YY/T 1929-2024 English PDF

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YY/T 1929-2024: Breast biopsy and excision equipment
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1929-2024	379	Add to Cart	4 days	Breast biopsy and excision equipment	Valid

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Basic data

Standard ID: YY/T 1929-2024 (YY/T1929-2024)
Description (Translated English): Breast biopsy and excision equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.30
Word Count Estimation: 18,116
Date of Issue: 2024-02-07
Date of Implementation: 2025-03-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the terms and definitions of breast biopsy and rotational resection equipment and rotational resection needles, stipulates materials and requirements, and describes corresponding test methods. This document applies to breast biopsy and rotational ablation equipment.

YY/T 1929-2024: Breast biopsy and excision equipment

---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.
ICS 11.040.30 CCSC35 Pharmaceutical Industry Standards of the People's Republic of China Breast Biopsy and Atherectomy Equipment Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

Table of Contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Materials 2 5 Requirement 2 5.1 Speed or frequency 2 5.2 Vacuum pressure 2 5.3 Waste collection container 2 5.4 Detectability 3 5.5 Functional Requirements 3 5.6 Peeling sampling time 3 5.7 Sampling 3 5.8 Sampling slot window length 3 5.9 Hardness 3 5.10 Rigidity 3 5.11 Roughness 3 5.12 Puncture performance 4 5.13 Corrosion resistance 4 5.14 Biological properties 4 5.15 Chemical properties 4 5.16 Noise 4 5.17 Appearance and structure 4 5.18 Size 4 5.19 Scale marking 5 6 Test methods 5 6.1 Speed or frequency 5 6.2 Vacuum pressure 5 6.3 Waste liquid collection container 5 6.4 Detectability 6 6.5 Functional Requirements 6 6.6 Peeling sampling time 6 6.7 Sampling 7 6.8 Sampling slot window length 7 6.9 Hardness 7 6.10 Rigidity 7 6.11 Roughness 7 6.12 Puncture performance 7 6.13 Corrosion resistance 7 6.14 Biological properties 7 6.15 Chemical properties 7 6.16 Noise 8 6.17 Appearance and structure 8 6.18 Size 8 6.19 Scale marking 8 Appendix A (Normative) Test method for rigidity of outer needle tube 9 A.1 Principle 9 A.2 Instruments 9 A.3 Test procedure 9 A.4 Test report 10 Appendix B (Informative) Test method for puncture performance evaluation 11 B.1 Principle 11 B.2 Test equipment and materials 11 B.3 Test Procedure 11 Reference 12

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. 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 provided by the National Technical Committee for Standardization of Medical Electrical Appliances, Medical Electronic Instruments Standardization Subcommittee (SAC/TC10/SC5) Centralized. This document was drafted by. Chongqing Xishan Technology Co., Ltd., Shanghai Institute of Medical Device Inspection, Chongqing Municipal Drug Technical Evaluation Inspection Center, Mammotome Medical Device Manufacturing (Shanghai) Co., Ltd., Bard Medical Technology (Shanghai) Co., Ltd., Shanghai Xiuneng Medical Device Co., Ltd. Limited company. The main drafters of this document are. Guo Yijun, Yu Yuanjun, Chen Lizhong, Xu Chao, Zheng Wenhao, Gu Lihua, Yue Xin, Jiang Xiaoqi, Zhang Yanqing, Chen Zhu, Sun Yunhui. Breast Biopsy and Atherectomy Equipment

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. ......

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