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YY/T 1795-2021: (Sperm quality analyzer)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1795-2021 | English | 259 |
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YY/T 1795-2021
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Basic data | Standard ID | YY/T 1795-2021 (YY/T1795-2021) | | Description (Translated English) | (Sperm quality analyzer) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 12,166 | | Issuing agency(ies) | State Drug Administration | YY/T 1795-2021: (Sperm quality analyzer)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Sperm quality analyzer)
ICS 11.100.10
C44
People's Republic of China Pharmaceutical Industry Standard
Sperm Quality Analyzer
2023-03-01 Implementation
Released by the State Drug Administration
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. The issuer of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136).
This standard was drafted by. Shanghai Beiang Pharmaceutical Technology Co., Ltd., Beijing Medical Device Inspection Institute, Shanghai Food and Drug Administration
Administration Certification and Evaluation Center, Jiangsu Ruiqi Life Science Instrument Co., Ltd., Saisi Medical Technology (Beijing) Co., Ltd.
The main drafters of this standard. Zheng Yan, Li Zheng, Mi Yunyi, Xu Yuancheng, Zhang Jiyou.
Sperm Quality Analyzer
1 Scope
This standard specifies the terms and definitions, requirements, test methods, signs, labels, instructions, packaging, transportation and
storage.
This standard applies to the use of microscopic digital imaging technology and computer-aided sperm analysis (computer-aided sperm analysis,
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
GB 4793.6 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 6.Characteristics of Laboratory Material Heating Equipment
special requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9.Laboratory use for analytical and other purposes
Particular requirements for automatic and semi-automatic equipment
GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Appliances
GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
GB/T 18268.26 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26.Special Requirements
In vitro diagnostic (IVD) medical devices
GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 3.In vitro diagnostic instruments for professional use
YY 0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101.In Vitro Diagnostic (IVD) Medical Equipment
specific requirements
WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
sperm quality analyzer spermqualityanalyzer
Usually consists of a microscope imaging module, a temperature control system module, a counting cell module, a computer system, software, etc.
Submotility classification and sperm morphology analysis.
3.2
forward movement progressivemotility; PR
Sperm actively move in a straight line or in a large circle, regardless of their speed.
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