NAMSA Test Navigator

It can be overwhelming to understand which testing is required for a medical device to meet all regulatory requirements. We have taken some of the stress out of that process. Answer a few quick questions below to learn which tests may be applicable. After reviewing the results schedule a free consultation with a NAMSA testing specialist to discuss your specific device and situation.

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NAMSA Test Navigator

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21CFR177.1520 polyethylene

21CFR177.1520 polypropylene or polymethylpentene

AATCC Test Method 100

AATCC Test Method 147

AATCC Test Method 174 Part I

AATCC Test Method 174, Part II

AATCC Test Method 174, Part III

AATCC Test Method 30, Part III

Absorption Capacity Testing for Chemistry

ADA Oral Toxicity Study

Aging/Thermal Conditioning – Program Schedule

Alkaline Phosphatase Activity

Alkaline Phosphatase Activity Determ. – ALP Assay Kit

Anion and Cation analysis by Ion Chromatography

Antimicrobial Evaluation Pink Stain Test

ASTM Condom Testing

ASTM D2240 Durometer Hardness

ASTM E2149 Test Method

ASTM Hemolysis

ASTM Partial Thromboplastin Time

Automated Washer/ Disinfector Cycle for validation of processing/ reprocess of medical devices

Bacteriostasis / Fungistasis

Bioburden Recovery Validation – Inoculative

Bioburden Recovery Validation – Repetitive

Biological Risk Assessment / Safety Evaluation Plan

Blank Glassware Analysis – Analysis of Semi-Volatile Organic Residuals Gas Chromatography

Bone Morphogenic Protein 2 (BMP-2) – In Vitro Osteoinduction Test

Burst and Creep Package Evaluation Tests

C3a Complement Activation Assay

Carbohydrate Analysis, in support of cleaning studies

Carcinogenicity Study

CFR General Safety Study

Chemical / Physical Characterization – Information

Chemical Residue by Gravimetric Analysis

Chronic Systemic Toxicity Study in Subjects Following Implant

Cycles performed in the automated washer/disinfector

Cytotoxicity Study – Colony Assay – Japanese MHLW

Cytotoxicity Study – ISO Direct Contact Method

Cytotoxicity Study Using the Agarose Overlay Method

Cytotoxicity Study Using the ISO Agarose Overlay Method

Cytotoxicity Study Using the ISO Elution Method

Cytotoxicity Study Using the MEM Elution Method

Cytotoxicity Study Using the USP Agar Diffusion Method

Cytotoxicity Study Using the USP Elution Method

Demineralized Bone PrepaSubjection

Determination of Extractable Elements by Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES) Full Scan

Determination of Extractable Semi – Volatile Organic Compounds by GC/MS

Determination of Extractable Volatile Organic Compounds by Headspace GC/MS

Digestion of Samples for ICP

DNA Microbial ID with MicroSEQ

Dry Heat Survival/Kill Time Verification

Environmental Monitoring of Viable Organisms

EO Survival/Kill Time Verification

EP 3.2.9 and USP Monograph Testing

EP Monograph Testing

EP Pyrogen Study

Ethylene Glycol Analysis

Ethylene Oxide Analysis

Exaggerated Extraction Procedure – Japanese MHLW

Exhaustive Extraction

External Standards Testing

Extraction of Medical Devices for Cleaning Studies

FHSA Dermal Toxicity Study

FHSA Ocular Irritation Study

FHSA Oral Toxicity Study

FHSA Skin Irritation Study

Filter Effectiveness Study (HIMA)

Gas Chromatography

Genotoxicity – Mouse Lymphoma Assay

Genotoxicity – Mouse Lymphoma Assay.

Genotoxicity – Bacterial Reverse Mutation Study

Genotoxicity – Bacterial Reverse Mutation Study – Japanese MHLW

Genotoxicity – Bacterial Reverse Mutation Study.

Genotoxicity – Chromosomal Aberation / Mammalian Cells

Genotoxicity – Chromosomal Aberation / Mammalian Cells – Japanese MHLW

Genotoxicity, Mouse Peripheral Blood Micronucleus Study

Gram Stain and Colony Morphology

Gurley Method Air Permeance Determination