Steam sterilization method for artificial organ assemblies and resultant sterilized product

Claim 1

A steam sterilization method for an artificial organ assembly which includes an artificial organ having a built-in body fluid treatment mechanism which has a body fluid inlet port and a body fluid outlet port, comprising: connecting a body fluid inlet line of an extracorporeal body fluid circulation mechanism to said body fluid inlet port; connecting a body fluid outlet line of said extracorporeal body fluid circulation mechanism to said body fluid outlet port; said extracorporeal body fluid circulation mechanism including a drip chamber and a pump tube coupled between said inlet and outlet lines; filling said artificial organ and said extracorporeal body fluid circulation mechanism with a liquid harmless to the human body, and sealing said artificial organ and extracorporeal body fluid circulation mechanism; at least one of said artificial organ and said extracorporeal body fluid circulation mechanism having an expandable member; hermetically accommodating, enclosing and vacuum-packing said artificial organ and extracorporeal body fluid circulation mechanism in a sealed steam permeable package in a vacuum-packed state without water disposed between said package and said organ and extracorporeal body fluid circulation mechanism; said package, artificial organ and extracorporeal body fluid circulation mechanism comprising said artificial organ assembly; and steam sterilizing said artificial organ assembly in the sealed vacuum-packaged state at a temperature ranging from 100° to 130° C. and under a pressure ranging from 1 to 3 kg/cm 2 of pressure (gauge pressure), wherein any expansion of said harmless liquid during the steam-sterilization is absorbed by said expandable member and any gas generated by the steam-sterilization can be trapped in said drip chamber of said extracorporeal body fluid circulation mechanism.