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A Medical Electronics Manufacturing Fall 1997 Reference

Standards, Guidelines, and Recommendations

ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION

3330 Washington Blvd., Ste. 400, Arlington, VA 22201; phone: 703/525-4890; fax: 703/276-0793.

Equipment Maintenance, Design, and Electrical Safety

Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices (ANSI/AAMI HE48­1993) Provides ergonomic information and human factors engineering guidance so that the optimum patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design. Recommendations address environmental and organizational considerations; console and panel layout; human factors and the work space; signs, symbols, and markings; controls and displays; and alarms and signals. The user-computer interface section includes information on manual data entry, automatic data entry, data display, interactive control, feedback, prompts, defaults, error management and data protection, user identification, and data and message transmission.

Safe Current Limits for Electromedical Apparatus (ANSI/AAMI ES1­1993) Provides limits and measuring techniques for risk currents of electromedical apparatus as a function of frequency, the characteristics of the apparatus, and the nature of the intentional contact with the patient. Requirements and tests are described for risk current, patient-applied risk current, enclosure risk current, patient isolation risk current, earth risk current, and risk current limits versus frequency. Labeling and documentation requirements are also included.

Developing Safe, Effective, and Reliable Medical Software (MDS­1991) A monograph that provides industry managers and users of computer-controlled medical devices with an introduction to development and quality assurance techniques used to ensure software effectiveness, safety, and reliability. The document includes sections on the purpose of software quality assurance, safety of computer-controlled devices, analysis of hazards of computerized medical devices, software quality assurance and reliability, and verifying purchased software.

General Surgery/General Hospital Use

Autologous Transfusion Devices (ANSI/AAMI AT6­1991) Includes labeling and performance requirements, test methods, and terminology to help establish a reasonable level of safety and efficacy for autologous transfusion devices. Performance requirements address system integrity, cleanliness, regional anticoagulation, filtration, interface characteristics, material safety requirements, and electrical safety. The labeling requirements section advises on electromechanical device markings, disposable blood contact components, operator's manual and instructions for use, and collection-container labeling.

Blood Transfusion Microfilters (ANSI/AAMI BF7­1989) Provides labeling requirements, performance requirements, test methods, and terminology for disposable blood transfusion microfilters. Material safety requirements address toxicity potential evaluation, sterility, and pyrogenicity.

Electrosurgical Devices (ANSI/AAMI HF18­1993, in draft form) Contains minimum label, performance, and safety requirements to ensure safe and effective use of electrosurgical devices. Also included are tests to verify compliance with the requirements.

Apnea Monitoring by Means of Thoracic Impedance Pneumography (AAMI Technical Information Report 4­1989) Covers patient transducers and connections, current monitor design, test methods, clinical applications, equipment operation, and a forecast of future development. A bibliography is also included.

Infant Incubators (ANSI/AAMI II36­1991) Addresses requirements for infant incubator labeling and performance and establishes referee tests by which the requirements can be verified. Performance requirements examine environmental performance, thermal characteristics, alarms, sound levels, CO2 concentration, fire prevention, mechanical and construction requirements, and electrical characteristics.

Infusion Devices (ANSI/AAMI ID26­1992) Establishes minimum labeling, safety, performance, and testing requirements for mechanical and electromechanical infusion devices that have a pumping or gravity-feed controlling function, that deliver fluid from either a separate or a self-contained source, and that are intended for use with parenteral fluids for such purposes as parenteral nutrition and administration of drugs and routine fluids. Performance and safety requirements address flow-rate accuracy as a function of container height, back pressure, and time; prevention of uncontrolled flow; security of disposable components; protection against air embolus; maximum occlusion pressure; electrical safety; and electrosurgical unit susceptibility.

Selection of Surgical Gowns and Drapes in Health-Care Facilities (AAMI Technical Information Report 11­1994) Describes safety and performance characteristics of surgical gowns or drapes­for example, strength, barrier effectiveness, comfort, stain resistance, electrostatic properties, flammability, toxicity, sterility assurance, longevity, and resistance to penetration by airborne, aerosol-borne, or dry particles­and gives information and guidance on their selection and care. Also includes an appendix on standard test methods used to evaluate safety and performance. An excellent resource for health-care personnel in evaluating gowns and drapes for their surgical team generally, or in deciding what questions to ask about specific products prior to purchase.

