探索B&D测试包和带通道器械中的蒸汽穿透差异.pdf

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1、EXPLORING DIFFERENCES BETWEEN STEAM PENETRATION IN A B&D TEST PACK AND IN A CHANNELLED INSTRUMENTFrancesco TessaroloDepartment of Industrial Engineering University of TrentoINTRODUCTIONINTRODUCTIONSteam sterilization requires that all surfaces to be processed are exposed long enough to steam sterili

2、zation conditions(i.e.defined combination of temperature and time in the presence of sufficient humidity).According to standards the steam penetration capacities of a sterilizer should be tested with a steam penetration test ISO 17665:2024.TimeTemperatureSteamcompositionINTRODUCTIONINTRODUCTIONIn th

3、e early 1960s Bowie and Dick developed the first steam penetration test.This test was further developed and minimum performance requirements are defined in standards ISO 11140-3,11140-4,11140-5.The original Huckaback Towel Pack according to Dr.J.H.Bowie and Mr.J.DickTHE BOWIE AND DICK AUTOCLAVE TAPE

4、 TEST,The Lancet,(1963),S.586INTRODUCTIONINTRODUCTIONThe number of medical devices with channels is increased in last decades and a test for steam penetration in these devices would be very helpful,if not necessary.INTRODUCTIONINTRODUCTIONOften,proposed Process challenge devices(PCDs)are helix-shape

5、d and are in practice referred to as hollow A,hollow load,helix,or helix shaped PCD.These test device may look like a channel in a medical device but differ strongly in characteristics.The PCDs defined in standards and those commercially available could be described as a system of two volumes connec

6、ted by a narrow channel.On one end of the channel there is the relatively large volume of the sterilizer,and on the other end the relatively small volume of the receptacle.INTRODUCTIONINTRODUCTIONCompared to a channel with a homogeneous radius over its full length,as present in medical devices,PCD s