ISO 17665:2024 医疗保健产品灭菌 湿热 医疗器械灭菌工艺的设定、确认和常规控制的要求

标准编号：ISO 17665:2024

中文名称：医疗保健产品灭菌 湿热 医疗器械灭菌工艺的设定、确认和常规控制的要求

英文名称：Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

发布日期：2024-03

标准范围

本文件提供了医疗器械湿热灭菌工艺的开发、验证和常规控制的要求。它还包含旨在解释规范性章节中规定的要求的指南。给出的指南旨在根据本文件促进与湿热灭菌工艺相关的良好实践。考虑在工业和医疗保健环境中的应用。

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

标准预览图