ISO 23162:2021
Basic semen examination — Specification and test methods
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation.
This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA).
This document does not apply to the post-vasectomy assessments.
NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
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Foreword
Introduction
1 Scope
2 Normative References
3 Terms and Definitions
4 Staff Training and Competence
4.1 General Aspects
4.2 Training
4.2.1 General
4.2.2 Training for quantitative assessments
4.2.3 Training for qualitative assessments
4.2.4 Training for pH assessment
4.3 Maintenance of Competence
5 Semen Characteristics, Sampling and Pre-Examination Handling
5.1 General Characteristics
5.2 Physical and Chemical Characteristics
5.3 Sample Collection and Initial Handling
5.4 Subject Information and Data Collection
5.4.1 Information to be Provided to Subjects
5.4.2 Data Collection from the Subject
5.5 Initial Sample Handling
5.6 Sperm Toxicity Testing
6 Examinations
6.1 Required Equipment
6.2 In-house Prepared Reagents
6.3 Assessments
6.3.1 Initiation of Assessments
6.3.2 Macroscopic Assessment
6.3.3 Direct Microscopy of the Wet Preparation
6.3.4 Sperm Motility Assessment
6.3.5 Sperm Concentration Assessment
6.3.6 Assessment of Absence of Spermatozoa
6.3.7 Sperm Vitality Assessment
6.3.8 Sperm Morphology Evaluation
7 Post-Examination Handling and Test Report
7.1 General
7.2 Results Calculations and Presentation
7.2.1 Total Amount in the Ejaculate
7.2.2 Other Calculations
7.3 Presentation of Results
7.3.1 General
7.3.2 Contents of the Semen Examination Report
7.4 Practical Aspects of Quality Assurance
7.4.1 Internal Quality Control
7.4.2 Intralaboratory Comparisons
7.4.3 Interlaboratory Comparisons
Annex A (informative) The statistical basis for determination of absence of spermatozoa
Annex B (informative) High power field
Annex C (informative) Motility assessment training
Annex D (informative) Diluent for sperm concentration assessment
Annex E (informative) Estimation of suitable dilution for the assessment of sperm concentration
Annex F (informative) Comparison of concordance between two replicate assessments that report percentages
Annex G (informative) Comparison of concordance between two replicate counts of sperm concentration
Annex H (informative) Sperm vitality assessment
Annex I (informative) Sperm morphology assessment
Bibliography
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Foreword
Introduction
1 Scope
2 Normative References
3 Terms and Definitions
4 Staff Training and Competence
4.1 General Aspects
4.2 Training
4.2.1 General
4.2.2 Training for quantitative assessments
4.2.3 Training for qualitative assessments
4.2.4 Training for pH assessment
4.3 Maintenance of Competence
5 Semen Characteristics, Sampling and Pre-Examination Handling
5.1 General Characteristics
5.2 Physical and Chemical Characteristics
5.3 Sample Collection and Initial Handling
5.4 Subject Information and Data Collection
5.4.1 Information to be Provided to Subjects
5.4.2 Data Collection from the Subject
5.5 Initial Sample Handling
5.6 Sperm Toxicity Testing
6 Examinations
6.1 Required Equipment
6.2 In-house Prepared Reagents
6.3 Assessments
6.3.1 Initiation of Assessments
6.3.2 Macroscopic Assessment
6.3.3 Direct Microscopy of the Wet Preparation
6.3.4 Sperm Motility Assessment
6.3.5 Sperm Concentration Assessment
6.3.6 Assessment of Absence of Spermatozoa
6.3.7 Sperm Vitality Assessment
6.3.8 Sperm Morphology Evaluation
7 Post-Examination Handling and Test Report
7.1 General
7.2 Results Calculations and Presentation
7.2.1 Total Amount in the Ejaculate
7.2.2 Other Calculations
7.3 Presentation of Results
7.3.1 General
7.3.2 Contents of the Semen Examination Report
7.4 Practical Aspects of Quality Assurance
7.4.1 Internal Quality Control
7.4.2 Intralaboratory Comparisons
7.4.3 Interlaboratory Comparisons
Annex A (informative) The statistical basis for determination of absence of spermatozoa
Annex B (informative) High power field
Annex C (informative) Motility assessment training
Annex D (informative) Diluent for sperm concentration assessment
Annex E (informative) Estimation of suitable dilution for the assessment of sperm concentration
Annex F (informative) Comparison of concordance between two replicate assessments that report percentages
Annex G (informative) Comparison of concordance between two replicate counts of sperm concentration
Annex H (informative) Sperm vitality assessment
Annex I (informative) Sperm morphology assessment
Bibliography