Overview
ISO 19001:2013 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology - defines the information manufacturers, suppliers and vendors must provide with reagents used for biological staining. The standard focuses on dyes, stains, chromogenic reagents, fluorochromes, antibodies and nucleic acid probes used in histology, cytology, bacteriology, haematology and histochemistry for both routine and research laboratories. Its purpose is to ensure comparable and reproducible staining results by standardizing labelling and documentation for in vitro diagnostic (IVD) reagents.
Key topics and requirements
- Scope and applicability: Applies to producers, suppliers and vendors of staining reagents used in medical laboratories (ISO 19001:2013).
- Chain of suppliers: Manufacturers must assure upstream suppliers meet recognized quality-system expectations (references to ISO 9001 and ISO 13485).
- Warnings and precautions: Labelling must include required safety information consistent with ISO 18113-1 and ISO 18113-2.
- Format and units: Information format must follow ISO 80000-1 and ISO 80000-9 (quantities and units).
- Product identification: Product name should include CAS registry number and Colour Index name/number where relevant.
- Product identity and batch data: Required physico‑chemical details (molecular formula, molar mass, allowable impurities, storage/handling) and analytical data (molar absorbance, λmax, TLC/HPLC/HPTLC).
- Suggested use and performance: Manufacturers must supply recommended protocols, sample types, expected results, appropriate positive/negative controls and literature references.
- Specific reagent requirements:
- Fluorochromes: selectivity, excitation/emission wavelengths, and F/P ratio for conjugates.
- Metal salts: systematic name and purity.
- Antibodies: antigen description, host/clonal data, form and concentration, purity and references.
- Nucleic acid probes: sequence/strandness, length/mass, labeling method, target gene, purity and patent information.
Applications and who uses it
- Clinical and research laboratories implementing staining protocols in histology, cytology, bacteriology, haematology and histochemistry.
- IVD reagent manufacturers and suppliers preparing labels, instructions for use (IFU) and batch data sheets.
- Quality and regulatory teams ensuring documentation supports reproducibility, traceability and compliance with labelling regulations.
- Purchasers and lab managers assessing reagent suitability and comparability across suppliers.
Related standards
ISO 19001:2013 is essential for ensuring clear, consistent manufacturer information that supports reliable staining results and regulatory compliance across clinical and research settings.