This depends on the product. For medical devices in the United States, quality requirements are defined by the Quality System Regulation (QSR), 21 CFR Part 820. Other quality systems can include ISO 13485 or ISO 9001. The standards used for defining, validating, and routinely monitoring electron beam sterilization processes from a technical perspective include a wide variety of documents – based on what is being sterilized – including the ISO 11137 series and ASTM E61 documents.