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.
Referenced standards
Normative references
- GB/T 6394Determination of estimating the average grain size of metal
- GB/T 8180Wrought titanium and titanium alloy products packing,marking,transporting and storing
- GB/T 8706Steel wire ropes -- Vocabulary, designation and classification
- GB/T 8834Fibre ropes - Determination of certain physical and mechanical properties
- GB/T 18876.1Standard practice for determining the metallographical constituent and inclusion content of steels and other metals by automatic image analysis - Part 1: Determining the inclusion or second-phase constituent content of steels and other metals by automatic image analysis and stereology
- GB/T 24627Wrought nickel-titanium shape memory alloys for surgical implants
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Related Standards
GB/T 18876.1-2024 — Standard practice for determining the metallographical constituent and inclusion content of steels and other metals by automatic image analysis - Part 1: Determining the inclusion or second-phase constituent content of steels and other metals by automatic image analysis and stereology
GB/T 24627-2023 — Wrought nickel-titanium shape memory alloys for surgical implants
GB/T 6394-2017 — Determination of estimating the average grain size of metal
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