C37 医疗设备通用要求 标准查询与下载

GOST R ISO/TR 16142-2008 医疗设备.确保医疗设备安全及性能的认可基本原则用标准选择指南

Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

ISO 22442-3:2007 医疗设备用动物组织及其衍生物.第3部分:病毒和传染性海绵状脑病(TSE)试剂的销毁和/或失效的确认

This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents. NOTE 1 Analysis and management of risk is described in ISO 22442-1. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy. Selective sourcing is extremely important (see ISO 22442-1 and ISO 22442-2). NOTE 2 ISO 11135, ISO 11137, ISO 11737-1, ISO 13408, ISO 14160, ISO 14937 and ISO 17665 may be relevant for bacteria, moulds and yeast (see Bibliography). This part of ISO 22442 does not cover the utilization of human tissues in medical devices. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 3 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form part of a quality management system conforming to ISO 13485. This part of ISO 22442 does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

ISO 22442-1:2007 医疗设备用动物组织及其衍生物.第1部分:风险管理的应用

This part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This part of ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This part of ISO 22442 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. NOTE 2 For guidance on the application of this part of ISO 22442 see Annex A.

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

ISO 22442-2:2007 医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理

This part of ISO 22442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management. NOTE 2 Manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 3 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485. NOTE 4 A general principle for the application of ISO 22442 is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

IEC 60601-1:2005/COR2:2007 医用电气设备.第1部分:基础安全和基本性能的一般要求.技术勘误2

This standard is Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 2.

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

DIN EN 60601-1-2:2007 医用电气设备.第1-2部分:基本安全和主要性能的一般要求.间接标准:电磁兼容性.要求和试验

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007, modified); German version EN 60601-1-2:2007

BS EN 60601-1-6:2007 医用电气设备.基本安全和实用性能的通用要求.间接标准: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 - General requirements for basic safety and essential Performance - Collateral standard - Usability

BS EN 60601-1-8:2007 医用电气设备.基本安全性和基本性能的通用要求.并行标准:医疗电气设备和医疗电气系统中警报系统的一般要求,试验和导则

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 ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

BS EN 60601-1-8:2007+A1:2013 医用电气设备.基本安全性和基本性能的通用要求.附属标准:医疗电气设备和医疗电气系统中警报系统的通用要求、试验和导则

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

JIS T 1022 AMD 1:2007 医院和诊所的医用房间电气装置的安全要求

This translation has been made based on the Amendment to the origi- nal Japanese Industrial Standard revised by the Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee based on the provision of Article 12 Clause '2 of the Industrial Standardization Law applicable to the case of revision by the provision of Article 14. Consequently, JIS T 1022:2006 is partially replaced with this Amend- ment.

Safety requirements of electrical installations for medically used rooms in hospitals and clinics (Amendment 1)

ISO 10993-12:2007 医疗器械的生物学评估.第12部分:样品制备和参考材料

This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically this part of ISO 10993 addresses: ? test sample selection; ? selection of representative portions from a device; ? test sample preparation; ? experimental controls; ? selection of and requirements for reference materials; ? preparation of extracts. This part of ISO 10993 is not applicable to materials or devices containing live cells.

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

IEC 60601-2-33/AMD2:2007 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.修改件2

This standard is Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis; Amendment 2.

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

IEC 60976:2007 医用电气设备.医用电子加速器.功能特性

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 62366:2007 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

BS EN 60601-1-2:2007 医疗电气设备.基本安全性和必要性能的一般要求.并行标准:电磁兼容性.试验和要求

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 applies to ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS.

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests

NF C74-012:2007 医用电气设备.第1-2部分:基本安全和基本性能的一般要求.间接标准:电磁兼容性.要求和试验

Medical electrical equipment - Part 1-2 : general requirements for basic safety and essential performance - Collateral standard : electromagnetic compatibility - Requirements and tests.

NF C74-345/A1:2007 医用电气设备.第2-13部分:麻醉系统安全和基本性能的特殊要求

Medical electrical equipment - Part 2-13 : particular requirements for the safety and essential performance of anaesthetic systems.

CSA C22.2 No.60601-2-47-03-CAN/CSA-2007 电子医疗设备 第2-47部分：动态心电图系统的特殊安全要求和基本性能 Premiere Edition

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

Electromedical devices - Part 2-47: Special safety requirements and essential performance of ambulatory electrocardiography systems Premiere Edition

CSA C22.2 No.60601-2-47-03-2007 医疗电气设备-第2-47部分:不固定的心电图监测系统安全的特殊要求及基本性能.第1版

This part of IEC 60745 deals with the safety of hand-held motor-operated or magnetically driven electric tools, the rated voltage of the tools being not more than 250 V for single-phase a.c. or d.c. tools, and 440 V for three-phase a.c. tools.

Medical electrical equipment ?Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems First edition

DIN EN ISO 14971:2007 医疗设备.医疗设备风险管理的应用(ISO 14971-2007)

This International Standard 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 this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clincal decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However,risk management can be an integral part of a quality management system.

Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007