maximum limit specified by the standard — ensuring consistent sharpness and patient comfort.
IS 9165-1:1992 Cl. 7.3 / ISO 9626 Annex C
The needle is placed on a three-point bend fixture. The crosshead pushes down at the centre at a defined speed to achieve a 90° bend angle. A needle that breaks before reaching 90° is deemed too brittle. The bending force profile is recorded to assess stiffness and deformation behaviour.
IS 9165-1:1992 / Manufacturer QC Protocol
The needle tube is gripped in a vise fixture while the hub is attached to the load cell. The hub is pulled upward until it separates from the needle tube. The separation force is recorded as the hub pull force. Alternatively, the test can be run to a preset target force to confirm the bond strength meets specification without destruction.
Specifications
| Parameter | Specification |
|---|---|
| Model | NTM-200N |
| Rated Force | 200 N (20 kgf) |
| Force Resolution | 0.1 N |
| Max Crosshead Travel | 200 mm |
| Displacement Resolution | 0.1 mm |
| Test Speed Range | 1 – 100 mm/min |
| Crosshead Drive | Servo Motor |
| Control Platform | Microcontroller-based |
| PC Interface | USB (with companion software) |
| Power Supply | 230 V, 50 Hz, Single Phase |
| Footprint (W × D) | 200 × 320 mm |
| Height | 400 mm |
As a result of continuous development, specifications are subject to change without notice. Contact us for the latest datasheet (ref. M-15-NTM-a).
Capabilities
Sharpness (puncture), bending strength (3-point), and hub pull-force — all performed on a single compact machine. No need to invest in separate test rigs for each needle QC parameter.
Closed-loop servo drive delivers precise, repeatable crosshead speed across the full 1–100 mm/min range, ensuring standardised test conditions for every needle sample.
High-sensitivity load cell with 0.1 N resolution captures the small piercing forces characteristic of medical needles — providing the discrimination needed for reliable sharpness classification.
On-board microcontroller handles test setup and live display. USB link to PC enables data logging, result storage, statistical analysis, and traceable QC reports via companion application software.
At just 200 × 320 mm and 400 mm tall, the NTM-200N fits on any lab bench or QC workstation — ideal for production-floor testing in needle manufacturing plants and medical device test labs.
Pre-configured test recipes aligned to IS 9165-1, ISO 7864, and ISO 9626 reduce setup time and eliminate operator-to-operator variability in test conditions.
Who Uses This Machine?
In-process and final QC for injection and infusion needles — every batch verified for sharpness, bend resistance, and hub bond strength.
Accredited testing against IS 9165, ISO 7864, and ISO 9626 for regulatory submissions and import/export certification.
Needle penetration and hub pull-force testing for pre-filled syringes, insulin pens, and auto-injectors per ISO 11040-4.
Sharpness and bending compliance testing per ISO 17218 for sterile acupuncture needles.
Characterise needle tip geometry, penetration force profiles, and hub bond performance during design validation.
Why AG Measurematics?
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Tell us your needle type (hypodermic, suture, acupuncture), applicable standard, and required test methods — our engineers will configure the NTM-200N for your QC requirements.
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