YY/T 1544-2017 in English
VALIDEthylene oxide sterilization safety and effectiveness basic supply requirements
- Issued on:2017-05-02
- Implemented on:2018-04-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
Price(USD)：
$220.00
$214.00
$214.00
本标准规定了环氧乙烷灭菌系统的质量管理体系、管理职责、人员要求、基础设施、工作环境、环氧乙烷灭菌系统的设计、环境监测等要求。
本标准适用于环氧乙烷灭菌，为环氧乙烷灭菌安全有效提供基础保障。
本标准不适用于规范环氧乙烷灭菌器性能、使用以及环氧乙烷灭菌工艺要求。
Introduction
This standard provides foundational requirements for ensuring the safety and effectiveness of ethylene oxide sterilization processes. It outlines essential criteria that must be met to guarantee consistent and reliable sterilization outcomes. The document covers key aspects such as equipment specifications, operational procedures, and quality control measures. It also includes guidelines for monitoring and validating the sterilization process to maintain product integrity. Additionally, it addresses environmental factors and personnel training necessary for safe handling and application of ethylene oxide. The standard aims to establish a uniform framework for sterilization practices across relevant industries.
*** Please note: This description may not be accurate, please refer to the official documentation.
Sample only — not a preview of YY/T 1544-2017
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