YY/T 1895-2023Intravascular optical coherence tomograph (English PDF)
血管内光学相干断层扫描成像设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 5, 2023
Implementation date
September 15, 2024
Scope
YY/T 1895-2023 is the English-translated version of 血管内光学相干断层扫描成像设备.
YY/T 1895-2023 is the Chinese standard "Intravascular optical coherence tomograph". Its scope clause reads: 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. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY/T 1895-2023
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- C40
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 Normative reference documents
- 3 Terms and Definitions
- 4 Requirements
- 5 Test method
- 6 Accompanying documents
- 7 Mark
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 7247.1Safety of laser products - Part 1: Equipment classification and requirements
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14233.1-2022Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- YY 0285.1-2017Intravascular catheters—Sterile and single-use catheters - Part 1: General requirements
- YY 9706.102Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- YY/T 0807-2010Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery system
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Related Standards
GB 7247.1-2012 — Safety of laser products - Part 1: Equipment classification and requirements
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
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YY/T 1895-2023
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