Placed this test inside the autoclave to win a much more significant result and ensure the control and the traceability during the sterilization sequences.
PRACTICALITY & SIMPLICITY:
The device is inserted into every load to sterilized in a steam autoclave to verify the penetration of the vapor inside the device.
The indicator ink passes of yellow to black indicates that all the parameters of sterilization were respected.
Not invasive devices, directive 93 / 42 / EEC
Products HELIX TEST PROCESS CHALLENGE DEVICE ( PCD) is controlled in every stage of the production as expected by the Management system of the company according to the standard UNITED EN ISO 9001:2008 " Management systems of the quality " and the standard UNITED EN ISO 13485:2004
The device HELIX TEST is produced in the respect for the following laws and regulations:
UNI CEI EN ISO 14971: 2009, " Application of the risk management of medical devices "
EN 11140-1: 2005 " medical products sterilization" - chemical Indicators
UNI EN 867-5: 2004 " non-biological systems for the use in the sterilizers - Specifications for indicators and for devices performance test of the small sterilizers Type B and Type S.