PCD w/ BI (3hr) for Steam, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD220-C

PCD w/ BI (3hr) for Steam, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD220-C

Usage For routine load release, especially for loads containing implants. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation). Detects inadequate air removal and steam penetration in dynamic-airremoval (pre-vacuum) and gravity displacement steam autoclaves. Conditions: vacuum-assisted steam sterilization processes at 132/135 °C ≥ 4 minutes and gravity-air displacement steam sterilization processes at 121 °C ≥ 30 minutes. Exclusive conditions for the United States:  Gravity cycles at 121 °C, 30 minutes.  Gravity cycles at 132 °C, 15/25 minutes.  Gravity cycles at 135 °C, 10 minutes.  Vacuum-assisted cycles at 132 °C, 4 minutes.  Vacuum-assisted cycles at 135 °C, 3 minutes. Applicable Regulation Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016. ISO 11140-1:2014, ISO 11138-1:2017, ISO 11138-3:2017, ANSI/AAMI ST79. Classification Class 1, according to risk. Authorization ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-4. Characteristics Porous cards system holding a Bionova® BT220 Self-contained Biological Indicator and a moving-front IT26-C Chemical Integrator (Type 5 according to ISO 11140-1: 2014). The system also contains a self-adhesive Record Card, PCDBI-C-RC, where data on sterilization cycle may be written. Cardboard box (10.5 cm x 6.5 cm x 1.8 cm approximately) with a Process Indicator (Type 1 according to ISO 11140-1: 2014). Process Indicator: Initial color: blue Final color: dark grey or black IT26-C Chemical Integrator (within the challenge device): The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. Integration condition is calibrated against the kill time of a 106 G. stearothermophilus ATCC 7953 spores’ population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. BT220 Rapid Self-contained Biological Indicator (within the challenge device): ≥ 106 G. stearothermophilus ATCC 7953 spores per vial in paper carrier. Glass ampoule with growth indicator medium. Label with chemical indicator line printed with Steam reactive ink (Color change: pink to brown).