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Home CV 简历 Report Hospital Industry Article Business Links   Home    Industry   Regulation IEC IEC Introduction: INTERNATIONAL STANDARD IEC 60601-1 IEC Premier: REGULATORY OUTLOOK IEC 60601-1   依照IEC 60601对医疗电器设备的定义，包括：提供不超过一个电源供应； 且在医疗监督管理下用来做诊断、治疗或监视病患；与病患做物理的或电气的接触及／或转换能量（包括能量的侦测）；设备包含任何正常使用状况下所必须的配件（用于启用／增加／改善设备功能）。 IEC60601系列（-1-4）涵括医疗系统（安规）、EMC要求、X-Radiation及软 件。其中，安规要求的部份IEC60601-1，是医疗设备指令中的一般要求，并做为特殊标准安规的基础，同时也针对主动式医疗设备。如欧盟（EN 60601-1）、美国、加拿大及日本的相关法规亦以此为基础。 相较于一般IT产品，通过IEC60601-1安规认证的医疗电器，要求须在设备上标示保险丝相关信息、额定输出、强度旋钮及显示幕的刻度及单位需为国 际标准单位、设备为耐麻醉气体或耐氧化亚胺，及警告标示。设备上的指示灯光也有特别的要求与代表意义。综合来看，与IT产品安规要求IEC 60950-1相较，IEC60601-1的电气规范均较严格。   European, Canadian and United States Product Safety Standards for Electrical Medical Equipment            ----Electrical Medical Devices and Appropriate Standards Becoming More Complex Authored by Heinz Joerg Steneberg, Medical Division Manager (USA) 925-249-9123, Ext. 111 Editor’s Note: This article has been reprinted with permission from Conformity? magazine, August 2003. The medical device and diagnostic industry is among the sectors with the strictest regulations. This fact should come as no surprise, considering that medical devices are used on ill, immobilized or unconscious patients who may depend on the medical equipment to support vital body functions, or who may be connected to more than one device at a time. Therapeutic and diagnostic radiation procedures are commonly used where malfunction or human error can have a significant impact on the health of a patient, a health care professional, or others. Engineers and regulatory professionals are not only facing an increasing variety of national and international standards and regulations, but also new challenges that arise out of more and more complex products that often include combinations of traditional medical devices and non-medical products. This article will provide an overview of the various standards and other requirements applicable to medical electrical equipment that should be considered not only during the product creation process but also during the entire product lifecycle. Definition of “Medical Electrical Equipment” One of the challenges that engineers and regulatory professionals are facing today is the determination of what is considered “medical equipment.” Today’s complex devices were not anticipated in the late 1980s when the second revision of IEC 60601-1 was published. Further, at that time, the Internet was not developed, and the sharing of diagnostic information or operations via the Internet was simply not possible. For this reason, the definition of medical electrical equipment from that time is sometimes interpreted in a much broader way. In the IEC 60601-1:1988 medical electrical equipment is defined as “Electrical equipment provided with not more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer. The equipment includes those accessories as defined by the manufacturer, which are necessary in normal use of the equipment.” The general interpretation of the term “particular supply mains” includes internally (battery) powered equipment. The term “medical supervision” does not mean that a nurse or physician has to be near the patient at all times, but that, in general, a certain degree of supervision is included in the use of the equipment. This can include regular scheduled follow up visits for patients with active implants, or transmission of measurements from a patient to a physician via the Internet. Based on this definition, a workstation that is placed in a physician’s office and which does not come in contact with the patient and is not used in the patient vicinity is not considered to be medical electrical equipment. In cases like this, it may not be necessary to apply the stringent requirements for medical equipment.  Finally, it should be noted that the definition of “medical device” according to the Canadian Medical Devices Regulations, the European Union’s Medical Device Directive, and the U.S. Food, Drug and Cosmetic Act differs from the definition of “medical electrical equipment.” Electrical equipment that is included in the scope of these regulations may not be included in the scope of IEC 60601-1. Therefore, these products may fall within the scope of IEC 61010 (laboratory equipment) or of IEC60950 (information technology equipment). Overview of Safety Standards for Electrical Medical Equipment The basic safety standard for electrical medical equipment is IEC 60601-1 (Medical Electrical Equipment – Part 1: General requirements for safety). The current revision of this standard was published by the International Electro-technical Commission in 1988. Two significant amendments to this standard were published in 1991 and 1995 to add requirements for electromagnetic compatibility, patient leads with a conductive patient connection, equipment labeling as well as additional requirements in several clauses of the standard. A further revision to the standard is being prepared, but is not expected to be published in the near future. Several countries, including Canada and the U.S., have specified national deviations to IEC 60601-1. However, these standards are closely aligned with IEC 60601-1, and use the same structure, numbering