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YY/T 1929-2024Breast biopsy and excision equipment (English PDF)

乳房活检与旋切设备

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 7, 2024

Implementation date

March 1, 2025

Scope

YY/T 1929-2024 is the English-translated version of 乳房活检与旋切设备.

YY/T 1929-2024 is the Chinese standard "Breast biopsy and excision equipment". Its scope clause reads: This document defines the terms and definitions for breast biopsy and excision equipment and excision needles, specifies materials, requirements, and describes the appropriate tests method.

This document applies to breast biopsy and excision equipment. Its clauses include terms and definitions.

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Document preview — YY/T 1929-2024

National Standard of the People's Republic of China

ICS: 11.040.30
Classification: C35

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Materials
5 Requirement
5.1 Speed or frequency
5.2 Vacuum pressure
5.3 Waste collection container
5.4 Detectability
5.5 Functional Requirements
5.6 Peeling sampling time
5.7 Sampling
5.8 Sampling slot window length
5.9 Hardness
5.10 Rigidity
5.11 Roughness
5.12 Puncture performance
5.13 Corrosion resistance
5.14 Biological properties
5.15 Chemical properties
5.16 Noise
5.17 Appearance and structure
5.18 Size
5.19 Scale marking
6 Test methods
6.1 Speed or frequency
6.2 Vacuum pressure
6.3 Waste liquid collection container
6.4 Detectability
6.5 Functional Requirements
6.6 Peeling sampling time
6.7 Sampling
6.8 Sampling slot window length
6.9 Hardness
6.10 Rigidity
6.11 Roughness
6.12 Puncture performance
6.13 Corrosion resistance
6.14 Biological properties
6.15 Chemical properties
6.16 Noise
6.17 Appearance and structure
6.18 Size
6.19 Scale marking
Appendix A (Normative) Test method for rigidity of outer needle tube
Appendix B (Informative) Test method for puncture performance evaluation

1 Scope

This document defines the terms and definitions for breast biopsy and excision equipment and excision needles, specifies materials, requirements, and describes the appropriate tests method.

This document applies to breast biopsy and excision equipment.

2 Normative references

The contents of the following documents constitute the 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 1220-2007 Stainless steel bars

GB/T 2965 Titanium and titanium alloy bars

GB/T 4340.1 Vickers hardness test for metallic materials Part 1.Test method

GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods

GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment Part 2.Biological test methods

GB/T 18457-2015 Stainless steel needle tubes for medical device manufacturing

Pharmacopoeia of the People's Republic of China (2020 Edition)

3 Terms and definitions

The following terms and definitions apply to this document.

3.1

Powered by the mains, it provides the mechanical power and vacuum source required by the rotary cutting needle, and vacuum-assisted suction of breast lesion tissue is used to

Medical electrical equipment that uses a rotary cutting needle to cut and obtain breast lesion tissue samples. The equipment generally consists of a host, a handle, a rotary cutting needle, and a foot switch.

And vacuum accessories.

3.2

An instrument clamped on a handle or integrally formed with the handle for tissue surgery. It consists of an outer needle tube, an inner needle tube, a main body and a vacuum catheter.

The handle outputs power to drive the driven structure in the main body to drive the inner needle tube to translate, swing or rotate.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1860.1|YY/T 1814|YY/T 1748|YY/T 1934|YY/T 1924

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