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 BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201@ hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS. NOTE For purposes of this document@ a pregnant mother and her fetus(es) are considered a single PATIENT. This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS such as ECG@ invasive pressure and pulse oximetry. The particular standards related to these PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the additional requirements related to MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case@ other relevant standards also apply. EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12 also applies. EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependent PATIENT where ISO 80601-2-72 also applies. EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also applies. EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment@ IEC 60601-2-16 also applies. This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS.
Medical electrical equipment- Part 2-49:Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2018-03-09
- 实施
- 2018-03-10
Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- ICS
- 11.040.55
- CCS
- 发布
- 2018-03-01
- 实施
Clinical glass thermometers with maximum device
- ICS
- 11.040.55
- CCS
- N11
- 发布
- 2018-02-01
- 实施
1.1 These practices establish procedures for the systematic interpretation and analysis of Psychophysiological Detection of Deception (PDD) data. 1.2 Any test data analysis procedure used shall be correctly matched to the PDD examination format. Examiners shall use evaluation methods for which they have been formally trained. 1.2.1 Acceptable test data analysis procedures are those published in refereed or technical journals, and for which published replications of the procedures have confirmed their efficacy. 1.3 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 Practices for Interpretation of Psychophysiological Detection of Deception (Polygraph) Data
- ICS
- 11.040.55
- CCS
- 发布
- 2018-02-01
- 实施
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- ICS
- 11.040.55
- CCS
- 发布
- 2017-12-29
- 实施
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- ICS
- 11.040.55
- CCS
- 发布
- 2017-12-29
- 实施
Medical electrical equipment－Part 2-33：Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- ICS
- 11.040.55
- CCS
- 发布
- 2017-09-29
- 实施
Medical electrical equipment－Part 2-33：Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- ICS
- 11.040.55
- CCS
- 发布
- 2017-09-29
- 实施
Medical electrical equipment－Part 2-47：Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
- ICS
- 11.040.55
- CCS
- 发布
- 2017-09-29
- 实施
Medical electrical equipment－Part 2-47：Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
- ICS
- 11.040.55
- CCS
- 发布
- 2017-09-29
- 实施
Medical electrical equipment－Part 2-33：Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- ICS
- 11.040.55
- CCS
- 发布
- 2017-09-29
- 实施
Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2017-09-28
- 实施
- 2017-09-30
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions@ hereafter referred to as ME EQUIPMENT. This document sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE 101 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN TEMPERATURE elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601-2-56 [30]). NOTE 102 The main part of such equipment is commonly referred to as an infrared camera. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and 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 relevant.
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2017-09-00
- 实施
- 2017-09-21
Traditional Chinese medicine. Pulse graph force transducer
- ICS
- 11.040.55
- CCS
- C31
- 发布
- 2017-07-04
- 实施
- 2017-07-04
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
- 2017-07-01
- 实施
Replacement: This International standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules); b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output; c) pulse oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61. d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy, which may require different test procedures than defined herein. e) FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin, which may require different test procedures than defined herein.
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
- 2017-07-01
- 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
- 发布
- 2017-06-16
- 实施
Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof@ intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME EQUIPMENT@ this is interpreted as X-RAY TUBE ASSEMBLIES in this particular standard. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only@ or to ME SYSTEMS only@ the title and 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 relevant. NOTE This document is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and XRAY TUBE HEADS.
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
- 2017-06
- 实施
- 2017-06-20
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2017-05-17
- 实施
This document specifies the technical requirements, classification and test method for a pulse graph force transducer, hereafter referred to as transducer. It only applies to pulse graph acquisition over the patient’s radial artery based on TCM pulse condition requirements.
Traditional Chinese medicine - Pulse graph force transducer
- ICS
- 11.040.55
- CCS
- C42
- 发布
- 2017-05
- 实施
