GB 11533-1989
Replaced
YY/T 0862-2023
Active
Industry standards-Medicine
YY/T 0862-2023 Ophthalmic Optics—Ocular endotamponades
YY/T 0862-2023 Ophthalmic Optics—Ocular endotamponades
Basic Information
Standard Code:
YY/T 0862-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Ophthalmic equipment
Publish Date:
2023-03-14
Implement Date:
2024-05-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用光学和仪器标准化分技术委员会(SAC/TC 103/SC 1)
Pages:
15 pages
Scope
本文件规定了有关眼内填充物的预期性能、设计属性、设计评价、灭菌、产品稳定性、输送系统的完整性及性能、包装、制造商提供的信息等通用要求。本文件适用于眼内填充物。
Development Information
Drafting Units:
浙江省医疗器械检验研究院、上海杰视医疗科技有限公司
Drafting Persons:
陈献花、方丽、张莉、赵金川、林心怡、韩银、胡美丽、夏忠诚、陈宇晖
Replace the following standards
Referenced Standards
中华人民共和国药典 四部
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 16886.6-1997 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 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 42062-2022 Medical devices—Application of risk management to medical devices
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY/T 0567.1-2005 Aseptic processing of health care products—Part 1:General requirements
YY/T 0567.1-2013 Aseptic processing of health care products—Part 1:General requirements
YY/T 0640-2008 Non-active surgical implants—General requirements
YY/T 0640-2016 Non-active surgical implants—General requirements
GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements
Adopt standards
ISO 16672:2020
Related Standards
GB/T 14148-1993
Replaced
GB/T 14148-1993 Glass blank of ophthalmic lenses
GB/T 14214-1993
Replaced
GB/T 14214-1993 Spectacle frames
GB 10810-1996
Replaced
GB 10810-1996 Spectacles lenses
GB 17342-1998
Replaced
GB 17342-1998 Ophthalmic instrument—Trial case lenses
GB 13511-1999
Replaced