35.240.80 (IT applications in health care technolo 标准查询与下载

ASTM E1475-97 数字放射性测试数据的计算机化传输数据组

1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological test data base to facilitate the transfer of such data. The guide is prepared for use particularly with digital images obtained from radiographic or radioscopic examination systems. Nevertheless, this document provides guidance for data bases for other radiological examinations. The field listing includes those fields regarded as necessary for inclusion in the data base: ( ) regardless of the radiological examination method (as indicated by Footnote C in Table 1), ( ) for radioscopic examination (as indicated by Footnote E in Table 1), and ( ) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications. 1.2 It is recognized that organizations may have in place an internal format for the storage and retrieval of radiological test data. This guide should not impede the use of such formats since it is probable that the necessary fields are already included in such internal data bases, or that the few additions can easily be made. The numerical listing indicated in this guide is only for convenience; the specific numbers carry no inherent significance and are not part of the data file. 1.3 The types of radiological test systems that appear useful in relation to this guide include radioscopic systems as described in Guide E1000, Practices E1255 and E1411, and radiographic systems as described in Guide E94 and Practices E748. Many of the terms used are defined in Terminologies E1013 and E1316. 1.4 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Data Fields for Computerized Transfer of Digital Radiological Test Data

ASTM E792-95e1 临床实验室信息管理系统选择的标准指南

1.1 This guide covers the selection, purchase, use, enhancement, and updating of computer technology supplied by a vendor as a complete system in the clinical laboratory. The purpose of the guide is to assist hospitals, clinics, and independent laboratories through the entire automation project in order to minimize the risks and maximize the benefits. It provides a process that may be used by the medical institution to carry out laboratory information projects in a rational and orderly manner. It also includes checklists of items to be considered at each stage of planning to help guard against the unpleasant consequences of oversights. It includes planning and design aids to assist in carrying out the project. In addition, there is information (see Section 18) about enhancement and updates after the system is purchased. Note 18212;The term "stat," as used in this guide is the abbreviation for the Latin word statim, which means immediately.1.2 This guide is not concerned with digital or computer electronics used only within instrumentation. Rather, it deals with the application of information systems to a large segment of the laboratory operation, and generally is concerned with how Information and Communications Technology (ICT) can be used to enhance the interaction of the laboratory with the rest of the institution, improve workflow in the laboratory, and help keep records. Such systems will normally include segments for patient biographical information, test ordering, specimen collection, workstations worklists, test result entry, result verification, patient result reporting, management reports, archiving, and other special functions.1.3 The major topics are found in the following sections: SectionProject Leader and Project Team 4Project Definition 5General5.1Self-Examination 5.2Unfulfilled Goals 5.3Alternatives 5.4Selection of Option5.5Laboratory Definition 5.6Functional Requirements 6General 6.1Admission-Discharge-Transfer6.2Test Ordering 6.3Specimen Pickup6.4Allocation6.5Test Performance 6.6Reports6.7Archival Storage 6.8Vendor Survey 7Refinement of Functional Requirements8General 8.1Priorities 8.2Preliminary Vendor Contact 8.3Site Visit 8.4Approvals 9Requests for Proposals10Evaluation of Vendor Proposals 11General 11.1Evaluation of Cost 11.2Warranty 11.3Maintenance 11.4Hardware 11.5Software 11.6Backup System 11.7Interfaces 11.8Training 11.9Acceptance11.10Evaluation of Vendors 11.11Selection of Vendor 12Purchase 13Installation 14Site preparation 14.1Delivery 14.2Installation 14.3Startup 14.4Training15Acceptance 16Records and Evaluations 17General17.1D......

