C37 医疗设备通用要求 标准查询与下载

BS EN 62353:2008 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

NF C74-122/A2:2008 医疗电气设备.第2-33部分:医疗诊断用磁共振设备的特殊要求

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

SANS 10993-11:2008 医疗器材的生物评价.第11部分:系统毒性试验

Specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Biological evaluation of medical devices Part 11: Tests for systemic toxicity

IEC 60601-1:2005/ISH1:2008 医疗电气设备.第1部分:基本安全和重要性能的一般要求

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

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

NF S97-601-2:2008 医疗设备用动物组织及其衍生物.第2部分:资源控制、采集和处理

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

NF S97-601-1:2008 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

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

NF S97-601-3*NF EN ISO 22442-3:2008 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

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.

DIN EN ISO 22442-1:2008 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 22442-1:2007); English version of DIN EN ISO 22442-1:2008-03

DIN EN ISO 22442-3:2008 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)试剂的消灭和/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 22442-3:2007); English version of DIN EN ISO 22442-3:2008-0

DIN EN ISO 22442-2:2008 医疗设备用动物组织及其衍生物.第2部分:来源、采集和处理控制(ISO 22442-2-2007)

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 (ISO 22442-2:2007); English version of DIN EN ISO 22442-2:2008-03

BS EN ISO 22442-2:2008 医疗设备用动物组织及其衍生物.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 - Controls on sourcing, collection and handling

BS EN ISO 22442-1:2008 医疗设备用动物组织及其衍生物.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 - Application of risk management

BS EN ISO 22442-3:2008 医疗设备用动物组织及其衍生物.病毒和传染性海绵状脑病(TSE)试剂的消灭和/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 - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

DIN EN 60601-1-6:2008 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

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability (IEC 60601-1-6:2006); German version EN 60601-1-6:2007

DIN EN 60601-1-8:2008 医用电气设备.第1-8部分:基本安全和基本性能通用要求.汇编标准: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 basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC

SANS 14971:2008 医疗器械．医疗器械风险管理的应用

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 o

Medical devices - Application of risk management to medical devices

ANSI/AAMI/ISO 22442-3:2007 医疗设备用动物组织及其衍生物.第3部分:病毒和遗传性海绵状脑病(TSE)试剂的消灭和/或失效的确认

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. Does not cover other transmissible and non-transmissible agents.

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

ANSI/AAMI/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

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.

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

ANSI/AAMI/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

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. Specifies, in conjunction with ISO 14971, a procedure to investigate, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control.

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

IEC 60601-1-3:2008 医用电气设备.第1-3部分:基本安全和基本性能的通用要求.并列标准:诊断X射线设备的辐射防护

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 X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment