1 Scope
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example:
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— As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971).
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— Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17).
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— Judging equivalence of a proposed material to a clinically established material.
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— Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former.
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— Screening of potential new materials for suitability in a medical device for a proposed clinical application.
This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003).
This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.