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YY/T 0811-2021: Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
YY/T 0811-2021
(High-dose radiation cross-linking promotional materials for healthy life)
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0811-2010
High-Dose Radiation Cross-Linked Ultra-High for Surgical Implants
Molecular weight polyethylene products
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Sampling 2
5 Relevant requirements for highly cross-linked UHMWPE products 2
6 Biocompatibility3
Appendix A (Informative Appendix) Rationale 4
Reference 5
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 Requirements for High-Dose Radiation Cross-linked Ultra-High Molecular Weight Polyethylene Products for Surgical Implants".
Compared with YY/T 0811-2010, the main technical changes except editorial changes are as follows.
--- Increased the requirements for elastic modulus (see Table 1);
--- Modified the test methods for compressive modulus and thermal properties (see Table 1, Table 1 of the.2010 edition);
---Small Punch Ultimate Load, Trans Vinylidene Index (TVI) test method replaces ASTM standard with converted industry standard
(See Table 2, Table 1 of the.2010 edition);
--- Adjusted the position of electron spin resonance in the standard (see 5.2.3, Table 1 of the.2010 edition);
--- Added requirements for preclinical simulation (see 5.2.4).
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is approved by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Orthopedic Implants Sub-Technical Committee (SAC/TC110/
SC1) focal point.
This standard was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, State Drug Administration Medical Device Technical Review
Heart, Quadrant Plastic Trading (Shanghai) Co., Ltd., Stryker (Beijing) Medical Equipment Co., Ltd., Zimmer (Shanghai) Medical International Trading Co., Ltd.
company.
The main drafters of this standard. Jing Ming, Liu Bin, Gao Jintao, Ma Chunbao, Zhu Jinqing, Yang Xiuyun, Zhang Haiming, Wang Yuhai.
The previous editions of the standard replaced by this standard are as follows.
---YY/T 0811-2010.
High-Dose Radiation Cross-Linked Ultra-High for Surgical Implants
Molecular weight polyethylene products
1 Scope
This standard specifies the relevant provisions of high-dose radiation cross-linked (highly cross-linked) ultra-high molecular weight polyethylene (UHMWPE) products for surgical implants.
Requirements and test methods.
This standard applies to the pure resin powder required by GB/T 19701.1 or the bulk of the molding compound required by GB/T 19701.2
Amount of radiation cross-linked UHMWPE articles. This standard applies only to UHM-
WPE products.
This standard does not apply to products that have only been treated with gas plasma, ethylene oxide or ionizing radiation with a dose of less than 40kGy
UHMWPE, that is, a material that has only undergone conventional sterilization.
Note 1.The specific relationship between the mechanical properties of the above products and their in vivo properties has not been determined. Although scientists are working on polymer structure, polymer characteristics
studies on the relationship between properties and polymer design, but these relationships have not been satisfactorily explained. The following mechanical tests are commonly used to evaluate the feasibility of a manufacturing process.
Repeatability, suitable for comparative studies of different materials.
Note 2.The following warning text only applies to the test method part of Chapter 5.This standard does not attempt to address all safety issues involved, even if
are those security concerns related to its use. Establishing appropriate safety and operational practices, and clarifying the applicability of regulatory limits prior to application, is an integral part of this
Standard user's own responsibility.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in 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.Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests
GB/T 16886.4 Biological Evaluation of Medical Devices Part 4.Selection of Tests for Interaction with Blood
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test
GB/T 16886.6 Biological evaluation of medical devices-Part 6.Local reaction test after implantation
GB/T 16886.7 Biological Evaluation of Medical Devices Part 7.Ethylene Oxide Sterilization Residues
GB/T 16886.9 Biological Evaluation of Medical Devices Part 9.Qualitative and Quantitative Framework for Potential Degradation Products
GB/T 16886.10 Biological Evaluation of Medical Devices Part 10.Irritation and Skin Sensitization Tests
GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test
GB/T 16886.12 Biological Evaluation of Medical Devices Part 12.Sample Preparation and Reference Materials
GB/T 19701.1 Surgical Implant Ultra High Molecular Weight Polyethylene Part 1.Powder
GB/T 19701.2 Surgical Implants Ultra High Molecular Weight Polyethylene Part 2.Molding Compounds
GB/T 21461.2 Plastic ultra-high molecular weight polyethylene (PE-UHMW) molding and extrusion materials-Part 2.Specimen preparation and
Performance measurement
YY/T 0772.4 Surgical Implant Ultra High Molecular Weight Polyethylene Part 4.Test Method for Oxidation Index