Lyon H O, Horobin R W
Department of Pathology 134, H:S, Hvidovre Hospital, Hvidovre, Denmark.
Biotech Histochem. 2007 Feb;82(1):1-11. doi: 10.1080/10520290601116590.
The reasons for standardization and the preparation of standards for dyes and stains are presented. The national, regional and international standardization agencies are described in detail prior to a consideration of why standards should be prepared for the field of biomedical staining. An outline is given of the standards for information supplied by the manufacturer for in vitro diagnostic reagents for biological staining, published by the European Committee for Standardization (CEN) in 1999, and in a practically unaltered form by the International Organization for Standards (ISO) in 2002. A more detailed description is given in Appendix A of the rules governing the work of the European Committee for Standardization (CEN) and of the technical co-operation between the International Organization for Standardization (ISO) and CEN (The Vienna Agreement). Finally, a short list of abbreviations used by CEN and ISO is included as Appendix B.
本文介绍了染料和染色剂标准化的原因以及标准的制定情况。在考虑为何应为生物医学染色领域制定标准之前,详细介绍了国家、区域和国际标准化机构。概述了欧洲标准化委员会(CEN)于1999年发布、国际标准化组织(ISO)于2002年以几乎未作改动的形式发布的关于生物染色体外诊断试剂制造商提供信息的标准。附录A更详细地描述了欧洲标准化委员会(CEN)的工作规则以及国际标准化组织(ISO)与CEN之间的技术合作(《维也纳协定》)。最后,附录B列出了CEN和ISO使用的缩写词简表。