GB 12264-1990
Replaced
YY/T 0811-2010
Replaced
Industry standards-Medicine
YY/T 0811-2010 Standard guide for extensively irradiation—Crosslinked ultra high molecular weight polyethylene fabricated forms for surgical implant applications
YY/T 0811-2010 Standard guide for extensively irradiation—Crosslinked ultra high molecular weight polyethylene fabricated forms for surgical implant applications
Basic Information
Standard Code:
YY/T 0811-2010
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2010-12-27
Implement Date:
2012-06-01
Pages:
8 pages
Scope
This standard applies to pure resin powders and cured high 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 undergone gas plasma, ethylene oxide, or ionizing radiation treatment at doses less than 40 kGy, i.e., materials that have only undergone conventional sterilization treatment.
This standard only applies to UHMWPE materials that have been irradiated with high doses from gamma ray and electron beam ionizing radiation sources.
The specific relationship between the mechanical properties of the aforementioned products and their performance in the body has not been determined. Although scientists are committed to studying the relationship between polymer characteristics, polymer structure, 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.
The following warning text only applies to the test method section of Chapter 5 of this standard. 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 application.
Development Information
Superseded by the following standards
Referenced Standards
ISO 10993-1
ISO 10993-2
ISO 10993-5
ISO 10993-6
ISO 10993-7
ISO 10993-11
ISO 10993-12
ASTM D 638
ASTM D 1621
ASTM D 2765
ASTM D 3418
ASTM E 647
ASTM F 619
ASTM F 648
ASTM F 748
ASTM F 749
ASTM F 756
ASTM F 763
ASTM F 813
ASTM F 895
ASTM F 981
ASTM F 2183
ASTM F 2214
ASTM F 2381
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 16886.9-2001 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 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
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
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced