Standardization and standards for dyes and stains used in biology and medicine

Abstract

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.

• biological stain commission
• biological staining
• BSC
• CEN
• Clinical Laboratory Standards Institute
• CLSI
• ISO
• standardization