Medical Device

Medical device testing services are indispensable for validating and ensuring that healthcare products, ranging from surgical instruments and diagnostic apparatus to wearable monitors and personal protective equipment, function safely and reliably throughout their projected operational lifespans. Infinita Lab’s Medical Device Testing Services facilitate the safety, performance, and regulatory compliance of healthcare products through advanced Physical, Chemical, Microbiological, and Performance Testing. Our accredited laboratories within the United States deliver precise, consistent, and expeditious results, enabling manufacturers to substantiate product durability, safety, and commercial viability.

These devices, encompassing surgical tools, diagnostic equipment, contemporary therapeutic instruments, and wearable healthcare monitors, constitute the essential framework of modern medical care. Consequently, their safety, functional utility, and performance must be verified through sophisticated testing methodologies and advanced technical expertise.

Infinita Lab assists medical device engineers and manufacturers by maintaining strict adherence to rigorous quality and compliance protocols, including international benchmarks such as ASTM, FDA, ISO 13485, and ISO 17025.

Our Medical Device Testing Services

Mechanical Testing for Medical Devices

Mechanical testing plays a crucial role in evaluating the structural integrity, durability, and performance of medical devices under real-world conditions. Our most experienced technicians conduct a range of tests, including tensile, compression, fatigue, and wear-resistance evaluations, to validate product reliability and functionality.

Mechanical testing provides yield strength, ultimate strength, elongation, and hardness data that are essential for device design validation, regulatory submissions, and quality assurance documentation.

Relevant ASTM Standards:

ASTM F2413 – Standard specification for performance requirements for protective footwear used in medical and healthcare environments, evaluating impact resistance, compression resistance, and metatarsal protection to ensure user safety.

Medical Face Mask Performance Testing

Medical face masks used in surgical and clinical environments must comply with strict performance requirements for bacterial filtration, fluid resistance, breathability, and flammability to protect both patients and healthcare workers.

Relevant ASTM Standards:

ASTM F2100 – Standard specification for performance of materials used to make medical face masks. The mask’s performance is determined by testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. The standard integrates multiple test methods to classify masks into Level 1, 2, and 3 performance categories.

ASTM F2101 – Standard test method for evaluating the Bacterial Filtration Efficiency (BFE) of medical face mask materials using a Staphylococcus aureus aerosol as the challenging micro-organism. The BFE value is reported as a percentage efficiency at 3.0 microns for ASTM F2100 Levels 1, 2, and 3, supporting surgical and procedure mask specification and FDA 510(k) clearance.

Barrier Face Covering Performance Testing

ASTM F3502 – Standard specification for barrier face coverings that specifies minimum design, performance, and testing requirements. The effectiveness of the barrier face covering depends on how well it blocks particles, minimizes leakage around the perimeter, and is comfortable for individuals (breathability). The standard evaluates particle filtration efficiency and airflow resistance to ensure that face coverings provide effective source control while maintaining breathability.

Medical Glove Testing

Medical gloves are critical personal protective equipment in healthcare settings. Comprehensive glove testing verifies tensile strength, elongation, barrier integrity, and antimicrobial efficacy, ensuring safe use across examination, surgical, and laboratory applications.

Relevant ASTM Standards:

ASTM D6319 – Standard specification for nitrile rubber examination gloves used in medical applications. It establishes performance criteria, such as tensile strength, elongation, and barrier protection, to ensure that gloves provide adequate safety for both healthcare professionals and patients. The standard covers the evaluation of physical properties such as strength and elasticity, as well as barrier protection against biological and chemical hazards.

ASTM D7907 – Standard test method for determining the bactericidal activity on either the inner or outer surface of medical gloves. The test determines whether the glove surface reduces the population of challenge bacteria – typically Staphylococcus aureus and Klebsiella pneumoniae – under defined test conditions, supporting glove manufacturers seeking to substantiate antimicrobial claims for healthcare, surgical, and examination gloves.

ASTM D6355 – Standard test method for human repeat-insult patch testing of medical gloves, evaluating the skin-sensitization potential of glove materials under repeated dermal exposure conditions to ensure patient and healthcare worker safety.

Medical Device Packaging & Sterile Barrier Testing

Medical devices must be delivered sterile to the point of use. Sterile barrier packaging testing verifies that packaging systems maintain microbial exclusion throughout the distribution chain, shelf life, and point-of-care handling.

Relevant ASTM Standards:

ASTM F1608 – Standard test method for evaluating the microbial barrier performance of porous packaging materials by measuring their resistance to airborne bacterial penetration under controlled aerosol exposure. It provides a comparative ranking of materials based on their ability to prevent microbial ingress, helping assess packaging integrity and long-term sterility assurance. It is essential for validating porous packaging used in healthcare environments where sterility must be maintained during storage and handling.

Water Vapor Transmission Rate (WVTR) Testing

Water vapor transmission rate testing is essential for qualifying medical device packaging materials, wound dressings, and moisture-sensitive device enclosures, ensuring that moisture ingress remains within specified limits throughout the product’s shelf life.

Relevant ASTM Standards:

ASTM E96 – Standard test methods for Water Vapor Transmission of Materials, measuring the rate at which water vapor passes through flat materials, such as medical packaging films, membranes, and barrier laminates, under specified temperature and humidity conditions.

Oxygen Transmission Rate (OTR) Testing

Oxygen transmission rate testing validates the barrier performance of medical packaging films and materials used to protect oxygen-sensitive pharmaceutical products and implantable device components from oxidative degradation.

Relevant ASTM Standards:

ASTM D3985 – Standard test method for Oxygen Gas Transmission Rate through plastic film and sheeting using a coulometric sensor, providing OTR data essential for qualifying medical device packaging materials and pharmaceutical barrier laminates.

Chemical Resistance Testing for Medical Device Materials

Medical device materials are exposed to sterilizing agents, disinfectants, cleaning solutions, bodily fluids, and pharmaceutical solvents throughout their service life. Chemical resistance testing verifies that materials maintain their mechanical and functional properties under these exposures.

Relevant ASTM Standards:

ASTM D543 – Standard practices for evaluating the resistance of plastics to chemical reagents, assessing dimensional change, mass change, and mechanical property retention of medical device polymer components after controlled immersion in specified chemicals and sterilizing agents.

Biocompatibility Testing

Biocompatibility assessments are a critical component of our testing services, evaluating interactions between medical device materials and living tissues. Using a combination of in vitro and in vivo testing, we assess cytotoxicity, sensitization, irritation, and systemic toxicity to ensure device compatibility with the human body.

Biocompatibility testing is conducted in compliance with ISO 10993 and relevant ASTM standards, providing manufacturers with the safety data required for FDA 510(k) submissions and CE marking.

Importance of Medical Device Testing

Product testing provides vital information about a product’s safety, quality, and performance before commercialization. It enables manufacturers and healthcare professionals to verify that every product exemplifies mechanical integrity, reliability, and safety under service conditions in reality, avoids material or design failures, returns correct diagnosis or therapy outcomes, and secures long-term usability and patient safety. Proper testing not just minimizes product risk, but also improves reliability, regulatory compliance, and patient faith in medical devices.