YY/T 0811-2021Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications (English PDF)

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces YY/T 0811-2010 "Standard guide for extensively irradiation.

Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications". Compared with YY/T 0811-2010, in addition to the editorial modifications, the main technical changes in this Standard are as follows.

-- Add the requirements for modulus of elasticity (see Table 1 of this Edition);

1 Scope

This Standard specifies relevant requirements and test methods for irradiation- crosslinked (extensively crosslinked) ultra-high molecular weight polyethylene fabricated (UHMWPE) forms for surgical implant applications.

This Standard is applicable to pure resin powder required by GB/T 19701.1 or extensively irradiation-crosslinked UHMWPE products produced by molding compounds required by GB/T 19701.2.This Standard is only applicable to UHMWPE products that have been extensively irradiated by gamma rays and electron beam ionizing radiation sources.

This Standard does not apply to UHMWPE that has only been treated with gas plasma, ethylene oxide or ionizing radiation with a dose of less than 40kGy, that is, materials that have undergone routine sterilization only.

NOTE 1.The exact relationship between the mechanical properties of the above articles and the in vivo performance has not been established. Although scientists are devoted to the study of the relationship between polymer structure, polymer properties and polymer design, the above relationship has not been satisfactorily explained. The following mechanical tests are commonly used to assess the repeatability of manufacturing procedures and are suitable for comparative studies of different materials.

NOTE 2.The following warning text applies only to the test method part of Chapter 5: This Standard does not attempt to describe all the safety issues involved, even those related 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.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 16886.1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

GB/T 16886.2, Biological evaluation of medical devices -- Part 2: Animal welfare requirements

GB/T 16886.3, Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

GB/T 16886.4, Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

GB/T 16886.5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

GB/T 16886.6, Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation

GB/T 16886.7, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

GB/T 16886.9, Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

4 Sampling

If applicable, each batch of powder and products shall be determined according to the requirements of this Standard.

5 Relevant requirements for extensively crosslinked UHMWPE products

6 Biocompatibility

The results of long-term clinical trial studies show that the biological reactions that occur when using this material are at an acceptable level.

Annex A (informative)

Basic principle A.1 This standard aims to provide the minimum necessary test methods for determining the physical, chemical and mechanical properties of radiation extensively crosslinked UHMWPE materials for orthopedic or spinal implants.

A.2 One of the purposes of this Standard is to provide guidance to regulatory authorities and surgical implant manufacturers through a set of standard test methods for determining the characteristics of extensively crosslinked UHMWPE materials.

A.3 Even though it is now possible to identify test methods for characterizing extensively crosslinked UHMWPE, it is still not possible to specify acceptable minimum values for each test method. Because in most of the above-mentioned test methods, the correlation between the measured properties of the material and the clinical performance is currently unknown. Therefore, material manufacturers are required to formulate minimum standards for the production process of their extensively crosslinked UHMWPE materials. At the same time, use the test methods provided by this Standard to verify the production process.