Phase 1 Tests ISO

Products that are to be sold outside of the United States must also take into consideration any requirements unique to other countries. 

If it is determined that the new material is acceptable for use in chronically implanted devices, then the following must be addressed  

Reproductive and developmental toxicity (ISO 10993-3) Reproductive/deve-lopmental toxicity tests or bioassays should only be conducted when the device has potential impact on the reproductive potential of the subject. The application site should be considered.  

ISO 10993 provides several standards for the identification and quantification of potential degradation products. Part-9 (biodegradation) states Where the potential for resorption and/or degradation exists, corresponding tests may determine the processes of absorption, distribution, biotransformation and elimination of leach-ables and degradation products of medical devices, materials and/or their extracts. This standard provides guidance for protocol development, but does not provide any test protocols. Parts 13, 14, and 15 address polymers, ceramics, and metals/alloys respectively. 

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