标准摘要
[中文适用范围]: 本国际标准规定了对制造商提供的生物学染色试剂信息的要求。 它适用于用于组织学和细胞学(包括细菌学、血液学、组织化学)染色的染料、染色剂、显色试剂和其他试剂的生产商、供应商和销售商,如在医学实验室、常规细菌学和研究细菌学中进行的染色。 本国际标准中规定的制造商提供信息的要求是在生物学染色的所有领域获得可比较和可重复结果的先决条件。 [外文原描述]: ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in ISO 19001:2013 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.
英文名称In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology