YY/T 0811-2021
Standard guide for extensively irradiation.Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications (English Version)
- Standard No.
- YY/T 0811-2021
- Language
- Chinese, Available in English version
- Release Date
- 2021
- Published By
- 国家药监局
- Latest
- YY/T 0811-2021
- Replace
- YY/T 0811-2010
- Scope
- This standard involves pure resin powder and cured highly cross-linked ultra-high molecular weight polyethylene materials (products) that meet all the requirements of GB/T 19701.1 and GB/T 19701.2. This standard does not include ultra-high molecular weight polyethylene that has only been treated with gas plasma, ethylene oxide or ionizing radiation at a dose of less than 40 kGy, that is, materials that have only been subjected to conventional sterilization. This standard only applies to UHMWPE materials that have been exposed to large doses of gamma rays and electron beam ionizing radiation sources. The specific relationship between the mechanical properties of the above-mentioned articles and their performance in vivo has not yet been determined. Although scientists are committed to studying the relationship between polymer properties, polymer structure and polymer design, the above relationships have not yet been satisfactorily explained. The following mechanical tests are commonly used to evaluate the repeatability of manufacturing procedures and are suitable for comparative studies of different materials. The following warning text only applies to the test methods part of Chapter 5 of this standard. This standard does not attempt to address all safety issues covered, even those relevant to its use. It is the responsibility of the user of this standard to establish appropriate safety and operating practices and to clarify the applicability of regulatory limitations prior to application.
YY/T 0811-2021 history
- 2021 YY/T 0811-2021 Standard guide for extensively irradiation.Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
- 2010 YY/T 0811-2010 Standard guide for extensively irradiation.Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
