GB 9706.8-1995
Replaced
YY/T 0290.5-2023
Active
Industry standards-Medicine
YY/T 0290.5-2023 Ophthalmic optics—Intraocular lenses—Part 5:Biocompatibility
YY/T 0290.5-2023 Ophthalmic optics—Intraocular lenses—Part 5:Biocompatibility
Basic Information
Standard Code:
YY/T 0290.5-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Medical equipment
Publish Date:
2023-09-05
Implement Date:
2024-09-15
Publisher:
国家药品监督管理局
Technical Committee:
全国光学和光子学标准化技术委员会医用光学和仪器分技术委员会(SAC/TC 103/SC 1)
Pages:
32 pages
Scope
本文件规定了人工晶状体的生物相容性评价专用要求,包括其在生产过程条件下材料的生物相容性评价要求、与生物相容性相关的物理化学特性的评价及眼植入试验方法。
本文件适用于人工晶状体。
Development Information
Drafting Units:
浙江省医疗器械检验研究院、爱博诺德(北京)医疗科技股份有限公司、爱尔康(中国)眼科产品有限公司
Drafting Persons:
方丽、周绮梦、徐畅、冯勤、陈献花、夏忠诚、周森婷、王曌、杨志芳
Replace the following standards
Referenced Standards
GB/T 11417.7-2012 Ophthalmic optics—Contact lenses—Part 7:Physicochemical properties test methods
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 16886.5-2003 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 16886.10-2000 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
GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances
GB/T 42062-2022 Medical devices—Application of risk management to medical devices
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 1815-2022 Biological evaluation of medical devices—Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements
Adopt standards
ISO 11979-5:2020
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