Neurosurgery/Neurology

Implantable Peripheral Nerve Stimulators (ANSI/AAMI NS15­1995) Establishes minimum labeling, safety, and performance requirements for implantable peripheral nerve stimulators intended for use in the relief of chronic, severe pain. Referee test methods and the rationale for the standard are addressed. Performance requirements cover electrical safety, stimulation parameters, waveform, controls, dimensions of cuff electrodes, and materials.

Implantable Spinal Cord Stimulators (ANSI/AAMI NS14­1995) Covers minimum labeling, safety, and performance requirements for implantable spinal cord stimulators intended for use in the relief of chronic, severe pain. Also covered are referee test methods and the rationale for the provisions of the standard. Performance requirements address electrical safety, stimulation parameters, waveform, controls, epidural stimulation test, and materials.

Transcutaneous Electrical Nerve Stimulators (ANSI/AAMI NS4­1986) Establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators (TENS) intended for use in the treatment of pain syndromes. Also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix that provides labeling/user guidelines for TENS devices and an appendix that explains the rationale for the provisions of the standard.

Intracranial Pressure Monitoring Devices (ANSI/AAMI NS28­1993) Provides minimum labeling, safety, and performance requirements for intracranial pressure­monitoring devices, whether percutaneous, fully implantable, or noninvasive.

Cardiovascular Monitoring, Surgery, and Therapy

Blood Pressure Transducers (ANSI/AAMI BP22­1994) Provides performance and safety requirements for transducers, including cables, designed for blood pressure measurements through an indwelling catheter or direct puncture. Also includes disclosure requirements to permit the user to determine the compatibility between the transducer and blood pressure monitor. The standard is a combined revision of two American National Standards (ANSI/AAMI BP22­ BP23).

Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring (AAMI Technical Information Report 9­1992) Intended primarily for biomedical equipment technicians, clinical engineers, and others who select complete invasive blood pressure­monitoring kits (tubing, stopcocks, transducers, and continuous flush devices) or individual components. The report describes the evaluation process and statistical sampling, static and dynamic response, devices to improve system response, failure modes, and evaluating system performance.

Cardiac Monitors, Heart Rate Meters, and Alarms (ANSI/AAMI EC13­1992) Describes minimum safety and performance requirements for cardiac monitors, heart rate meters, and alarms that are used to acquire and display electrocardiographic signals with the primary purpose of continuous detection of cardiac rhythm. Performance requirements address operating conditions; overload protection; risk current; auxiliary output; respiration, leads-off sensing, and active noise suppression; QRS detection, range and accuracy of heart rate meter; alarm system; and special requirements for monitors with ECG waveform display capability.

Diagnostic Electrocardiographic Devices (ANSI/AAMI EC11­1991) Establishes minimum safety and performance requirements for electrocardiographic ECG systems with direct writing devices that are intended for use in ECG contour analysis for diagnostic purposes. Performance requirements address operating conditions, lead definition, input dynamic range, time base selection and accuracy, output display, accuracy of input signal reproduction, standardizing voltage, input impedance, direct currents in patient electrode connections, common mode rejection, and overload protection.

Disposable ECG Electrodes (ANSI/AAMI EC12­1991) Contains minimum labeling, safety, and performance requirements; test methods; and terminology for disposable electrocardiographic electrodes. Performance requirements are listed for electrical performance as well as packaging and shelf life. Safety requirements address biological response and preattached lead wire safety.

Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms (AAMI ECAR­1987) Establishes a method for the beat-by-beat testing of the performance of arrhythmia-monitoring algorithms using annotated databases. Includes information on testing protocol, label definitions, QRS and VEB detection, and consecutive VEB detection.

Nonautomated Sphygmomanometers (ANSI/AAMI SP9­1994) Establishes labeling requirements, performance requirements, test methods, and referee test methods for nonautomated sphygmomanometers used in the indirect measurement of blood pressure. Requirements are listed for the manometer, inflation source and pressure control valve, inflatable bladder and cuff, and system leakage.

Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10­1992) Covers labeling requirements, safety and performance requirements, and referee test methods for electronic or automated sphygmomanometers used in indirect blood pressure measurement. Specific requirements for ambulatory blood pressure monitors are included.

Cardiovascular Implants­Cardiac Valve Prostheses (ANSI/AAMI/CV 5840­1991) Specifies test methods and recommends performance characteristics of equipment used to determine the biological and mechanical properties of heart valve substitutes of all types and the materials they are made of.

Cardiovascular Implants­Vascular Graft Prostheses (ANSI/AAMI VP20­1994) Establishes requirements for labeling, ensuring uniformity of materials, and achieving uniformity of end-product performance characteristics of textile and nontextile synthetic grafts, vascular heterografts, and vascular homografts. Test methods are provided to allow verification of conformance with the requirements and to promote uniform reporting of performance data.

Automatic External and Remote Control Defibrillators (AAMI DF39­1993) Covers testing and reporting performance results of automatic external defibrillators, primarily through description of the performance for the arrhythmia detection component.

Cardiac Defibrillator Devices (ANSI/AAMI DF2­1989) Provides minimum labeling, performance, and safety requirements for cardiac defibrillator devices. Requirements for performance cover energy range, limited energy output, energy accuracy, pulse shape and duration, controls and indicators, energy level indicator, reduce-charge capability, paddle electrode contact area, and other characteristics.

Ambulatory Electrocardiographs (EC38-177­1994) Covers safety and performance requirements for long-term electrocardiographic monitoring devices­also commonly called ambulatory electrocardiographs­used in the analysis of the rhythm and relevant morphology of cardiac complexes.

Pacemaker Emergency Intervention System (PAC49-177­1993) Specifies labeling and performance requirements for an intervention system for use in emergency rooms and other medical locations where a physician skilled in pacemakers is not immediately available.

ECG Cables and Lead Wires (ANSI/AAMI EC53­1995) Allows cable lead wires to be interchanged between ECG monitors with isolated patient connections by establishing a common cable­lead wire connector interface. Performance and safety criteria for patient cables and lead wires used with isolated patient connectors are also specified.

INTERNATIONAL ELECTROTECHNICAL COMMISSION

3, rue de Varembé, CH-1211 Geneva 20, Switzerland; phone: +41 22 9190211; fax: +41 22 9190300.

Medical Electrical Equipment, Part 1: General Requirements for Safety (IEC 601-1, 1988), Amendment No. 1 (1991), Amendment No. 2 (1995) This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. Includes sections about protection against electric shock hazards, mechanical hazards, hazards from unwanted or excessive radiation, hazards of ignition of flammable anesthetic mixtures, and excessive temperatures. The standard also addresses environmental conditions, accuracy of operating data and protection against hazardous output, and abnormal operation and fault conditions. Construction requirements are specified for enclosures and covers, marking on outside of equipment, components and general assembly, protective grounding of terminal and connections, and components and layout of main parts.

Part 1: General Requirements for Safety. 1. Collateral Standard: Safety Requirements for Medical Electrical Systems (IEC 601-1-1, 1992), Amendment No. 1 (1995) The first in a series of collateral standards that specify general requirements for safety applicable to a group of electromedical equipment not fully addressed in the general standard. The publication deals with safety requirements for medical electrical systems.

Part 1: General Requirements for Safety. 2. Collateral Standard: Electromagnetic Compatibility­Requirements and Tests (IEC 601-1-2, 1993) Applies to medical equipment, medical electrical systems, information technology equipment used in medical electrical applications, and all other equipment forming part of medical electrical systems. Specifies general requirements and tests for electromagnetic compatibility of equipment and systems.

Part 1: General Requirements for Safety. 3. Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment (IEC 601-1-3, 1994) Establishes general requirements for protection against ionizing radiation in medical diagnostic x-ray equipment to keep the dose equivalent to the patient, the operator, and other staff as low as possible.

