标准编号：ISO/TS 11135-2:2008
中文名称：医疗保健产品的灭菌 环氧乙烷法 第2部分：ISO 11135-1的应用指南
英文名称：Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1
发布日期：2008-08
标准范围
This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeatthe requirements and is not intended to be used in isolation.The exclusions in ISO 11135-1 apply also to this Technical Specification.For ease of reference, the clause numbering in this Technical Specification corresponds to that inISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C ofISO 11135-1:2007 and should be used in conjunction with this Technical Specification.This guidance document is intended for people who have a basic knowledge of the principles of EOsterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1.This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
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