11.040.55 诊断设备 标准查询与下载

BS EN 61391-1:2007 超音波 脉冲回波扫描器 第1部分：校准空间测量系统用技术和系统点传播功能响应的测量

Ultrasonics - Pulse-echo scanners - Techniques for calibrating spatial measurement systems and measurement of system point-spread function response

DS/EN 61391-1:2007 超声波 脉冲回波扫描仪 第1部分：校准空间测量系统和测量系统点扩散函数响应的技术

This International Standard describes methods of calibrating the spatial measurement facilities and point-spread function of ultrasonnic imaging equipment in the ultrasonic frequency range 0,5 MHz to 15 MHz. This standard is relevant for ultrasoninc scanners based on the pulse-echo principle of the types listed below:- mechanical sector scanners;- electronic phased-array sector scanners;- electronic liniar-array scannars;- electronic curved-array sector scanners;- water-bath scanners based on any of the above four scanning mechanisms;- 3D-volume reconstruction systems.

Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response

ANSI/AAMI/ISO 81060-1:2007 非侵入式血压计.第1部分:非自动测量式血压计的要求和试验方法

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated meaasurement type

GOST R ISO 9919-2007 医疗电气装置.脉搏氧饱和度仪的基本安全性与主要性能的特定要求

Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeters

JJG 1016-2006 心电监护仪检定仪检定规程

本规程适用于心电监护仪检定仪的首次检定、后续检定和使用中的检验；也适用于具有心电监护检定功能的心、脑电图机检定仪中心电监护仪检定功能的首次检定、后续检定和使用中检验。

Verification Regulation of Calibration Device for Electric Cardiac Monitor

CAN/CSA-C22.2 No.60601-2-27-2006 医用电气设备 第2-27部分：心电图监测设备安全（包括基本性能）的特殊要求

This National Standard of Canada is equivalent to International Standard CEI/IEC 60601-2-27:2005. 1 Scope and object This clause of the General Standard applies except as follows: *1.1 Scope Addition: This Particular Standard specifies the particular safety requirements, including essential performance, for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101 and hereinafter also referred to as EQUIPMENT. This standard is applicable to EQUIPMENT used in a hospital environment. If the EQUIPMENT is used outside the hospital environment, such as in ambulances and air transport, the EQUIPMENT shall comply with this standard. NOTE Additional standards apply to the EQUIPMENT covering specifically use outside the hospital environment. 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. ECG telemetry systems, ambulatory ("Holter") monitors and other ECG recording devices are outside the scope of this Particular Standard.

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

CAN/CSA-C22.2 No.60601-2-33-2004(C2009) 电子医疗设备 第2-33部分：用于医疗诊断的磁共振设备的特殊安全要求

La présente norme nationale du Canada est équivalente a la norme internationale IEC 60601-2-33:2002. INTRODUCTION La présente Norme Particulière est écrite à un moment où l'évolution technique des APPAREILS À RM est en rapide progrès et les fondements scientifiques de leur utilisation sûre sont constamment en évolution. Cette norme traite des aspects techniques des SYSTÈMES À RM et des APPAREILS À RM destinés au diagnostic médical, relatifs à la sécurité des PATIENTS examinés avec ce système et du personnel associé à son fonctionnement. Lorsque les limites d'exposition des PATIENTS et du personnel médical sont établies, ces limites n'impliquent pas que de tels niveaux d'exposition puissent être considérés comme acceptables pour le grand public. Leur incidence réside davantage dans le fait que ces limites offrent au PATIENT un équilibre raisonnable entre les risques et les bénéfices, et au personnel médical un risque équilibré, compte tenu de sa responsabilité dans le bien-être du PATIENT. Les aspects d'organisation de la sécurité relèvent de l'UTILISATEUR. Cette tâche comprend une formation appropriée du personnel, des règles d'accès aux SYSTÈMES À RM, une qualification du personnel concernant les décisions relatives à la sécurité, une définition de la responsabilité médicale et des exigences spécifiques pour le personnel en raison de la responsabilité qu'il a lorsque le PATIENT se trouve à l'intérieur ou à proximité du SYSTÈME À RM.

