GB 9706.8-1995
Replaced
YY/T 0290.6-2021
Active
Industry standards-Medicine
YY/T 0290.6-2021 Ophthalmic optics—Intraocular lenses—Part 6:Shelf-life and transport stability
YY/T 0290.6-2021 Ophthalmic optics—Intraocular lenses—Part 6:Shelf-life and transport stability
Basic Information
Standard Code:
YY/T 0290.6-2021
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:
2021-09-06
Implement Date:
2022-09-01
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:
20 pages
Scope
YY/T 0290的本部分规定了确定完整包装下的无菌人工晶状体(IOLs)有效期的试验，这些试验包括了建立人工晶状体在经销和贮存期间稳定性的程序。
Development Information
Drafting Units:
浙江省医疗器械检验研究院、爱尔康(中国)眼科产品有限公司、爱博诺德(北京)医疗科技股份有限公司
Drafting Persons:
冯勤、宋婷、杨志芳、王韶华、张莉、胡洁峰、骆永洁、陆佳俊
Same series standard
Replace the following standards
Referenced Standards
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 16886.12-2000 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 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
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/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 0942-2014 Ophthalmic optics—Injection system of intraocular lenses
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
Adopt standards
ISO 11979-6:2014
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