1.1 该分类适用于所有工业微生物，包括经典衍生微生物和通过基因工程方法生产的微生物。 1.2 这种分类的范围不包括植物和动物。这种分类不适用于任何来自工业微生物的下游产品，除非它们含有微生物脱氧核糖核酸（DNA）。 1.3 该分类包括特定工业微生物菌株的基因型类别、生物安全性、使用模式/意图和DNA序列信息范围。 1.4 单位- 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 工业微生物工程技术发展迅速，公众、监管机构和工业部门需要新的工具来帮助评估生物技术产品 ( 1. ) 3. . 特别是，需要澄清许多工业微生物菌株中存在的遗传改变的性质和意图 ( 2. , 3. ) . 4.2 目前，没有系统的分类系统来帮助区分工程工业微生物的许多亚型 ( 4. , 5. ) . 为此，开发了工业微生物分类系统，旨在促进工业微生物和生物技术部门的商业应用和发展。 4.3 该分类将适用于所有预期用途的微生物，广义上称为“工业微生物”除了包含微生物DNA的任何产品外，该分类还包括活菌和非活菌。 4.4 该分类不适用于不含微生物DNA的工业微生物的下游产品，例如，工业微生物产生的高纯度蛋白质或小分子。

1.1 This classification applies to all industrial microorganisms, both classically derived and those produced through genetic engineering methods. 1.2 The scope of this classification does not include plants and animals. This classification would not be applied to any downstream products derived from industrial microorganisms unless they contain microbial deoxyribonucleic acid (DNA). 1.3 This classification includes fields for genotype class, biosafety, mode/intent of use, and the extent of DNA sequence information for a given industrial microbial strain. 1.4 Units— The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 The technology to engineer industrial microorganisms (IMs) is evolving rapidly and the public, regulatory bodies, and industrial sectors require new tools to help evaluate the products of biotechnology ( 1 ) 3 . In particular, there is a need to clarify the nature and intent of genetic alterations present in many industrial microbial strains ( 2 , 3 ) . 4.2 Currently, there is no systematic classification system to help differentiate among the many subtypes of engineered industrial microorganisms ( 4 , 5 ) . In response, a classification system for industrial microorganisms has been developed with the intent of facilitating the commercial use and development of industrial microorganisms and the biotechnology sector in general. 4.3 This classification will be applied to all microorganisms for which there is an intended use, broadly referred to as “industrial microorganisms.” This classification covers both viable and non-viable microorganisms, in addition to any product that contains microbial DNA. 4.4 This classification is not intended to apply to downstream products of industrial microorganisms that do not contain microbial DNA, for example, highly purified proteins or small molecules produced by industrial microorganisms.