YY/T 1895-2023 Active Industry standards-Medicine

YY/T 1895-2023 Intravascular optical coherence tomograph

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 1895-2023

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: 2023-09-05

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: 17 pages

Scope

本文件规定了血管内光学相干断层扫描成像设备的要求、试验方法、随附文件和标记。本文件适用于采用光学相干断层扫描术对冠状动脉进行断层扫描成像的仪器及其附件。

Development Information

Drafting Units:

浙江省医疗器械检验研究院、国家药品监督管理局医疗器械技术审评中心、苏州微创阿格斯医疗科技有限公司、深圳市中科微光医疗器械技术有限公司、南京沃福曼医疗科技有限公司、中国计量科学研究院、江苏省医疗器械检验所

Drafting Persons:

王敬涛、陈敏、彭建华、王正义、李嘉南、陶魁园、胡志雄、张林涛、曹一挥、匡皓、李宁、胡一平、黄涛、葛群

Word Count: 35 Thousand words Pages: 17 pages

Referenced Standards

GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods YY 0285.1-2017 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements YY/T 0807-2010 Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery system 中华人民共和国药典2020年版　四部 GB 7247.1-2001 Safety of laser products—Part 1:Equipment classification, requirements and user's guide GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements

Related Standards

GB 11533-1989 Replaced

GB 11533-1989 Standard logarithmic visual acuity charts

Publish Date: 1989-03-27

GB/T 14148-1993 Replaced

GB/T 14148-1993 Glass blank of ophthalmic lenses

Publish Date: 1993-02-15

GB/T 14214-1993 Replaced

GB/T 14214-1993 Spectacle frames

Publish Date: 1993-03-01

GB 10810-1996 Replaced

GB 10810-1996 Spectacles lenses

Publish Date: 1996-12-17

GB 17342-1998 Replaced

GB 17342-1998 Ophthalmic instrument—Trial case lenses

Publish Date: 1998-05-05

GB 13511-1999 Replaced

GB 13511-1999 Assembled spectacles

Publish Date: 1999-08-12