| medical Device Catalog | Table of Contents INTRODUCTION BIOBURDEN / MICROBIAL ASSAYS
Bioburden Testing
Microbial Identification
Microbial Limit Testing
Antimicrobial Assays
Bacteriostasis / Fungistasis
BIOCOMPATIBILITY
Cytotoxicity
Genotoxicology / Mutagenicity
Hemocompatibility
Implantation
Irritation / Intracutaneous
Pyrogenicity
Sensitization
Subchronic (Subacute) Toxicity
Systemic (Acute) Toxicity
Finished Product Release
REFERENCE
Biocompatibility Testing Flow Chart
Required Biocompatibility Tests for Classifications of Plastics (USP)
Device Categories
Initial Evaluation Tests for Consideration [Chart based on ISO 1993-1 and FDA G95-1 Guidelines]
"Quick Guide" to Sample Requirements and Turnaround Times
Testing Requirements Under GLP Regulations CHEMISTRY
Chemical/Physical Tests
EO Residual Testing ENDOTOXIN (LAL)
Gel Clot Tests
Kinetic Chromogenic Tests ENVIRONMENTAL
Environmental Monitoring Programs
Microbial Identification
Microbial Sampling Tests
Environmental Sampling Products PACKAGE TESTING
Seal Integrity Testing
Package Integrity Testing
Transportation/Distribution Simulation Qualification
Accelerated Aging / Shelf-Life Testing STERILITY TESTING
Bacteriostasis/Fungistasis
Biological Indicators
Inoculated Product Tests
Liquid Sterility Tests
Product Sterility Tests STERILIZATION VALIDATION
EO Half Cycle Sterilization Validation
Radiation Sterilization Validation
Reusable Medical Device Validation |
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