J B20003.5-2004-滴眼剂联动线贴标机.pdf

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1、ICS11.120.30C92J/,'中华人民共和国制药机械行」k标准JB20003.5-2004滴眼剂联动线贴标机Productionlineforeyedrops一Labellingmachine2004-02-05发布2004-06-01实施国舅鼠W)w和.!,交鞠玺导.员钾鉴纷发布JBZ003.5-Z04目次前言····························································································

2、···················⋯⋯421范围·········································································································⋯⋯432规范性引用文件··························································································⋯⋯433型号和标记··········

3、······················································································⋯⋯434要求·········································································································⋯⋯445试验方法··············································

4、·····················································⋯⋯456检验规则··········································································.········...······......⋯⋯477标志、使用说明书、包装和贮存·····································································⋯⋯’‘’

5、48JB20003.5-2004月Ii吕本标准由中国制药装备行业协会提出。本标准由制药装备行业标准化技术委员会归口。本标准起草单位:北京航天万达高技术开发中心。本标准主要起草人:王金燕、冯瑞馨、袁景洲。JB20003.5-2004滴眼剂联动线贴标机范围本标准规定了滴眼剂贴标机的标记、要求、试验方法、检验规则和标志、使用说明书、包装和贮存本标准适用于滴眼剂塑料瓶贴标机(以下简称贴标机)。2规范性引用文件下列文件中的条款，通过在本标准中引用而成为本标准的条款。凡是注日期的引用文件，其随后所有的修改单(不包

6、括勘误的内容)或修订版均不适用本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准。GB/T191包装储运图示标志GB/T5226.1-2002机械安全机械电气设备第1部分:通用技术条件GB/T6388运输包装收发货标志GB/T9969.1工业产品使用说明书总则GB/T10111利用随机数般子进行随机抽样的方法GB/T13306标牌GB/T13384机电产品包装通用技术条件GB/T16769金属切削机床噪声声压级测量方法YY/T02

7、16-1995制药机械产品型号编制方法药品生产质量管理规范(1998修订版)国家药品监督管理局中华人民共和国药典(200()版)国家药典委员会3型号和标记3.1型号贴标机的型号应符合YY/T0216的规定。DL·T口/巨二主要参数(适用瓶子直径，佃1公主要参数(生产能力，支/min)产品型式及特征代号(L一联动T--M标)产品功能代号(D-滴眼剂机械),Js20003.5-20043.2型号标记示例DL·T120/22丁几瓶子Al一一生产能力120支hnm滴眼剂联动线·贴标机4要求4.1总则贴标机的设

8、计、制造、安装、使用、维修、保养和验证应符合《药品生产质量管理规范》(1998修订版)有关原则性指令。4.2工作条件4.2.1环境温度:正常工作的环境空气温度为18℃一28`1Co4.2.2湿度:相对湿度为50%一60%o4.3材质要求4.3.1贴标机材质应无毒、耐磨蚀或经防锈处理、无微粒析出。4.3.2打印字头耐用。4.3.3打印板的材质不易老化、变形。4.4外观要求4.4.1贴标机外表面应平整、光滑，无凸起、凹陷、裂缝和死角，易清洗、消毒。4.4.2