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YY/T 1795-2021Sperm quality analyzer (English PDF)

精子质量分析仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

March 1, 2023

Scope

YY/T 1795-2021 is the English-translated version of 精子质量分析仪.

YY/T 1795-2021 is the Chinese pharmaceutical industry standard for the sperm quality analyser, the instrument that examines a semen sample by microscopic digital imaging and computer-aided sperm analysis.

It gives the terms and definitions, the requirements the analyser must meet and the test methods for them, and the rules for marks, labels, instructions for use, packaging, transport and storage.

It is written for the manufacturers of these analysers and for the laboratories that verify them, so that counts, concentrations and motility parameters measured on different machines can be compared. Issued on 6 September 2021, it has applied since 1 March 2023.

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Document preview — YY/T 1795-2021

National Standard of the People's Republic of China

Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and Definitions

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

GB 4793.9

Similar standards

GB/T 37906-2019

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