T/HIMIA 002-2024 Active Group standards

T/HIMIA 002-2024 Three-dimensional fluorescence laparoscope

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 002-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Optical 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, test methods, and marking, packaging, transportation, and storage for three-dimensional fluorescent laparoscopes. This standard applies to three-dimensional fluorescent laparoscopes. The product is used in medical institutions, connected to an image processor host, and inserted into the human body through an incision for observation and imaging during laparoscopic surgery. 2. Normative Reference Documents The content of the following documents is an integral part of this document through normative references. Among them, the referenced documents with a date apply only to the version corresponding to that date; the unreferenced documents apply to the latest version (including all amendment sheets). - GB/T 2828.1 Counting Sampling Inspection Procedures Part 1: Batch Inspection Sampling Plans Retrieved by Acceptance Quality Limit (AQL) - GB/T 2829 Periodic Inspection Counting Sampling Procedures and Tables (Applicable to the Inspection of Process Stability) - GB/T 4208 Enclosure Protection Class (IP Code) - GB 4824 Industrial, Scientific, and Medical Equipment – Radio Frequency Interference Characteristics – Limits and Measurement Methods - GB 9706.1 Medical Electrical Equipment Part 1: General Safety Requirements - GB 9706.218 Medical Electrical Equipment Part 2-18: Basic Safety and Performance Requirements for Endoscopic Equipment - GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Equipment - GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Risk Management Process - YY/T0068.1 Medical Endoscopes – Rigid Endoscopes Part 1: Optical Performance and Test Methods - YY/T0068.2 Medical Endoscopes – Rigid Endoscopes Part 2: Mechanical Performance and Test Methods - YY/T0068.3 Medical Endoscopes – Rigid Endoscopes Part 3: Labeling and Accompanying Documentation