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BS EN ISO 23162:2021

BS EN ISO 23162:2021

$167.15

Basic semen examination. Specification and test methods

Published By Publication Date Number of Pages
BSI 2021 42
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This document will describe pre-examination, examination and post-examination processes for medical laboratory examination of human semen. It is intended to be used for diagnostics in small and large medical laboratories performing semen analysis. Preparation of semen for therapeutic use is not included.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative References
3 Terms and Definitions
12 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
13 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
14 5.4 Subject Information and Data Collection
5.4.1 Information to be Provided to Subjects
5.4.2 Data Collection from the Subject
15 5.5 Initial Sample Handling
5.6 Sperm Toxicity Testing
6 Examinations
6.1 Required Equipment
16 6.2 In-house Prepared Reagents
6.3 Assessments
6.3.1 Initiation of Assessments
17 6.3.2 Macroscopic Assessment
6.3.3 Direct Microscopy of the Wet Preparation
6.3.4 Sperm Motility Assessment
18 6.3.5 Sperm Concentration Assessment
6.3.6 Assessment of Absence of Spermatozoa
19 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
20 7.3 Presentation of Results
7.3.1 General
7.3.2 Contents of the Semen Examination Report
21 7.4 Practical Aspects of Quality Assurance
7.4.1 Internal Quality Control
7.4.2 Intralaboratory Comparisons
22 7.4.3 Interlaboratory Comparisons
23 Annex A (informative) The statistical basis for determination of absence of spermatozoa
24 Annex B (informative) High power field
25 Annex C (informative) Motility assessment training
28 Annex D (informative) Diluent for sperm concentration assessment
29 Annex E (informative) Estimation of suitable dilution for the assessment of sperm concentration
30 Annex F (informative) Comparison of concordance between two replicate assessments that report percentages
32 Annex G (informative) Comparison of concordance between two replicate counts of sperm concentration
35 Annex H (informative) Sperm vitality assessment
36 Annex I (informative) Sperm morphology assessment
39 Bibliography

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BS EN ISO 23162:2021
$167.15