修订附件E 单批次释放

[中文适用范围]： 灭菌产品用环氧乙烷 - 医疗器械灭菌工艺开发、验证和常规控制的要求。本修正案修订了附件E（单批放行），规定了在以下情况下释放单批产品的要求：仅存在有效灭菌工艺时；或用于临床试验产品的工艺开发；或单批放行数据可单独生成，也可作为完整验证的一部分；单批放行过程应包括对产品组成、设计、包装、生物负荷和负载密度的评估；应确认产品组成、设计、包装、生物负荷和负载密度；在验证或临床研究中，应使用内部过程挑战装置（PCD），其中包含生物指示剂，并测试灭菌参数如温度、相对湿度、压力、气体浓度等；应评估灭菌负载，确保其代表生产批次；应进行生物负荷测定、内毒素测试、包装完整性测试、EO残留测试、生物指示剂挑战测试等；灭菌负载应放置在灭菌 chamber 的最不利位置；释放标准包括确认数据在灭菌过程中满足规格、确认负载在灭菌过程中满足规格、确认测试设备无故障、确认内部PCD的灭菌能力被适当评估、确认灭菌负载在灭菌过程中满足规格、确认灭菌负载在灭菌过程中满足规格、确认生物负荷在灭菌过程中满足规格、确认灭菌过程中无微生物生长、确认灭菌过程中无内毒素污染、确认灭菌过程中无EO残留超标、确认生物指示剂挑战测试通过。 Health care products sterilization using ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. This amendment revises Annex E (Single batch release), specifying requirements for releasing single batches under conditions where: only an effective sterilization process exists; or for clinical trial product development; or where single batch release data can be generated stand-alone or as part of full validation; the process should include assessment of product composition, design, packaging, bioburden, and load density; process assessment should cover product composition, design, packaging, bioburden, and load density; internal process challenge devices (PCDs) containing biological indicators should be used, and sterilization parameters such as temperature, relative humidity, pressure, and gas concentration should be monitored; bioburden determination, endotoxin testing, packaging integrity testing, EO residue testing, and biological indicator challenge testing should be performed; the sterilization load should be placed in the most challenging location within the sterilization chamber; release criteria include confirmation that data meet specifications during the sterilization process, confirmation that the load meets specifications, confirmation that test equipment is functional, confirmation that the sterilization capacity of internal PCDs is appropriately assessed, confirmation that the load meets specifications, confirmation that bioburden meets specifications, confirmation that no microbial growth occurs, confirmation that no endotoxin contamination occurs, confirmation that no EO residue exceeds limits, and confirmation that biological indicator challenge tests pass.