11.040 医疗设备 标准查询与下载

YY 0607-2007 医用电气设备 第2-10部分：神经和肌肉刺激器安全专用要求

Medical electrical equipment—Part 2: Particular requirements for the safety of nerve and muscle stimulators

CENELEC EN 62366-2008 医疗器械 可用性工程在医疗器械中的应用

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2). This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.

Medical devices - Application of usability engineering to medical devices

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

KS P ISO 11334-4:2007 单臂操作助行器具.第4部分:三脚或多脚手杖

손잡이와 발이 장착된 삼족 이상 지팡이를 35 kg 이상인 사람이 일상 생활에서 사용할 때

Walking aids manipulated by one arm－Part 4：Walking sticks with three or more legs

KS P ISO 11334-4-2007(2017) 走由一个4臂部分操作的助:手杖具有三个或更多个腿

Walking aids manipulated by one arm－Part 4：Walking sticks with three or more legs

YY/T 0615.1-2007 标示“无菌”医疗器械的要求 第l部分：最终灭菌医疗器械的要求

YY/T 0615的本部分规定了标示“ 无菌”最终灭菌医疗器械的要求。YY/T 0615第2部分规定了标示“ 无菌”的无菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“ 无菌”.GB 18278、GB 18279、GB 18280、GB/T 19974、ISO 14160规定了医疗器械灭菌的确认和常规控制的要求。

Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices

YY/T 0086-2007 药品冷藏箱

本标准规定了药品冷藏箱(以下简称冷藏箱)的主要技术要求、试验方法、检验规则、标志、运输、贮存等要求。 本标准适用于容积为600L以下，箱内温度范围为2℃-14℃电机驱动压缩式全封闭型制冷系统的冷藏箱，该产品供医药卫生、科研部门储存药品和生物制品。

Pharmaceutical refrigerator

YY/T 0168-2007 血液冷藏箱

本标准规定了血液冷藏箱(以下简称冷藏箱)的主要技术要求、试验方法、检验规则、标志、运输、贮存等要求。 本标准适用于容积600 L以下，箱内温度为4℃±1℃的电机驱动的全封闭式压缩机制冷系统的冷藏箱。该产品供医院、血站及医疗科研部门储存血液。

Blood refrigerator

JJG 749-2007 心、脑电图机检定仪检定规程

本规程适用于心电图机检定仪、脑电图机检定仪及心、脑电图机检定仪的首次检定、后续检定和使用中的检验。

Verification Instrument for Electrocardiograph and Electroencephalograph

GSO IEC 60601-1:2007 电气医疗器械 第1部分：基本安全和基本性能的通用要求

IEC 60601-1:2005+A1:2012(E) contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, December 2007 and November 2012, the interpretation sheets of April 2008, January 2009 and May 2013 have been included in this copy. This consolidated version consists of the third edition (2005) and its amendment 1 (2012). Therefore, there is no need to order the amendment in addition to this publication. This is an English version.

Medical electrical equipment –Part 1: General requirements for basic safety and essential performance

LST EN 60601-1-2007 医用电气设备 第1部分：基本安全和基本性能的一般要求（IEC 60601-1:2005）

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

JJG 893-2007 超声多普勒胎心仪超声源检定规程

本规程适用于超声多普勒胎心仪超声源（即超声多普勒胎儿心率仪，以下简称仪器）的首次检定、后续检定和使用中检验。

Verification Regulation of Ultrasonic Source of Ultrasonic Doppler Foetal Meters

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

YY/T 1088-2007 在0.5MHz至15MHz频率范围内采用水听器测量与表征医用超声设备声场特性的导则

本标准就 0.5MHz 至 15 MHz 频率范围内采用水听器法对各类医用超声设备声输出进行的实际测量提供了指南。 本标准给出了医用超声设备声输出测量的简化步骤和指南，以及对因使用有限带宽和有限敏感元件尺寸的水听器所引起的限制进行修正的步骤。

Guidance for the measurement and characterization of ultrasonic fields generated by medical ultrasonic equipment using hydrophones in the frequency range 0.5MHz to 15MHz

LST EN 62304-2006 医疗设备软件 软件生命周期过程（IEC 62304:2006）

Medical device software - Software life-cycle processes (IEC 62304:2006)

KS X ISO 21549-2-2006 健康信息学-患者健康卡数据-第2部分：常用对象

Health informatics -Patient healthcard data -Part 2：Common objects

KS X ISO 21549-1:2006 健康信息学 患者健康卡数据 第1部分：一般结构

Health informatics -Patient healthcard data -Part 1 : General structure

KS X ISO 21549-2:2006 健康信息学 患者健康卡数据 第2部分：常见对象

Health informatics -Patient healthcard data -Part 2：Common objects

CAN/CSA-C22.2 No.60601-1-6-2005 医疗电气设备 第1-6部分：一般安全要求 并列标准：可用性

This National Standard of Canada is equivalent to International Standard CEI/IEC 60601-1-6:2004. Scope This Collateral Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to SAFETY of MEDICAL ELECTRICAL EQUIPMENT, hereinafter referred to as EQUIPMENT. This standard addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.

Medical Electrical Equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability

GA 544-2005 多道心理测试系统通用技术规范

本标准规定了多道心理测试系统的技术要求、试验方法、检验规则、标志、包装、运输和贮存等要求。 本标准适用于多道心理测试系统的设计、生产、检验和贸易。

General specification for polygraph system