C37 医疗设备通用要求 标准查询与下载

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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. 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.

Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

BS EN 60601-2-39:2008+A11:2011 医疗电气设备.腹膜透析设备基本安全性和必要性能的详细要求

Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

BS EN ISO 5359:2008+A1:2011 医疗用气体设备的低压软管组件

Low-pressure hose assemblies for use with medical gases

ANSI/AAMI ES60601-1 C 1 and A2-2009 医疗电器设备.第一部分:基本安全和实用性的一般要求

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

DIN EN 60601-2-31:2009 医疗电气设备.第2-31部分:用内供电源的体外心脏起博器基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source (IEC 60601-2-31:2008); German version EN 60601-2-31:2008

IEC 60601-1:2005/ISH2:2009 医疗电气设备.第1部分:基本安全和基本性能的通用要求.解释清单2

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Interpretation sheet 2

ASTM F2761-09 医疗器械和医疗系统.包含病人的设备用基础安全要求.中心综合临床环境(ICE).第1部分:一般要求和概念模型

This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy and workflow efficiency than can be achieved with independently used MEDICAL DEVICES.This series of standards establishes requirements for design, verification, and validation processes of a modelbased integration system for an INTEGRATED CLINICAL ENVIRONMENT. This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance. NOTE These requirements were derived to support the clinical scenarios or clinical concepts of operations described in Annex B.

Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

ANSI/AAMI/ISO 10993-5:2009 医疗器械生物学评价.第5部分:体外细胞毒性试验

Describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

SANS 1409:2008 医院医疗服务(气体和真空)用外导插座和探针

Specifies the requirements for nine types of non-interchangeable outlet sockets and probes for specific medical (gas and vacuum) services used in hospitals.

Outlet sockets and probes for medical (gas and vacuum) services used in hospitals

YY 0677-2008 液氮冷冻外科治疗设备

本标准规定了液氮冷冻外科治疗设备的范围、定义和术语、要求、试验方法、检验规则及标志、标签、包装等要求。 本标准适用于制冷剂为液氮，利用其汽化相变潜热制冷，且液氮存贮器容量大于1L的冷冻外科治疗设备。治疗设备主要对靶组织产生低温，用于冷冻坏死、冷冻阻滞、炎性反应及冷冻粘连用。

Liquid nitrogen cryosurgical equipment

YY/T 0678-2008 医用冷冻外科治疗设备性能和安全

Standard performance and safety specification for cryosurgical medical instruments

YY 0678-2008 医用冷冻外科治疗设备性能和安全

本标准规定了医用冷冻外科治疗设备在冷冻系统性能和复现性、公布、标记、文件和安全方面所应遵循的基本要求。 本标准所指医用冷冻外科治疗设备采用相变汽化潜热或焦耳-汤姆逊效应原理，在冷冻探杆内或直接在靶组织产生低温，用于产生冷冻坏死、炎性反应或冷冻粘连。 医用冷冻外科设备使用时是由可显示冷冻探头或冷冻区域温度的附件来对治疗过程进行监测的，本标准的要求适用于这些附件。

Standard performance and safety specification for cryosurgical medical instruments

YY/T 0677-2008 液氮冷冻外科治疗设备

Liquid nitrogen cryosurgical equipment

DIN EN 62366:2008 医疗设备.医疗设备可用性工程的应用

Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008

BS EN 60601-1-10:2008 医用电气设备.基本安全和基本性能的一般要求.补充标准.物理闭环控制器开发的要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE. NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard does not specify: − additional mechanical requirements; or − additional electrical requirements. This collateral standard applies to a closed-loop controller (see Figure 1) that sets the CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE. A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard.

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers

BS EN 14931:2006 载人高压氧仓(PVHO).高压治疗用多位压力仓.性能、安全要求和测试

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chambers for hyperbaric therapy - Performance, safety requirements and testing

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一般要求.附属标准:环境意识设计用要求

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. 1.2 Object The object of this collateral standard is to specify general requirements, in addition to those of the general standard, for the reduction of the adverse ENVIRONMENTAL IMPACT of ME EQUIPMENT, and to serve as the basis for particular standards.

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

NF C74-019*NF 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:环境意识设计的要求

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

BS EN 60601-1-9:2008 医疗设备综合.基本安全和基本性能的通用要求.间接标准.环保意识的设计的要求

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 EN 60601-1-9:2008+A1:2013 医疗电气设备. 基本安全和主要性能的一般要求. 附属标准. 环境意识设计要求

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for environmentally conscious design