T/HIMIA 003-2024 3D endoscopic image processor

Scope

Main technical content: 1. Scope This standard specifies the scope, requirements, inspection methods, inspection rules, and marking, packaging, transportation, and storage of 3D endoscopic image processors. This standard applies to 3D endoscopic image processors. The products are suitable for processing images captured by electronic endoscopes and transmitting them to displays during endoscopic diagnosis or surgical procedures. 2. Normative references The content of the following documents is an essential part of this document 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 this document with their latest version (including all amendments). - GB/T 2828.1 Counting sampling inspection procedures Part 1: Batch sampling plans for inspection based on AQL (Acceptable Quality Limit) - 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 9706.1 Medical electrical equipment Part 1: General requirements for basic safety and performance - GB 9706.218 Medical electrical equipment Part 2-18: Specific requirements for basic safety and performance of endoscopic equipment - GB 14710 Environmental requirements and test methods for medical electrical equipment - YY/T 0466.1 Medical devices for labeling, marking, and providing information Part 1: General requirements - YY 9706.102 Medical electrical equipment Part 1-2: General requirements for basic safety and performance Parallel standard: Electromagnetic compatibility Requirements and tests 3. Terms and definitions This standard does not define any terms or definitions that require clarification.

Development Information

Related Standards