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ISO 10993
Lot Release Testing
In Vivo Biocompatibility
Reusable Testing
Cadaveric Testing
100
While ISO 10993-2 outlines Animal Welfare Requirements, this group is required by federal regulations for the oversight, review and approval of animal use activities, and inspection of animal facilities at NAMSA.
What is Institutional Animal Care and Use Committee (IACUC)
100
For cleaning, disinfection, sterilization or packaging validation studies, if the client doesn't have this, our NAMSA point of contact is PS&V
What is a protocol
100
These NAMSA facilites perform Biocompatibility testing
What is Northwood and Lyon
100
How many markers does the FDA require to be included in reusable device cleaning validations
What is 2
100
This area of functional testing utilizes human tissue for the evaluation of Medical Devices
What is Cadaveric Testinmg
200
ISO 10993 requires that all medical devices be tested for these three biological effects?
What is Cytotoxicity, Sensitization and Irritation
200
Before we can initiate bioburden, product sterility, endotoxin, microbial limits, incubation or EO residuals testing, NAMSA must prepare one of these.
What is a test specification
200
In comparing the ISO and USP Irritation tests, this difference in animals makes up the greatest significance
What is 2 vs 3 rabbits ISO Intracutaneous Study = 3 Rabbits USP Intracutaneous Study = 2 Rabbits
200
What are two types of steam sterilization validation cycles that are recommended by ANSI/AAMI ST79 and available at NAMSA
What is Gravity Air Displacement; Prevacuum Air Removal
200
Aside from in-house (Minneapolis), name another location where Cadaveric studies can be performed?
What is Trade Shows, other laboratory locations and sponsor facilites
300
This is the part of ISO 10993 that pertains to Genotoxicity Testing
What is Part 3: Tests for genotoxicity, carcinogenicity & repro tox
300
What is defined as "the population of viable microorganisms on or in a product and/or sterile barrier system?
What is bioburden
300
Biocompatibility Tox test codes ending in 300s, have this significance
What is a Guinea pig test system 300s = Guinea Pig 500s = Mice 800s = Rabbit 900s = Rat
300
How many soiling/cleaning cycles has the FDA considered acceptable for automated and manual cleaning validations
What is 6
300
In addition to animal studies, Marketing and Sales departments within Medical Device companies use cadaveric testing for this type of training?
What is Physician Training
400
When genotoxicity testing is necessary, this test makes the biggest difference between ISO and FDA requirements?
What is the in vivo genotoxicity assay (Mouse Micronucleus) MHLW – AMES and CA ISO – AMES & CA or MLA FDA – AMES, CA or MLA and the In Vivo Mouse Micronucleus
400
What are the common method validation names for radiation sterilization
What is VDmax, Method 1
400
USP Class II testing consists of this testing (specifically)
What is Acute Systemic Toxicity and Intracutaneous (saline and alcohol in saline injections)
400
Do automated cleaning validations typically require pre-manual cleaning methods
What is Yes
400
Cadaver specimens are routinely screened for three common viruses. Name one of the three of these viruses.
What is Hep A, Hep B, HIV
500
How many sections of ISO 10993 directly pertain to Biocompatibility
What is 8 - parts 1, 2, 3, 4, 5, 6, 10 & 11 ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation & testing in the risk management Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity & repro tox Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 10: Tests for irritation & delayed-type hypersensitivity Part 11: Tests for systemic toxicity
500
In addition to sterilization, disinfection and durability, what else do medical device manufacturers have to prove regarding the reprocessing of their devices
What is cleanability
500
This is the amount of test and/or control extract that is injected per site with the ISO Intracutaneous Irritation method?
What is 0.2ml
500
Name four out of seven phases typically included in an automated cycle
What is Pre-Wash Pulsed-Enzyme Wash Neutralizer Rinse Thermal Rinse Drying
500
This University is the primary source of specimens for cadaveric testing at NAMSA
What is the University of Minnesota