YY/T 0862-2023 Active Industry standards-Medicine

YY/T 0862-2023 Ophthalmic Optics—Ocular endotamponades

YY/T 0862-2023 Ophthalmic Optics—Ocular endotamponades

Publish Date: 2023-03-14 Implement Date: 2024-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 31 Thousand words Pages: 15 pages

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

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