YY/T 1535-2024 Medical devices for human assisted reproductive technology - Human sperm viability assay (HSVA) English, Anglais, Englisch, Inglés, えいご
1 Scope
This document describes the human sperm viability assay methods for medical devices for human assisted reproductive technology, including human sperm motility assay, human sperm motility recovery assay and human sperm cryo-survival assay.
The human sperm motility assay is applicable to evaluating the potential toxicity risks from culture solutions and appliances/consumables that are in direct contact with sperms in medical devices for human assisted reproductive technology. The potential risks of sperm toxicity caused by culture solutions and appliances/consumables are evaluated by observing the change of motility of sperm after direct contact with liquid products or extracts.
The human sperm motility recovery assay is applicable to evaluating the possible toxicity risks of sperm immobilizing fluids and similar products. The potential toxicity risks of sperm immobilizing fluids or similar products are evaluated by observing the motility recovery of sperm after direct contact with sperm immobilizing fluid or similar products.
The human sperm cryo-survival assay is applicable to evaluating the potential risk of sperm toxicity and cryo-survival injury caused by human sperm freezing medium products. The potential toxicity and cryo-survival injury risk of perm freezing medium products are judged by observing the direct contact between sperm and sperm freezing medium and the motility recovery after cryo-survival.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
YY/T 0995 Medical devices for human assisted reproductive technology - Terminology and definitions
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purpose of this document, the terms and definitions given in YY/T 0995 and the following apply.
3.1.1
human sperm motility assay
assay involving co-culture of sperms with the test product or its extract, observation of the changes in sperm motility and judgment of the toxicity risk of the test product to sperms
3.1.2
sperm motility
motile sperms in semen, expressed as the percentage of motile sperms relative to the total number of sperms
3.1.3
sperm motility assay
determination of sperm movement capability
3.1.4
category of sperm movements
sperm movements classified into four categories: rapid progressive motility, slow progressive motility, non-progressive movement, non-progressive motility and immotility.
3.1.5
sperm motility index
ratio of sperm motility after a certain culture period to that at the beginning of culture
Note: It reflects the changes of sperm motility.
3.1.6
relative ratio of sperm motility index
ratio of sperm motility in the test product to that in the negative control group after the same culture period
Note: It reflects the degree of effect of test product on sperm motility.
3.1.7
sperm motility recovery
recovery of sperm motility after the sperms are exposed to the test product (sperm immobilizing fluids or similar products) for 30 min, followed by washing and culture for a certain period
3.1.8
sperm motility recovery index
ratio of sperm motility of the test product (sperm immobilizing fluids or similar products) to that of the negative control group after the same culture period
Note: It reflects the degree of effect of test product on sperm motility.
3.1.9
sperm cryo-survival index
ratio of the motility of sperm in direct contact with the test product after cryo-survival to that before cryopreservation
Note: It reflects the effect of test product on sperms during cryo-survival.
3.2 Abbreviations
For the purposes of this document, the following abbreviations apply.
CASA: Computer-Aided Sperm Analysis
HSCA: Human Sperm Cryo-survival Assay
HSMRA: Human Sperm Motility Recovery Assay
HSMA: Human Sperm Motility Assay
IM: Immotility
NM: Non-Progressive Motility
PM: Progressive Motility
PVP: Polyvinyl Pyrrolidone
SCI: Sperm Cryo-survival Index
SMI: Sperm Motility Index
SMRI: Sperm Motility Recovery Index
Contents
Foreword i
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
4 Test methods
5 Method I Human sperm motility assay
6 Method II Human sperm motility recovery assay
7 Method III Human sperm cryo-survival assay
8 Test report
Annex A (Informative) Test operation of test products
Bibliography
