论文部分内容阅读
前言 生物物质无菌性基本要求(生物物质规程第六号)系于1959年由世界卫生组织的一个研究组制订。这些基本要求对于所有不得污染微生物的生物制品都适用,并在迄今已行制订的所有单项生物物质的规程中俱已引用。第24次生物检定专家委员会同意:鉴于近来生物制品无菌试验方法的发展以及可供实用的检定方法的进展,无菌性基本要求应予修订,从而进行了此项工作。
Preface The Essential Requirements for the Sterility of Biological Substances (Biological Substances Code, No. 6) was established in 1959 by a study group of the World Health Organization. These basic requirements are applicable to all biological products that are not contaminated with microorganisms and are cited in the procedures for all single biological substances that have been established to date. The 24th Committee of Experts on Biostatistics agreed: In view of the recent developments in sterile test methods for biological products and the progress made in practical test methods, the basic requirements for sterility should be revised to allow for this.