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/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/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/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…

ASTM E1475-13(2023) 数字放射检查数据计算机化传输的数据字段标准指南

Standard Guide for Data Fields for Computerized Transfer of Digital Radiological Examination Data

T/CAB 0254-2023 生物气溶胶监控处置系统应用技术规程 第2部分：医疗机构

标准的第1章“范围”。规定了医疗机构生物气溶胶监控处置系统的适用范围。 标准的第2章“规范性引用文件”。汇集了标准编写所引用的主要标准及文件，是引用标准的清单，充分保证了本标准条款的可依性和可行性. 标准的第3章“术语和定义”。对标准中的重要术语为了加深理解进行了解释，引用了GB/T 39990-2021的术语和定义并对本文件病原微生物、细菌、病毒、生物气溶胶、采样介质、多重耐药性菌、呼吸道烈性传染病、样本采集人员、实验室操作人员、实验室辅助人员、一~三级安全防护进行了定义。 标准的第4章“监测准备”。监测准备包括了人员要求、防护要求、设备要求、环境要求，其中防护要求是根据一~三级安全防护等级，对处于不同安全防护等级的人员采取不同防护措施。对在医疗机构常见的监测生物中的病毒、细菌及其他危害因子进行了明确的规定。 标准的第5章“采样”。采样环节包括了采样原理、采样仪器类型、采样程序、采样场景、采样点、采样频率、运送七部分的内容，其中主要是对采样点的位置和数量进行了明确的规定，并根据采样场所的面积规定了采样时间及运送过程中需注意的事项。 标准的第6章“样本接收与处理”。规定了监测系统接收要求、样本实验操作要求、样本保存与使用要求、销毁要求中应注意的事项。 标准的第7章“运行流程”。明确采样系统从采样到运输到检测站进行检测，再到最后数据结果上传云平台以及后续的消杀处置工作流程。 标准的第8章“数据处理”。明确了采集传输、存储、异常值取舍、应用与分析环节的具体要求。 标准的第9章“消杀处置”。规定了消杀设备、消杀效果及监督的要求。 标准的第10章“运维管理”。规定了日常巡检、日常维护保养、系统检修的具体要求。 标准的第11章“生物安全”。规定了生物安全方面要遵照GB 19489的要求。

Code of practice for the application of the monitoring and disposal system of bioaerosol Part 2: Medical institution

T/SDBDA 41-2023 智慧医养 脊柱骨折智能分析平台功能与要求

本文件规定了脊柱骨折智能分析平台建设的基本原则、功能架构和基本要求。 本文件适用于脊柱骨折智能分析平台的设计、开发、运维和测评。

Functions and requirements of intelligent analysis platform for spinal fractures in smart healthcare

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

ISO/TR 11147:2023 健康信息学 个性化数字健康 数字治疗健康软件系统

Health informatics — Personalized digital health — Digital therapeutics health software systems

ISO/DTR 24290 健康信息学 放射治疗中临床和生物学评估指标的数据集和数据结构

Health informatics — Datasets and data structure for clinical and biological evaluation metrics in radiotherapy

ISO/CD TS 9321:2023 健康信息学 多中心医疗数据协同分析通用要求

Health informatics — General requirements of multi-center medical data collaborative analysis

ISO/CD TS 14265 健康信息学 个人健康信息处理目的分类

Health Informatics — Classification of purposes for processing personal health information

ISO 41064:2023 健康信息学 标准通信协议 计算机辅助心电图

Health informatics — Standard communication protocol — Computer-assisted electrocardiography

ISO/CD 21564 健康信息学 — 术语资源图质量测量 (MapQual)

Health Informatics — Terminology resource map quality measures (MapQual)

ISO/FDIS 22077-3 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

ISO/DIS 21549-7 健康信息学《患者健康卡数据》第7部分：用药数据

Health informatics — Patient healthcard data — Part 7: Medication data

ISO/CD 12052 健康信息学 医学数字成像和通信（DICOM），包括工作流程和数据管理

Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management

ISO/CD 22287 健康信息学 医疗保健中术语和术语服务的劳动力角色和能力（术语劳动力）

Health informatics — Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)