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/SIOT 323-2022 智慧健康养老 智慧养老院 数据规范

本文件规定了智慧养老院场景内的数据采集、数据传输、数据存储和数据分析等规范。

Data Specifications for Smart, Healthy, and Smart Nursing Homes

T/SIOT 322-2022 智慧健康养老 智慧养老院 支撑平台技术规范

本文件规定了智慧养老院的通用术语和定义、平台基本功能框架、平台功能要求等内容。

Technical Specifications for Supporting Platform of Smart Healthy Elderly Care Smart Nursing Home

T/GZBD 6-2022 基于区块链的互联网医疗健康平台建设指南

本文件提供了基于区块链的互联网医疗健康建设的术语和定义、总则、平台架构、功能、管理要素等指南。适用于指导基于区块链的互联网医疗健康平台的建设。

Guidelines for the construction of Internet medical and health platform based on blockchain

IEC 63203-801-1:2022 可穿戴电子设备和技术.第801-1部分:智能体域网（SmartBAN）.增强型超低功率物理层

Wearable electronic devices and technologies - Part 801-1: Smart body area network (SmartBAN) - Enhanced ultra-low power physical layer

IEC 63203-801-2:2022 可穿戴电子设备和技术.第801-2部分:智能体域网（SmartBAN）.SmartBAN的低复杂度介质访问控制（MAC）

Wearable electronic devices and technologies - Part 801-2: Smart body area network (SmartBAN) - Low complexity medium access control (MAC) for SmartBAN

ISO/TS 5568:2022 健康信息学.中药.人类生物样品信息的标签元数据

Health informatics — Traditional Chinese medicine — Labelling metadata of human biological sample information

EN ISO 13119:2022 健康信息学.临床知识资源.元数据

This document specifies a number of metadata elements that describe resources containing medical knowledge, primarily digital documents provided as web resources, accessible from databases or via file transfer, but can be applicable also to paper documents, e.g. articles in the medical literature. The metadata elements — support unambiguous and international understanding of important aspects to describe a resource, e.g. purpose, issuer, intended audience, legal status and scientific background, — are applicable to different kinds of digital resources, e.g. recommendation from consensus of a professional group, regulation by a governmental authority, clinical trial protocol from a pharmaceutical company, scientific manuscript from a research group, advice to patients with a specific disease, review article, — are possible to present to human readers including health professionals as well as individuals/patients, and — are potentially usable for automatic processing, e.g. to support search engines to restrict matches to documents of a certain type or quality level. The metadata elements defined in this document are not intended to — describe documents about a single patient, such as medical records, — describe details of the medical content of the resource (but some idea of the content can be described via keywords or codes), or — prescribe criteria for the quality of the resource content.

Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2022)

ISO/TS 17975:2022 健康信息学.收集、使用或披露个人健康信息的同意原则和数据要求

Health informatics — Principles and data requirements for consent in the collection, use or disclosure of personal health information

CAN/CIOSC 100-6:2022 数据治理 第6部分：负责任地使用数字接触者追踪、工作场所监控数据

This Standard specifies minimum requirements for the acceptable and responsible collection and use of contact tracing and monitoring data in the workplace. This Standard applies to the governance of current and future use of data that is created, collected, stored or controlled by contact tracing and monitoring solutions, and impacts the management processes and decisions relating to data security and privacy within and between organizations. This Standard does not cover the use of contact tracing, monitoring and surveillance solutions applied in public health. NOTE: While this Standard was developed to mitigate the spread of an infectious agent in the workplace, the requirements and principles may be applied for other uses.

Data Governance – Part 6: The responsible use of digital contact tracing, monitoring data in the workplace

BS ISO 81001-1:2021 健康软件和健康 IT 系统的安全性、有效性和保障 原则和概念

What is ISO 81001‑1 about?    ISO 81001‑1 provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning.    ISO 81001‑1 identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points.  ISO 81001‑1 establishes a coherent concept and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.   Who is ISO 81001‑1

Health software and health IT systems safety, effectiveness and security - Principles and concepts

T/SHDSGY 040-2022 LIN-36型表情特征分析系统技术规范

本文件规定了 LIN-36 型表情特征分析系统的术语、定义和缩略语、构成、设计原则、一般要求、系统功能要求、安全要求和备份与恢复。 本文件适用于林雨阁(上海)智能科技有限公司的 LIN-36 型表情特征分析系统

Technical specification of LIN-36 facial expression feature analysis system

T/SHDSGY 039-2022 DesX 肺部 X 光片 AI 影像快速分析系统技术规范

本文件规定了 DesX 肺部 X 光片 AI 影像快速分析系统技术规范的术语和定义、系统架构、系统基本要求、系统功能要求、数据管理、系统安全要求。 本文件适用于辅助肺部肿瘤医院及其研究学院进行影像分析的DesX 肺部 X 光片 AI 影像快速分析系统。

Specification for DesX lung X-ray AI image rapid analysis system

22/30452589 DC BS ISO 22077-2 健康信息学 医疗波形格式 第 2 部分：心电图

BS ISO 22077-2. Health informatics. Medical waveform format - Part 2. Electrocardiography

DB12/T 1164-2022 传染病信息报告数据集采集交换规范

Infectious disease information report data set collection and exchange specification

ISO 13119:2022 健康信息学.临床知识资源.元数据

This document specifies a number of metadata elements that describe resources containing medical knowledge, primarily digital documents provided as web resources, accessible from databases or via file transfer, but can be applicable also to paper documents, e.g. articles in the medical literature. The metadata elements — support unambiguous and international unders tanding of important aspects to describe a resource, e.g. purpose, issuer, intended audience, legal s tatus and scientific background, — are applicable to different kinds of digital resources, e.g. recommendation from consensus of a professional group, regulation by a governmental authority, clinical trial protocol from a pharmaceutical company, scientific manuscript from a research group, advice to patients with a specific disease, review article, — are possible to present to human readers including health professionals as well as individuals/ patients, and — are potentially usable for automatic processing, e. g. to support search engines to res trict matches to documents of a certain type or quality level. The metadata elements defined in this document are not intended to — describe documents about a single patient, such as medical records, — describe details ofthe medical content ofthe resource (but some idea ofthe content can be described via keywords or codes) , or — prescribe criteria for the quality of the resource content.

Health informatics — Clinical knowledge resources — Metadata

23/30452592 DC BS ISO 22077-3 健康信息学 医疗波形格式 第 3 部分：长期心电图

BS ISO 22077-3. Health informatics. Medical waveform format - Part 3. Long term electrocardiography

22/30430505 DC BS ISO 29585 健康信息学 医疗保健和相关数据报告框架

BS ISO 29585. Health informatics. Framework for healthcare and related data reporting

BS EN ISO 11615:2017+A1:2022 健康信息学 医药产品的鉴定 用于受监管药品信息的唯一识别和交换的数据元素和结构

1   Scope This document establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products . Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products , the use of other normative IDMP messaging standards is included, which are to be applied in the context of this document.

Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information

22/30447791 DC BS EN ISO 11239 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、途径等监管信息的数据元素和结构

BS EN ISO 11239. 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…

22/30434911 DC BS 30440 在医疗保健领域使用人工智能的验证框架 规格

BS 30440 Validation framework for the use of AI within healthcare. Specification