35.240.80 信息技术在医药卫生技术中的应用 标准查询与下载

T/YNGCH 007-2023 医疗影像数据区块链上链规范

      1. 数据结构：DICOM 定义了一种称为 DICOM 文件格式的数据结构，用于储存医疗影像和相关的患者、检查、诊断等信息。每个 DICOM 文件不仅包含影像（或者声音、波形等数据），同时包 含了描述该影像的元数据。        2. 数据格式：数据的一致性是决定患者诊断和治疗正确性的关键因素，因此医疗影像数据上链时，必须保证数据的一致性，即数据在任何时候都被一致地、准确地记录和更新。为保持 一致性，需要标准中规定数据元名称、数据类型、数据长度、是否必选、数据元内容统一作出规定。        3. 数据应用管理：医疗影像等敏感信息的安全至关重要。数据上链前应保证数据的安全性和数据操作的合规性，对参与者进行身份验证，对数据访问权限进行控制，对数据操作进行记录。        4. 数据的隐私保护、安全性与合规性：为防止敏感数据泄露，通过数据加密匿名处理的方式对隐私信息进行保护。通过管理和技术手段，从设计、传输、储存等全过程进行安全性与合规性保护。

Standards for blockchain uploading of medical imaging data

T/AII 007-2023 儿科诊疗知识表示

本团体标准的主要技术内容为规范儿科诊疗知识表示，适用于指导儿科疾病诊疗知识图谱构建、包括儿科诊疗知识标注、知识抽取、知识推理、知识计算等。

Knowledge representation of pediatric diagnosis and treatment

ISO/TS 5569:2023 健康信息学——中药材概念数据模型

Health informatics — Conceptual data model for Chinese medicinal herbs

ISO/PRF 16527:2023 健康信息学 HL7 个人健康记录系统功能模型 第 2 版 (PHRS FM)

Health informatics — HL7 Personal Health Record System Functional Model, Release 2 (PHRS FM)

ISO/PRF 10781:2023 健康信息学 HL7 电子健康记录系统功能模型，版本 2.1 (EHR FM)

Health Informatics — HL7 Electronic Health Record-System Functional Model, Release 2.1 (EHR FM)

ISO/TR 9143:2023 健康信息学——电子健康记录中的性别和性别

Health informatics — Sex and gender in electronic health records

BS ISO 22077-3:2023 健康信息学 医学波形格式-长期心电图

Health informatics. Medical waveform format - Long-term electrocardiography

BS EN ISO/IEEE 11073-10419:2023 健康信息学 个人健康设备通信 设备专业化 胰岛素泵

Health informatics. Personal health device communication - Device specialization. Insulin pump

BS ISO 22077-2:2023 健康信息学 医学波形格式 心电图

Health informatics. Medical waveform format - Electrocardiography

T/CI 134-2023 主动健康平台医学科学数据共享管理规范

本文件规定了主动健康平台医学科学数据共享管理的总体要求、管理框架和数据共享管理。 本文件适用于主动健康平台医学科学数据的共享管理。

management specification of active health platform medical science data sharing

ISO 21549-5:2023 健康信息学 — 患者健康卡数据 — 第 5 部分：识别数据

Health informatics — Patient healthcard data — Part 5: Identification data

DB31/T 1422-2023 健康体检基本数据集

Basic data set of health examination

23/30468796 DC BS ISO 22287 健康信息学 医疗保健术语和术语服务的劳动力角色和能力（术语劳动力）

BS ISO 22287. Health informatics. Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)

ASTM E2699-23 数字 X 射线 (DX) 测试方法无损评估中数字成像和通信 (DICONDE) 的标准实施规程

1.1  This practice covers the interoperability of digital X-ray imaging equipment using Digital Detector Arrays (DDA) as described in Practice E2698 by specifying image data transfer and archival methods in commonly accepted terms. A separate practice, Practice E2738 , addresses this topic for digital X-ray imaging equipment using Computed Radiography (CR). This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of DICOM NEMA PS3 / ISO 12052 (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage, and archival storage. The goal of Practice E2339 , commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules, and a data dictionary that are specific to digital X-ray test methods. 1.2  This practice has been developed to overcome the issues that arise when analyzing or archiving data from digital X-ray test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the digital X-ray technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3  This practice does not specify: 1.3.1  A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2  The implementation details of any features of the standard on a device claiming conformance. 1.3.3  The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4  Units— Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this standard. 1.5  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6  This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Digital X-ray (DX) Test Methods

ISO/DTS 4424:2023 基因组信息学 — 用于描述临床大规模并行 DNA 测序的肿瘤突变负担 (TMB) 信息的数据元素及其元数据

Genomics informatics — Data elements and their metadata for describing the tumor mutation burden (TMB) information of clinical massive parallel DNA sequencing

ISO/DTS 8376:2023 基因组信息学 — 基因组监测互操作系统指南

Genomics informatics — Guidelines for interoperable systems for genomic surveillance

ISO 22077-2:2023 健康信息学 医学波形格式 第 2 部分：心电图

Health informatics — Medical waveform format — Part 2: Electrocardiography

ISO 22077-3:2023 健康信息学 医学波形格式 第 3 部分：长期心电图

Health informatics — Medical waveform format — Part 3: Long-term electrocardiography

T/CASME 577-2023 医学影像云平台技术规范

本文件规定了医学影像云平台的总体架构、功能要求、性能要求和云服务能力。

Technical specification for cloud platform of medical imaging

DB42/T 2088.2-2023 湖北省药品、医疗器械、化妆品监管数据采集规范 第2部分：医疗器械

Hubei Province Drugs, Medical Devices, and Cosmetics Supervision Data Collection Specifications Part 2: Medical Devices