ISO 11737-1:2018规定了医疗保健产品、成分、原材料或包装上或包装中活微生物种群的计数和微生物特征的要求，并提供了指导。 注1:微生物特性的性质和范围取决于生物负荷数据的预期用途。 注2:关于第1条至第9条的指导，见附件A。 ISO 11737-1:2018不适用于病毒、朊病毒或原生动物污染物的计数或鉴定。这包括去除和检测海绵状脑病的病原体，如羊瘙痒病、牛海绵状脑病和克雅氏病。 注3:ISO 22442-3、ICH Q5A（R1）和ISO 13022中提供了灭活病毒和朊病毒的指南。 ISO 11737-1:2018不适用于医疗保健产品生产环境的微生物监测。

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442？3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.