Definitions
Ability of a medical device or material to perform with an appropriate host response in a specific application
Biocompatibility
What is the first step of biological evaluation, according to 10993-1?
Categorization of the Device
Which ISO 10993 section addresses animal welfare requirements?
ISO 10993-2
Quantity of a constituent (3.4) that does or can contact the body by an exposure route over a specified time period
Exposure Dose
Combination of the probability of harm to health occurring as a result of adverse reactions associated with medical device or material interactions, and the severity of that harm
Biological Risk
Annex of ISO 10993-1 that details risk assessment and estimation?
Annex B
ISO 10993 standard that is owned by the sterilization team?
ISO 10993-7
Cumulative exposure dose (3.7) to an identified constituent (3.11) over a specified time period that is without appreciable harm to health
Toxicological Screening Limit
Freedom from unacceptable biological risk in the context of the intended use
Biological Safety
Table that describes endpoint selection
Table A.1
Which ISO 10993 section specifically covers ceramics?
ISO 10993-14
Lowest amount per surface area of an identified constituent (3.4) that is irritating to the tissue at the contact site as determined by valid experimental or observational evidence
Minimally Irritating Level
Any synthetic or natural substance that is used in a process for manufacturing materials (3.12) and/or medical devices (3.14), including the base material(s), additives (antioxidants, UV stabilizers, color additives, dyes, etc.), and processing aids (solvents, lubricants, antifoaming agents, etc.)
Chemical Constituent
What is the primary consideration when selecting in vitro or in vivo endpoint tests?
Intended Use of The Device
Which ISO 10993 section covers immunotoxicology standards?
ISO 10993-20
Level of exposure for constituents, below which there would be no appreciable risk to human health
Threshold of Toxicological Concern
Medical device or medical device component that has been subjected to all manufacturing processes for the “to be marketed” medical device including packaging and if applicable, sterilization
Final Product
Section of ISO 10993-1 that describes literature review
Annex C
Which set of standards describes application of risk management to medical devices?
ISO 14971
Upper-bound estimate of the lifetime cancer risk per increment of dose that can be used to estimate risk probabilities for different exposure levels
Slope Factor