Biological Indicater 50/Box BT222 1HR
Bionova® BT223 1HR Ultra Rapid for Vacuum assisted steam or Gravity air displacement steam sterilization processes
Spore: (ATCC 7953). in a 105 or 106 population.
Applicable regulations: IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3.
Exposure conditions: box:
USAGE
Monitoring dynamic-air-removal (pre-vacuum) steam sterilization processes at 121 ºC – 135 ºC and gravity steam sterilization processes at 121 ºC – 135 ºC.
Applicable Regulation ISO 11138-1:2006 and ISO 11138-3:2006; IRAM 37102-1:1999 and IRAM 37102-3:1999
Classification Class 1, according to risk.
Authorization Designed under Quality Managment Systems standards ISO 9001:2008 and ISO 13485:2012. ANMAT (Argentinean National Administration of Drugs, Food and Medical Technology) PM 1614-1.