T/HIMIA 001-2024 Active Group standards

T/HIMIA 001-2024 Fluorescent endoscope cold light source

Publish Date: 2024-08-30 Implement Date: 2024-08-30 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/HIMIA 001-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: X-ray, magnetic particle, fluorescence, and other nondestructive testing instruments

ICS Name: Optoelectronics, laser equipment

Publish Date: 2024-08-30

Implement Date: 2024-08-30

Scope

Main Technical Content: 1. Scope This standard specifies the requirements, inspection methods, inspection rules, and requirements for marking, labeling, and packaging of fluorescent endoscopic cold light sources (hereinafter referred to as "the product"). This standard applies to fluorescent endoscopic cold light sources. The product is intended to be used in conjunction with endoscopic fluorescence imaging systems and is suitable for special lighting for fluorescence imaging during clinical endoscopic procedures. 2. Normative References The content of the following documents is incorporated into this document as essential provisions through normative references. Among them, the referenced documents with a date are applicable only to the version corresponding to that date; the unreferenced documents are applicable to the latest version (including all amendment sheets). - GB/T 2828.1 Counting sampling inspection procedures - Part 1: Batch sampling plans for acceptance quality limits (AQL) - GB/T 2829 Periodic inspection counting sampling procedures and tables (applicable to the inspection of process stability) - GB 4824 Industrial, scientific, and medical equipment - Radio frequency interference characteristics - Limits and measurement methods - 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 performance - GB 9706.218 Medical electrical equipment - Parts 2-18: Specific requirements for basic safety and performance of endoscopic equipment - GB/T 14710 Environmental requirements and test methods for medical electrical equipment - YY/T 0466.1 Medical devices - Labeling, marking, and information provision for medical devices - Part 1: General requirements - YY/T 1081 Medical endoscopes - Endoscope functional supply devices - Cold light sources - YY 9706.102 Medical electrical equipment - Parts 1-2 - General requir