DS/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.

DS/EN ISO 14160:2011

Release Date

2011

Published By

Danish Standards Foundation

Status

Be replaced 2021-07

Replace By

DS/EN ISO 14160:2021

Latest

DS/EN ISO 14160:2021

Replace

DS/EN ISO 14160:1998

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

DS/EN ISO 14160:2011 history

• 2021 DS/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 DS/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 DS/EN ISO 14160:1998