60.60 Standard published Jul 14, 2021
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100.01 Laboratory medicine in general
Published
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).
PUBLISHED
EN ISO 23162:2021
60.60
Standard published
Jul 14, 2021
