YY/T 0811-2021 Active Industry standards-Medicine

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

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

Publish Date: 2021-09-06 Implement Date: 2022-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0811-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-09-06

Implement Date: 2022-09-01

Pages: 12 pages

Scope

This standard specifies the relevant requirements and test methods for high-dose radiation cross-linked (high cross-linked) ultra-high molecular weight polyethylene (UHMWPE) products used in surgical implants.
This standard applies to UHMWPE products that have undergone high-dose radiation cross-linking, produced from pure resin powders as required by GB/T 19701.1, or molded materials as required by GB/T 19701.2. This standard only applies to UHMWPE products that have been irradiated with high doses of gamma rays and electron beam ionizing radiation sources.
This standard does not apply to UHMWPE products that have only undergone gas plasma, ethylene oxide, or ionizing radiation treatment with doses less than 40 kGy, i.e., materials that have only undergone conventional sterilization treatment.
Note 1: The specific relationship between the mechanical properties of the aforementioned products and their performance in the body has not yet been determined. Although scientists are committed to studying the relationship between polymer structure, polymer properties, and polymer design, this relationship has not yet been fully explained. The following mechanical tests are often used to evaluate the reproducibility of manufacturing procedures and are suitable for comparative studies of different materials.
Note 2: The following warning text only applies to the test methods section of Chapter 5. This standard does not attempt to address all safety issues involved, even those related to its use. It is the responsibility of the users of this standard to establish appropriate safety and operating norms and to clarify the applicability of management restrictions before use.

Development Information

Word Count: 14 Thousand words Pages: 12 pages

Replace the following standards

YY/T 0811-2010 Standard guide for extensively irradiation—Crosslinked ultra high molecular weight polyethylene fabricated forms for surgical implant applications

Referenced Standards

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.9-2001 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 19701.1-2005 Implants for surgery—Ultra-high molecular weight polyethylene—Part 1:Powder form GB/T 19701.1-2016 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1:Powder form GB/T 19701.2-2005 Implants for surgery Ultra-high molecular weight polyethylene—Part 2:Moulded forms GB/T 19701.2-2016 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2:Moulded forms GB/T 21461.2-2008 Plastics—Ultra-high-molecular-weight polyethylene(PE-UHMW)moulding and extrusion materials—Part 2:Preparation of test specimens and determination of properties GB/T 21461.2-2023 Plastics—Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials—Part 2:Preparation of test specimens and determination of properties YY/T 0772.4-2022 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4:Oxidation index measurement method YY/T 0814-2010 Standard test method for evaluating trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants by infrared spectroscopy YY/T 0815-2010 Standard test method for measurement of enthalpy of fusion,percent crystallinity,and melting point of ultra-high-molecular weight polyethylene by means of differential scanning calorimetry YY/T 1430-2016 Standard test method for small punch testing of ultra-high molecular weight polyethylene used in surgical implants GB/T 19701.2-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2:Moulded forms GB/T 19701.1-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1:Powder form GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

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