11.040.55 诊断设备 标准查询与下载
共找到 856 条与 诊断设备 相关的标准，共 58 页
This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204@ hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities@ the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: ?C phono-photic stimulators; ?C EEG data storage and retrieval; ?C ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title or content of that clause or subclause will say so. If that is not the case@ the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS@ as follows. The clause or subclause applies to ME EQUIPMENT@ as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM@ the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document. NOTE See also 4.2 of the general standard.
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- ICS
- 11.040.55
- CCS
- 发布
- 2019-05-22
- 实施
- 2019-05-22
Medical electrical equipment -- Medical image display systems -- Part 1: Evaluation methods
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2019-04-01
- 实施
本标准规定了镓基液态合金玻璃体温计（以下简称体温计）的术语和定义、型式与参数、基本要求、技术要求、试验方法、检验规则、标志与使用说明书、包装、运输与贮存、质量承诺等要求。 本标准适用于具有测温留点结构、感温液为镓基液态合金，供测量人体口腔、腋下和肛门体温使用的医用体温计。
Gallium-base liquid alloy clinical thermometer
- ICS
- 11.040.55
- CCS
- C358
- 发布
- 2019-03-21
- 实施
- 2019-04-29
1 Scope This document provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection. NOTE The equipment standard for screening thermographs is found in IEC 80601–2-59.
Medical electrical equipment—Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
- ICS
- 11.040.55
- CCS
- 发布
- 2019-03-01
- 实施
Traditional Chinese medicine — Abdominal physiological parameter detectors
- ICS
- 11.040.55
- CCS
- 发布
- 2019-02-18
- 实施
本标准规定了肺结节人工智能辅助诊断系统的术语与定义、系统功能模块、运行环境、要求及试验方法等内容。
Technical requirements of the artificial intelligence diagnostic system for pulmonary nodules
- ICS
- 11.040.55
- CCS
- I6490
- 发布
- 2019-01-23
- 实施
- 2019-01-23
Amendment 1 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- 发布
- 2018-12-04
- 实施
本标准规定了全自动核酸提取与反应体系构建系统的术语和定义、技术要求、试验方法。 本标准适用于全自动核酸提取与反应体系构建，该系统由样本架、试剂架、运动系统、加样系统、 核酸提取模块、核酸检测反应体系构建模块等组成。
Fully automatic nucleic acid extraction and reaction system construction system
- ICS
- 11.040.55
- CCS
- C 30
- 发布
- 2018-11-13
- 实施
- 2018-12-13
BS ISO 18615. Traditional Chinese medicine. General requirements of electric radial pulse tonometric device
- ICS
- 11.040.55
- CCS
- 发布
- 2018-11-12
- 实施
- 2018-11-12
本标准规定了数字动态心电图机的术语和定义、基本要求、技术要求、试验方法、检验规则、标志、包装、运输、贮存等要求及质量承诺。 本标准适用于可连续记录24 h及以上心电图和分析心电图的数字动态心电图机。
Digital ambulatory electrocardiographs
- ICS
- 11.040.55
- CCS
- C358
- 发布
- 2018-11-09
- 实施
- 2019-03-05
1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. 1.2 This specification does not cover infrared thermometers. Specification E1965 covers specifications for IR thermometers. 1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.4 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification. 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 Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- ICS
- 11.040.55
- CCS
- 发布
- 2018-10-01
- 实施
Medical electrical equipment — Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2018-08-22
- 实施
Medical electrical equipment — Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2018-08-22
- 实施
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- 发布
- 2018-08-22
- 实施
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- 发布
- 2018-08-22
- 实施
Medical electrical equipment — Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2018-08-22
- 实施
Medical electrical equipment — Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2018-08-22
- 实施
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2018-06-01
- 实施
Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- ICS
- 11.040.55
- CCS
- C43
- 发布
- 2018-05-01
- 实施
