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ISO 10555 · ISO 14630 · ASTM F88 · ISO 11607Servo-motorized tensile and compression testing systems for medical device quality control — catheters, sutures, orthopaedic implants, syringes, and sterile packaging validated to ISO, ASTM, and IS standards.
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Applicable Standards
Medical Device Testing
Tensile · Compression · Peel — ISO 10555 · ISO 14630 · ISO 11607
Medical devices must demonstrate consistent mechanical performance before reaching patients. Catheters that separate at the hub, sutures that break prematurely, implants that deform under load, or sterile pouches with inadequate seal strength all represent critical safety failures — making controlled mechanical testing an essential step in device development and production QC.
AG Measurematics supplies servo-motorized tensile and compression testing machines configured specifically for medical device applications — from sub-Newton suture testing to multi-kilonewton orthopaedic implant testing — in a single, interchangeable-load-cell platform.
Each machine is supplied with test protocols aligned to the applicable standard (ISO, ASTM, or IS), PC software for traceable data logging and report generation, and a set of precision fixtures matched to the device type being tested.
Test Capabilities
A single servo frame with interchangeable fixtures covers tensile, compression, and peel testing for a wide range of medical device types.
ISO 10555 / ISO 14630 / ASTM F617
The device or component is gripped between precision fixtures and pulled apart at a controlled crosshead speed. Peak tensile force, elongation at break, and force-displacement profile are recorded. Used for catheters, sutures, guide wires, hub-to-tube bonds, and connector pull-out strength verification.
ISO 14630 / ISO 7206 / ASTM F543
A compressive platen or probe advances onto the specimen at a defined speed. Stiffness, yield force, and maximum compressive load are captured. Applications include plunger break-loose and glide-force testing for syringes, radial crush resistance of implants, and fatigue-strength screening of orthopaedic devices.
ASTM F88 / ISO 11607
The sealed edge of sterile packaging (blister, pouch, or lidded tray) is peeled at a controlled 90° or 180° angle. Mean peel force and force-vs-distance profile are recorded to verify packaging integrity and seal consistency — a critical step in demonstrating that sterile barrier systems meet ISO 11607 requirements.
Specifications
| Parameter | Specification |
|---|---|
| Force Capacity | 100 N / 500 N / 1 kN / 5 kN (load cell options) |
| Force Resolution | 0.01 N (100 N cell) · 0.1 N (5 kN cell) |
| Force Accuracy | ±0.5% of reading (full scale) |
| Max Crosshead Travel | 600 mm |
| Displacement Resolution | 0.01 mm |
| Test Speed Range | 0.1 – 500 mm/min |
| Crosshead Drive | Servo Motor (closed-loop) |
| Control Platform | PC-based with touchscreen display |
| PC Interface | USB / RS-232 with companion software |
| Power Supply | 230 V, 50 Hz, Single Phase |
| Frame Capacity | 5 kN (standard) |
Specifications vary by load cell selection and customer requirements. As a result of continuous development, all specifications are subject to change without notice. Contact us for the latest datasheet.
Capabilities
Tensile (pull-out), compression, and peel/seal-strength tests are all performed on the same machine by swapping interchangeable fixtures — eliminating the need for separate rigs for each test type.
Plug-and-play load cells from 100 N to 5 kN allow the same frame to handle delicate suture testing at 0.01 N resolution and high-force implant testing without recalibration of the entire system.
Closed-loop servo drive maintains crosshead speed accuracy across the full 0.1–500 mm/min range — critical for rate-sensitive polymeric materials and standardised test conditions.
Companion software captures force-displacement curves in real time, applies pass/fail limits, exports CSV data, and generates traceable QC reports with batch statistics — ready for regulatory submission.
Precision fixtures for flat-jaw gripping, pin gripping, pneumatic clamping, compression platens, peel arms, and mandrel sets — designed specifically for delicate medical device specimens to prevent specimen damage.
Pre-configured test recipes for ISO 10555, ISO 14630, ASTM F88, ISO 11607, and ASTM F617 reduce setup time and ensure operator-to-operator consistency across shifts.
Who Uses This Machine?
Tensile and bond-strength testing of catheter hubs, lumens, and connectors per ISO 10555 for regulatory submissions and production QC.
Tensile break strength and knot pull-out testing for absorbable and non-absorbable sutures, staples, and clips per ISO 10334 and ASTM F617.
Compression, bending, and pull-out testing of bone screws, plates, and hip/knee prosthesis components per ISO 14630 and ISO 7206.
Plunger break-loose force, glide force, and stopper pull-out testing for pre-filled syringes, pens, and auto-injectors per ISO 11040.
Peel strength and seal integrity testing for Tyvek®, foil, and film pouches used in sterile medical device packaging per ISO 11607 and ASTM F88.
Accredited mechanical testing of medical devices for CDSCO submissions, CE marking, and import/export certification against IS, ISO, and ASTM standards.
Why AG Measurematics?
Also in Medical / Mobility Device
Tell us your device type (catheter, suture, implant, syringe), applicable standard, and required test methods — our engineers will configure the right machine and fixtures for your QC requirements.
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