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YY/T 1535-2024: Medical devices for human assisted reproductive technology - Human sperm viability assay(HSVA)
Status: Valid YY/T 1535: Evolution and historical versions
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Medical devices for human assisted reproductive technology - Human sperm viability assay(HSVA)
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YY/T 1535-2024
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| YY/T 1535-2017 | English | 199 |
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Medical devices for human in vitro assisted reproductive technology - Biological evaluation - Human sperm survival assay
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YY/T 1535-2017
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Basic data | Standard ID | YY/T 1535-2024 (YY/T1535-2024) | | Description (Translated English) | Medical devices for human assisted reproductive technology - Human sperm viability assay(HSVA) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 18,193 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Older Standard (superseded by this standard) | YY/T 1535-2017 | | Issuing agency(ies) | State Drug Administration | YY/T 1535-2024: Medical devices for human assisted reproductive technology - Human sperm viability assay(HSVA)
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ICS 11.040.30
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1535-2017
Medical devices for human assisted reproductive technology
Human sperm survival test
Released on 2024-07-08
2025-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms, definitions and abbreviations 1
4 Test methods 2
5 Methods Human sperm motility test 3
6 Methods Two-person sperm motility recovery test 4
7 Methods Triple sperm cryopreservation experiment 6
8 Test report contents 7
Appendix A (Informative) Test operation of the test product 8
References 9
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 replaces YY/T 1535-2017 "Biological Evaluation of Human Sperm Survival Tests for Medical Devices Used in Human In Vitro Assisted Reproductive Technology"
Compared with YY/T 1535-2017, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) In the “Scope”, the test methods of human sperm survival test are increased to three. human sperm motility test, human sperm motility recovery test
and human sperm cryopreservation and resuscitation studies (see Chapter 1);
b) The term “human sperm viability test” was changed to “human sperm motility test” and its definition was changed (see 3.1.1,.2017 Edition)
3.1.1);
c) The definition of "sperm motility" has been changed (see 3.1.2, 3.1.2 of the.2017 edition);
d) The term “sperm motility classification” was changed to “sperm movement classification” and the definition was changed (see 3.1.4, 3.1.4 of the.2017 edition);
e) Change the terms "sperm motility coefficient" and "relative sperm motility coefficient" to "sperm motility ratio" and "relative sperm motility ratio" respectively.
Ratio” (see 3.1.5, 3.1.6, 3.1.5, 3.1.6 of the.2017 edition);
f) Added terms and definitions used in human sperm motility recovery test and human sperm cryopreservation test (see 3.1.7, 3.1.8 and
3.1.9);
g) Some abbreviations have been changed (see 3.2, 3.2 of the.2017 edition);
h) Deleted the overview of the test method in the human sperm viability test (see 4.1 of the.2017 version);
i) The description of the main instruments and apparatus has been changed (see 4.1, 4.2 of the.2017 edition);
j) Changed the description of consumables and reagents (see 4.2, 4.2 of the.2017 edition);
k) The material requirements have been changed (see 4.3, 4.3 of the.2017 edition);
l) Added requirements for computer-assisted sperm analysis (see 4.4.2);
m) Changed the sperm sample preparation method (see 4.5, 4.4.2 of the.2017 edition);
n) Added the sample volumes required for the “negative control group” and the “test product group” (see 5.1 and 5.2), and deleted the “positive control”
(See 4.4.3.1 and 4.4.3.2 of the.2017 edition), and added the specific operation method of "Method One Sperm Motility Test" (see
5.3, 5.4);
o) The positive control group indicator in the test acceptance criteria was deleted (see 4.4.5.2 of the.2017 version);
p) Added the “Method for two-person sperm motility recovery test” and the “Method for three-person sperm cryo-resuscitation test” (see Chapters 6 and 7);
q) Table A.1 of Appendix A was changed (see Table A.1, A.1 of the.2017 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the technical coordination unit for standardization of medical devices used in human assisted reproductive technology.
This document was drafted by. Reproductive Medicine Center of Shanghai Tenth People's Hospital, Peking University Third Hospital, Shanghai Jiaotong University School of Medicine
It is affiliated to Renji Hospital, the Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army, the Reproductive Hospital Affiliated to Shandong University, and the Shanghai Biomedical Technology Research Institute.
Institute, Zhejiang Medical Device Evaluation Center.
The main drafters of this document are. Qian Richeng, Zhou Jing, Yan Jie, Sun Yun, Li Jianhua, Gao Xuan, Shi Huijuan, Zhang Kunzhi, Qiao Jie.
The previous versions of this document are as follows.
---First published in.2017 as YY/T 1535-2017;
---This is the first revision.
Medical devices for human assisted reproductive technology
Human sperm survival test
1 Scope
This document describes the test methods for human sperm survival of medical devices used in human assisted reproductive technology, including human sperm motility test
test, human sperm motility recovery test and human sperm cryopreservation test.
The human sperm motility test is applicable to the evaluation of culture fluids and instruments that are in direct contact with sperm in medical devices used in human assisted reproductive technology.
Toxicity risks that may arise from instruments/consumables.
According to the situation, evaluate the possible sperm toxicity risk of culture fluids and instruments/consumables.
The human sperm motility recovery test is suitable for evaluating the possible toxicity risk of sperm brake fluids and similar products.
To evaluate the potential toxicity risk of sperm brake fluid or similar products and to determine the recovery of sperm vitality after direct contact with sperm brake fluid or similar products.
The human sperm cryo-thawing test is suitable for evaluating the sperm toxicity and cryo-thawing injury risks that may be caused by human sperm cryopreservation products.
By observing the direct contact between sperm and sperm freezing solution and the recovery of sperm vitality after freezing and thawing, it is possible to judge whether the sperm freezing solution product has
Risk of toxicity and cryo-thawing injury.
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.
GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference samples
YY/T 0995 Terms and definitions of medical devices for human assisted reproductive technology
3 Terms, definitions and abbreviations
3.1 Terms and definitions
The terms and definitions defined in YY/T 0995 and the following apply to this document.
3.1.1
After co-culturing sperm with the test product or its extract, the toxicity risk of the test product to sperm is determined by observing changes in sperm motility.
3.1.2
Sperm motility
Motile sperm in semen, expressed as the percentage of motile sperm to all sperm.
3.1.3
Sperm motility assay
Determination of sperm motility.
3.1.4
There are four levels of sperm motility. rapid progressive motility, slow progressive motility, non-progressive motility and inactivity.
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