PCD, ULTRA RAPID, w/ BI (20MIN) for Steam, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD224-C

PCD, ULTRA RAPID, w/ BI (20MIN) for Steam, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD224-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 dynamicair-removal (pre-vacuum) and gravity displacement, steam autoclaves. Conditions: 132/135 ºC ≥ 4 minutes steam sterilization processes. Exclusive conditions for United States:  Gravity cycles at 132 °C, 10 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 Systems 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 The kit consist of 25 Porous cards systems plus a Bionova® BT224 Self-Contained Biological Indicator (SCBI) box (25 units). Each porous cards system contains a BT224 SCBI, an IT26-C moving-front Type 5 Integrator Indicator and a self-adhesive Record Card, PCDBI-C-RC, where data on sterilization cycle may be written. Process Indicator: Initial color: blue. Final color: dark grey or black. IT26-C Integrator Indicator (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 spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 ºC, 128 ºC, 135 ºC