system and basic principles. The national deviations for Canada are defined in CAN/CSA-C22.2 No. 601.1-M90, and include testing of the protective earth connection, as well as for fire prevention and pressure vessels. UL 2601-1:1997 describes the U.S. deviations from IEC 60601-1. These deviations include specific requirements for leakage currents, equipment used with oxygen or used in oxygen-enriched atmospheres, and equipment with polymeric enclosures, among other specific requirements. Both amendments to IEC 60601-1 have been integrated in UL 2601-1:1997, with the exception of the requirement to use SI (System International) units. However, this clause will be mandatory after February 6, 2004. An overview of the U.S. and Canadian deviations is provided in Table 1 (see below).. General Principles The most important principle of the IEC 60601-series is to ensure safety for patients, users and others in normal use and normal condition as well as in a single fault condition. This is specifically important for life supporting and life-sustaining equipment where an interruption could cause a hazard for the patient. Safety of the equipment should be considered part of the overall safety situation, comprised also of the safety of the equipment installation, equipment maintenance and the safety of equipment application. Hazards should be eliminated as far as reasonably possible, in the following order: 1. Protective precautions incorporated in the design (inherently safe design) 2. Additional protective precautions, such as alarms 3. Restrictions and warnings in instructions and on labels.  Considerations should also include hazards from electric shock, mechanical failures, unintentional or excessive radiation, excessive temperatures, or abnormal conditions or human error.  Compliance to the IEC 60601-series is essential in order to obtain regulatory approvals in the European Union, Canada and the United States. Although compliance with the EN 60601-1 standard is not mandatory in order to satisfy the essential requirements of the EU’s Medical Device Directive, it may be cumbersome to demonstrate that medical electrical equipment meets these requirements on an alternative way. The new Canadian Medical Devices Regulations include safety and effectiveness requirements that must be satisfied by all devices. In the U.S., medical electrical equipment must either be tested to the UL 2601-1 standard by a Nationally Recognized Testing Laboratory (NRTL), or be subject to “field labeling.” The FDA published a guidance document on the recognition and use of consensus standards on June 20, 2001 to provide guidance for industry and FDA reviewers on the recognition of national and international consensus standards. Although the agency clearly states that compliance to IEC 60601-1 or UL 2601-1 is not mandatory, compliance with either of these standards may simplify the regulatory process. Collateral Standards In addition to IEC 60601-1, which describes the general requirements for safety, the IEC 60601-series also includes collateral and product specific standards. Collateral standards are applicable to specific categories of medical electrical equipment and can only be used in conjunction with IEC 60601-1. With the exception of IEC 60601-1-4:2000 (Consolidated Edition), these standards are recognized by the FDA and may be used to support premarket submissions, and technically identical versions are published as harmonized standards in the EU. Canadian deviations are defined to IEC 60601-1-1:2000 and IEC 60601-1-4:2000. IEC 60601-1-1:2000 (Medical electrical equipment – Part 1: General requirements for safety – 1. Collateral standard: Safety requirements for medical electrical systems). Medical electrical systems include combinations of medical and nonmedical electrical equipment that are interconnected by a functional connection or a multiple socket outlet. The equipment is either used within the patient vicinity or in rooms used for medical purposes. Examples of medical electrical systems include patient monitoring equipment connected to a computer workstation. Based on the combination and intended use, not all equipment might have to meet the stringent requirements of IEC 60601-1. Specific requirements are defined for protective earthing, leakage current measurements and other clauses. IEC 60601-1-2:2001 (Medical electrical equipment – Part 1: General requirements for safety – 2. Collateral standard: Electromagnetic compatibility – Requirements and tests).  IEC 60601-1-2 specifies the requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. Limits on electromagnetic emissions are essential for the protection of other medical electrical equipment and medical electrical systems. Electromagnetic immunity requirements are essential to assure safety of equipment and systems, specifically for life supporting and life sustaining equipment. IEC 60601-1-3:1994 (Medical electrical equipment – Part 1: General requirements for safety – 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment). IEC 60601-1-3 defines general requirements for protection against ionizing radiation in medical diagnostic X-ray equipment, including some installation requirements to ensure that the dose equivalent to the patient, the operator and other staff are as low as reasonably possible. It should be noted that several countries specify processes for performance testing, installation, operation and maintenance. IEC 60601-1-4:2000 Consolidated Edition (Medical electrical equipment – Part 1: General requirements for safety – 4. Collateral Standard: Programmable electronic medical systems). IEC 60601-1-4 defines the requirements for the lifecycle of programmable electrical medical systems. It covers software requirements specification, software architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.  (Note: IEC 60601-1-4 should be used as part of an overall risk management system, as described in ISO 14971:2000.) DIS IEC 60601-1-6 The draft standard DIS IEC 60601-1-6 addresses aspects of usability of safety for electrical medical equipment. Although devices are more complex today and often combine several functions, they should still be easy to use. This can be achieved through the use of recognized symbols as well as through design according to ergonomic principles. Product Specific Standards Product specific standards (IEC 60601-2-x) define requirements for specific products, such as diagnostic and therapeutic lasers, endoscopic equipment or infusion pumps, and are used in conjunction with the general standard. Product specific standards amend or supersede corresponding clauses in the general standard. It should be noted that in some cases several product specific standards could be applicable to one product. Here is a list of applicable standards for a software controlled bone densitometer that is part of a medical electrical system (national deviations not considered): IEC 60601-1:1988 (+A1, +A2) IEC 60601-1-1:2000 (Medical Electrical Systems) IEC 60601-1-2:2001 (Electromagnetic Compatibility) IEC 60601-1-3:1994 (Diagnostic X-ray Equipment) IEC 60601-1-4:2000 (Programmable Electronic Medical Systems) IEC 60601-2-7:1998 (High Voltage Generators of Diagnostic X-ray Generators) IEC 60601-2-28:1993 (X-ray Source Assemblies and X-ray Tube Assemblies) IEC 60601-2-32:1994 (Associated Equipment of X-ray Equipment) Medical Product Safety Standards Not Included in the IEC 60601 Series In addition to the IEC 60601series, several other standards define requirements for safety of electrical medical equipment, such as the ISO 10079 series for suction equipment or ISO 9919:1992 and EN 865:1997 for pulse oximeters. In addition, generic standards for specific functional aspects have been developed, such as the EN 475 series for electrically generated alarm signals, and IEC 60825 for laser safety (e.g. for lasers used in computed tomography systems). Additional U.S. Regulatory Requirements Title 21 of the United States Code of Federal Regulations defines in subchapter J provisions for radiation protection and specifies reporting and record keeping requirements for medical electrical equipment and non-medical electrical equipment. Manufacturers of diagnostic X-ray systems, therapeutic ultrasound equipment and other products must submit product reports to the FDA before the product is introduced into the market. The reports must include a description of the physical or electrical characteristics of the device, as well as a statement of standards, design specifications and a description of the test methods that were applied. Listed below are specific performance standards defined that must be met by electrical medical equipment: 21CFR1010 (Electronic products), 21CFR1020 (Ionizing radiation emitting products) 21CFR1030 (Microwave and RF emitting products) 21CFR1040 (Light emitting products) 21CFR1050 (Ultrasonic and infrasonic products) See also “Radiation Control for Health and Safety Act of 1968.” Product Lifecycle Considerations Considerations for safety of electrical medical equipment should begin in the early stages of the product creation process. In order to avoid compliance related problems during the product verification and validation phase, applicable requirements need to be identified early and incorporated into the design specifications. As part of this process, aspects related to equipment maintenance and aging of materials should also be addressed. Information can be derived from reliability studies or calculations and, if available, experience with previous products. Finally, one of the changes of the second amendment to IEC 60601-1 was the requirement to identify risks associated with the disposal of waste products, residues and the equipment including accessories in the user instructions. Thus, safety considerations should include these aspects as well. References IEC 60601-1:1988 (+A1, +A2) IEC 60601-1-1:2000 IEC 60601-1-2:2001 IEC 60601-1-3:1994 IEC 60601-1-4:2000 IEC 60601-2-7:1998 IEC 60601-2-32:1994 EN 60601-1:1990 (+A1, +A2, +A11, +A13) EN 60601-1-1:2000 EN 60601-1-2:2001 EN 60601-1-3:1994 EN 60601-1-4:2000 CAN/CSA C22.2 No. 601.1 M90 (+CAN/CSA C22.2 No. 601.1 S194) UL 2601-1:1997 ISO 14971:2000 United States Code of Federal Regulations (Title 21, Subchapter J) Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA Staff (June 20, 2001) Directive 93/42/EEC – Medical Device Directive 　 Table 1. Overview of deviations to IEC 60601-1 for UL 2601:1997 and CAN/CSA 22.2.601

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