C39 医用电子仪器设备 标准查询与下载

KS C IEC 60601-2-17:2007 医用电气设备.第2-17部分:自动控制近距放射治疗后装设备安全的特殊要求

1.1.101 이 규격은 후장진법을 사용한 사람을 대상으로 한 근접 방사선 치료를 위한 자

Medical electrical equipment－Part 2－17：Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

KS C IEC 60601-2-34:2007 医疗电气设备.第2-34部分:侵入式血压监测仪器安全性(包括基本性能)的特殊要求

이 규격은 2.101에 정의된 관혈식 혈압 감시 기기의 안전에 관한 요구사항에 대하여 규정

Medical electrical equipment－Part 2－34：Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

KS C IEC 62266:2007 医疗电气设备.放射疗法中DICOM的实现指南

Medical electrical equipment－Guidelines for implementation of DICOM in radiotherapy

KS C IEC 60580:2007 医用电气设备.剂量面积仪

이 규격은 의료용 방사선 검사(MEDICAL RADIOLOGICAL EXAMINATIONS

Medical electrical equipment－Dose area product meters

KS C IEC 60601-2-11:2007 γ射线治疗仪

다음 사항을 제외하고 KS P IEC 60601-1의 1.에 따른다.KS P IEC 6

Gamma beam therapy equipment

IEC 60601-1-9:2007 医疗电气设备.第1-9部分:基本安全和重要性能的一般要求.附属标准:环境意识设计的要求

This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT,hereafter referred to as ME EQUIPMENT. MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard.

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

BS ISO 17593:2007 临床实验室测试和体外医疗设备.口服抗凝血剂治疗自测用体外监测系统的要求

This International Standard specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. This International Standard pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios (INR). This International Standard is applicable to manufacturers of such systems and those other organizations (e.g., regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not -- pertain to in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist therapy used by physicians or healthcare providers, -- provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, or -- address the medical aspects of oral-anticoagulation therapy.

Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

DIN EN 60601-2-27 Berichtigung 1:2007 医用电气设备.第2-27部分:包括心电图仪监测设备基本性能的安全性专用要求

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, Corrigenda to DIN EN 60601-2-27 (VDE

YY 0602-2007 测量、控制和试验室用电气设备的安全使用热空气或热惰性气体处理医用材料及供试验室用的干热灭菌器的特殊要求

1 范围和目的 除下述内容外，GB 4793.1的本章适用 1．1 范围 代替： 本标准适用于一切包括带自动装载和卸载系统的灭菌器，它们有一个或多个灭菌室，采用热空气或 热惰性气体，在接近于大气压力下运行，拟用于处理医用材料及供试验室处理使用 注1：自动装载和卸载系统的安全性能，采用国家安全规范或其他安全规范和法规 注2：通常对采用高温的设备推荐配置自动控制，因为手动控制可能会对操作人员产生严重的危害。

Safety requirements for electrical equipment for measurement,control, and laboratory use-Part 2-043:Particular requirements for bry heat sterilizers using either hot air or hot inert gas for the treeatment of medical materials,and for laboratory processes

UL 1069-2007 医院信号和护士呼叫设备

These requirements cover the individual units employed to form a hospital nurse call system (NCS) intended to provide audible and visual communication between patients and hospital personnel. They also cover miscellaneous signaling equipment employed in hospitals. Some examples include bedside tables, annunciators, power supplies for nurse call systems, and gas monitoring units. 1.2 An NCS minimally employs fundamental devices that perform these fundamental operations as follows: a) Notification - Call annunciation at a primary nurse's station (audible and visual on a wired device - signal and power), b) Notification - Call annunciation at the dome light, c) Notification - Call-placed indicator on the patient station (visual), d) Notification - Zone annunciation (audible and visual), and e) Call reset/cancellation. 3 An NCS may employ a wireless interface for: a) Notification by redundant call annunciation device at a portable nurse's station. b) Initiation of a patient or staff call. 1.4 The units covered by these requirements are intended to be installed in either general or critical care areas in accordance with the National Electrical Code, NFPA 70, and the Standard for Health Care Facilities, NFPA 99. 1.5 These requirements do not cover medical and dental equipment, line isolation monitors, X-ray equipment, electrically heated pads, therapeutic lamps, refrigerated oxygen therapy equipment, food warming cabinets and carts, equipment employed in inhalation anesthetizing or hazardous locations, office intercoms, or similar equipment and products covered by individual requirements. These requirements do not cover equipment employed in an area of hyperbaric oxygenation, in which a patient is exposed during oxygen therapy to pressures greater than ambient atmosphere. 1.6 A product that contains features, characteristics, components, materials, or systems new or different from those covered by the requirements in this standard, and that involves a risk of fire or of electric shock or injury to persons shall be evaluated using appropriate additional component and end-product requirements to maintain the level of safety as originally anticipated by the intent of this standard. A product whose features, characteristics, components, materials, or systems conflict with specific requirements or provisions of this standard does not comply with this standard. Revision of requirements shall be proposed and adopted in conformance with the methods employed for development, revision, and implementation of this standard.

UL Standard for Safety Hospital Signaling and Nurse Call Equipment Seventh Edition

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

IEC 60601-1:2005/COR1:2006 医疗电气设备.第1部分:基本安全和实用性的一般要求.技术勘误1

This standard is Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 1.

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 1

JIS T 0601-2-25:2006 医疗电气设备.第2部分:心电图仪的安全用特殊要求

この個別規格は，診断目的のために心電図を記録することを意図する2.102で定義した心電計に対し,適用する。ベクトル心電計,運動負荷試験装置にも適用する。

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

JIS T 0601-2-39:2006 医疗电气设备.第2-39部分:腹膜透析设备的安全用特殊要求

この規格は,2.1.102に定義した自動腹膜かん(灌)流用装置(以下，機器という。)の安全に関する要求事項について規定する。これは，医療スタッフによって使用される，又は医師の指導下に患者が操作する機器に適用する。

Medical electrical equipment -- Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment

JIS T 0601-2-2 ERRATUM 1:2006 勘误

次を除いて，JIS T 0601-1の1.を適用する。

ERRATUM

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.

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