YY 0336-2020《一次性使用无菌阴道扩张器》标准解析

Analysis on YY 0336-2020"Sterile vaginal dilator for single use"

介绍了YY 0336—2020《一次性使用无菌阴道扩张器》的制定背景,对比了YY 0336新、旧标准的主要内容变化,分析了YY 0336—2020中外观、尺寸、抗变形能力、结构强度、环氧乙烷残留量等重要条款,总结了YY 0336—2020的改进及优势。指出了YY 0336—2020的发布实施,对于生产该类产品的生产商稳步提高产品质量具有实际的指导意义,对于检验机构统一理解标准条款、统一判定尺度起到一定的推动和规范作用。

The background for developing YY 0336—2020"Sterile vaginal dilator for single use"was introduced,the main content changes between the old and new YY 0336 standards were compared,the important articles in YY 0336—2020 such as appearance,dimensions,resistance to deformation,structural strength and ethylene oxide residues were analyzed,and the improvement and advantages of YY 0336—2020 were summarized.It was pointed out that the release and implementation of YY 0336—2020 were of practical significance for manufacturers of such products to improve product quality,and for inspection bodies to unify the understanding of the standard provisions and standardize the determination scale.