C37 医疗设备通用要求 标准查询与下载

DIN EN 60601-1:2007 医用电气设备.第1部分:基本安全和主要性能一般要求(IEC 60601-1:2005)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005); German version EN 60601-1:2006

IEC 62353:2007 医疗电气设备.医疗电气设备的循环试验和维修后试验

This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME EQUIPMENT OR ME SYSTEM is designed. This standard contains: – "general requirements", which contain clauses of general concern, and – "particular requirements", further clauses handling special types of ME EQUIPMENT or ME SYSTEMS and applying in connection with the "General requirements". NOTE 1 At this stage, there are no particular requirements. This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMS or any other equipment comply with the relevant standards for their design. This standard does not define requirements for REPAIR, exchange of components and MODIFICATION of ME EQUIPMENT or ME SYSTEMS. NOTE 2 All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements have to be assessed and verified. This standard is also applicable to tests after REPAIR. The testing shall be defined according to the extent of work performed and applicable guidance from the MANUFACTURER. This standard is not intended to define time intervals for RECURRENT TESTS. If such intervals are not defined by the MANUFACTURER, Annex F may be used to help establish such intervals.

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

BS EN 60601-2-2:2007 医用电气设备.高频外科设备安全特殊要求

Addition: This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES used in medical practice, as defined in 2.1.110 and hereinafter referred to as HF SURGICAL EQUIPMENT. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this Particular Standard. These exemptions are indicated in the relevant requirements.

Medical electrical equipment - Particular requirements for the safety of high frequency surgical equipment

BS EN ISO 14971:2007 医疗设备.医疗设备风险管理的应用

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Medical devices - Application of risk management to medical devices

SANS 60601-1:2007 医疗电气设备．基本安全和基本性能的一般要求

Applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems.

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

DOD MIL-STD-2525 B CHANGE 2-2007 共同作战符号

This standard provides common warfighting symbology along with details on its display and plotting to ensure the compatibility, and to the greatest extent possible, the interoperability of DOD Command, Control, Communications, Computer, and Intelligence

COMMON WARFIGHTING SYMBOLOGY

CSA Z21647-07-CAN/CSA-2007 电气医疗器械 呼吸气体监测仪安全和基本性能相关的特殊要求 第一版

Canadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve co

Electrical medical devices - Special requirements relating to the safety and basic performance of respiratory gas monitors first edition

DOD MIL-HDBK-857 A-2007 用于数字演示的地理空间符号(GEOSYM)

This handbook is for guidance only. Do not cite this document as a requirement. If it is, the contractor does not have to comply.

GEOSPATIAL SYMBOLS FOR DIGITAL DISPLAYS (GEOSYM)

IEC 60601-1-6:2006 医用电气设备.第1-6部分:基本安全和实用性能的通用要求.汇编标准:可用性

This International Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This collateral standard addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

BS EN 60601-1:2006+A11:2011 医疗电气设备.基本安全性和必要性能的一般要求

Medical electrical equipment. General requirements for basic safety and essential performance

BS EN 60601-1:2006+A1:2013 医用电气设备.基本安全性和基本性能的一般要求

Medical electrical equipment. General requirements for basic safety and essential performance

BS EN 60601-1:2006 医疗电气设备.基本安全性和必要性能的一般要求

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. 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. This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability. In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series FF2F). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1

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

CSA Z22857-06-CAN/CSA-2006 基于个人健康信息利于数据流动的数据保护的健康信息指导.第1版

This International Standard provides guidance on data protection requirements to facilitate the transfer of personal health data across national borders. It does not require the harmonisation of existing national standards, legislation or regulations. I

Health informatics Guidelines on data protection to facilitate trans-border flows of personal health information First Edition

SANS 14969:2006 医疗器械．质量管理制度．ISO 13485：2003适用指南

Provides guidance for the application of the requirements for quality management systems contained in ISO 13485 (published in South Africa as an identical adoption under the designation SANS 13485). It does not add to, or otherwise change, the requiremen

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

BS EN 61010-2-040:2005 测量,控制和实验室用电气设备的安全性要求.第2-040部分:医疗材料处理用灭菌器和清洗消毒器的详细要求

To be read in conjunction with BS EN 61010-1

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

DOD MIL-STD-6017 A CONT. DIST.-2006 可变信息格式(VMF)电文标准(U)

VARIABLE MESSAGE FORMAT (VMF) MESSAGE STANDARD (U)

VARIABLE MESSAGE FORMAT (VMF) MESSAGE STANDARD (U)

YY/T 0595-2006 医疗器械.质量管理体系.YY/T 0287-2003应用指南

本标准是为YY/T 0287标准中包含的医疗器械质量管理体系要求的应用提供指南。本标准不增加或更改YY/T 0287的要求。本标准中不包含用作监管机构检查或认证机构评定活动的要求。 该指南可以用来更好地理解YY/T 0287的要求，并阐明一些能满足YY/T 0287要求的各种可用的方法和途径。

Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003

JIS T 1022:2006 医院和诊所的医用房间电气设备的安全要求

この規格は，医用電気機器などの使用上の安全確保のため，病院，診療所などに設ける電気設備のうち，医用接地方式，非接地配線方式，非常電源及び医用室の電源回路に対する安全基準について規定する。

Safety requirements of electrical installations for medically used rooms in hospitals and clinics

DOD MIL-STD-6017 A ADMIN NOTICE 1-2006 可变信息格式(VMF)电文标准(U)

The activities listed above were interested in this document as of the date of this document. Since organizations and responsibilities can change, you should verify the currency of the information above using the ASSIST Online database at http://assist.

VARIABLE MESSAGE FORMAT (VMF) MESSAGE STANDARD (U)

CSA C22.2 No.60601-2-33-04-2006 医用电气设备 第2-33部分：医疗诊断用磁共振设备安全的特殊要求

Les normes de l’Association canadienne de normalisation (CSA) sont élaborées selon un processus consensuel approuvé par le Conseil canadien des normes. Ce processus rassemble des volontaires représentant différents intérêts et points de vue dans le but d

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