YY/T 1431-2026Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns (English PDF)
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Issued by
State Food and Drug Administration
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1431-2026 (Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns) is available as an English-translated PDF.
YY/T 1431-2026 is the Chinese standard "Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns". This standard applies to ultra-high molecular weight polyethylene (UHMWPE) yarns used as raw materials for medical device parts (eg for stitching or ligament fixation).
The purpose of this standard is to describe the properties required for ultra high molecular weight polyethylene yarns as raw materials for medical devices and the test procedures to be followed.
This standard is not intended to address the tests required for the components of medical devices or medical devices processed from the raw materials specified in this standard.
The basic principles of this standard are given in Appendix A. This standard adopts the international unit system. This standard does not include other units of measurement.
The following warnings apply only to the test method section of Chapter 6 of this standard: This standard does not attempt to address all the security issues involved, even those related to their use.
It was issued by State Food and Drug Administration. Issued on 2016-01-26, in force from 2017-01-01. It cites 18 other standards.
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Document preview — YY/T 1431-2026
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C35
Issued by: State Food and Drug Administration
Contents
- Document data
- Standards quoted by this standard
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document.
GB/T 1033.1
GB/T 1632.3
GB/T 3916
GB/T 4743
GB/T 16886.10
GB/T 16886.12
GB/T 16886.13
GB/T 16886.14
GB/T 16886.15
GB/T 16886.17
GB/T 16886.3
GB/T 16886.4
GB/T 16886.5
GB/T 16886.9
GB/T 16886.2
GB/T 16886.19
GB/T 16886.1
GB/T 16886.18
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1033.1Plastics -- Methods for determining the density of non-cellular plastics -- Part 1: Immersion method, liquid pycnometer method and titration method
- GB/T 1632.3Plastics -- Determination of the viscosity of polymers in dilute solution using capillary viscometer -- Part 3: Polyethylenes and polypropylenes
- GB/T 3916Textiles -- Yarns from packages -- Determination of single-end breaking force and elongation at break using constant rate of extension (CRE) tester
- GB/T 4743Textiles -- Yarn from packages -- Determination of linear density (mass per unit length) by the skein method
- GB/T 16886.10Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- GB/T 16886.12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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Related Standards
GB/T 1033.1-2008 — Plastics -- Methods for determining the density of non-cellular plastics -- Part 1: Immersion method, liquid pycnometer method and titration method
GB/T 1632.3-2010 — Plastics -- Determination of the viscosity of polymers in dilute solution using capillary viscometer -- Part 3: Polyethylenes and polypropylenes
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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YY/T 1431-2026
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