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

DB42/T 2080-2023 湖北省药品监管数据治理规范

Hubei Province Drug Supervision Data Governance Specifications

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

DB42/T 2088.1-2023 湖北省药品、医疗器械、化妆品监管数据采集规范 第1部分：药品

Hubei Province Drugs, Medical Devices, and Cosmetics Supervision Data Collection Specifications Part 1: Drugs

T/DGZYY 001-2023 名中医经验传承辅助系统要求

本文件规定了名中医经验传承辅助系统的功能要求、性能要求、安全要求和合格评定。 本文件适用于名中医经验传承辅助系统的研发、设计、应用效果评价。

Requirement of Traditional Chinese Medicine Inheritance Computer System

ISO/TS 23357:2023 基因组学信息学 下一代测序的临床基因组学数据共享规范

Genomics informatics — Clinical genomics data sharing specification for next-generation sequencing

ISO/CD 13940:2023 健康信息学 — 支持护理连续性的概念系统

Health informatics — System of concepts to support continuity of care

ISO/CD TR 11636:2023 健康信息学 — 用于健康信息基础设施的动态按需虚拟专用网络

Health Informatics — Dynamic on-demand virtual private network for health information infrastructure

ISO/DTS 14265:2023 健康信息学——处理个人健康信息的目的分类

Health Informatics — Classification of purposes for processing personal health information

T/SIGA 001.2-2023 互联网青光眼管理平台 第 2 部分：技术要求

互联网青光眼管理平台是一种以互联网为载体，储存、展示、分析青光眼患者的就诊资料、提供长期病情管理解决方案及相关服务的平台。本文件的制定，是为了规范互联网青光眼管理平台及其相关产品的功能要求、技术规定，并为其设计、开发、测试、应用提供技术支撑，及为市场监管、消费者权益保护等工作提供依据，进而推动我国互联网青光眼管理平台发展进程。

Internet glaucoma management platform part 2: technical requirements

KS X ISO 27269-2023 健康信息学.国际患者摘要

Health informatics — International patient summary

T/GDC 236-2023 医疗机构物流机器人业务应用及信息技术规范

医疗机构物流机器人的术语与定义、一般要求、应用场景说明、试验与验证、标志、使用说明书、包装、运输和贮存。

Application and Information Technology Specification for Logistics Robot Business in Medical Institutions

T/SIGA 001.1-2023 互联网青光眼管理平台 第1部分：功能要求

互联网青光眼管理平台是一种以互联网为载体，储存、展示、分析青光眼患者的就诊资料、提供长期病情管理解决方案及相关服务的平台。本文件的制定，是为了规范互联网青光眼管理平台及其相关产品的功能要求、技术规定，并为其设计、开发、测试、应用提供技术支撑，及为市场监管、消费者权益保护等工作提供依据，进而推动我国互联网青光眼管理平台发展进程。

Internet glaucoma management platform part 1: functional requirements

DB11/T 2117-2023 专项体检服务规范 征兵体检

Special physical examination service standardizes military recruitment physical examination

T/ZXCH 0016-2023 护理信息系统功能指南

本文件以护士的日常临床工作为视角，指引护理信息系统的功能需求，旨在为护士的临床工作提供信息使用工具。 本文件适用于护理信息系统的使用、开发和维护等人员。 本文件不包含医院信息系统（HIS）基础功能、医技及辅助科室相关功能、医院资源规划（HRP）相关功能、以及其它部分功能。

Nursing Information System Capabilities Guide

T/ZXCH 0017-2023 专科病种随访管理系统功能规范

本标准规定了专科病种随访管理系统的功能构成、功能要求和系统质量要求。 本标准适用于各级各类医疗机构专科病种随访管理系统的规划、设计、开发、部署和应用。

Functional specification of follow-up management system for specialized diseases

T/AIMC 007-2023 出口疫苗产品追溯标识技术规范

本文件规定了出口疫苗产品追溯标识的一般要求、编码、条码表示及标签。 本文件适用于出口疫苗产品进行追溯标识编码、条码生成、标签印制及质量检测。

Technical specifications for traceability labeling of exported vaccine products

ASTM E2738-23 计算机射线照相（CR）试验方法无损评价（DICONDE）中数字成像和通信的标准实施规程

1.1 This practice covers the interoperability of computed radiography (CR) imaging and data acquisition equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This practice 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 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 computed radiography test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from CR 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 standard CR 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 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 practice. 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 Computed Radiography (CR) Test Methods

KS X 2200-2023 健康信息学.数字医院的安全要求

Health informatics — Security requirements for digital hospitals

ISO 11239:2023 健康信息学 医药产品的鉴定 用于唯一识别和交换有关药物剂型、呈现单位、给药途径和……的监管信息的数据元素和结构

Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and…

CAN/DGSI 100-5:2023 数据治理： 第5部分 健康数据和信息能力框架

This standard specifies the minimum requirements for organizations to define the depth, diversity and complexity of capabilities, including criteria to assess the degree to which the capability is mature and consistently applied across an organization’s data assets and processes; and The framework also aims to help networks of organizations (e.g., multiple agencies within a jurisdiction) understand the alignment required within the network for a given Health Data and Information (HDI) capability through: • Identifying the need for and extent of alignment required of their HDI principles, practices and content where it is practical and beneficial toward achieving common aims; and • A common language for multi-organizational collaboration as a basis for exchange of leading practices and lessons learned in a meaningful and constructive way that fosters improvement and alignment. The framework is not intended to prescribe how these capabilities and related processes should be implemented. Individual organizations will need to design or refine their own policies, processes and practices given their scope, mandate, priorities and legislative authorities.

Data Governance: Part 5 - Health data and information capability framework