包装有效期讨论讨论内容: 一次性高频内窥镜手术器械包装讨论验证 公司名称:_ ＿浙江舒友仪器设备有限公司 _ __ ＿＿ _ 时 间:___ 2025 年 _ 目 录1 讨论验证目得，时间及人员安排························································· 32 讨论验证方案········································································· 43 相关标准及文件······································································· 54 设备确认············································································· 65 包装验证············································································· 106 有效期讨论验证确认··································································· 147 包装及包装完整性确认································································· 238 结论················································································· 2 ８１ 讨论验证目得、时间及人员安排1、1 讨论验证目得1、１、１ 通过安装、运行与性能鉴定来证明使用得自动包装封口机功能完善，工艺可持续稳定控制，能在规定得标准范围内稳定得运行,产品性能稳定且能达到规定标准得要求.验证包装材料就是否符合 E Ｎ３ 63、I Ｓ O11607 标准要求，及包装能否满足运输存储得要求,并通过老化试验对产品得包装有效期与包装完整性进行讨论验证.１、1、2 为包装热封确定有效得工艺.1、２验证时间2025 年 2 月 — 2025 年 6 月1、3 人员安排验证小组成员工 作 内 容组长刘天国负责验证方案、验证报告得审核工作,负责验证得组织协调及不...
