ISO 10993: Degradation And Percentage

1 .Scope
This part of ISO 10993 provides guidance on -
⦁ general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use
⦁ two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test
⦁ considers only those degradation products generated by a chemical alteration of the finished polymeric device
2. Normative references
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods.
ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing.
ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

4.1.10 Determination of the mass balance after removal from test solution sample shall be rinsed with adequate quantities of analytical grade water sample and the debris eventually obtained from the separation apparatus shall be dried to a constant mass after that the mass balance shall be determined.
4.1.11 Final material characterization
The material shall be determined using the same methods as used in the initial material characterization.
4.2 Accelerated degradation test
4.2.1 Temperature temperature greater than 37 °C and below the melting or softening range of the polymer
4.2.2 Test periods intended use is longer than 30 days - test periods of 2 and 60 days shall be used. intended use is less than 30 days - test periods of 2 and 7 days shall be used.
Additional test periods may be chosen depending on the polymer under investigation or the intended use of the device
4.3 Real-time degradation test
4.3.1 Temperature
Carry at the test temp 37 °C ± 1 °C.
4.3.2 Test period intended use is longer than 30 days- test periods of 1 month, 3 months, 6 months and 12