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表征、开发、确认和常规控制要求
标准编号：ISO 14160:2011
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：2011-07
标准范围
ISO 14160:2011规定了液体化学杀菌剂的特性要求，以及液体化学杀菌剂对一次性医疗器械（包括全部或部分动物源性材料）杀菌的开发、验证、过程控制和监测要求。ISO 14160:2011涵盖了通过使用液体化学灭菌过程控制细菌和真菌污染所产生的风险。需要评估与其他微生物相关的风险。ISO 14160:2011不适用于人类来源的材料。ISO 14160:2011未描述病毒和可传播海绵状脑病（TSE）药物灭活的验证方法。ISO 14160:2011未描述原生动物和寄生虫失活、消除或消除和失活的验证方法。ISO 14160:2011中描述的验证和常规控制要求仅适用于医疗器械的规定灭菌过程，该过程在制造过程之后进行，且不考虑其他生物负载减少步骤的致命影响。ISO 14160:2011未规定确定任何选定灭菌方法对医疗器械适用性影响的试验。ISO 14160:2011不包括医疗器械中残留杀菌剂的水平。ISO 14160:2011没有描述用于控制所有制造阶段的质量管理体系。
ISO 14160:2011 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.ISO 14160:2011 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 need to be assessed.ISO 14160:2011 is not applicable to material of human origin.ISO 14160:2011 does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopath (TSE) agents.ISO 14160:2011 does not describe methods for validation of the inactivation, elimination, or elimination and inactivation of protozoa and parasites.The requirements for validation and routine control described in ISO 14160:2011 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.ISO 14160:2011 does not specify tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device.ISO 14160:2011 does not cover the level of residual sterilizing agent within medical devices.ISO 14160:2011 does not describe a quality management system for the control of all stages of manufacture.
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