It should be noted that the FDA and other regulatory bodies may only accept a portion of a ratified ISO document.  To ensure your method or testing program adheres to the appropriate agency visit the associated websites.  For FDA go to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm and select "ISO" for the Standards Organization and "Biocompatibility" for Specialty Task Group Area.