标准编号：ISO 14160:2020
中文名称：医疗保健产品灭菌 使用动物组织及其衍生物的一次性医疗器械用液体化学灭菌剂 医疗器械灭菌工艺的表征、开发、确认和常规控制要求
英文名称：Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen
发布日期：2020-09
标准范围
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).
标准预览图
立即下载标准文件