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ILNAS-EN ISO 23162:2021 Edition 07/2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
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  • 49.3 / copy
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Abstract

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).

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 140 : In vitro diagnostic medical devices

Implementation

start of the vote on the project    16/07/2020   date of ratification (dor)    11/06/2021
end of the vote on the project    05/10/2020   date of anouncement (doa)    31/10/2021
start of the vote on the final project    18/03/2021   date of publication (dop)    31/01/2022
end of the vote on the final project    10/05/2021   date of withdrawal (dow)    31/07/2024


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/01/2022
Reference Mémorial A N° 19

Relations

Relations to international standards
ISO 23162:2021 
ISO 23162 

International Classification for Standards (ICS codes) :

11.100.01 : Laboratory medicine in general

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