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AAMI BE83 pdf free download

AAMI BE83 pdf free download.Biological evaluation of medical devices—Part 1 8: Chemical characterization of materials.
5 General principles Consideration of the chemical characterization of the materials from which a medical device is made is a necessary first step in assessing the biological safety of the device. It is also important in judging equivalence of a) a proposed material to a clinically established material, and b) a prototype device to a final device. Qualitative data shall be obtained to describe the chemical composition of a material. When relevant to biological safety, quantitative data shall also be obtained. For some materials compositional information may be readily available as part of the material specification. Materials such as polymers may possess more complex formulations and compositional details should be obtained from the supplier of the material. In the absence of such details appropriate analytical techniques should be applied to a material to yield compositional data. Identification of the constituents of a material intended for use in the manufacture of a medical device enables the intrinsic toxicity of each constituent to be investigated. The data obtained are intended for use by the medical device manufacturer as part of the overall biological safety evaluation of the medical device. It is therefore important that controls should be introduced to prevent a material supplier from changing the composition of a material supplied under a specific commercial trade name or supply agreement without prior notification to the medical device manufacturer. The manufacturer should assess the consequences of any notified changes on the biological safety of the product. Any of the constituents of a material or additives used in the process of manufacture of a medical device are potentially bio-available. However it is necessary to obtain information demonstrating the extent to which the constituents will be available under the actual conditions of use of the finished product to estimate the risk arising from them. This can be estimated from extraction tests on the material. Appropriate extraction conditions (simulated extraction) are used to ensure that any constituent which is likely to be released during finished product use will be released into the extraction media. The extract obtained can be analysed qualitatively and/or quantitatively to generate data that can then be used in the biological safety evaluation of the medical device. The extent of chemical characterization required should reflect the nature and duration of the clinical exposure and shall be determined by the toxicological risk assessor based on the data necessary to evaluate the biological safety of the device. It will also reflect the physical form of the materials used, e.g. liquids, gels, polymers, metals, ceramics, composites or biologically sourced material. The successful completion of the chemical characterization outlined in this document requires the close collaboration of material scientists, analytical chemists and toxicological risk assessors. In this partnership, the material scientist and analytical chemist provide the necessary qualitative and quantitative data that a risk assessor may use to determine device safety.
6 Characterization procedure 6.1 General The generation of chemical characterization data is a process linked to risk assessment. The chemical characterization requirements and guidance are specified in Subclauses 6.2 to 6.3. The analytical methods shall be selected to give the required information for the toxicological evaluation. If suitable methods cannot be identified, appropriate new methods shall be developed. Prior to new method development, existing standards, monographs, scientific articles or other relevant scientific documents should be consulted to check for existing appropriate test methods. Methods from the literature may need to be adapted and validated before use.AAMI BE83 pdf download.

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