Overview
ISO/TS 17518:2015 - Medical laboratories - Reagents for staining biological material - Guidance for users - provides requirements and practical guidance for selecting, acquiring and assessing the quality of reagents used for in vitro diagnostic (IVD) staining in biology. The Technical Specification is written for professional use in medical laboratories and addresses disciplines such as clinical cytology, haematology, histopathology, microbiology and molecular biology. Its aim is to help laboratories obtain the information needed from suppliers so staining procedures are reproducible and results are comparable.
Key topics and requirements
The standard covers the essential information and quality-control considerations laboratories need when working with dyes, stains, chromogenic reagents and fluorochromes:
- Information supplied by the manufacturer
- Intended use and instructions for use
- Manufacturer identification and reagent description
- Batch code (lot number), contents and kit component identification
- Storage, handling and expiry
- Required storage conditions, shelf life and expiry date reporting
- Safety and performance information
- Warnings, precautions and limitations of the examination procedure
- Control procedures and interpretation guidance
- Specific reagent considerations
- Fluorochromes, metal salts and other reagent‑type specific data
- Required additional equipment and reagent preparation instructions
- Quality assurance
- Guidance for validation and verification of biological stains for intended use
- Verification of supplier specifications and acquisition practices
- Supporting materials
- Checklist for establishing or verifying specifications and relevant literature references
Practical applications
ISO/TS 17518:2015 is practical for organizations and roles involved with staining workflows and reagent procurement:
- Medical laboratory managers and quality managers - to define procurement criteria and verify supplier information for staining reagents
- Histotechnologists, cytotechnologists and clinical microbiologists - to ensure proper reagent identification, storage and handling for reliable staining
- Procurement and supplier assessment teams - to request consistent documentation (batch code, instructions, hazards)
- Laboratories preparing in-house IVD procedures - to guide validation and verification activities for reagents not explicitly marketed as IVD
Using ISO/TS 17518 helps laboratories reduce variability, document traceability (batch codes) and comply with quality/competence frameworks for clinical diagnostics.
Related standards
- ISO 19001 - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (basis for this Technical Specification)
- ISO 15189 - Medical laboratories - Requirements for quality and competence (quality management context)
Keywords: ISO/TS 17518:2015, medical laboratories, reagents for staining biological material, in vitro diagnostic staining, dyes and stains, validation and verification, quality management.