Electromedical devices - Part 2-33: Particular safety requirements for magnetic resonance devices used for medical diagnosis

NF C74-018/A1:2006 医用电气设备.第1-8部分:安全性一般要求.并列标准.医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南

Medical electrical equipment - Part 1-8 : general requirements for safety - Collateral standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

DIN EN 60601-2-27:2006 医用电气设备.第2-27部分:心电图监护设备基本性能安全性专用要求

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005); German version EN 60601-2-27:2006

NF C74-349:2006 医疗用电气设备.第2-27部分:心脏监测仪的包括主要性能的安全的特殊要求

Medical electrical equipment - Part 2-27 : particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment.

KS B ISO 8600-3-2006(2016) 光学和光学仪器 - 医疗内窥镜和内窥镜附件 - 第3部分:视野内视镜的定位和光学内窥镜的方向

Optics and optical instruments — Medical endoscopes and endoscopic accessories — Part 3: Determination of field of view and direction of view of endoscopes with optics

KS B ISO 8600-2:2006 光学和光学仪器.医疗内窥镜和内窥镜附件.第2部分:硬支气管内窥镜的特殊要求

이 규격은 마취 및 의료 내시경 업무시 사용되는 경성 기관지경 및 내시경 부속품의 정의 및

Optics and optical instruments-Medical endoscopes and endoscopic accessories-Part 2:Particular requirements for rigid bronchoscopes

KS B ISO 8600-3:2006 光学和光学仪器.医用内窥镜和内窥镜附件.第3部分:光学内窥镜观察方向和观察区域的测定

이 규격에서는 내시경의 시야 및 시선 방향 측정에 대한 요건을 명시하고 권장하는 시험 방

Optics and optical instruments－Medical endoscopes and endoscopic accessories－Part 3：Determination of field of view and direction of view of endoscopes with optics

KS B ISO 8600-3-2006(2021) 光学和光学仪器.医用内窥镜和内窥镜附件.第3部分:光学内窥镜视野和视野方向的测定

Optics and optical instruments — Medical endoscopes and endoscopic accessories — Part 3: Determination of field of view and direction of view of endoscopes with optics

BS EN 60601-2-27:2006 医疗电气设备.第2-27部分:心电图监测设备的安全(包括基本性能)特殊要求

Addition: This Particular Standard specifies the particular safety requirements, including essential performance, for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101 and hereinafter also referred to as EQUIPMENT. This standard is applicable to EQUIPMENT used in a hospital environment. If the EQUIPMENT is used outside the hospital environment, such as in ambulances and air transport, the EQUIPMENT shall comply with this standard. NOTE Additional standards apply to the EQUIPMENT covering specifically use outside the hospital environment. 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. ECG telemetry systems, ambulatory ("Holter") monitors and other ECG recording devices are outside the scope of this Particular Standard.

Medical electrical equipment — Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

JJF 1149-2006 心脏除颤器和心脏除颤监护仪校准规范

本规范适用于新制造、使用中及修理后的普通心脏除颤器（以下简称除颤器）和心脏除颤监护仪（以下简称除颤监护仪）除颤部分（含除颤过程中除颤部分对心电监护部分的影响）的校准；不适用于自动外部除颤器、体内植入式除颤器的校准，除颤监护仪心电的计量特性及其校准可参照JJG 760-2003 心电监护仪检定规程相应条款进行。

Calibration Specification for Cardiac Defibrillators & Cardiac Defibrillator-monitors

IEC 60601-2-47:2006 医用电气设备.第2-47部分:移动式心电描记系统安全(包括主要性能)的特殊要求

This Particular Standard specifies the particular safety requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, as defined in 2.101. 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 safety, including essential performance, of ambulatory electrocardiographic systems

NF C74-122/A1:2006 医用电气设备.第2-33部分：医疗诊断用磁共振设备安全专用要求

Medical electrical equipment - Part 2-33 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.

