首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 ISO 19001:2013
到馆阅读
收藏跟踪
购买正版
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.
分类信息
发布单位或类别: 国际组织-国际标准化组织
关联关系
研制信息
归口单位: ISO/TC 212
相似标准/计划/法规
现行
DIN EN 12376
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;德文版EN 12376:1999
1999-04-01
现行
BS EN ISO 19001-2013
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
体外诊断医疗设备 制造商提供的用于生物学染色的体外诊断试剂的信息
2013-08-31
现行
YY/T 0639-2019
体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息
In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
2019-07-24
现行
UNE-EN 12376-1999
IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
体外诊断医疗设备 制造商提供的用于生物学染色的体外诊断试剂的信息
1999-07-20
现行
BS EN ISO 18113-2-2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for professional use
体外诊断医疗设备 制造商提供的信息(标签)
2012-01-31
现行
BS EN ISO 18113-4-2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for self-testing
体外诊断医疗设备 制造商提供的信息(标签)
2012-01-31
现行
BS EN ISO 18113-3-2011
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for professional use
体外诊断医疗设备 制造商提供的信息(标签)
2011-11-30
现行
BS EN ISO 18113-5-2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for self-testing
体外诊断医疗设备 制造商提供的信息(标签)
2012-01-31
现行
GOST R ISO 19001-2021
Медицинские изделия для диагностики in vitro. Информация, предоставляемая изготовителем с диагностическими реагентами in vitro, применяемыми для окрашивания биологических материалов
体外诊断医疗设备 制造商提供的关于生物材料染色用体外诊断试剂的信息
现行
GB/T 29791.5-2013
体外诊断医疗器械 制造商提供的信息(标示) 第5部分:自测用体外诊断仪器
In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 5:In vitro diagnostic instruments for selftesting
2013-10-10
现行
GB/T 29791.4-2013
体外诊断医疗器械 制造商提供的信息(标示) 第4部分:自测用体外诊断试剂
In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftesting
2013-10-10
现行
KS P ISO 19001
체외진단용 의료기기 — 생물학에서 염색을 위한 체외진단 시약에 대하여 제조자가 제공하여야 할 정보
在virto诊断医疗设备中 制造商提供的用于生物染色的体外诊断试剂信息
2017-12-29
现行
KS P ISO 19001(2022 Confirm)
체외진단용 의료기기 — 생물학에서 염색을 위한 체외진단 시약에 대하여 제조자가 제공하여야 할 정보
体内诊断医疗器械.生物学染色用体外诊断试剂制造商提供的信息
2017-12-29
现行
DIN EN ISO 19001
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
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(ISO 19001-2013);德文版EN ISO 19001:2013
2013-07-01
现行
KS P ISO 18113-2
체외진단 의료기기 — 제조자가 제공하는 정보(라벨링) — 제2부: 전문가용 체외진단 시약
体外诊断医疗设备 - 制造商提供的信息(标签) - 第2部分:专业使用的体外诊断试剂
2018-08-22
现行
GB/T 29791.3-2013
体外诊断医疗器械 制造商提供的信息(标示) 第3部分:专业用体外诊断仪器
In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use
2013-10-10
现行
GB/T 29791.2-2013
体外诊断医疗器械 制造商提供的信息(标示) 第2部分:专业用体外诊断试剂
In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
2013-10-10
现行
ISO 18113-5-2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
体外诊断医疗器械.制造商提供的信息(标签).第5部分:自测用体外诊断仪器
2022-10-06
现行
ISO 18113-4-2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
体外诊断医疗器械.制造商提供的信息(标签).第4部分:自测用体外诊断试剂
2022-10-06
现行
ISO 18113-2-2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
体外诊断医疗器械.制造商提供的信息(标签).第2部分:专业用体外诊断试剂
2022-10-06