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ISO 10555 · ISO 14630 · ASTM F88 · ISO 11607

Medical Device Testing Machines

Servo-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

  • ISO 10555Intravascular catheters — sterile and single-use: tensile, kink, and bond strength tests
  • ISO 14630Non-active surgical implants — general requirements including mechanical test methods
  • ISO 11607Packaging for terminally sterilised medical devices — seal strength and integrity
  • ASTM F88Standard test method for seal strength of flexible barrier materials (peel test)
  • ASTM F617Standard test method for measuring flexibility of surgical staples
  • ISO 7206Implants for surgery — partial and total hip joint prostheses: mechanical testing

Medical Device Testing

Overview

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.

  • Tensile, compression, and peel — three modes, one frame
  • Interchangeable load cells: 100 N to 5 kN
  • 0.01 N resolution for delicate device components
  • Servo drive — precise, repeatable crosshead speed
  • PC software with force-displacement curves and QC reports
  • Compliant with ISO 10555, ISO 14630, ASTM F88, ISO 11607
  • Custom fixtures for special device geometries on request

Test Capabilities

Three Test Methods, One Machine

A single servo frame with interchangeable fixtures covers tensile, compression, and peel testing for a wide range of medical device types.

Tensile / Pull-Out Test

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.

  • Interchangeable grips — flat jaw, pin, pneumatic, and custom fixtures
  • Records peak force, break force, and elongation
  • Programmable preload and test speed
  • Applicable to sutures, catheters, wires, implants, and tubing joints

Compression Test

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.

  • Flat-platen, ball-end, and mandrel compression fixtures
  • Measures break-loose force, glide force, and radial stiffness
  • Configurable pre-load hold before ramp
  • Applicable to syringes, implants, stents, and surgical devices

Peel / Seal-Strength Test

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.

  • 90° and 180° peel angle fixtures
  • Mean, peak, and minimum peel force reported
  • Compatible with Tyvek®, foil, and film pouches
  • Essential for sterile barrier validation per ISO 11607

Specifications

Technical Specifications

ParameterSpecification
Force Capacity100 N / 500 N / 1 kN / 5 kN (load cell options)
Force Resolution0.01 N (100 N cell) · 0.1 N (5 kN cell)
Force Accuracy±0.5% of reading (full scale)
Max Crosshead Travel600 mm
Displacement Resolution0.01 mm
Test Speed Range0.1 – 500 mm/min
Crosshead DriveServo Motor (closed-loop)
Control PlatformPC-based with touchscreen display
PC InterfaceUSB / RS-232 with companion software
Power Supply230 V, 50 Hz, Single Phase
Frame Capacity5 kN (standard)

Supply Includes

  • Medical device tensile/compression testing machine (servo drive frame)
  • Load cell of selected capacity (100 N / 500 N / 1 kN / 5 kN)
  • Standard flat-jaw tensile grips (pair)
  • Compression platen set (flat + ball-end)
  • Peel test fixture (90° and 180°)
  • PC companion software with USB interface cable
  • Calibration certificate (NABL-traceable on request)
  • Operation and maintenance manual

Note

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

Key Features

Three Test Modes in One Frame

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.

Interchangeable Load Cells

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.

Servo-Motorized Precision

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.

PC Software with Reporting

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.

Medical-Grade Test Fixtures

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.

Standards-Ready Protocols

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?

Applications

Catheter & Vascular Device Manufacturers

Tensile and bond-strength testing of catheter hubs, lumens, and connectors per ISO 10555 for regulatory submissions and production QC.

Suture & Wound Closure Manufacturers

Tensile break strength and knot pull-out testing for absorbable and non-absorbable sutures, staples, and clips per ISO 10334 and ASTM F617.

Orthopaedic Implant Testing

Compression, bending, and pull-out testing of bone screws, plates, and hip/knee prosthesis components per ISO 14630 and ISO 7206.

Syringe & Drug Delivery Devices

Plunger break-loose force, glide force, and stopper pull-out testing for pre-filled syringes, pens, and auto-injectors per ISO 11040.

Sterile Packaging Validation

Peel strength and seal integrity testing for Tyvek®, foil, and film pouches used in sterile medical device packaging per ISO 11607 and ASTM F88.

Regulatory & NABL Test Labs

Accredited mechanical testing of medical devices for CDSCO submissions, CE marking, and import/export certification against IS, ISO, and ASTM standards.

Why AG Measurematics?

50+ Years of Precision Testing Expertise

  • Indigenous design & manufacture — fully serviceable in India
  • Standards-compliant protocols (IS, ISO, ASTM) pre-configured
  • Custom fixtures for special device geometries on request
  • On-site installation, operator training & calibration
  • Spare parts & AMC support nationwide
  • NABL-traceable calibration certificates available

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Need a Medical Device Testing Machine?

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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