IEC TS 62306:2006 超声波学.野外特性.在诊断超声波场内测定温度上升的试验目标

This Technical Specification is applicable to medical diagnostic ultrasonic fields. This Technical Specification establishes: – the important characteristics and terminology for test objects containing an embedded thermal sensor to determine ultrasonic heating; – requirements for defining particular types of test object for specific applications; – examples of design features which will ensure that the performance specifications are achieved; – validation procedures; – general test methods for using test objects to determine standardised temperature rises. NOTE 1 This Technical Specification specifically relates to test objects which contain an embedded thermal sensor (such as a thermocouple or thermistor). Although it may be possible to use non-embedded methods of temperature determination to achieve the same ends, these are outside of the scope of this Technical Specification. NOTE 2 The test objects specified in this Technical Specification are for the measurement of temperature rise and not for the determination of Thermal Index which is, by definition, an algebraic combination of acoustical field quantities and is therefore not a physically measurable quantity.

Ultrasonics - Field characterisation - Test objects for determination temperature elevation in diagnostic ultrasonic fields

CAN/CSA-C22.2 No.60601-2-51-2004(C2009) 电子医疗设备 第2-51部分：单通道和多通道记录和分析心电图机的特殊安全规则和基本性能

La presente norme nationale du Canada est equivalente a la norme internationale IEC 60601-2-51:2003. 1 Domaine d'application et objet Cet article de la Norme Générale s'applique, excepté ce qui suit: *1.1 Domaine d'application Addition: La présente Norme Particulière spécifie les exigences en matière de sécurité et de performances essentielles des ÉLECTROCARDIOGRAPHES ENREGISTREURS ET ANALYSEURS MONO ET MULTI-CANAUX, tels que définis en 2.101, 2.111, 2.117, 2.123, 2.126, désignés ci-après sous le nom d'APPAREILS. L'APPAREIL peut fonctionner sous surveillance d'un opérateur ou non. La présente Norme Particulière complète la CEI 60601-2-25 et son Amendement 1 (1999). 1.2 Objet Remplacement: L'objet de la présente Norme Particulière est d'établir des exigences particulières, en complément des exigences de la CEI 60601-2-25 concernant la sécurité et les performances essentielles des ÉLECTROCARDIOGRAPHES ENREGISTREURS ET ANALYSEURS MONO ET MULTICANAUX. Ces exigences doivent s'appliquer en particulier aux - ÉLECTROCARDIOGRAPHES ENREGISTREURS; - ÉLECTROCARDIOGRAPHES intégrés à d'autres APPAREILS ÉLECTROMÉDICAUX, tels que les systèmes d'épreuve d'effort, si ces APPAREILS servent à l'enregistrement d'ECG à des fins de diagnostic; - ÉLECTROCARDIOGRAPHES utilisés en tant qu'unités de sortie par des systèmes de gestion de base de données d'ECG ou aux ÉLECTROCARDIOGRAPHES utilisés en tant qu'unités de sortie à d'autres endroits que l'unité d'enregistrement; - ÉLECTROCARDIOGRAPHES ANALYSEURS, systèmes et équipements informatiques qui à l'aide d.un traitement informatique et d'imagerie calculent des mesures (telles que des intervalles et des amplitudes) et établissent des diagnostics à partir de l'ÉCG; - parties d'appareils de surveillance de PATIENTS ou autres ÉLECTROCARDIOGRAPHES spéciaux capables de remplir les fonctions d.un ÉLECTROCARDIOGRAPHE ANALYSEUR. La présente Norme ne doit pas être appliquée aux ÉLECTROCARDIOGRAPHES destinés à un enregistrement continu (méthode de Holter), à l'électrocardiographie invasive, aux systèmes de surveillance de PATIENTS et aux ÉLECTROCARDIOGRAPHES haute résolution (tels que les ÉLECTROCARDIOGRAPHES à faisceau de HIS ou pour une détection de potentiel tardif) autres que ceux indiqués ci-dessus.

Electromedical devices - Part 2-51: Particular safety rules and essential performances of single and multi-channel recording and analyzing electrocardiographs