Part 2: Particular Requirements for Medical Electron Accelerators in the Range of 1 MeV to 50 MeV. (IEC 601-2-1, 1981) Section 1: General, Section 2: Radiation Safety for Equipment, Amendment No. 1 (1984), Amendment No. 2 (1990) Establishes requirements for a satisfactory level of radiation safety for medical electron accelerators used in human medical practice for therapy under the jurisdiction of a qualified person. Applies to accelerators that deliver a useful beam of either x-radiation or electron radiation, with energies in the range 1 to 50 MeV, and at maximum absorbed dose rates between 0.001 and 1 Gy and 1 m from the radiation source and at normal treatment distances between 0.5 and 2 m from the radiation source. The second amendment specifies test procedures for items that require a radiation safety compliance test.

Part 2: Particular Requirements for the Safety of High-Frequency Surgical Equipment (IEC 601-2-2, 1991) Specifies requirements for the safety of high-frequency medical electrical equipment and its associated accessories that are used in surgical cutting or coagulation.

Part 2: Particular Requirements for the Safety of Short-Wave Therapy Equipment (IEC 601-2-3, 1991) Concerns the safety of short-wave therapy equipment having a rated output power not exceeding 500 W. This second edition corrects the shortcomings of the earlier standard and provides greater detail on inductive applicators.

Part 2: Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator Monitors (IEC 601-2-4, 1983) Specifies requirements for the safety of cardiac defibrillators and cardiac defibrillator monitors incorporating a capacitive energy storage device.

Part 2: Particular Requirements for the Safety of Ultrasonic Therapy Equipment (IEC 601-2-5, 1984) Specifies the requirements for the safety of ultrasonic equipment used in medical practice.

Part 2: Particular Requirements for the Safety of Microwave Therapy Equipment (IEC 601-2-6, 1984) Contains requirements for the safety of microwave therapy equipment used in medical practice, but does not apply to equipment specified for hyperthermia.

Part 2: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-Ray Generators (IEC 601-2-7, 1987) Specifies particular requirements for the safety of high-voltage generators of diagnostic x-ray machines operating between 10 and 400 kV.

Part 2: Particular Requirements for the Safety of Therapeutic X-Ray Generators (IEC 601-2-8, 1987) Contains requirements for the safety of therapeutic x-ray generators operating with nominal x-ray tube voltages from 10 to 400 kV inclusive.

Part 2: Particular Requirements for the Safety of Dosimeters Used in Radiotherapy with Electrically Connected Radiation Detectors (IEC 601-2-9, 1996) Specifies particular requirements for the safety of dosimeters used in medical practice in the patient environment for radiotherapy.

Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators (IEC 601-2-10, 1987) Contains requirements for the safety of electrical stimulators of muscles and nerves in the specialized practice of physical medicine. (It excludes stimulators used with implanted electrodes, brain stimulation, neurological research, cardiac pacemakers, defibrillators, and other surgical procedures.)

Part 2: Particular Requirements for the Safety of Gamma-Beam Therapy Equipment (IEC 601-2-11, 1987), Amendment No. 1 (1988), Amendment No. 2 (1993) Establishes requirements for a satisfactory level of radiation safety and of electrical and mechanical safety for gamma-beam radiotherapy equipment used in medicine.

Part 2: Particular Requirements for the Safety of Lung Ventilators for Medical Use (IEC 601-2-12, 1988) Supplementing the general safety requirements of medical equipment formulated in the basic publication IEC 601-1, this standard gives specific requirements for lung ventilators that incorporate electrical devices designed for medical use.

Part 2: Particular Requirements for the Safety of Anesthetic Machines (IEC 601-2-13, 1989) Specifies safety requirements for medical anesthetic machines that incorporate electrical components, lung ventilators, and inhalation-anesthetic applications.

Part 2: Particular Requirements for the Safety of Electroconvulsive Therapy Equipment (IEC 601-2-14, 1989) Sets requirements to lessen risks for patient, operators, or surroundings in environments where this equipment is used.

Part 2: Particular Requirements for the Safety of Capacitor Discharge X-Ray Generators (IEC 601-2-15, 1988) Establishes requirements applying to capacitor discharge x-ray generators for medical radiology in which electrical energy for loading the x-ray tube is primarily stored at and switched in the high-voltage circuit. Methods for demonstrating compliance with the safety requirements are specified.

Part 2: Particular Requirements for the Safety of Hemodialysis Equipment (IEC 601-2-16, 1989) Specific requirements for the safety and performance of hemodialysis equipment are described.

