信息技术在医药卫生技术中的应用标准-分析测试百科网

EN ISO 11615:2017/A1:2022 健康信息学.医疗产品的识别.物品药物上规定信息的唯一标识和交换用数据元素和结构包含修改件A1,2022

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)

ICS: 35.240.80
CCS
发布: 2022-09-21
实施: 2022-12-31

T/XSMIA 0005-2022 综合细胞资源库数字化建设应用技术指引

一、业务应用技术（一）采集管理：基本信息、评估筛查、机构资质、采集计划、采集方法、材料交接（二）制备管理：试剂耗材、原材料接收、原材料管理、制备计划、分离制备、送检管理（三）质检管理：质检计划、样品交接、质检操作、外送检测、质检信息、报告管理（四）存储管理：入库管理、冻存管理、复苏管理、存储管理、出库管理、销毁管理（五）科研项目管理：项目备案、项目审核、项目申报项目评审、数据管理数据分析、项目绩效、项目成果（六）临床试验研究：备案审核、立项审核、设计评估、经费管理、变更管理、监察督导、结题报告、档案管理（七）对外培训项目管理：直播课程、录播课程、考试系统、会议管理、实操管理、后台管理、数据统计、个人中心（八）实验室运营管理：租用申请受理、租用协议审核、租用进程管理、租用终止审计、托管受理、托管协议审核、托管进程管理、托管终止审计（九）生物信息管理：病历管理、健康档案、遗传家系、基因检测、报告管理（十）留样管理：入库管理、物料留样、中间产品留样、成品留样、出库管理、销毁管理（十一）外供管理：账户注册、申请审核、放行审批、运输监控、外供回溯、公众号二、管理应用技术伦理管理、法务管理、财务管理、物业管理、档案管理三、数字基础技术（十二）公共服务：告警服务、消息服务、内容和知识管理、安全与隐私服务（十三）消息总线：企业服务总线、服务交互、监控平台、故障预警（十四）数据总线：原材料采集编码、供者编码、机构编码、实验室样本编码、生物信息编码、保藏编码、出库批号编码四、安全保障技术防火墙、数据加固、系统加固、安全审计、入侵防范、介质安全、身份认证、通信加密、数据备份、备用网络、应用容灾、综合管理

Digitization Consultant for Cell Bank

ICS: 35.240.80
CCS: M751
发布: 2022-09-20
实施: 2022-10-26

T/JD 0007-2022 强制隔离戒毒人员 VR-tDCS毒瘾评估矫治系统操作规范

前言　 1 范围　 2 规范性引用文件　 3 术语和定义　 4 基本原则 4.1 科学性　 4.2 规范性　 4.3 有效性　 4.4 安全性　 5 人员要求　 5.1 操作人员　 5.2 戒毒人员　 6 场地及设备　 6.1 场地条件　 6.2 硬件配置　 6.3 系统功能　 7 毒瘾评估　 7.1 评估准备　 7.2 评估实施　 7.3 评估结果　 8 毒瘾矫治　 8.1 矫治准备　 8.2 矫治实施　 8.3 后续巩固　 9 应急管理　 9.1 行为异常情况　 9.2 身心异常情况　附录A（资料性）VR-tDCS毒瘾评估矫治系统使用知情同意书　附录B（资料性）VR-tDCS毒瘾评估系统VAS量表　附录C（资料性）VR-tDCS毒瘾评估系统评估分析报告　附录D（资料性）VR-tDCS毒瘾评估系统课程　参考文献　

Operation specification for virtual reality and transcranial direct current stimulation system for drug addicts under compulsory isolation

ICS: 35.240.80
CCS: I6540
发布: 2022-09-19
实施: 2022-09-23

T/JD 0006-2022 强制隔离戒毒人员防复吸脑功能训练系统操作规范

前言　 1 范围 2 规范性引用文件　 3 术语和定义　 4 基本原则　 4.1 科学性　 4.2 规范性　 4.3 有效性　 4.4 安全性　 5 人员要求　 5.1 操作人员　 5.2　戒毒人员　 6 场地及设备　 6.1 场地条件　 6.2 硬件配置　 6.3 系统功能　 7 训练流程　 7.1 训练准备　 7.2 训练实施　 7.3 训练评价　 8 后续巩固　 9 应急管理　 9.1　行为异常情况　 9.2　身心异常情况　附录A（资料性）防复吸脑功能训练系统使用知情同意书　附录B（资料性）脑电设备佩戴示意图　附录C（资料性）防复吸脑功能训练系统课程报告　参考文献　

Operation specification for anti-relapse brain functioning training of drug addicts under compulsory isolation

ICS: 35.240.80
CCS: I6540
发布: 2022-09-19
实施: 2022-09-23

T/GDPA 1-2022 企事业单位医务室药品配备参考目录

本标准依据职业场所的人群与病种特征以及样本医务室的实际用药统计分析，制定出了企事业单位医务室药品配备参考目录，包括：药品通用名；ATC、处方和中西三大类型；参考商品——剂型、规格、最小单位；并将企事业单位按照作业场景分为工厂类型和写字楼类型，每种类型均按照千人配比，给出了明确的配置量。

Reference catalogue of drug provisions in infirmary of enterprises and institutions

ICS: 35.240.80
CCS: Q849
发布: 2022-09-08
实施: 2022-09-08

T/SIOT 320-2022 智能核酸采样站技术规范

本文件规定了智能核酸采样站的产品要求、技术要求、智能化要求、试验检验方法及保证运输、存储等。

Technical Specifications for Intelligent Nucleic Acid Sampling Station

ICS: 35.240.80
CCS: I651
发布: 2022-09-02
实施: 2022-09-22

ASTM F2554-22 计算机辅助外科手术系统的位置精度测量标准实践

1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated): (1) Accuracy of a single point relative to a coordinate system. (2) Sensitivity of tracking accuracy due to changes in pointer orientation. (3) Relative point-to-point accuracy. 1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume. 1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees. 1.4 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. 1.5 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 Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

ICS: 35.240.80
CCS
发布: 2022-09-01
实施

BS EN ISO/IEEE 11073-40102:2022 健康信息学设备互操作性基础网络安全缓解能力

1 Overview 1.1 General Many Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs) provide vital support for people living with chronic disease or experiencing a life-threatening medical event. Cybersecurity attacks on vulnerable devices may lead to the alteration of prescribed therapy (e.g., sleep apnoea breathing therapy, insulin therapy) or to information disclosure that results in insurance or identity fraud or in direct or indirect patient harm. Companies subject to a successful cybersecurity attack may suffer financial harm and a negative reputation. Manufacturers of PHDs/PoCDs may be required to support application layer end-to-end information security. PHD / PoCD data exchange may be conducted over an untrusted transport. Also, a requirement may exist for multiple access control levels (e.g., restricted read access, restricted write access, full read access, full write access, full control access). Most PHDs/PoCDs have limited resources (e.g., processing power, memory, energy). Current standardized PHD / PoCD data exchange assumes the exchange is secured by other means, such as secure transport channel. This assumption requires that manufacturers define solutions by, for example, extensions or using mechanisms on the transport layer. Such solutions limit the usage of PHD / PoCD data exchange standards and restricts interoperability. This standard is based on the PH...

Health informatics. Device interoperability - Foundational. Cybersecurity. Capabilities for mitigation

ICS: 35.240.80
CCS
发布: 2022-08-31
实施: 2022-08-31

ISO 11615:2017/Amd 1:2022 健康信息学.医药产品的识别.受管制医药产品信息的唯一识别和交换用数据元素和结构.修改件1

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1

ICS: 35.240.80
CCS
发布: 2022-08-25
实施