The Association for the Advancement of Medical Instrumentation has published an updated international standard designed to help manufacturers of certain medical devices ensure their products are in fact sterile.
Most devices are sterilized using steam, but not all materials can withstand exposure to it. The standard, 14160, deals with liquid chemical sterilizing agents used on devices that utilize animal tissues and their derivatives. Charles Roberts, convener of ISO/TC 198/WG 10, Liquid Chemical Sterilization Working Group, said the updated standard contains a new feature to help manufacturers identify microorganisms that are hard to kill. It now includes an annex with a table listing rare and obscure microorganisms that manufacturers could encounter.
The formal name of the standard is: ANSI/AAMI/ISO 14160:2011, Sterilization of healthcare products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices.
Note: The list price for the standard is $100 and the AAMI member price is $50. For more information, click here.
Most devices are sterilized using steam, but not all materials can withstand exposure to it. The standard, 14160, deals with liquid chemical sterilizing agents used on devices that utilize animal tissues and their derivatives. Charles Roberts, convener of ISO/TC 198/WG 10, Liquid Chemical Sterilization Working Group, said the updated standard contains a new feature to help manufacturers identify microorganisms that are hard to kill. It now includes an annex with a table listing rare and obscure microorganisms that manufacturers could encounter.
The formal name of the standard is: ANSI/AAMI/ISO 14160:2011, Sterilization of healthcare products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices.
Note: The list price for the standard is $100 and the AAMI member price is $50. For more information, click here.
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