Overview - ISO 23162:2021 (Basic semen examination)
ISO 23162:2021 specifies minimum requirements for equipment and critical test‑method aspects for best practice in basic manual examination of human semen collected by ejaculation. The standard covers the entire workflow for a basic semen analysis and sample preparation for Computer‑Aided Sperm Analysis (CASA). It is intended to improve consistency, reliability and traceability of semen analysis results used in clinical assessment and research. Note: the document does not apply to post‑vasectomy clearance assessments (methodology is likely inadequate to establish complete absence of spermatozoa for medico‑legal purposes).
Key topics and technical requirements
- Staff training and competence: requirements for training, assessment, and maintenance of competency for quantitative and qualitative assessments (including pH and motility training).
- Sample collection and pre‑examination handling: guidance on collection methods, subject data, initial handling and avoiding sperm toxicity.
- Required equipment and reagents: minimum laboratory equipment and in‑house reagent considerations needed for reliable manual examination and CASA sample prep.
- Core assessments:
- Macroscopic examination (volume, appearance, liquefaction, viscosity, pH)
- Direct microscopy (wet preparation)
- Sperm motility assessment
- Sperm concentration (count) assessment
- Evaluation for absence of spermatozoa (statistical basis provided)
- Sperm vitality and sperm morphology evaluations
- Post‑examination handling and reporting: result calculations (total sperm count, concentrations), report content, and presentation of findings.
- Quality assurance: internal QC, intra‑ and inter‑laboratory comparisons, and annexes with statistical and methodological support.
Practical applications - who uses ISO 23162:2021
- Clinical laboratories and andrology labs performing routine semen analysis.
- Fertility clinics and reproductive medicine centres assessing male fertility.
- Laboratory managers and quality officers implementing procedures to meet ISO 15189 accreditation requirements.
- Developers and manufacturers of CASA systems (for sample preparation guidance) and diagnostic assay designers.
- Regulatory and accreditation bodies evaluating laboratory competence and standard operating procedures.
Related standards and resources
- ISO 15189 - Medical laboratories - Requirements for quality and competence (normative reference)
- ISO/TS 20914 - Guidance for estimation of measurement uncertainty in medical labs
- Annexes in ISO 23162 provide supporting content (statistical basis for azoospermia testing, high power field definitions, motility training, diluents and morphology/vitality guidance).
Keywords: ISO 23162:2021, basic semen examination, semen analysis, CASA, sperm concentration, sperm motility, azoospermia, laboratory accreditation, ISO 15189, quality assurance, sperm morphology.