Part 2: Particular Requirements for the Safety of Remote-Controlled Automatically Driven Gamma-Ray Afterloading Equipment (IEC 601-2-17, 1989), Amendment No. 1 (1996) Emphasizes requirements for the safety of remote-controlled automatically driven electromedical equipment for gamma-ray therapy of human subjects using afterloading. Specifications include requirements for equipment that contains and uses only gamma-ray sealed radioactive sources and that automatically drives such sources. (The standard does not apply to neutron radioactive sources.)

Part 2: Particular Requirements for the Safety of Endoscopic Equipment (IEC 601-2-18, 1996) Includes requirements for the safety of endoscopic equipment and integrated instrumentation used for medical diagnosis and therapy. The document is divided into five endoscope applications: direct visualization, integration with thermocautery, lithotrite, electrosurgery, and other specialized endoscopes.

Part 2: Particular Requirements for the Safety of Baby Incubators (IEC 601-2-19, Amendment 1, 1996) Establishes safety requirements for baby incubators to minimize hazards to the patient and user. Specifies tests to verify compliance.

Part 2: Particular Requirements for Safety of Transport Incubators (IEC 601-2-20, Amendment 1, 1996) Establishes safety standards to minimize hazards to patients and users of transport incubators and specifies tests to verify compliance with the requirements. (It does not apply to baby incubators or radiant warmers.)

Part 2: Particular Requirements for the Safety of Infant Radiant Warmers (IEC 601-2-21, Amendment 1, 1996) Specifies requirements for infant radiant warmers. Requirements for equipment intended for use outside a hospital baby-care environment, equipment having a heated mattress, and equipment powered by an internal electrical power source are not included in this part.

Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment (IEC 601-2-22, 1995) Applies to laser equipment for medical applications, classified as a Class 3B or Class 4 laser product according to IEC 825. The standard addresses safety requirements including identification, marking, accuracy of operating data, protection against hazardous output, and constructional requirements.

Part 2: Particular Requirements for the Safety of Transcutaneous Partial Pressure Monitoring Equipment (IEC 601-2-23, 1993) Specifies requirements for transcutaneous monitors used with adults, children, and neonates, and the use of these devices in fetal monitoring during birth.

Part 2: Particular Requirements for the Safety of Electrocardiographs (IEC 601-2-25, 1993) Specifies the particular safety requirements for electrocardiographs intended for the production of detachable electrocardiograms for diagnostic purposes. The standard also applies to vector-cardiographs and equipment for stress testing.

Part 2: Particular Requirements for the Safety of Electroencephalographs (IEC 601-2-26, 1994) Specifies the particular safety requirements for electroencephalographs defined as "medical electrical equipment intended for the production of graphic recordings and/or a visual display of electrical activity of the brain for diagnostic purposes."

Part 2: Particular Requirements for the Safety of Electrocardiographic Monitoring Equipment (IEC 601-2-27, 1994) Specifies requirements for electrocardiographic monitoring equipment defined as "equipment and associated electrodes for the monitoring and/or recording of heart action potentials and displaying the resultant data locally and/or transmitting to a central station."

Part 2: Particular Requirements for the Safety of X-Ray Source and Assemblies and X-Ray Tube Assemblies for Medical Diagnosis (IEC 601-2-28, 1993) Specifies the safety requirements for x-ray tube assemblies for medical diagnoses and components thereof, specified for use in medical x-ray equipment, including devices for computed tomography, that incorporates a specified high-voltage generator complying with IEC 601-2-7 or IEC 601-2-15. (The document supersedes IEC 637.)

Part 2: Particular Requirements for the Safety of Radiotherapy Simulators (IEC 601-2-29, Amendment 1, 1996) Applies to radiotherapy simulators that use diagnostic x-ray equipment to physically simulate a therapeutic radiation beam, so that the treatment volume to be irradiated during radiotherapy can be localized and the position and size of the therapeutic radiation field can be confirmed.

Part 2: Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment (IEC 601-2-30, 1995) Specifies particular requirements for the safety of automatic cycling indirect blood pressure­monitoring equipment, with special attention being paid to the avoidance of hazards due to the inflation process.

