EN ISO 14160 Sterilization of One-Use Medical Devices Containing Substances of Animal Origin - Validity and Routine Control of Sterilization with Liquid Sterilizers

This standard specifies requirements for the characterization of a liquid chemical sterilizing agent and the development, verification, process control and monitoring of sterilization with liquid chemical sterilizing agents for single-use medical devices containing materials of wholly or partly animal origin.

This standard covers the control of risks arising from bacterial and fungal contamination by applying the liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods.

• This standard does not apply to materials of human origin.
• This standard does not describe methods for validation of inactivation of viruses and infectious spongiform encephalopathy (TSE) agents.
• This standard does not describe methods for confirming inactivation or elimination of protozoa and parasites.
• The verification and routine control requirements described in this standard apply only to the defined sterilization process of a medical device performed after the manufacturing process and do not take into account the lethal effects of other bioburden reduction steps.

Guidance is provided informatively for the characterization of the liquid chemical sterilization agent and the development, validation, process control and monitoring of the sterilization with liquid chemical sterilization agents of disposable medical devices composed entirely or partially of animal origin materials.

Liquid chemical sterilizing agents traditionally used in medical devices to sterilize animal tissues may not be effective in neutralizing TSE-causing agents such as bovine spongiform encephalopathy (BSE) or scrapia. Satisfactory verification according to this standard does not necessarily indicate inactivation of such infective agents.

Manufacturing processes for medical devices containing animal tissues often involve exposure to chemicals that can significantly reduce the bioburden on the medical device. After the production process, the medical device is subjected to a certain sterilization process.

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