制药装备 生物反应器通用技术要求（英文版）
Pharmaceutical equipment—General technical requirements for bioreactor
标准状态
发布于：2026-05-25
实施于：2026-12-01
废止
基本信息
GB/T 47606-2026
即将实施
2026-05-25
2026-12-01
11.120.30
Standardization Administration of China
State Administration for Market Regulation and Standardization Administration of China
National Technical Committee 356 on Pharmaceutical Equipment of Standardization Administration of China (SAC/TC 356)
National Technical Committee 356 on Pharmaceutical Equipment of Standardization Administration of China (SAC/TC 356)
山东新华医疗器械股份有限公司; 成都英德生物医药装备技术有限公司; 楚天科技股份有限公司; 东富龙科技集团股份有限公司; 上海高机生物工程有限公司; 山东九泽换热系统有限公司; 河南大学; 山东泓邦百年生物工程有限公司
ZHU Qingguo, LI Chunyang, YANG Wenlu, ZHENG Jinwang, JIN Kuiqi, LIU Hanqi, ZHANG Rui, WANG Dong, HAN Feifei, LIU Zhi, YAO Jianlin, LIU Qiang, HAN Qiang, LIU Yingtao, ZHAO Hao, LIU Hui, SONG Chuanbing, ZHANG Yushan, ZHANG Xianheng, DING Hongyong, SUN Yang, SONG Youxing
标准简介
This document specifies the requirements, inspection rules, marking, packaging, transport and storage of bioreactors for pharmaceutical equipment, and describes the corresponding test methods. This document is applicable to the design, manufacture, inspection and acceptance of stainless steel stirred-tank bioreactors for pharmaceutical equipment (hereinafter referred to as "bioreactors").
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