C39 医用电子仪器设备 标准查询与下载

DIN EN 60601-1-9:2008 医疗电气设备.第1-9部分:基本安全和重要性能的通用要求.附属标准:环境意识设计用要求

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007); German version EN 60601-1-9:2008

DIN EN 60601-2-39:2008 医疗电气设备.第2-39部分:腹膜透析设备基本安全和重要性能的特殊要求

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007); German version EN 60601-2-39:2008

KS C IEC 60601-3-1:2008 医用电气设备.第3.1部分:经皮氧分压和二氧化碳分压监护设备基本性能要求

이 표준은 3.1에서 정의한 대로, 앞으로 기기(EQUIPMENT)라고 통칭하게 될 경피

Medical electrical equipment-Part 3-1:Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment

KS C IEC 60601-2-26:2008 医用电气设备.第2-26部分:脑电图机基本安全性

다음 사항을 제외하고는 공통 표준의 내용을 적용한다.추가:이 개별 표준은 2.2

Medical electrical equipment-Part 2-26:Particular requirements for the safety of electroencephalographs

KS C IEC 60601-2-31:2008 医用电气设备.第2-31部分:带内部能源的体外心脏起搏器安全性和基本性能的特殊要求

추가:이 개별 표준은 2.1.101에 정의된 내부 전원을 사용하는 체외용 인공 심장 박

Medical electrical equipment－Part 2－31：Particular requirements for the safety of external cardiac pacemakers with internal power source

KS C IEC 60601-2-51:2008 医用电气设备.第2-51部分:单道和多道心电描记器记录和分析的安全性的特殊要求

이 개별 표준에서는 2.101, 2.111, 2.117, 2.123, 2.126에 정의된

Medical electrical equipment-Part 2-51:Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

DIN EN 62353:2008 医疗电气设备.医疗电气设备的循环试验和维修后试验

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007); German version EN 62353:2008

DIN EN 60601-1 Berichtigung 1:2008 医疗电气设备.第1部分:基本安全和重要性能的一般要求.技术勘误DIN EN 60601-1(VDE 0750-1)-2007

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005); German version EN 60601-1:2006, Corrigendum to DIN EN 60601-1 (VDE 0750-1):2007-07

JIS T 0601-1 ERRATUM 3:2008 勘误表

ERRATUM

JIS T 0601-1 ERRATUM 1:2008 勘误表

ERRATUM

IEC TR 60977:2008 医用电气设备.医用电子加速器.功能特性指南

This technical report applies to medical ELECTRON ACCELERATORS when used, for therapy purposes, in human medical practice. This technical report applies to medical ELECTRON ACCELERATORS which deliver a RADIATION BEAM of either X-RADIATION or ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV to 50 MeV at maximum ABSORBED DOSE RATES between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the RADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm from the RADIATION SOURCE.

Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics

DIN EN 60601-2-33:2008 医用电气设备.第2-33部分:医疗诊断用磁共振设备的安全用特殊要求

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002 + A1:2005 + A2:2007); German version EN 60601-2-33:2002 + A1:2005 + A2:2008

JJG 543-2008 心电图机检定规程

本规程适用于实时测量人体表面心脏电位的模拟单通道、多通道心电图机的首次检定和后续检定。 本规程不适用于数字心电图机、向量心电图机、心电监护仪等具有非线性系统及信息处理和用于特殊用途的心电测量仪器。

Verification Regulation of Electrocardiograph

YY/T 1143-2008 电桥式阻抗血流图仪

本标准规定了该仪器的术语和定义、基本参数、技术要求、试验方法、检验规则和标志、包装、运输、贮存的要求。 本标准适用于电桥式阻抗血流图仪（以下简称为仪器）。 该仪器主要用于脑、肢体、内脏等血流图检查，供临床诊断或生理研究之用。

Bridge type impedance blood flow recorder

YY 0001-2008 体外引发碎石设备技术要求

本标准规定了体外引发碎石设备（按3.1的定义，以下简称设备）的术语和定义、产品分类、技术要求、试验方法、检验规则及标志等要求。 本标准适用于以液电式、电磁式、压电式压力脉冲发生器为碎石波源的设备，设备主要用于粉碎泌尿系结石。

Technical requirements of equipment for extracorporeally induced lithotripsy

YY/T 0001-2008 体外引发碎石设备技术要求

Technical requirements of equipment for extracorporeally induced lithotripsy

YY 1079-2008 心电监护仪

本标准对预期在本标准所规定的工作条件下使用的采用心电图方法获得心率和波形的监护仪，确立了最低性能要求。这类监护仪的下列所有部分应满足本标准: a)从患者身体通过无创心电检测获得心率显示; b)放大和传输这些信号，显示心率和/或心电波形;以及 c)基于可调的报警限对持续发生的与心率相关的下列现象提供报警:心脏停跳、心动过缓、和/或心动过速。

Electrocardiographic monitors

YY/T 1078-2008 直接式阻抗血流图仪

本标准规定了该仪器的基本参数、技术要求、试验方法、检验规则和标志、包装、运输、贮存的要求。该仪器主要用于脑、肢体、内脏等血流图检查，供临床诊断或生理研究之用。 本标准适用于直接式阻抗血流图仪（以下简称为仪器）。

Direct impedance blood flow recorder

IEC 60601-2-33:2008 医用电气设备.第2-33部分:医疗诊断用磁共振设备安全性的特殊要求

This Particular Standard applies to MR EQUIPMENT as defined in 2.2.101 and MR SYSTEMS as defined in 2.2.102. This Standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE.

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

CENELEC EN 60976-2007 医疗电气设备.医用电子加速器.功能执行程序特性（IEC 60976-2007）

This International Standard applies to medical ELECTRON ACCELERATORS when used, for therapy purposes, in human medical practice. This standard applies to medical ELECTRON ACCELERATORS which deliver a RADIATION BEAM of either X-RADIATION or ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV to 50 MeV at maximum ABSORBED DOSE RATES between 0,001 Gy s–1 and 1 Gy s–1 at 1 m from the RADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm from the RADIATION SOURCE. The present standard describes measurements and test procedures to be performed by the MANUFACTURER at the design and construction stage of a medical ELECTRON ACCELERATOR but does not specify ACCEPTANCE TESTS to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for ACCEPTANCE TESTS. The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the PHANTOM position for measurements and the measurement of distances from the ISOCENTRE. These new conditions should be substituted for and not be added to previous methods. This standard specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical ELECTRON ACCELERATOR and which are to be declared in the ACCOMPANYING DOCUMENTS together with the greatest deviation or variation to be expected under specific conditions in NORMAL USE. A format for presentation of functional performance values is given in Annex A. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the TREATMENT of PATIENTS. Except where otherwise stated this standard assumes that the medical ELECTRON ACCELERATORS have an ISOCENTRIC GANTRY. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted. NOTE A statement of compliance with this standard does not necessarily imply that these tests will be or have been applied as TYPE TESTS or as individual tests.

Medical electrical equipment - Medical electron accelerators - Functional performance characteristics (IEC 60976:2007)