YY/T 1924-2025 English PDF

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YY/T 1924-2025: Implants for surgery - Nickel-titanium shape memory alloy ropes
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1924-2025	299	Add to Cart	3 days	Implants for surgery - Nickel-titanium shape memory alloy ropes	Valid

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Basic data

Standard ID: YY/T 1924-2025 (YY/T1924-2025)
Description (Translated English): Implants for surgery - Nickel-titanium shape memory alloy ropes
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 14,135
Date of Issue: 2025-02-26
Date of Implementation: 2026-03-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the classification, requirements, inspection rules and requirements for marking, packaging, transportation, storage and quality certificates of nickel-titanium shape memory alloy ropes with a nominal composition (mass fraction) of 54.5% to 57.0% nickel for the manufacture of medical devices such as surgical implants, and describes the corresponding test methods. This standard is applicable to nickel-titanium shape memory alloy ropes for the manufacture of medical devices such as orthopedic wire guides, cables, grabbers, catching rings, baskets, guide ropes and surgical implants.

YY/T 1924-2025: Implants for surgery - Nickel-titanium shape memory alloy ropes

---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 11.040.40 CCSC35 Pharmaceutical Industry Standards of the People's Republic of China NiTi Shape Memory Alloy Cables for Surgical Implants Released on 2025-02-26 2026-03-01 Implementation The State Drug Administration issued

Table of contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Categories 2 5 Requirement 2 6 Test methods 4 7 Inspection Rules 5 8 Marking, packaging, transportation, storage and quality certificate 5 Appendix A (Normative) Rope material state, equivalent diameter conversion 7 References 8

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 under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document was drafted by. Jiangyin Perl Technology Co., Ltd., Northeastern University, Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Medical Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), LifeTech Scientific (Shenzhen) Co., Ltd., Dabo Medical Technology Limited by Share Ltd. The main drafters of this document are. Chen Qingfu, Zhang Kai, Qin Gaowu, Zhang Erlin, Ma Chunbao, Chen Sibin, Chen Yu, Hao Fengyang, Hu Junyuan, Liu Panpan, Zeng Da, Liang Xiongwei. NiTi Shape Memory Alloy Cables for Surgical Implants

1 Scope

This document specifies nickel-titanium with a nominal composition (mass fraction) of 54.5% to 57.0% nickel for the manufacture of medical devices such as surgical implants. The classification, requirements, inspection rules and requirements for marking, packaging, transportation, storage and quality certification of shape memory alloy ropes describe the corresponding Test method. This document is suitable for the production of orthopedic wire guides, cables, grabbers, capture rings, baskets, guide ropes and other medical devices and surgical implants. Nickel-titanium shape memory alloy rope.

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 6394 Determination of average grain size of metals GB/T 8180 Packaging, marking, transportation and storage of titanium and titanium alloy processed products GB/T 8706 Terminology, marking and classification of wire ropes GB/T 8834 Determination of physical and mechanical properties of fiber ropes GB/T 18876.1 Standard test for determination of metallographic structure, inclusion content and grade in steel and other metals using automated image analysis Methods - Part 1.Image analysis and stereological determination of inclusion or second phase content in steel and other metals GB/T 24627 Nickel-titanium shape memory alloy materials for surgical implants YS/T 1064 Terminology of Nickel-Titanium Shape Memory Alloys YS/T 1147 Superelastic NiTi Alloy Tensile Test Method YY/T 1771 Bend-free recovery method for testing phase transition temperature of nickel-titanium shape memory alloy

3 Terms and definitions

The terms and definitions defined in GB/T 8706, GB/T 8834, YS/T 1064 and the following apply to this document. 3.1 diameterdiameter The distance from the center of the circumscribed circle of the rope cross section to two points on the edge. 3.2 M×N The name of a rope structure in which M refers to the number of strands and N refers to the number of wires in the strand. 3.3 laydirection The twisting direction of the outer metal wire in a single-twist metal wire rope and the outer strands in a multi-strand metal wire rope along the rope axis. Note. Conventional rope products can be twisted left or right, and the default twist is left twist. According to the requirements of the purchaser, right twist or other twist directions can also be produced. ......

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