DSF/prEN ISO 14160 ( Draft )

Sterilization of health care 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 (ISO/DIS 14160:2018)



This document specifies requirements for the characterization of a liquid chemical sterilizing agent
and for the development, validation, process control and monitoring of sterilization by liquid chemical
sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by
application of a liquid chemical sterilization process. Risks associated with other microorganisms can
be assessed using other methods (see Note 1).
This document is not applicable to material of human origin.
This document does not describe methods for the validation of the inactivation of viruses and
transmissible spongiform encephalopathy (TSE) agents (see Note 2 and Note 3).
This document does not describe methods for validation of the inactivation or elimination of protozoa
and parasites.
The requirements for validation and routine control described in this document are only applicable
to the defined sterilization process of a medical device, which is performed after the manufacturing
process, and do not take account of the lethal effects of other bioburden reduction steps (see Note 4).
This document does not specify tests to establish the effects of any chosen sterilization process upon
the fitness for use of the medical device (see Note 5).
This document does not cover the level of residual sterilizing agent within medical devices (see Note 6).
This document does not describe a quality management system for the control of all stages of
manufacture (see Note 7).
NOTE 1 – The prior application of risk management principles to medical devices utilizing animal tissues, as
described in ISO 22442-1, is important.
NOTE 2 – Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices
might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy
(BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate
inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal
materials are described in ISO 22442-2.
NOTE 3 – The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE
agents is described in ISO 22442-3.
NOTE 4 – Manufacturing processes for medical devices containing animal tissues frequently include
exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the
manufacturing process, a medical device is exposed to a defined sterilization process.
NOTE 5 – Such testing is a crucial part of the design and development of a medical device.
NOTE 6 – ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents

Number of pages: 48

International relationships : prEN ISO 14160 IDT ISO 14160:2020 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: M322866



  • CEN/TC 204
  • ISO/TC 198

Danish committee