This part of ISO 10993 specifies two methods for obtaining a solution of degradation products from ceramics (including glasses). For quantification purposes. It also provides guidance on the analysis of these solutions to identify degradation products. Due to the generalized nature of this part of ISO 10993, product-specific standards that address decomposition product formation under more relevant conditions of use should be considered first, when available.
This part of ISO 10993 considers only the degradation products resulting from the chemical decomposition of ceramics. Any deterioration caused by mechanical stress or external energy is not covered. It is noted that ISO 6872 and ISO 9693 cover chemical degradation tests, but do not address analysis of degradation products.
Due to the diversity of ceramics used in medical devices and different requirements for accuracy and precision of results, specific analytical techniques are not defined. Also, this part of ISO 10993 provides no specific requirements for acceptable levels of decomposition products.
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