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

Publish Date: 2023-09-05 Implement Date: 2024-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 52 Thousand words Pages: 32 pages

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

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