SIST EN 1659:2000

Overview

EN 1659:1996 is a CEN (European Committee for Standardization) vocabulary standard for in vitro diagnostic systems that specifically addresses culture media for microbiology. The document provides standardized terms and definitions used to classify culture media applied in bacteriology and mycology. Its purpose is to ensure consistent language across laboratories, manufacturers and regulatory bodies involved with diagnostic culture media. The standard has been adopted by national bodies (for example as SIST EN 1659:2000).

Key Topics

This standard focuses on establishing a clear, shared vocabulary rather than prescribing laboratory procedures. Key technical topics include:

• Standardized terminology for different classifications of culture media used in microbiology and diagnostic settings.
• Definitions relevant to culture media as part of in vitro diagnostic systems (IVD).
• Scope limited to media used in bacteriology and mycology, supporting consistent reporting and procurement.
• Alignment with CEN practice for vocabulary standards to improve interoperability between manufacturers, laboratories and regulators.

Note: EN 1659:1996 is a terms-and-definitions standard. It does not specify test methods, performance criteria or compositional formulations for culture media.

Applications

EN 1659:1996 is practical for anyone who needs consistent, unambiguous language around culture media in diagnostic microbiology:

• Clinical microbiology laboratories - for standardized reporting, SOP development and inter-laboratory communication.
• In vitro diagnostic (IVD) manufacturers - to label products and prepare technical documentation using harmonized terms.
• Regulatory and conformity assessment bodies - to interpret product descriptions and market documentation consistently.
• Standards committees and technical writers - when drafting or harmonizing standards or guidance documents concerning microbiological media.
• Educational and reference resources - to teach and document accepted terminology in bacteriology and mycology.

Using EN 1659:1996 helps reduce ambiguity in procurement, quality management and regulatory submissions by aligning stakeholders on the meaning of common terms related to culture media classification.

Related Standards

• EN 1659:1996 is a CEN vocabulary standard for culture media in microbiology and is typically used alongside other CEN/ISO standards that cover IVD test systems, performance evaluation and manufacturing practices. Users should consult their national adoptions (e.g., SIST EN 1659:2000) and related standards for method, quality and regulatory requirements.

Keywords: EN 1659:1996, culture media, microbiology, in vitro diagnostic systems, terms and definitions, bacteriology, mycology, CEN, culture media classification.