YY/T 1430-2016Standard test method for small punch testing of ultra-high molecular weight polyethylene used in surgical implants (English PDF)

1 Scope

This standard is a small disc test (thickness 0.5mm, diameter 6.4mm) small punching test method to determine the ultra-high molecular

The mechanical properties of polyethylene (UHMWPE). This standard applies to characterization of plunger extrusion or compression molding after UHMWPE surgery

The properties of the material are also suitable for the evaluation of radiation cross-linked and sterilized after the same process to manufacture the implant, but also for the recovery of the human body (Taken from the body) of the corresponding implants were tested.

The small punch test parameters, that is, peak load, ultimate displacement, ultimate load and loss of work, can provide UHMWPE in the multi-axis

Measurement of yield strength, ultimate strength, ductility and toughness under loading conditions. Due to UHMWPE under uniaxial and multi-axis loading conditions

Mechanical properties are not the same, small punching test GB/T 19701.2 Chinese medicine grade UHMWPE uniaxial tensile test conducted a mechanical test

Test technology.

In addition to the study tools for implantation analysis, the small punch test can also be used in laboratory screening tests to evaluate the new UH-

MWPE material, such as gamma irradiation or electron beam irradiation. The test method is also applicable to accelerated aging of UHMWPE materials (Eg, ASTMF2003), and can specify the mechanical properties of different UHMWPE samples after oxidative aging

Down grade.

Small punch test can be used for other polymers, including polymethyl methacrylate (PMMA) bone cement, polyacetal and high density polyethylene (HDPE). However, other polymer non-UHMWPE materials, small punching test is not within the scope of this standard test method.

International units (SI) are used in this standard.

This standard does not attempt to address all the security issues involved, even those related to its use. establish

Appropriate safety and health practices, as well as the applicability of regulatory restrictions before application, are the responsibility of the user of this standard.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 16825.1 Tests for static uniaxial testing machines - Part 1. Testing and testing of force systems for tension and/or pressure testing machines (GB/T 16825.1-2008, ISO 7500-1..2004, IDT)

GB/T 19701.2 Surgical implants - Ultrahigh molecular weight polyethylene - Part 2. Molded plastics (GB/T 19701.2-2005,

ISO 5834-2..1998, IDT)

YY/T 0651.1 Surgical implants for wear of total hip prostheses Part 1. Load and displacement parameters for wear testing machines and

Related test environmental conditions (YY/T 0651.1-2016, ISO 14242-1..2012, IDT)

YY/T 1426.1 Surgical implants of total knee prosthesis wear - Part 1. Load - controlled wear test machine load and

Displacement parameters and associated test environmental conditions (YY/T 1426.1-2016, ISO 14243-1..2009, IDT)

3 terms and definitions

The following terms and definitions apply to this document.