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The purpose of this plan is to identify which tests need to be performed in regards to the biological and biocompatibility testing requirements laid out in ISO 10993-1.
This document applies to products that come into contact directly or indirectly with the patient or user and require testing or risk estimation according to ISO 10993 standard.
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Coatings, dyes, or additives during the manufacturing process can affect the biocompatibility of the product should these products remain in the final product.
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The product uses the following sterilization method: Sterilizationus MethodicusSterilization impactus dolor sit amet, consectetur adipiscing elit.
Materials that degrade or elute materials over time shall have additional considerations regarding their impact on biological safety of the device.
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Hazards related to use of the device including potential biological hazards are captured as part of the risk assessment. The full list of hazards can be found below.
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Testing shall be performed on the final medical device, or representative samples from the
final device or materials processed in the same manner as the final medical device (including
sterilization, if needed).
If the combination of all materials, chemicals and processes has an established history of safe use in the intended application, and the physical properties have not changed, then it is possible that further characterization and additional data sets (e.g. chemical analysis of extracts or biological testing) will not be necessary.
As such, biological testing is chosen according to the gaps of knowledge on biological impact and biocompatibility of the materials which come into direct or indirect impact with the human body.
Refer to Annex A for the list of potential tests to be performed under ISO 10993-1.
The following table lists the tests that will be performed considering the type and user characteristics of the device.
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Reports from testing will be captured in the Biological Evaluation Report. The test protocols and results from those tests will be captured separately, as required.
