jb20010-2004 三维混合机

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1、J日中华人民共和国制药机械行」k标准JB20010--20013-2004三维混合机周转料斗混合机槽式混合机双锥回转式真空干燥机2004-02-05发布2004-06-01实施习氧丈W万瞪和百硬欠A&L-AZ~员J鉴纷发布ICS11.120.30C92JH中华人民共和国制药机械行」尘标准JB20010-2004::y释;e之签士n—二详IX:匕A"17‘Threedimensionalmotionsmixer2004-02-05发布2004-06-01实施EA菊之是睦不日欠鞠鳖粤员鉴纷发布JB2001仆一ZX娜目次前言·············

2、·······························································································⋯⋯41范围·································，·····。··············。，···········································⋯⋯52规范性引用文件····························。。··································

3、···················⋯⋯53术语和定义··············································································，，··。······..........⋯⋯54分类和标记·······························································································，···⋯⋯65要求··································

4、·············。·············。·，，·，，··································⋯⋯76试验方法··············································································，，·。·····，·，，··········⋯⋯77检验规则·················································································，·。·····，

5、，········⋯⋯88标志、使用说明书、包装、运输和贮存······················································..........⋯⋯9附录A(规范性附录)用苯甲酸含量测定法确定混合均匀度M的测试方法··················⋯⋯10附录B(规范性附录)清洗后洁净度试验··································⋯⋯，..............⋯⋯12JB20010-2004ol1音本标准的附录A和附录B为规范性附录。本标准由中国制药装备行业协会提出。

6、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:温州市制药设备厂。本标准主要起草人:王小伦、黄新恩、苏长华、梅庆胜、杨俊。.扭20010-2004三维混合机范围本标准规定了三维混合机(以下简称混合机)的术语和定义、分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输和贮存。本标准适用于主动轴与从动轴平行，通过万向节与Y型摇臂传动，使混合桶运行轨迹为三维空间的混合机。2规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件，其随后所有修改单(不包括勘误的内容)或修订版均不适用于本标准，然而，

7、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/T1220不锈钢棒GB/T3280不锈钢冷轧钢板GB/T3323-1987钢熔化焊对接接头射线照相和质量分级GB/T4237不锈钢热轧钢板GB5226.1-2002机械安全机械电气设备第1部分:通用技术条件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

8、量方法YY/T0216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(2000版)国家药典委员会3