YY/T 1708.2-2020 in English
VALIDBasic requirements of communication and conformance for medical X-ray image equipment—Part 2:X-ray equipment for computed tomography
- Issued on:2020-09-27
- Implemented on:2021-09-01
- File Format:PDF
- Delivery:Via email within 5 business days
$534.00
| Standard No: | YY/T 1708.2-2020 |
| Document status: | VALID |
| Title in English: | Basic requirements of communication and conformance for medical X-ray image equipment—Part 2:X-ray equipment for computed tomography |
| Title in Chinese: | 医用诊断X射线影像设备连通性符合性基本要求 第2部分：X射线计算机体层摄影设备 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 5 business days |
| Issued on: | 2020-09-27 |
| Implemented on: | 2021-09-01 |
| ICS Classification: | 11.040.50-Radiographic equipment |
| Chinese Classification: | C43-Medical radiographic equipment |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | medical x-ray image equipment part
x-ray equipment test requirements basic requirements technical requirements dicom compliance |
| Related Topics: | United Imaging X-ray
United Imaging + x-ray Mobile x-ray computed tomography equipment X-ray microscopy equipment x-photography computed tomography equipment Classification of x-ray equipment X-ray camera system Mobile X-ray Imaging Equipment x-rays for diagnosis |
本标准在YY/T 1708.1的基础上规定了X射线计算机体层摄影设备（CT）及其相关的软件组件的连通性符合性的术语和定义、要求和试验方法。
本标准适用于具有可通过数字介质存储或通过网络传输健康数据功能的X射线计算机体层摄影设备及其相关软件组件，本标准不适用于不具备数字介质存储功能和通过网络传输健康数据功能的X射线计算机体层摄影设备（CT）及其相关软件组件。
Introduction
Standard Overview
YY/T 1708.2-2020 is a medical device industry standard that puts forward specific requirements for the communication and compliance of computed tomography (CT) equipment. As the second part of the YY/T 1708 series of standards, it focuses on standardizing the implementation details of CT equipment under the DICOM standard framework.
Core Technical Requirements
DICOM Compliance
The standard requires that CT equipment must support the following DICOM service classes:
| Service Type | SCU Support | SCP Support |
|---|---|---|
| CT Image Storage | Required | Optional |
| Modality Execution Steps | Required | - |
| Query/Retrieval | Optional | Optional |
Technology Evolution Analysis
Compared with the previous version, this standard has the following major updates:
- Added support for CT-specific IOD in DICOM PS3.16
- Strengthened network security requirements and clarified IPV6 protocol support
- Improved media storage specifications, including physical media formats such as CD/DVD/USB
Implementation Recommendations
Compatibility Design
Recommendations for equipment manufacturers:
- Implement Standard SOP Class to include at least 1.2.840.10008.5.1.4.1.1.2 (CT image storage)
- Support implicit VR little-endian transfer syntax (1.2.840.10008.1.2)
- The length of the device AE title shall not exceed 16 characters.
Test requirements
The compliance test shall verify:
| Test dimension | Verification method | Judgment criteria |
|---|---|---|
| Communication protocol | DICOM association test | Successfully establish TCP connection |
| Data format | IOD instance verification | Comply with PS3.3 attribute requirements |
| Security specification | TLS encryption test | Support AES-128 encryption |
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