GB/T 44671-2024Basic semen examination - Specification and test methods (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document is equivalent to ISO 23162:2021 "Basic requirements and test methods for semen".

1 Scope

This document specifies the equipment and key parameters for laboratory best practice test methods for basic testing of human semen collected by ejaculation.

Minimum requirements in this regard.

This document applies to the entire process of manual basic examination of human semen, and also applies to samples of computer-assisted sperm analysis (CASA) preparation.

This document does not apply to the evaluation of semen after vasectomy.

Note. Given the medical-legal consequences of semen evaluation after vasectomy, the methods in this document cannot definitively determine the complete absence of sperm in the semen.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to this document.

and competence)

Note. GB/T 22576.1-2018 Requirements for quality and competence of medical laboratories Part 1: General requirements (ISO 15189:2012, IDT) Note. GB/Z 43280-2023 Guidelines for the evaluation of uncertainty in measurement in medical laboratories (ISO/T S20914.2019, IDT)

3 Terms and definitions

The following terms and definitions apply to this document.

ISO and IEC maintain terminology databases for standardization at the following addresses.

Ordinary laboratory pipettes with disposable tips, where the amount of liquid aspirated is controlled by the amount of air in the closed chamber inside the pipette handle.

Note. Air displacement pipettes can only give accurate volumes for liquids with viscosities close to that of water.

azoospermia

No sperm was found in the ejaculated semen.

Note. The term azoospermia is not a clinical diagnosis but rather a description of laboratory test results. The complete absence of sperm is difficult to determine.

A portion of semen (3.4), the modern definition being based on a probability calculation obtained from the evaluation of a random aliquot of semen (3.4) Data (see Appendix A).