EN ISO 23162:2021

Basic semen examination - Specification and test methods (ISO 23162:2021)

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).

Grundlegende Samenanalyse - Spezifikation und Testmethoden (ISO 23162:2021)

Dieses Dokument legt die Mindestanforderungen an die Laborausstattung und entscheidende Aspekte der Prüfverfahren für bewährte Vorgehensweisen in Laboratorien fest, die eine grundlegende Analyse von durch Ejakulation gesammelten menschlichen Samen durchführen.
Dieses Dokument ist anwendbar auf den gesamten Prozess der manuellen grundlegenden Samenanalyse und auch auf die Probenvorbereitung für die computerassistierte Spermienanalyse (CASA).
Dieses Dokument ist nicht anzuwenden für Bewertungen nach einer Vasektomie.
ANMERKUNG Angesichts der medizinisch-rechtlichen Folgen, die mit der Evaluierung von Ejakulaten nach einer Vasektomie einhergehen, reicht die Methodik in diesem Dokument aller Wahrscheinlichkeit nach nicht aus, um ein Ejakulat als vollständig „frei“ (d. h. ohne Spermien im Ejakulat) zu bezeichnen.

Analyse de base du sperme - Spécifications et méthodologie analytique (ISO 23162:2021)

Le présent document spécifie les exigences minimales applicables aux équipements et aux points critiques des méthodes d’essai pour de bonnes pratiques dans les laboratoires réalisant une analyse de base du sperme humain obtenu par éjaculation.
Le présent document est applicable à l’ensemble du processus d’analyse de base du sperme, mais aussi à la préparation de l’échantillon en vue d’une analyse assistée par ordinateur du sperme (CASA).
Le présent document ne s’applique pas aux évaluations post-vasectomie.
NOTE            Du fait des implications médico-légales entourant l’évaluation des éjaculats post-vasectomie, la méthodologie du présent document est selon toute vraisemblance inadéquate pour établir qu’un éjaculat est totalement «exempt de spermatozoïde» (c’est-à-dire aucun spermatozoïde dans l’éjaculat).

Osnovne preiskave semena - Specifikacija in preskusne metode (ISO 23162:2021)

General Information

• Status: Published
• Publication Date: 13-Jul-2021
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 3 - Quality management in the medical laboratory
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 14-Jul-2021
• Completion Date: 14-Jul-2021
• Ref Project: SIST EN ISO 23162:2021 - Basic semen examination - Specification and test methods (ISO 23162:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Osnovne preiskave semena - Specifikacija in preskusne metode (ISO 23162:2021)
Basic semen examination - Specification and test methods (ISO 23162:2021)
Grundlegende Samenanalyse - Spezifikation und Testmethoden (ISO 23162:2021)
Analyse de base du sperme - Spécifications et méthodologie analytique (ISO
23162:2021)
Ta slovenski standard je istoveten z: EN ISO 23162:2021
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23162
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.100.01
English Version
Basic semen examination - Specification and test methods
(ISO 23162:2021)
Analyse de base du sperme - Spécifications et Grundlegende Samenanalyse - Spezifikation und
méthodologie analytique (ISO 23162:2021) Testmethoden (ISO 23162:2021)
This European Standard was approved by CEN on 11 June 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23162:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23162:2021) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2022, and conflicting national standards shall
be withdrawn at the latest by July 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 23162:2021 has been approved by CEN as EN ISO 23162:2021 without any modification.

INTERNATIONAL ISO
STANDARD 23162
First edition
2021-07
Basic semen examination —
Specification and test methods
Analyse de base du sperme — Spécifications et méthodologie
analytique
Reference number
ISO 23162:2021(E)
©
ISO 2021
ISO 23162:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 23162:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative References . 1
3 Terms and Definitions . 1
4 Staff Training and Competence . 4
4.1 General Aspects . 4
4.2 Training . 4
4.2.1 General. 4
4.2.2 Training for quantitative assessments . 4
4.2.3 Training for qualitative assessments. 4
4.2.4 Training for pH assessment . 4
4.3 Maintenance of Competence . 5
5 Semen Characteristics, Sampling and Pre-Examination Handling .5
5.1 General Characteristics . 5
5.2 Physical and Chemical Characteristics . 5
5.3 Sample Collection and Initial Handling . 5
5.4 Subject Information and Data Collection . 6
5.4.1 Information to be Provided to Subjects . 6
5.4.2 Data Collection from the Subject. 6
5.5 Initial Sample Handling . 7
5.6 Sperm Toxicity Testing . 7
6 Examinations . 7
6.1 Required Equipment . 7
6.2 In-house Prepared Reagents . 8
6.3 Assessments . 8
6.3.1 Initiation of Assessments . 8
6.3.2 Macroscopic Assessment . 9
6.3.3 Direct Microscopy of the Wet Preparation . 9
6.3.4 Sperm Motility Assessment . 9
6.3.5 Sperm Concentration Assessment .10
6.3.6 Assessment of Absence of Spermatozoa .10
6.3.7 Sperm Vitality Assessment .11
6.3.8 Sperm Morphology Evaluation .11
7 Post-Examination Handling and Test Report .11
7.1 General .11
7.2 Results Calculations and Presentation .11
7.2.1 Total Amount in the Ejaculate .11
7.2.2 Other Calculations .11
7.3 Presentation of Results .12
7.3.1 General.12
7.3.2 Contents of the Semen Examination Report .12
7.4 Practical Aspects of Quality Assurance .13
7.4.1 Internal Quality Control .13
7.4.2 Intralaboratory Comparisons .14
7.4.3 Interlaboratory Comparisons .14
Annex A (informative) The statistical basis for determination of absence of spermatozoa .15
Annex B (informative) High power field .16
Annex C (informative) Motility assessment training .17
Annex D (informative) Diluent for sperm concentration assessment .20
SIST EN ISO 2316
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