Medical Device Testing: Ensuring Safety and Effectiveness
At Micom Laboratories, we specialize in medical devices accelerated aging to ensure that your medical devices meet safety and efficacy requirements. As a trusted partner in the medical device industry, we offer a range of testing services that can help you comply with regulatory requirements, validate product performance, and maintain quality control.
Why Work with Micom for Medical Device Testing
Our team of specialists is highly experienced in conducting climatic chamber testing, UV testing, material testing and package testing. We can assist you in designing a meaningful test plan that addresses your specific needs and provides actionable insights.
You can count on Micom to offer:
- Comprehensive testing services: We offer comprehensive testing services that include environmental testing, mechanical testing, thermal aging, accelerated functional aging, and packaging testing. Our team of experienced and knowledgeable professionals utilizes advanced equipment and techniques to provide reliable test results that you can use for internal purposes or submit to regulatory bodies.
- Customized material testing: Each medical device is unique, and we offer customized material testing services that are designed to meet your budget, timeline, and specific needs. If you’re a small start-up or a large organization, we can work with you to create a testing program that will fit your requirements.
- Competitive pricing: At Micom Laboratories, we offer competitive pricing and excellent customer service. Our goal is to help you to bring your medical devices to the market as securely as possible, enabling you to focus on improving the lives of patients worldwide.
Medical Device Testing Services
Environmental Testing Services
Our environmental testing services for medical devices evaluate the durability and reliability of these devices under various conditions, such as temperature and humidity cycling, shock and vibration, mechanical stress testing, UV exposure, corrosion, and moisture.
Mechanical Testing Services
Our mechanical testing services for medical devices can evaluate strength, durability, and other mechanical properties, including fatigue, compression, and torsion testing of these devices.
Packaging Testing Services
Micom also offers packaging testing services for medical devices to evaluate the performance of medical device packaging, including seal strength testing and accelerated aging testing.
Medical Device Testing Services Video
Medical Package Testing Services Video
Detailed List of Testing Methods for Medical Devices & Packaging
If you are interested, you can see the list of our testing methods below. We can create a testing plan that will meet your requirements. Contact us today to discover more about our testing services and how we can assist you.
Films, Sterile Barriers and Seals
- ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM D6653/D6653M-13 Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
- ASTM D3420-08a Standard Test Method for Pendulum Impact Resistance of Plastic Film
- ASTM D1922-09 Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
- ASTM F1886/F1886M-09(2013) Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM D3045 a standard practice for heat aging of plastics without load.
Packages
- ISTA testing
- ASTM D5276 Standard Test Method for Drop Test of Loaded Containers by Free Fall
- ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D642 Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads
- ASTM D4332-13 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM D4728 Standard Test Method for Random Vibration Testing of Shipping Containers
Temperature Chain Qualification (Cold Chain)
- ASTM D3103 Standard Test Method for Thermal Insulation Performance of Distribution Packages
- Custom protocols
Material Testing
- Tensile Strength – ASTM D638, D1623, D-2990, D5574
- Compressive Strength – ASTM D695, D2990, D4762
- Flexural Strength – ASTM D790, D3043, D5616
- Foam – ASTM D3574
- Moisture Absorption – ASTM D570
- Particle Board Testing – ASTM D1037
- Specular Gloss – ASTM D523
- Conical Mandrel – ASTM D522
- Hardness – ASTM D2240
- Color Measurement – ASTM D-2244
- Abrasion Resistance – ASTM D4060
- Flatwise Tensile Strength of Sandwich Constructions – ASTM C297
- Coating Film Thickness – ASTM D1196
- Paint Adhesion – ASTM D3359
- Salt fog exposure – ASTM B117
Accelerated Aging
- Climatic chamber – Humidity, temperature cycling -78oC to +150oC, 10 – 95% RH
- UV testing – ASTM G155, ASTM G154, ISO 4892
- Salt spray – ASTM B117, ISO 7253, ASTM D1735, ASTM D2247, ASTM D5894, ASTM G85
- Heat aging testing
- Laboratory simulations of field failures
- Thermal shock testing (-78oC to +200oC)
- HASS/HALT
- High & low temperature tensile & compression tests
Coating Testing
- Weatherometer testing, Q-UV, U.V. exposure (ASTM G155, G154)
- Test chamber – temperature and Humidity cycling
- Taber Abrasion – ASTM D4060
- Gloss ASTM D523
- Salt spray (ASTM B117)
- Scratch resistance (ASTM D3363)
If you have any questions about medical packaging testing, we invite you to contact our material testing lab today. It will be our pleasure to answer your questions and help you with your custom testing requirements.