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diagnostic display breast medical diagnostic display device introduction analysis diagnostic display test basis resolution ≥1600×1200 ≥2048×2560 sj/t11292-2016 breast diagnosis display display area edge integrity error technical requirements technical dimensions requirements low-production lithium batteries capital construction items
T/CAME 33-2021 in English

T/CAME 33-2021 in English

VALID

Medical diagnostic display device

  • Issued on:2021-06-30
  • Implemented on:2021-06-30
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $100.00
$97.00

本文件规定了医用诊断显示器的技术要求以及试验方法。
本文件适用于普通医用诊断显示器和乳腺医用诊断显示器。


Introduction

Analysis of the core technical requirements of the standard

Parameters General diagnostic display Breast diagnostic display Test basis
Resolution ≥1600×1200 ≥2048×2560 SJ/T11292-2016 5.6.12
Calibrated luminance (cd/m²) ≥350 ≥450 YY/T0910.1-2013 7.4.1
Contrast ratio ≥300 ≥500 YY/T0910.1-2013 7.4.1

Detailed explanation of key technical indicators

Brightness uniformity requirements

The standard adopts the nine-point measurement method (screen size ≥23 inches), and the calculation formula is: Lu=100-200×(Lhighest-Llowest)/(Lhighest+Llowest). The breast diagnosis display requires ≥85%, which is 10 percentage points higher than the ordinary type.

TG18-OIQ Test Specification

Contains 8 visual inspection items, with special requirements: Breast Diagnosis Display must fully display the letters "QUALITYCONTROL" in the black area, while the ordinary type is allowed to lack the last 3 letters.


Clinical Application Recommendations

Equipment Selection Guide

1. Radiology CT/MRI diagnosis should choose ordinary diagnostic monitors, which can meet the brightness of 350cd/m²
2. Mammography examination must be equipped with a dedicated breast diagnostic monitor, ensuring a high brightness of 450cd/m²
3. PACS reading workstations are recommended to have dual screens, with the main screen resolution not less than 2048×2560


Key Points for Implementation of Standards

1. A color analyzer should be used for grayscale chromaticity detection every quarter (Δu'v'≤0.01)
2. When detecting brightness response error, the tolerance of the breast monitor is only 5%, and professional calibration equipment is required
3. The grid test requires that the display area edge integrity error is less than 1%

Sample only — not a preview of T/CAME 33-2021
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