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YY/T 1924-2025Implants for surgery - Nickel-titanium shape memory alloy ropes (English PDF)

外科植入物 镍钛形状记忆合金绳材

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 26, 2025

Implementation date

March 1, 2026

Scope

YY/T 1924-2025 is the English-translated version of 外科植入物 镍钛形状记忆合金绳材.

YY/T 1924-2025 is the Chinese standard "Implants for surgery - Nickel-titanium shape memory alloy ropes". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY/T 1924-2025

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C35

Issued by: National Medical Products Administration

Contents

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.

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