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Allowable Limit

 

AL-Definition

According to ISO 10993-17, AL (allowable limit) is the largest amount of a leachable that is deemed acceptable on a daily basis, when taken into the body through exposure to a medical device. This limit is expressed in dose to the patient for each applicable exposure period, and the units used are mass per unit time, e.g. milligrammes per day. The doses represent tolerable risks for medical devices under the circumstances of intended use.

 

 

UF

Uncertainty factor provides a margin of safety for allowable human exposure, derived from measurements regarding the reaction of the most sensitive animal species in order to estimate an NOAEL or a LOAEL for humans.

 

TTC

TTC (Threshold of Toxicological Concern) allows for the estimation of safe exposure levels for chemicals where toxicological data are limited or non-existent. While it is mainly used for the evaluation of impurities in pharmaceuticals and food-/feedstuff, it can also be used for safety evaluation and toxicological qualification of substances found in or intentionally added to medical devices.

 

LOAEL-/NOAEL-based approach

LOAEL (Lowest-observed-adverse-effect Level) and NOAEL (No-Observed(-Adverse)-Effect Level) data are frequently used to determine allowable limits for exposure to the leachable compounds. In several studies on different effects, relevant NOAEL (or LOAEL) is selected to form the basis of AL-calculations.

 

Approval and registration support of new
drugs and medical devices

 


Approval and license renewals with
regard to performance and safety

 


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