Part 2: Particular Requirements for the Safety of External Cardiac Pacemakers with Internal Power Source (IEC 601-2-31, 1994) Specifies the particular safety requirements for external pacemakers powered by an internal electrical power source. Applies also to patient cables but does not apply to equipment that can be directly or indirectly connected to a power line.

Part 2: Particular Requirements for the Safety of Associated Equipment of X-Ray Equipment (601-2-32, 1994) Applies to equipment and devices associated with x-ray equipment that are used for the support and relative positioning of the functional components, including the patient support, employed in the application of the x-radiation. This standard applies to all associated equipment not covered by other particular standards.

Part 2: Particular Requirements for the Safety of Direct Blood Pressure Monitoring Equipment (IEC 601-2-34, 1994) Establishes particular requirements for the safety of direct blood pressure­ monitoring equipment and the electrical safety requirements for catheter-tip transducers. Does not apply to catheter tubing, catheter needles, luer locks, taps, and so on.

IEC Standards can also be obtained through Global Engineering Documents, which provide on-demand technical and regulatory documents from standards organizations worldwide: 15 Inverness Way E., Englewood, CO 80112; phone: 800/ 624-3974 or 303/792-2181; fax: 303/ 397-7935.

NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION

1300 N. 17th St., Ste. 1847, Rosslyn, VA 22209; phone: 703/841-3241; fax: 703/841-3341.

Health-Care Facilities Equipment

Impact of Electrostatic Discharges in the Hospital Environment (SB 29) Describes the problem of electrostatic discharge events in the hospital and associated measurement techniques and simulation and testing. Possible solutions are also introduced.

Magnetic Resonance Imaging Systems

Determination of Signal-to-Noise Ratio in Diagnostic Magnetic Resonance Imaging (MS 1­1988) (R1994) Describes test methods for measuring the signal-to-noise ratio performance of diagnostic magnetic resonance imaging systems under a specific set of conditions, using head and body coils and performing proton imaging. (Does not address the use of surface coils, chemical shift imaging, or spectroscopy.)

Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images (MS 2­1989) Describes a method for determining the maximum percent difference between measured distances in an image and actual corresponding phantom dimensions. Evaluates geometric distortion over the entire specification volume. (Does not address the measurement of slice flatness.)

Determination of Image Uniformity in Diagnostic Magnetic Resonance Images (MS 3­1989) Defines a test method for measuring image-uniformity performance of diagnostic magnetic resonance imaging systems using head and body coils and performing proton imaging. (Does not address the use of surface coils, chemical shift imaging, or spectroscopy.)

Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices (MS 4­1989) One of a series of test standards developed by the medical diagnostic industry for the measurement of parameters governing the safety of magnetic resonance imaging systems. Two measurement procedures, maximum gradient acoustic noise and maximum clinical acoustic noise, are described.

Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging (MS 5­1991) Describes a method for determining the slice thickness of proton images. (Spectroscopy, chemical shift imaging, and warped slices are not addressed.)

Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images (MS 6­1991) Defines test methods for measuring signal-to-noise ratio and image nonuniformity of diagnostic magnetic resonance imaging systems using special-purpose coils and performing proton imaging (receive-only and transmit-receive coils).

Measurement Procedure for Time-Varying Gradient Fields (dB/dt) for Magnetic Resonance Imaging Systems (MS 7­1993) Describes the procedures for measuring maximum dB/dt generated by whole-body gradient coils in diagnostic magnetic resonance imaging systems: the maximum gradient rate, the maximum sinusoidal rate, and the maximum clinical rate.

Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems (MS 8­1993) Describes pulse-energy and calorimetric methods of whole-body SAR measurements. Specifies tests for volume RF transmit coils that produce relatively homogeneous RF fields.

Medical Picture Archiving and Communications Equipment

Standard for Magnetic Tape (PS 1­1991) Defines the physical and logical requirements for magnetic-tape media used in an interchange environment.

Data Compression Standard (PS 2­1989) Specifies the way in which header data can permit a variety of data compression schemes, either reversible or irreversible, to be fully defined.

Digital Imaging and Communications in Medicine (DICOM) Part 1: Introduction and Overview (PS 3.1­1992, 1996) Provides an overview of the entire Digital and Communications in Medicine (DICOM) standard. It describes the history, scope, goals, and structure of the standard, in addition to briefly describing each of its parts.

