PCD w/ BI (3hr) for Steam, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD220-2

PCD w/ BI (3hr) for Steam, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD220-2

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 Chemical Integrator (Type 5 according to ISO 11140-1:2014) printed on PCDBI-2-RC self-adhesive Record Card, where data on sterilization cycle may be written. Two possibilities for documentation record: the whole Record Card can be adhered, or alternatively, only the area containing the indicator may be recorded. 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 PCDBI-2-RC Chemical Integrator (within the challenge device): Initial color: purple Final color: green 100 % Toxic Heavy Metals free