无菌物品包装及灭菌标识参考幻灯片

1、无菌物品包装及灭菌标识,专科业务培训 周春翠,定义,无菌物品：经过灭菌处理的物品叫做无菌物品 手术物品要求 凡进入无菌体腔的物品，必须经过灭菌处理。 灭菌的方式 化学灭菌 物理灭菌,2,手术物品灭菌前要求,最贵的包装成本是包装失败,包装的重要性：,3,包装定义,包装是指在流通过程中保护产品、方便储存、促进销售，按一定技术方法而采用的容器、材料及辅助物等等总体名称,包括为了达到上述目的而进行的操作活动。,包装的目的：延续灭菌后的效果到使用前 保证无菌器械、物品使用前还能保持无菌的状态,4,包装的功能,保护功能,方便功能,防止产品的破损变形 防止产品发生化学变化 防止有害生物对产品的影响 防止异物

2、混入、污物污染、丢失、散失。,方便产品储存 方便产品装卸,5,医疗器械灭菌包装的关键,包装材料和灭菌方式相适应 包装材料与灭菌物品的兼容性 包装的完整性和保护性 经过灭菌的指示性 无菌状态的维持性能 洁净开口性,6,强制性卫生行业标准（ 2009年4月1日正式颁布）,WS310.1医院消毒供应中心 第1部分管理规范； WS310.2医院消毒供应中心 第2部分清洗消毒及灭菌技术操作规范； WS310.3医院消毒供应中心 第3部分清洗消毒及灭菌效果监测标准,7,包装材料分类,硬质容器 无纺布,纺织品,WS310.1 第1部分 管理规范,一次性医用皱纹纸 纸塑袋 纸袋,应符合GB/T 19633的要

3、求,8,包装材料（符合GB/T 19633的要求）,一次性医用皱纹纸、纸塑袋、纸袋、纺织品,9,包装材料,硬质容器,无纺布,10,GB/T 19633的要求,使用棉布包装材料 包布除四边外不应有缝线，不应缝补 初次使用前应高温洗涤脱脂去浆、去色 应有使用次数的记录 为非漂白织物 使用不符合质量标准的包布，视为灭菌包失效,11,GB/T 19633的要求,清洗消毒及灭菌技术操作规范 5.7.8.1灭菌包装材料应符合GB/T19633的要求。开放式的储槽不应用于灭菌物品的包装。纺织品包装材料应一用一清洗，无污渍，灯光检查无破损。,12,GB/T 19633的要求,纸塑袋、纸袋等密封包装其密封宽度应

4、6mm，包内器械距包装袋封口处2.5。 硬质容器应设置安全闭锁装置，无菌屏障完整性破坏时应可识别。,13,包装材料的对比,14,WS310.3 第3部分 清洗消毒及灭菌效果监测标准,5.9.5 无菌物品储存有效期 5.9.5.2医用一次性纸袋包装的无菌物品，有效期宜为1个月；使用一次性医用皱纹纸、医用无纺布包装的无菌物品，有效期宜为6个月；使用一次性纸塑袋包装的无菌物品，有效期宜为6个月。硬质容器包装的无菌物品，有效期宜为6个月。,15,GB/T196332005最终灭菌医疗器械的包装 棉布没有列入标准之内 逐步淘汰！,无菌物品灭菌标识,16,Diagram,ThemeGallery is a

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6、all developed by Guild Design Inc.,Click to add Text,Click to add Text,Click to add Text,Click to add Text,17,包装分类,Product,工作包装和商业包装两个大类,按包装层次不同，包装可分为个包装、中包装、外包装,Product,容器质地不同，包装可分为硬包装、半硬包装和软包装,使用范围，包装可分为专用包装和通用包装,Product,按包装使用的次数，包装可分为一次用包装、多次用包装和周转用包装,1,100,000,18,现代医学包装材料,纸和纸塑,玻璃包装材料,棉布包装,铝铂包装,无

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