DICOM Part 2: Conformance (PS 3.2­1993, 1996) Specifies the purpose and structure of a conformance statement and describes general requirements that must be met by any implementation claiming conformance to the DICOM standard.

DICOM Part 3: Information Object Definitions (PS 3.3­1993, 1996) Provides an abstract definition of real-world objects applicable to communication of digital medical information.

DICOM Part 4: Service Class Specifications (PS 3.4­1993, 1996) Specifies the set of service-class definitions that provide an abstract definition of real-world activities applicable to communication of digital medical information.

DICOM Part 5: Data Structure and Semantics (PS 3.5­1993, 1996) Specifies the structure and encoding of data sets.

DICOM Part 6: Data Dictionary (PS 3.6­1993, 1996) Contains the registry of all DICOM data elements and all DICOM-unique identifiers that are defined within the DICOM standard.

DICOM Part 7: Message Exchange (PS 3.7­1993, 1996) Specifies the DICOM Message Service Element.

DICOM Part 8: Network Communication Support for Message Exchange (PS 3.8­1992, 1996) Specifies the services and upper-layer protocols necessary to support the communication of DICOM application entities in a networked environment.

DICOM Part 9: Point-to-Point
Communication Support for Message Exchange (PS 3.9­1993, 1996) Specifies the services and protocols necessary to support the DICOM application entity over a point-to-point interface.

DICOM Part 10: Media Storage and File Format for Media Interchange (PS 3.10­1995, 1996) Specifies a general model for the storage of medical imaging information on removable media. It provides a framework allowing the interchange of various types of medical images and related information on a broad range of physical media.

DICOM Part 11: Media Storage Application Profiles (PS 3.11­1995, 1996) Specifies a general model for the storage of medical imaging information on removable media. It enables interoperability by specifying standard sets of elements related to a specific clinical need identified in other parts of the DICOM Standard.

DICOM Part 12: Media Formats and Physical Media for Media Interchange (PS 3.12­1995, 1996) Facilitates the interchange of information between digital imaging computer systems in medical environments. This interchange enhances diagnostic imaging and potentially other clinical applications.

DICOM Part 13: Print Management and Point-to-Point Communication Support (PS 3.13­1995) Specifies the services and protocols necessary to support the communication of DICOM print management application entities over point-to-point links between print users and print providers.

Nuclear Diagnostic Equipment

Performance Measurements of Scintillation Cameras (NU 1­1994)

Provides a uniform criterion for the measurement and reporting of scintillation camera performance parameters for single- and multiple-crystal cameras and tomographic devices that image a section or reconstruct image volume, or both.

Performance Measurements of Positron Emission Tomographs (NU 2­1994) Provides a uniform and consistent method for measuring and reporting performance parameters of positron emission tomographs. Included are time-of-flight and non-time-of-flight coincidence systems, discrete and continuous detector designs, single- and multiple-slice devices, and multiplanar and volume reconstruction models.

Radiation Therapy Equipment

X-Ray Tube Assemblies for Medical Diagnosis­Characteristics of Focal Spots (IEC 336­R1993)

High-Voltage Cable Plug and Socket Connections for Medical X-Ray Equipment (IEC 526­R1978)

Ultrasound Imaging Equipment

NEMA Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD 2­1992) Describes a set of measurement procedures for ultrasonic output parameters by specifying precise definitions of quantities, primarily those relating to acoustic output levels and procedures for measuring pertinent acoustic output parameters.

Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (UD 3­1992) Provides a method for applying the principle of ALARA to the performance of ultrasound examinations. Applies to diagnostic ultrasound equipment that is intended for use on humans and is capable of exceeding a thermal index of 1.0, or a mechanical index of 1.0.

X-Ray Imaging Products

Measurement of Dimensions and Properties of Focal Spots of Diagnostic X-Ray Tubes (XR 5­1992) Provides test methods for assessing the properties of focal spots for medical diagnostic x-ray tubes (is not intended for use with x-ray tubes used in computed tomography scanners).

High-Voltage X-Ray Cables and Receptacles (XR 7­1995) Defines test methods and structural details of the high-voltage cable assemblies and receptacles used in medical diagnostic x-ray equipment to establish minimum electrical requirements and component interchangeability.

