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YY/T 1895-2023 English PDF

YY/T 1895-2023_English: PDF (YY/T1895-2023)
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YY/T 1895-2023English359 Add to Cart 4 days [Need to translate] Intravascular optical coherence tomograph Valid YY/T 1895-2023


BASIC DATA
Standard ID YY/T 1895-2023 (YY/T1895-2023)
Description (Translated English) Intravascular optical coherence tomograph
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 18,134
Date of Issue 2023-09-05
Date of Implementation 2024-09-15
Drafting Organization Zhejiang Institute of Medical Device Inspection, Medical Device Technology Review Center of the State Food and Drug Administration, Suzhou MicroPort Argus Medical Technology Co., Ltd., Shenzhen Zhongke Weiguang Medical Device Technology Co., Ltd., Nanjing Wolfman Medical Technology Co., Ltd. Company, China Institute of Metrology, Jiangsu Medical Device Inspection Institute
Administrative Organization National Optics and Photonics Standardization Technical Committee Medical Optics and Instruments Sub-Technical Committee (SAC/TC 103/SC 1)
Proposing organization State Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements, test methods, accompanying documents and markings for intravascular optical coherence tomography imaging equipment. This standard applies to instruments and accessories for tomographic imaging of coronary arteries using optical coherence tomography.


YY/T 1895-2023. Intravascular optical coherence tomography imaging equipment ICS 11.040.70 CCSC40 Pharmaceutical Industry Standards of the People's Republic of China Intravascular optical coherence tomography imaging device Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration Table of contents Prefaceā…  1 range 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 6 6 Accompanying documents 13 7 Mark 13 Preface This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is sponsored by the Medical Optics and Instruments Sub-Technical Committee of the National Technical Committee on Optics and Photonics Standardization (SAC/TC103/SC1) Return to home. This document was drafted by. Zhejiang Medical Device Inspection Institute, Medical Device Technical Review Center of the State Food and Drug Administration, Suzhou MicroPort Argus Medical Technology Co., Ltd., Shenzhen Zhongke Weiguang Medical Device Technology Co., Ltd., Nanjing Wolfman Medical Technology Co., Ltd. Department, China Institute of Metrology, Jiangsu Medical Device Inspection Institute. The main drafters of this document. Wang Jingtao, Chen Min, Peng Jianhua, Wang Zhengyi, Li Jianan, Tao Kuiyuan, Hu Zhixiong, Zhang Lintao, Cao Yihui, Kuang Hao, Li Ning, Hu Yiping, Huang Tao, Ge Qun. Intravascular optical coherence tomography imaging device 1 Scope This document specifies the requirements, test methods, accompanying documentation and markings for intravascular optical coherence tomography imaging equipment. This document applies to instruments and accessories for tomographic imaging of coronary arteries using optical coherence tomography. 2 Normative reference documents The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB 7247.1 Safety of laser products Part 1.Equipment classification and requirements GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance GB/T 14233.1-2022 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods YY 0285.1-2017 Intravascular Catheters Disposable Sterile Catheters Part 1.General Requirements YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance Parallel standards. Electromagnetic and Capacity requirements and testing YY/T 0807-2010 Standard test method for stability performance of balloon-expandable vascular stents pre-installed on delivery system Pharmacopoeia of the People's Republic of China 2020 Edition Four Parts 3 Terms and definitions The following terms and definitions apply to this document. 3.1 OCT An optical interferometry technology used to obtain tomographic images of target objects, using a partially coherent narrow scanning beam to determine the internal reflection of the object. The relative depth of the surface. 3.2 Intravascular OCT device Equipment for scanning, processing and displaying OCT images of coronary arteries, including intravascular OCT host computer (including catheter connection controller) and intravascular imaging catheters. 3.3 Used in conjunction with the catheter connection controller on the intravascular OCT host, inserted into the cardiovascular system for scanning and imaging of coronary arteries of tubular instruments. 3.4 sensitivitysensitivity The ratio of the optical power output by the conduit connected to the controller to the minimum detectable optical power reflected from the sample to the device. ......

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