Overview
EN ISO 23162:2021 - Basic semen examination: specification and test methods provides an internationally agreed Technical Standard for performing reliable, reproducible basic semen analysis in clinical laboratories. Endorsed by CEN (as EN ISO 23162:2021), the document defines minimum requirements for equipment, staff competence, sample handling and core test methods for manual semen examination and for sample preparation used with Computer‑Aided Sperm Analysis (CASA). It explicitly excludes post‑vasectomy clearance assessments (noted as likely inadequate for medico‑legal “clear” declarations).
Keywords: EN ISO 23162:2021, basic semen examination, semen analysis, CASA, clinical laboratory standard, semen testing.
Key Topics
The standard covers practical and technical requirements without prescribing proprietary methods. Major topics include:
- Staff training and competence - general training, quantitative and qualitative assessments, maintenance of skills.
- Sample collection and pre‑examination handling - subject information, initial handling and sperm toxicity considerations.
- Required equipment and reagents - minimum instrumentation and in‑house reagent guidance for routine testing.
- Core examinations / test methods:
- Macroscopic assessment (volume, appearance, pH)
- Direct microscopy (wet mount examination)
- Sperm motility assessment
- Sperm concentration assessment (including dilution guidance)
- Absence of spermatozoa (statistical basis for declaring absence)
- Sperm vitality and morphology assessments
- Post‑examination handling and reporting - result calculations, presentation and contents of the semen report.
- Quality assurance - internal quality control (IQC), intra‑ and inter‑laboratory comparisons.
- Informative annexes on statistics, training exercises, diluent formulations, concordance evaluation and method details.
Keywords: sperm motility, sperm concentration, sperm morphology, sperm vitality, quality assurance, sample collection.
Applications
EN ISO 23162:2021 is intended for:
- Clinical andrology and fertility laboratories performing routine semen analysis
- Assisted reproduction clinics preparing samples for CASA
- Laboratory managers and technical staff seeking accreditation (alignment with ISO 15189)
- Manufacturers of in‑vitro diagnostic devices and consumables used in semen testing
- Accreditation bodies and auditors assessing laboratory conformity to best practice
Practical benefits include improved reproducibility of semen test results, clearer reporting for clinicians, and support for laboratory accreditation and quality management.
Keywords: laboratory accreditation, ISO 15189, fertility testing, andrology lab, CASA sample preparation.
Related Standards
- WHO Laboratory Manual for the Examination and Processing of Human Semen (referenced as influential background)
- ISO 15189 (medical laboratory accreditation framework)
- CEN adoption: EN ISO 23162:2021 (identical text for European implementation)
Keywords: EN ISO 23162, WHO semen manual, ISO 15189, CEN.