J BT20077-2005-崩解仪.pdf

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1、ICS11.120.30C9备案号:16958-2006中华人民共和国制药机械行业标准JB/T20077-2005代替YY0132-1993崩解仪Disintegrationtester2005一11一28发布2006一06一01实施匡.写乏继之夕民不口}Aw-}&b发布中华人民共和国国家发展和改革委员会月匕公口2005年第71号国家发展改革委批准《送电线路带电作业技术导则》等93项行业标准(标准编号、名称及实施日期见附件)，其中电力行业标准43项、石化行业标准30项、黑色冶金行业标准4项、物流行业标准1项、制药装备行业标准12项、汽车行业标准3项，现予

2、公布。以上电力行业标准由中国电力出版社出版，石化行业标准由中国石化出版社出版，黑色冶金行业标准由冶金工业出版社出版，制药装备、汽车行业标准由中国计划出版社出版，物流行业标准由中国标准出版社出版。附件:12项制药装备行业标准编号、名称及实施日期中华人民共和国国家发展和改革委员会-00五年十一月二十八日附件:12项制药装备行业标准编号、名称及实施日期序号标准编号标准名称被代替标准编号实施日期制药机械符合药品生产质量管理78JB20067-20052006-06-01规范的通则79JB/T20068-2005结晶器YY/T0138-19932006-06-01

3、80JB/T20069-2005臣卜式安瓶机组YY0232-19952006-06-0181JB/T20070-2005立式安瓶生产线YY0233.1-19952006-06-0182JB/T20071-2005立式安瓶机YY0233.2-19952006-06-0183JB/T20072-2005离心式包衣造粒机2006-06-0184JB/T20073-2005流化床包衣机2006-06-0185JB/T20074-2005药物配料罐2006-06-0186JB/T20075-2005振动式药物超微粉碎机2006-06-0187JB/T20076-2

4、005药物溶出试验仪2006-06-0188JB/T20077-2005崩解仪YY0132-19932006-06-0189JB/T20078-2005玻璃输液瓶T型塞压胶塞机YY0235.5-19952006-06-01JB/T20077-2005目次前言····························........................................................................................f1范围·······························

5、···········································································⋯⋯12规范性引用文件·············································‘····，·············。··........·······........⋯⋯13分类和标记，··，，，············，，，·········，，，，，·········⋯⋯，，··················，，......⋯⋯，.，，.⋯14要求·········

6、································.......................................................................25试验方法·······································，·····························································⋯⋯26检验规则··，···················，，··········。······，····················

7、····································，··⋯⋯47标志、包装、运输与储存················································.....⋯⋯，，，，.......⋯⋯，.....⋯⋯4JB/T20077-2005月U吕本标准是根据《药品生产质量管理规范》和GB/T1-2000,GB/T1.2-2002(标准化工作导则》的要求，对YY0132-1993《崩解仪》进行的修订。本标准实施之日起代替YY0132-19930本标准与YY0132-1993相比，内容变化如下:1删除了YY0

8、132-1993中的部分章、条:—部分引用标准;—技术要求(4.1,4.9.1,