jbt20005.1-2004 玻璃输液瓶清洗机

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1、JH中华人民共和国制药机械行」k标准JB20005.1-20005.4-2004玻璃输液瓶联动线www.bzfxw.com2004-02-05发布2004-06-01实施虱舅之卫万录和1i-!交消声二寻导员鉴纷发布ICS11.120.30C92中华人民共和国制药机械行」坐标准JB20005.1-2004代替YY0235.1-1995玻璃输液瓶清洗机Glassinfusionbottlewashingmachinewww.bzfxw.com2004-02-05发布2004-06-01实施习舅芡是月醚和Je-欠肖薛寻导员雀纷发布.扭ZX>o51-2IX)4目次

2、前言·····································································，······。·································⋯⋯41范围··············································································································一52规范性弓}用文件··········································

3、·········································。。····⋯⋯53分类和标记···，·············，·，，···，···································································⋯⋯54要求··································，····，·············。。···，，，，···································⋯⋯65试验方法······················

4、······················································，············。··，········⋯⋯86检验规则····································································································⋯⋯97标志、使用说明书、包装和贮存··································································⋯⋯10附录A(资料

5、性附录)型式检验试验记录表··，···················································.⋯⋯12www.bzfxw.comJBZX幻5o11言本标准是根据《药品生产质量管理规范》和GB/T1.1-2000,GB/T1.2-2002标准化工作导则的要求，对YY0235.1-1995《玻璃输液瓶滚筒式清洗机》进行的修订。本标准自实施之日起代替YY0235.1-1995a本标准与YY0235.1-1995相比，主要内容改变如下;a)删除了YY025.1-1995中的3.1,3.3,4.2,4.9.2,4.11,4.

6、12,5.4条款。b)修订了YY0235.1-1995中的如下条款—标准名称改为《玻璃输液瓶清洗机》，适用范围广泛;—根据《药品生产质量管理规范》关于验证的四个步骤，对原标准中的“要求”章节的条款做了重新编排。“要求”的内容按验证顺序分类提出;—增强了试验方法的可操作性。试验方法与要求章节的内容一一对应;—对检验规则条款和内容进行了修订;—强调了电气质量要求的重要性，按GB5226.1-2002进行了修订;—机器负荷运转噪声降低到80dB(A)oc)本标准增加的主要条款:—外观质量要求(见4.3);—结构要求(见4.4);—工作条件要求(见4.5.1一4.

7、5.3,4.5.5);—控制功能、显示功能、连锁功能、保护功能的要求(见4.6.5一4.6.8);—清洗瓶子的质量要求(见4.7.4.3和4.7.4.4);—试验方法中增加了与要求内容对应的条款(见第5章);—明确了工作条件的检验www.bzfxw.com(见6.1.2);—增加了资料性附录A"型式检验试验记录表，’。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:重庆江山制药机械有限公司。本标准主要起草人:孙金莲、周杰、王远平、黄云。本标准所代替标准的历次版本发布情况为:GB11753.1-1989,YY023

8、5.1-1995"JB20005玻璃输液瓶清洗机范围本标准规定了玻