YY/T 0814-2010Standard test method for evaluating trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants by infrared spectroscopy (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the re-drafting method to refer to ASTM F2381-2004 "Infrared Spectroscopy for Evaluating Surgical Implants with Radiation Ultra- Amount of polyethylene products in the trans-vinylidene content of the standard test method "preparation.

The technical differences between this standard and ASTM F2381-2004 are as follows.

--- on the normative reference documents, this standard has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows.

- Replace the ASTM F2102 with YY/T 0772.4.

--- removed Chapter 12 "Keyword";

--- change Appendix X1 to Appendix A, the same.

1 Scope

This test method describes the determination of the number of trans-vinylidene groups in medical implants of ultra-high molecular weight polyethylene (UHMWPE) Method, should use infrared spectroscopy to analyze the material. The test method is based on YY/T 0772.4.

The applicability of IR spectroscopy has been described in other literature reports. This method utilizes CH absorption centered at 1370 cm-1 The thickness of the normalized area of the peak (area) is verified by the inter-laboratory study (ILS) according to ASTM E691.

This standard does not attempt to address all the security issues involved, even those related to its use. Indeed It is the responsibility of the user of this standard to establish appropriate safety and health practices and to apply the limits of management clearly before application.

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

YY/T 0772.4 Surgical implants - Ultrahigh molecular weight polyethylene - Part 4. Test method for oxidation index ASTM E691 Guidelines for laboratory test methods for the determination of precision (Practice forconductinganinter-laboratorystudytodetermineprecisionofatestmethod Performance Description and Measurement of ASTM E1421 Fourier Transform Infrared (FT-IR) Spectrometer. Level 0 and Level 1 fordescribingandmeasuringperfomanceoffouriertransforminfrared (FTIR) spectrometers. Level zeroandlevelonetests)

3 Terms and definitions

The following terms and definitions apply to this document.