Archives: Tests
Genotoxicity – Mouse Lymphoma Assay.
Carcinogenicity Study
Genotoxicity – Bacterial Reverse Mutation Study.
Subacute – Subchronic Systemic Toxicity Study Following Implant
Subacute – Subchronic Systemic Toxicity Study Following Implant.
ISO Muscle Implantation Study.
ISO Pyrogen Study – Material Mediated
Genotoxicity – Chromosomal Aberation / Mammalian Cells – Japanese MHLW
Genotoxicity – Bacterial Reverse Mutation Study – Japanese MHLW
Cytotoxicity Study – Colony Assay – Japanese MHLW
ISO-10993-18 Chemical Characterization
Biological Risk Assessment / Safety Evaluation Plan
ISO Pyrogen Study – Material Mediated.
Gram Stain and Colony Morphology
USP/NF Monograph Testing – Potentiometric Titration
ADA Oral Toxicity Study
CFR General Safety Study
Oral Mucosal Irritation Study – Surgical Method
Intravitreal Injection Study
JP Systemic Toxicity Study
USP Muscle Implantation Study
Bioburden Recovery Validation – Repetitive
Zone of Inhibition
Environmental Monitoring of Viable Organisms
Filter Effectiveness Study (HIMA)
AATCC Test Method 30, Part III
Bioburden Recovery Validation – Inoculative
AATCC Test Method 100
Identification of Fungi Using an Automated Biochemical System
Kirby-Bauer Susceptibility Test
Sterility Dose Set
Preservative Effectiveness Test USP
Microbiological Examination of Nonsterile Products; USP 61 Microbial Enumeration Test, and USP 62 Test For Specified Microorganisms
Sterilization – EO Conventional Chamber
Bacteriostasis / Fungistasis
Alkaline Phosphatase Activity
Sterility-Inoculated Product
AATCC Test Method 147
AATCC Test Method 174 Part I
AATCC Test Method 174, Part II
USP Growth Promotion
USP (LAL) Test – Kinetic Turbidimetric Method (Pos, Neg, Inhib)
USP (LAL) Testing – Gel – Clot Method
USP (LAL) Limulus Amebocyte Lysate Testing, Kinetic-Chromogenic
In Vivo Osteoinduction Assay
Bone Morphogenic Protein 2 (BMP-2) – In Vitro Osteoinduction Test
Sterility-in situ-Product
Sterility Positive Investigation Report
Sterility-Direct Transfer Method
AATCC Test Method 174, Part III
Antimicrobial Evaluation Pink Stain Test
USP <1227>
USP <55> Total Viable Spore Count
ASTM E2149
DNA Microbial ID with MicroSEQ
Sterility – Membrane Filtration
ICH Stability Aging Chambers
Ultra Performance Liquid Chromatography/Mass Spectrometry (UPLC/MS)
Determination of Extractable Volatile Organic Compounds by Headspace GC/MS
Residual Acetate Determination by Ion Chromatography
Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan
Rotational Viscosity Determination
USP Cysteine Hydrochloride – Assay and Loss on Drying
Specific Gravity of Liquids
Blank Glassware Analysis – Analysis of Semi-Volatile Organic Residuals Gas Chromatography
USP <661>, Containers – Plastics, Polypropylene Container, Complete
USP <671>, Containers, Light Transmission
Visual Inspection of Medical Packaging to Determine Integrity
External Standards Testing
Preliminary Extraction Test – Japanese MHLW
Exaggerated Extraction Procedure – Japanese MHLW
Determination of Extractable Semi – Volatile Organic Compounds by GC/MS
Exhaustive Extraction
ISO Ophthalmic Implants – Intraocular Lenses: Test for Hydrolytic Stability
Chemical Residue by Gravimetric Analysis
Package Seal Dye Penetration for Glass Vials
Determination of Extractable Elements by Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES) Full Scan
USP/NF Monograph Testing – Potentiometric Titration
Inoculation
Total Viable Spore Count
EO Survival/Kill Time Verification
Dry Heat Survival/Kill Time Verification
Steam Sterilization
Spore Stain
Bioburden
Cycles performed in the automated washer/disinfector
Extraction of Medical Devices for Cleaning Studies
Protein Analysis, in Support of Cleaning Studies
Hemoglobin Analysis, in support of cleaning studies
Carbohydrate Analysis, in support of cleaning studies
21CFR177.1520 polypropylene or polymethylpentene
21CFR177.1520 polyethylene
Transportation Simulation Testing
Soiling and Manual Cleaning of Medical Devices
Soiling and Automated Cleaning of Medical Devices
Identification of Microorganisms – Aerobic Bacteria/Yeast
Gurley Method Air Permeance Determination
Automated Washer/ Disinfector Cycle for validation of processing/ reprocess of medical devices
Anion and Cation analysis by Ion Chromatography
Digestion of Samples for ICP
EP 3.2.9 and USP Monograph Testing
USP Glass Container Testing, Complete
USP Polyethylene Container Testing, Complete
USP Polyethylene Terephthalate Bottle Testing
JP Test for Rubber Closure for Aqueous Infusions
Demineralized Bone PrepaSubjection
Osteoinduction Activity – C2C12 Cell Culturing
Protein Concentration Determ. – Bicinchoninic Acid (BCA) Kit
Alkaline Phosphatase Activity Determ. – ALP Assay Kit
Chronic Systemic Toxicity Study in Subjects Following Implant
Systemic Toxicity Study – Repeated Parenteral Subjection
Absorption Capacity Testing for Chemistry
pH Determination
USP Physicochemical Tests for Plastics (Aqueous), Complete
Physicochemical Tests for Elastomeric Closures, Complete
ISO Vaginal Irritation Study
USP Systemic Toxicity Study – Extract
FHSA Dermal Toxicity Study
USP Safety Study
Maximization Sensitization Study – Japanese MHLW
ISO Closed Patch Sensitization Study
ISO Maximization Sensitization Study
USP Acute Toxicity Study
Systemic Toxicity Study – Japanese MHLW
ISO Acute Systemic Toxicity Study – Extract
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