In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
体外诊断医疗器械——制造商提供的用于生物学染色的体外诊断试剂的信息
发布日期:
2013-03-07
ISO 19001:2013规定了制造商提供的生物染色用试剂的信息要求。它适用于染料、染色剂、显色试剂和其他用于组织学和细胞学染色的试剂的生产商、供应商和供应商,包括在医学实验室进行的细菌学、血液学、组织化学染色,包括常规细菌学和研究细菌学。ISO 19001:2013中规定的制造商提供的信息要求是在生物学染色的所有领域获得可比和可复制结果的先决条件。
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.