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DIN EN ISO 14160-2011

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特性、设定、确认和常规控制的要求

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 p

适用范围: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.

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