EN ISO 14160:2011 PDF

Scope: This International Standard 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 International Standard 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 International Standard is not applicable to material of human origin. This

EN ISO 14160:2011 Referenced Document

ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
ISO 13408-3:2006 Aseptic processing of health care products - Part 3: Lyophilization
ISO 13408-4:2005 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ISO 13408-5:2006 Aseptic processing of health care products - Part 5: Sterilization in place
ISO 13408-6:2005 Aseptic processing of health care products - Part 6: Isolator systems
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes

2021 EN ISO 14160:2021 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 pr
2011 EN ISO 14160:2011 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 pr
1998 EN ISO 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ISO 14160: 1998