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.
CONFORMITY :
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:
MDD 93/42;
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.
