Product Description
25 Bis + 25 PCDs, 9kt/cs
Terragene KPCD220-2″ title=”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
UsageFor routine load release, especially for loads containing implants. Forroutine 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 sterilizationprocesses 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 minutesApplicable RegulationDesigned under Quality Management System standards ISO13485:2016/NS-EN ISO 13485:2016.ISO 11140-1:2014, ISO 11138-1:2017, ISO 11138-3:2017, ANSI/AAMIST79ClassificationClass 1, according to risk.AuthorizationANMAT (Argentinean National Administration of Drugs, Food andMedical Devices) PM 1614-4.CharacteristicsPorous cards system holding a Bionova® BT220 Self-containedBiological Indicator and a Chemical Integrator (Type 5 according to ISO11140-1:2014) printed on PCDBI-2-RC self-adhesive Record Card,where data on sterilization cycle may be written. Two possibilities fordocumentation record: the whole Record Card can be adhered, oralternatively, only the area containing the indicator may be recorded.Cardboard box (10.5 cm x 6.5 cm x 1.8 cm approximately) with aProcess Indicator (Type 1 according to ISO 11140-1: 2014).
Process Indicator:Initial color: blueFinal color: dark grey or black
PCDBI-2-RC Chemical Integrator (within the challenge device):Initial color: purpleFinal color: green100 % Toxic Heavy Metals free
