ISO/TS 17665-2:2009 医疗保健产品的湿热灭菌法 第2部分:ISO 17665-1的应用指南

标准编号:ISO/TS 17665-2:2009

中文名称:医疗保健产品的湿热灭菌法 第2部分:ISO 17665-1的应用指南

英文名称:Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1

发布日期:2009-01

标准范围

ISO/TS 17665-2:2009提供了湿热灭菌过程的开发、验证和常规控制的一般指南,旨在解释ISO 17665-1中规定的要求。本技术规范中给出的指南旨在促进与湿热灭菌工艺相关的良好实践,并帮助根据ISO 17665-1开发和验证湿热灭菌工艺的人员。

ISO/TS 17665-2:2009 provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1.

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