Medical Device Cleanliness Testing Services
MEDICAL DEVICE CLEANLINESS MITIGATES POTENTIAL PATIENT COMPLICATIONS
Medical devices must adhere to stringent cleanliness standards, ensuring cleanliness is critical for safe use in clinical settings. Evaluation of the cleanliness of medical devices is a critical measure of their viability after implant surgery and minimizes patient complications. IMR Test Labs helps medical device manufacturers avoid risk of adverse reactions due to contaminants on implants.
Supported by our skilled chemical, metallurgical, corrosion, and failure analysis departments, IMR Test Labs offers comprehensive testing methods, including the characterization and quantification of residues and particulates, to help eliminate the source of contamination. Our testing follows the ASTM F2459 method to ensure accurate detection and identification of contaminants, debris, oils, detergents, residues, and particulates. Identifying contaminates determines pinpoint areas of the manufacturing process that compromise device cleanliness.
MEDICAL DEVICE CLEANLINESS TESTING METHODS
GRAVIMETRIC DETERMINATION
Allows for the total mass of debris extracted by either Polar (DI Water) or Non-Polar (solvents) solutions. If debris is detected, additional techniques, such as the following methods, can be used to further characterize the material and identify possible sources.
TOTAL ORGANIC CARBON (TOC) ANALYSIS
A rapid examination of extracts for residual organic materials such as oils, cleaning agents, and lubricants. If no contaminants are found in TOC analysis, the sample can be said to be clean. If a TOC test is positive for a contaminant, further analysis can determine the specific origin of the contaminant.
FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS
Used to detect and identify organic compounds like oils, cleaning agents, plastic particulars, and packaging residues on device surfaces.
ION CHROMATOGRAPHY
An analytical technique that permits the dynamic separation and detection of anions in an aqueous solution, down to ppb levels. We can work with a variety of solvents, from reagent grade, to common cleaners or your proprietary blends. Residual ionics can lead to corrosion and other degradation of components.
SCANNING ELECTRON MICROSCOPY / ENERGY DISPERSIVE X-RAY ANALYSIS (SEM/EDS)
Offers high magnification examination of debris, combined with chemical analysis through EDS, to reveal the elemental composition of particles, helping to trace their origin.
At IMR Test Labs, we take every precaution to prevent cross-contamination during sample preparation. Our lab adheres to strict protocols and industry best practices, ensuring tha tour cleanliness testing provides accurate, reliable results you can trust.
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Antimony Analysis (ICP)
Cadmium Analysis (ICP)
Carbon, Sulfur, Hydrogen, Oxygen & Nitrogen
Hex Chrome (UV-VIS)
ICP-AES Analysis
ICP-MS Analysis
Impurities Analysis
Ion Chromatography
Material Certification
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OES Analysis
On-site PMI
PMI Testing (Positive Material ID)
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Percent Crystallinity
pH
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Powdered Metal Analysis
Precious Metal Assay
Quantitative Analysis
Resistivity (ASTM D1125)
SEM-EDS
Semi-Quantitative Analysis
Trace Element Analysis
Unknown Alloy Identification
Unknown Material Identification
XRD Analysis
XRF Analysis
Bond Strength / Coating Adhesion
Charpy Impact Testing
Fatigue Testing
Flexural
Hardness
Tensile Testing
Weld Inspection
Contaminant Identification
Corrosion Failure
Litigation/Expert Witness Services
Nonmetallic Failure Analysis
Structural Failures
Warranty Returns
