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Medical Device Force and Torque Testing Solution

Medical Device Force and Torque Testing Solution

Medical Device Force and Torque Testing Solution

Product catalog summary
Overview
The document discusses the importance of force and torque testing solutions in the medical devices and pharmaceuticals sector, emphasizing the need for compliance with safety and quality standards. Mecmesin provides testing equipment to ensure the mechanical strength and reliability of medical devices and packaging.

Specifications and Equipment
Mecmesin offers a range of testing solutions, including portable force gauges and complete tensile/compression systems. Their equipment is designed to comply with FDA 21 CFR Part 11 and international standards like ISO and ASTM. Key products include:
  • Helixa/Vortex: Bench-top torque testing systems for precise measurement of torque values, suitable for small medical devices and larger surgical instruments.
  • OmniTest/MultiTest: Single-column test systems for measuring tensile/compressive forces, ideal for various medical device testing applications.

Software Solutions
Mecmesin's VectorPro software ensures data integrity and compliance with FDA regulations. It features an SQL database for secure data storage, active directory for user management, electronic signatures, and customizable test reports.

Testing Standards
The document outlines specific international standards for testing medical packaging, such as ASTM F88 for seam strength and EN 868-5 for sealable pouches. Torque and puncture resistance standards are also highlighted.

Grips and Fixtures
Mecmesin provides a range of grips and fixtures to ensure repeatability in testing. Custom-designed fixtures are available for unique medical devices, utilizing 3D printed materials for optimal performance.

Customer Feedback
Testimonials from users like Owen Mumford Ltd highlight the reliability and ease of use of Mecmesin equipment for regular quality checks.

Additional Resources
The document encourages downloading a free whitepaper on force and torque testing of syringes, needles, and vials from Mecmesin's website.
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Catalog excerpts

Medical Device Force and Torque Testing Solution-1

Medical device force and torque testing solutions

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Medical Device Force and Torque Testing Solution-2

Explore our range of medical device testing equipment The medical devices and pharmaceuticals sector is highly regulated, driven by compliance and auditing processes. Safety requirements for devices are paramount since they are predominantly used on humans. This puts a heavy emphasis on quality control of devices, during the development, production and packaging phases, to ensure they meet exacting standards thereby minimising the risks to patients and users. Testing the mechanical strength of materials, assemblies and finished medical devices is a key part of the quality assurance process. Manufacturers...

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Medical Device Force and Torque Testing Solution-3

Torque testing Helixa/Vortex The Mecmesin range of bench-top torque testing systems has been designed to measure clockwise and counter-clockwise torque from a few N.mm up to 10 N.m. The precise measurement of very low torque values in N.mm and ozf.in is often required for small medical devices and their components, which rely on a minimal friction fit for smooth operation. The Helixa is a precision torque testing system, powered by Emperor software, which can be fitted with torque sensors from 0.1 – 6 N.m capacity thus allowing even the finest of measurements for medical devices. It features...

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Medical Device Force and Torque Testing Solution-4

Force testing OmniTest/MultiTest The Mecmesin range of single-column test systems is ideal for measuring tensile/compressive forces up to 7 kN. They fit neatly on a workbench .5 occupying very little space and can be fitted with interchangeable loadcells to cover precision measurements from upwards of a few grammes-force. Various models are available to suit your medical device testing applications including extended column-length versions for measuring highly elastic materials. At the heart of Mecmesin test systems are 2 software platforms - the new VectorPro software and the established Emperor...

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Medical Device Force and Torque Testing Solution-5

VectorPro Software Medical packaging Solutions To assist with your organisation becoming compliant with FDA 21 CFR Part 11, Mecmesin software is packed with features and functionality to ensure data integrity. It helps a manufacturer to track who did what, when they did it, and why, in case a faulty batch of medical devices or pharmaceuticals is accidentally sent to market. FDA 21 CFR Part 11 Core functionality of VectorPro software includes: • QL database - stores data for a secure audit trail S of information • ctive Directory – ensures management controls A around logins, User ID & password-complexity...

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Medical Device Force and Torque Testing Solution-6

Medical device Grips and fixtures Medical devices, their components and sub-assemblies all come in various shapes, sizes and materials. To achieve repeatability when testing it is important to hold the devices consistently and securely without them slipping but also without gripping them so tightly that the material is deformed. Mecmesin has a standard range of tensile grips and compression fixtures for the most common applications. They can be easily fitted to all test stands, force gauges and loadcells to provide the ultimate in flexibility. For torque applications chucks and vices are available...

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Medical Device Force and Torque Testing Solution-7

Discover your next Mecmesin medical device solution online - visit mecmesin.com Mecmesin reserves the right to alter equipment specifications without prior notice. E&OE.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.