YY 0221-1995旋转式压片机.pdf
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J.
中华 人 民共 和 国制药 机械 行业 标准
JB20019-20023-2004
药品电子计数瓶装机
旋转式压片机
高速旋转式压片机
压片机药片冲模
铝塑泡罩包装机
2004-02-05发布 2004-06-01实施
匡习舅c 是月愁不口-00-交 醉 导员 纷 发布
ICS 11.120.30
C92 J日
中华 人 民共和 国制 药 机械 行 」k标准
JB20020-2004
代替 YY0221-1995
旋 转 式 压 片 机
Rotaytabletpress
2004-02-05发布 2004-06-01实施
匡虱舅0%左 不口X!,交一直攀粤导步改雀纷 发布
招 20020-21沉辫
目 次
前言 ··········,············…… 16
1范围 4·4··················,·,················································。···。。········,········。········。。… 17
2规范性引用文件 ·一 17
3术语和定义 ············。。。···。。。···········。··············,····························.·..··············…·… 17
4 分类和标记 .·18
5要求 ············································································。。,·············。········,…… 19
6 试验方法 。··········,·,·,··························.·..···················…·…,,,二20
7 检验规则 ······················································································。·········……,,,22
8标志、说明书、包装和贮存 ····················。·。,······················…·…,,,……22
B 200202004
前 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YY0221-1995《旋转式压片机》进行的修订。
本标准自实施之日起代替YY0221-19950
本标准与YY0221-1995相比,主要技术内容改变如下:
a) 删除了、、0221-1995的主要章、条:
— 产品分类(4.1);
— 按规定程序制造要求(5.1);
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