11.040.55 诊断设备 标准查询与下载

JIS T 1140:2014 带最大仪表的临床电子体温计

Clinical electrical thermometers with maximum device

JIS T 4206:2014 带有最大仪表的玻璃临床温度计

Clinical glass thermometers with maximum device

CAN/CSA-C22.2 NO.60601-2-47-2014 医用电气设备 第 2-47 部分：动态心电图系统基本安全和基本性能的特殊要求（第二版）

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems (Second edition)

CAN/CSA-C22.2 No.60601-2-47-2014(R2018) 医用电气设备 第2-47部分：动态心电图系统基本安全和基本性能的特殊要求(IEC 60601-2-47:2012 MOD)

This Standard covers ME EQUIPMENT that is intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I. 201.1 Scope, object and related standards Clause 1 of the general standard1 applies, except as follows: 201.1.1 Scope 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’). 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. 201.1.3 Collateral Standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: "Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. "Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc. The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

Medical electrical equipment — Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems(IEC 60601-2-47:2012, MOD)

ISO 8600-4:2014 内窥镜. 医用内窥镜和内疗器械. 第4部分: 插入部分最大宽度的测定

Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion

DB22/T 2032-2014 医用多参数监护仪质量控制规范

Specifications for quality control of medical multi-parameter monitors

DB22/T 2030-2014 婴儿培养箱质量控制规范

Specifications for quality control of infant incubators

CAN/CSA-C22.2 NO.60601-2-26-2014 医用电气设备 第2-26部分：脑电图仪基本安全和基本性能的特殊要求（第三版）

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Third Edition)

CAN/CSA-ISO/TR 13154:2014 医用电气设备 使用筛查温度记录仪识别发热人员的部署、实施和操作指南（第一版）

Medical electrical equipment - Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph (First Edition)

GOST R 56326-2014 医疗电气设备. 多功能患者监测设备. 政府采购技术要求

Medical electrical equipment. Multifunction patient monitoring equipment. Technical requirements for governmental purchases

GOST R 56329-2014 医疗电气设备. 体外诱导碎石术使用设备. 政府采购技术要求

Medical electrical equipment. Equipment for extracorporeally induced lithotripsy. Technical requirements for governmental purchases

GOST R 56327-2014 医疗电气设备. 专家级超声设备. 政府采购技术要求

Medical electrical equipment. Ultrasonic equipment of expert class. Technical requirements for governmental purchases

GOST R 56323-2014 医疗电气设备. 霍尔特氏心电动态监测系统. 政府采购技术要求

Medical electrical equipment. System of Holter monitoring. Technical requirements for governmental purchases

GOST R 56279-2014 医疗电气设备. 内窥镜架. 政府采购规范

Medical electrical equipment. Endoscopic racks. Specifications for governmental purchase

GOST R 56310-2014 医疗电气设备. 带超导磁铁的磁共振设备. 政府采购技术要求

Medical electrical equipment. Magnetic resonance equipment with superconduction magnets. Technical requirements for governmental purchases

GOST R IEC 60601-2-18-2014 医疗电气设备. 第2-18部分. 内窥镜设备的基本安全和基本性能的特殊要求

Medical electrical equipment. Part 2-18. Particular requirements for the basic safety and essential performance of endoscopic equipment

GOST R 55952-2014 医疗电气设备. 心电监护设备. 公共采购的技术要求

Medical electrical equipment. Electrocardiographic monitoring equipment. Technical requirements for public procurement

GOST R 56331-2014 医疗电气设备. 医疗诊断超声设备. 政府采购技术要求

Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases

GOST R 56320-2014 医疗电气设备. 带永久磁铁的磁共振设备. 政府采购技术要求

Medical electrical equipment. Magnetic resonance equipment with permanents magnets. Technical requirements for governmental purchases

GOST R 56280-2014 医疗电气设备. 带内窥镜组的神经外科操作架. 政府采购规范

Medical electrical equipment. Neurosurgical operating racks with a set of endoscopes. Specifications for governmental purchase