Test Methods for Diagnostic X-Ray Machines for Use During Initial Installation (XR 8­1979, R1994) Prescribes test methods for verifying compliance with 1968 Radiation Control for Health and Safety Act.

Power Supply Guidelines for X-Ray Machines (XR 9­1984, R1994) Covers conventional medical and dental diagnostic x-ray equipment. (Computed tomography, battery-powered therapy, and industrial equipment are not included.)

Measurement of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube Used for Medical Diagnosis (XR 10­1986, R1992) Provides methods for measuring the maximum symmetrical radiation field from a rotating anode x-ray tube used for medical diagnosis. (Not applicable for measuring the radiation field of a used tube with a roughened focal track or a tube that was designed to have a nonuniform air kerma rate for special applications.)

Test Standard for Determination of the Limiting Spatial Resolution of X-Ray Image Intensifier Systems (XR 11­1993) The systems addressed in this standard include optical viewing systems, video systems, photofluorographic film recording systems, and cine film recording and projection systems.

Mechanical Safety Standard for Power Driven Motions of Electromedical Equipment (XR 13­1990) Covers all power-driven equipment motions that are accessible to patients or operators during intended use. (Does not include transport drives for mobile equipment.)

Recommended Practices for Load-Bearing Mechanical Assemblies Used in Diagnostic Imaging (XR 14­1990) Outlines practices for the design, construction, and use of load-bearing castings, weldments, and threaded fasteners.

Test Standard for the Determination of the Visible Entrance Field Size of an X-Ray Image Intensifier System (XR 15­1991) Defines the test standard method for determining the visible entrance field size of an x-ray image intensifier system. Includes direct viewing systems, video systems, photofluorographic film recording systems, and cine film recording and projection systems.

Test Standard for the Determination of the System Contrast Ratio and the System Veiling Glare Index of an X-Ray Image Intensifier System (XR 16­1991) Determines the system contrast ratio and the system veiling glare index at the center of the image produced by an XRII system under a given set of test conditions. The measurement procedures described pertain to images formed by the photofluorographic film system, the cine film system, the video system, and the direct-viewing system.

Test Standard for the Measurement for the Image Signal Uniformity of an X-Ray Image Intensifier System (XR 17­1993) Provides procedures for defining the method of measuring the image signal uniformity produced by an XRII system under a given set of test conditions.

Test Standard for the Determination of the Radial Image Distortion of an X-Ray Image Intensifier System (XR 18­1993) Defines the NEMA standard method for determining radial image distortion of XRII systems under a given set of test conditions.

Electrical, Thermal, and Loading Characteristics of X-Ray Tubes Used for Medical Diagnosis (XR 19­1993) Provides test and presentation-of-data methods for assessing the electrical and thermal performance of x-ray tubes used in medical diagnosis.

X-Ray Tube Assemblies for Medical Diagnosis­Characteristics of Focal Spots (IEC 336­R1993) Determination of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube for Medical Diagnosis (IEC 806­1984)

UNDERWRITERS LABORATORIES, INC.

333 Pfingsten Rd., Northbrook, IL 60062; phone: 847/272-8800; fax: 847/272-8129.

Medical Electrical Equipment, Part 1: General Requirements for Safety (UL 2601-1) This safety standard for medical electrical equipment is harmonized with the International Electrotechnical Commission's publication IEC 601-1, second edition, 1988. The document contains construction and performance requirements including protection against fire, shock, and casualty hazards for medical equipment including x-ray equipment.

Medical and Dental Equipment (UL 544) Requirements cover electric medical and dental equipment intended for professional use in health-care facilities. Investigations according to UL 544 will be conducted until January 1, 2003. Certifications to UL 544 will be retained until January 1, 2005. At that time, all medical and dental equipment will be required to comply with UL 2601-1.

X-Ray Equipment (UL 187) Requirements cover x-ray equipment. This standard addresses fire, shock, and casualty hazards. Investigations according to UL 187 will be conducted until January 1, 2003. Certification to UL 187 will be retained until January 1, 2005. At that time, all x-ray equipment will be required to comply with UL 2601-1.

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