E3609 ISO 10993-5 and -10 Compliant EPDM Seal Material | Zatkoff

E3609 ISO 10993-5 and -10 Compliant EPDM Seal Material

E3609 ISO 10993-5 and -10 Compliant EPDM Seal Material


Proven Biocompatibility

Parker’s 70 durometer EPDM compound E3609-70 has successfully passed ISO 10993-5 and -10 requirements. This material is also compliant to USP Class VI and USP <87>.

ISO 10993-5 evaluates materials for their potential to kill cell cultures. ISO 10993-10 tests materials for sensitivity and biological response. These standards are accepted in both the United States and the European Union for rubber materials used in surgical instruments, drug delivery devices, pharmaceutical and biopharmaceutical manufacturing, and other medical device applications.

Benefits

  • Excellent resistance to repeated steam, gamma, ozone, and ethylene oxide sterilization
  • Compliant with ISO 10993-10 and USP Class VI biocompatibility standards
  • Compliant with ISO 10993-5 and USP <87> cytotoxicity standards
  • Low compression set
  • Temperature range -65 to +250°F
  • Compatible with all water-soluble chemistries