DIN 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
- Standard No.
- DIN EN ISO 14160:2011
- Release Date
- 2011
- Published By
- German Institute for Standardization
- Status
- 2018-05
- Replace By
- DIN EN ISO 14160:2018
- Latest
- DIN EN ISO 14160:2011
- DIN EN ISO 14160:2018
- DIN EN ISO 14160:2021-11
- Replace
- DIN EN ISO 14160:1998 DIN EN ISO 14160:2009
- 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.
DIN EN ISO 14160:2011 Referenced Document
- ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
- ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
- ISO 13408 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products*， 2012-08-01 Update
- ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 22442-2 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling*， 2020-09-15 Update
DIN EN ISO 14160:2011 history
- 2021 DIN 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
- 2018 DIN EN ISO 14160:2018 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 DIN 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
- 0000 DIN EN ISO 14160:2009
- 0000 DIN EN ISO 14160:1998
