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

Publish Date: 2008-10-17 Implement Date: 2010-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 38 Thousand words Pages: 23 pages

Same series standard

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Superseded by the following standards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

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