GB 9706.8-1995
Replaced
YY/T 0290.5-2008
Replaced
Industry standards-Medicine
YY/T 0290.5-2008 Ophthalmic implants—Intraocular lenses—Part 5:Biocompatibility
YY/T 0290.5-2008 Ophthalmic implants—Intraocular lenses—Part 5:Biocompatibility
Basic Information
Standard Code:
YY/T 0290.5-2008
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Medical equipment
Publish Date:
2008-10-17
Implement Date:
2010-06-01
Pages:
23 pages
Scope
This part of YY 0290 specifies the special requirements for the evaluation of the biocompatibility of intraocular lenses (IOL) materials, including the evaluation of the biocompatibility of materials under production conditions. These requirements include the evaluation of physicochemical properties related to biocompatibility. This part also provides guidelines for intraocular implantation trials.
Development Information
Same series standard
YY/T 0290.1-2008 Ophthalmic implants—Intraocular lenses—Part 1:Terminology
YY 0290.3-2008 Ophthalmic implants—Intraocular lenses—Part 3:Mechanical properties and test methods
YY/T 0290.4-2008 Ophthalmic implants—Intraocular lenses—Part 4:Labeling and information
YY 0290.8-2008 Ophthalmic implants—Intraocular lenses—Part 8:Fundamental requirement
Replace the following standards
Superseded by the following standards
Referenced Standards
ISO 10339
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 16886.6-1997 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 16886.10-2000 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 16886.12-2000 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
YY 0290.1-1997 Intraocular lenses—Part 1:Terminology
YY/T 0290.1-2008 Ophthalmic implants—Intraocular lenses—Part 1:Terminology
YY/T 0290.1-2021 Ophthalmic optics—Intraocular lenses—Part 1:Terminology
YY 0290.2-1997 Intraocular lenses—Part 2:Optical properties and their test methods
YY 0290.2-2009 Ophthalmic implants—Intraocular lenses—Part 2:Optical properties and test methods
YY 0290.2-2021 Ophthalmic optics—Intraocular lenses—Part 2:Optical properties and test methods
YY 0290.3-1997 Intraocular lenses—Part 3:Mechanical properties and their test methods
YY 0290.3-2008 Ophthalmic implants—Intraocular lenses—Part 3:Mechanical properties and test methods
YY 0290.3-2018 Ophthalmic optics—Intraocular lenses—Part 3:Mechanical properties and test methods
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements
Adopt standards
ISO 11979-5:2006
Related Standards
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced