ISO/TS 11135-2:2008 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

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

ISO/TS 11135-2:2008为ISO 11135-1:2007中的要求提供了指南。它不重复这些要求，也不打算单独使用。ISO 11135-1中的除外条款也适用于本技术规范。本指导文件适用于对环氧乙烷灭菌原理有基本了解，但在确定如何最好地满足ISO 11135-1中包含的要求时可能需要帮助的人员。本文件不适用于缺乏EO灭菌原理基本知识的人员。

ISO/TS 11135-2:2008 provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification.This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization 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.

标准预览图