PCD kit for Steam with BI (1h), IT26-C Integrator Indicator, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD222-C

PCD kit for Steam with BI (1h), IT26-C Integrator Indicator, 25 Bis + 25 PCDs, 9kt/cs , Terragene KPCD222-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. Condition: 132/135 ºC ≥ 4 minutes and 121 ºC ≥ 30 minutes, steam sterilization processes. Applicable Regulation EN ISO 11140-1:2009, ISO 11138-1:2006, ISO 11138-3:2006, ANSI/AAMI ST79 Classification Class 1, according to risk. Authorization Designed under Quality Management System standards ISO 13485:2003/NS-EN ISO 13485:2012. ANMAT (Argentinean National Administration of Drugs, Food and Medical Technology) PM 1614-4. Characteristics Porous cards system holding a Self-contained Biological Indicator and IT26-C moving-front Class 5 Integrator Indicator. 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 6.6 cm x 1.8 cm) with a Class 1 Process Indicator printed. 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 spores’ population, calculated in BIER (Biological Indicator Evaluator). Conditions: saturated steam at 121 ºC, 128 ºC, 135 ºC. Self-contained Super Rapid 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). Final results: by fluorescence after incubation for 1 hour at 60 ºC (sensitivity 97%). A 7-day readout is optional to confirm 1-hour results by color change. NOTE: If sterilization process was not successful, indicator medium will turn yellow after incubation, thus indicating the presence of living G. stearothermophilus spores. If sterilization process was successful, indicator medium will remain purple after incubation