11.040.55 诊断设备 标准查询与下载
共找到 858 条与 诊断设备 相关的标准，共 58 页
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
- C43
- 发布
- 2012-06-01
- 实施
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (Third Edition)
- ICS
- 11.040.55
- CCS
- 发布
- 2012-06-01
- 实施
201.1.1 * Domaine d’application Remplacement: La présente norme particulière s'applique à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE SURVEILLANCE DE LA PRESSION SANGUINE PRÉLEVÉE DIRECTEMENT définis en 201.3.63, désignés ci-après APPAREILS EM. La présente norme particulière ne s'applique pas aux tubes et aiguilles de cathéter, aux connecteurs Luer, et aux prises et panneaux de prises de connexion au DOME. La présente norme particulière ne s'applique pas non plus aux APPAREILS DE SURVEILLANCE DE LA PRESSION SANGUINE PRÉLEVÉE INDIRECTEMENT.
Medical electrical devices — Part 2-34: Particular requirements for the basic safety and essential performance of direct blood pressure monitoring devices
- ICS
- 11.040.55
- CCS
- 发布
- 2012-06-01
- 实施
IEC/TS 62791: Ultrasonics - Pulse-echo scanners - Low-echo sphere phantoms for performance testing of gray-scale medical ultrasound scanners applicable to a broad range of transducer types
- ICS
- 11.040.55
- CCS
- 发布
- 2012-06-01
- 实施
This Standard specifies general, performance and mechanical and electrical safety requirement for non-invasive mechanical sphygmomanometers and their accessories which by means of an inflatable cuff, are used for the non-invasive measurement of blood pressure.
Non-invasive mechanical sphygmomanometers
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2012-06-01
- 实施
This part of I SO 81060 specifies r equirements f or non-automated sphygmomanometers, as defined in 3.11,and their a ccessories, which, by m eans o f inflatable cuffs, a re u sed for the non-invasive blood pressuremeasurement by operator observation.
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
- ICS
- 11.040.55
- CCS
- 发布
- 2012-05-01
- 实施
"Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment@ such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment@ such as in ambulances and air transport@ shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However@ MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE. Ambulatory (""Holter"") monitors@ fetal heart rate monitoring@ pulse plethysmographic devices@ and other ECG recording equipment are outside the scope of this particular standard."
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment; Corrigendum 1
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2012-05
- 实施
- 2012-05-31
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007); German version EN 60601-2-37:2008 + A11:2011
- ICS
- 11.040.55
- CCS
- C41
- 发布
- 2012-05
- 实施
- 2012-05-01
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (Third Edition)
- ICS
- 11.040.55
- CCS
- 发布
- 2012-02-01
- 实施
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (Third Edition; Incorporates Corrigendum 1: October 2012)
- ICS
- 11.040.55
- CCS
- 发布
- 2012-02-01
- 实施
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS@ hereafter referred to as ME SYSTEMS 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. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit@ or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the abovementioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis@ minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example@ ??intermittent event recorders').
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2012-02-01
- 实施
- 2012-04-18
Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Second Edition)
- ICS
- 11.040.55
- CCS
- 发布
- 2012-02-01
- 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
- 2012-01-31
- 实施
- 2012-01-31
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (First Edition)
- ICS
- 11.040.55
- CCS
- 发布
- 2012-01-01
- 实施
Specifies basic safety and essential performance requirements for electrocardiographs for the production of ECG reports for diagnostic purposes. This particular standard does not include the part of electrocardiographs that povides vector loops, ambulatory electrocardiographic equipment covered by IEC 60601-2-47, and cardiac monitors covered by IEC 60601-2-27.
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2012-01-01
- 实施
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011); German version EN ISO 80601-2-61:2011
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2012-01
- 实施
- 2012-01-01
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
- 2012
- 实施
- 2015-01-01
Medical maximum glass thermometrs. General specifications
- ICS
- 11.040.55
- CCS
- 发布
- 2012
- 实施
- 2015-01-01
Medical electrical equipment. Part 2-49. Particular requirements for the safety of multifunction patient monitoring equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2012
- 实施
- 2015-01-01
State system for ensuring the uniformity of measurements. Medical ultrasonic diagnostic equipment. General requirements to methods of measurement of maximum depth of penetration and local dynamic range
- ICS
- 11.040.55
- CCS
- 发布
- 2012
- 实施
- 2014-01-01