Standard Guide for Selection of a Clinical Laboratory Information Management System

ASTM E1381-95 临床实验室装置和计算机系统间传送信息的低级协议

1.1 This specification describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. The clinical laboratory instruments under consideration are those that measure one or more parameters from one or more patient samples. Often they will be automated instruments that measure many parameters from many patient samples. The computer systems considered here are those that are configured to accept instrument results for further processing, storage, reporting, or manipulation. This instrument output may include patient results, quality control results, and other related information. Typically, the computer system will be a Laboratory Information Management System (LIMS).1.2 The terminology of the Organization for International Standards (ISO) Reference Model for Open Systems Interconnection (OSI) is generally followed in describing the communications protocol and services. The electrical and mechanical connection between instrument and computer is described in the Physical Layer section. The methods for establishing communication, error detection, error recovery, and sending and receiving of messages are described in the Data Link Layer section. The data link layer interacts with higher layers in terms of sends and receives "messages," handles data link connection and release requests, and reports the data link status.1.3 Specification E 1394 is concerned with message content in the interface between clinical instruments and computer systems. The major topics are found in the following sections: SectionPhysical Layer5Overview 5.1Electrical Characteristics5.2 Signal Levels 5.2.1Character Structure 5.2.2Speed5.2.3Interface Connections5.2.4Mechanical Characteristics 5.3Connector5.3.1 Cable 5.3.2Data Link Layer6 Overview 6.1Establishment Phase (Link Connection)6.2Contention6. 2.1 Transfer Phase6.3 Frames 6.3.1Frame Number6.3.2 Checksum 6.3.3Acknowledgments 6.3.4Receiver Interrupts6.3.5 Termination Phase (Link Release)6.4Error Recovery6.5 Defective Frames6.5.1 Timeouts 6.5.2Restricted Message Characters6.6

Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems

ASTM E1695-95(2006)e1 计算机层析X射线摄影(CT)系统性能测量的标准试验方法

Two factors affecting the quality of a CT image are geometrical unsharpness and random noise. Geometrical unsharpness limits the spatial resolution of a CT system, that is, its ability to image fine structural detail in an object. Random noise limits the contrast sensitivity of a CT system, that is, its ability to detect the presence or absence of features in an object. Spatial resolution and contrast sensitivity may be measured in various ways. ASTM specifies spatial resolution be quantified in terms of the modulation transfer function (MTF) and contrast sensitivity be quantified in terms of the contrast discrimination function (CDF) (see Guide E 1441 and Practice E 1570). This test method allows the purchaser or the provider of CT systems or services, or both, to measure and specify spatial resolution and contrast sensitivity.1.1 This test method provides instruction for determining the spatial resolution and contrast sensitivity in X-ray and -ray computed tomography (CT) images. The determination is based on examination of the CT image of a uniform disk of material. The spatial resolution measurement is derived from an image analysis of the sharpness at the edge of the disk. The contrast sensitivity measurement is derived from an image analysis of the statistical noise at the center of the disk.1.2 This test method is more quantitative and less susceptible to interpretation than alternative approaches because the required disk is easy to fabricate and the analysis is immune to cupping artifacts. This test method may not yield meaningful results if the disk image occupies less than a significant fraction of the field of view.1.3 This test method may also be used to evaluate other performance parameters. Among those characteristics of a CT system that are detectable with this test method are: the mid-frequency enhancement of the reconstruction kernel, the presence (or absence) of detector crosstalk, the undersampling of views, and the clipping of unphysical (that is, negative) CT numbers (see Air Force Technical Report WL-TR-94-4021). It is highly likely that other characteristics as well can be detected with this test method.1.4 The values stated in SI units are to be regarded as the standard. Inch-pound units are provided for information only.This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Measurement of Computed Tomography (CT) System Performance

ASTM E1672-95(2001)e1 计算机层析X射线摄影(CT)系统选择的标准导则

1.1 This guide covers guidelines for translating application requirements into computed tomography (CT) system requirements/specifications and establishes a common terminology to guide both purchaser and supplier in the CT system selection process. This guide is applicable to the purchaser of both CT systems and scan services. Computed tomography systems are complex instruments, consisting of many components that must correctly interact in order to yield images that repeatedly reproduce satisfactory examination results. Computed tomography system purchasers are generally concerned with application requirements. Computed tomography system suppliers are generally concerned with the system component selection to meet the purchaser's performance requirements. This guide is not intended to be limiting or restrictive, but rather to address the relationships between application requirements and performance specifications that must be understood and considered for proper CT system selection.1.2 Computed tomography (CT) may be used for new applications or in place of film radiography, provided that the capability to disclose physical features or indications that form the acceptance/rejection criteria is fully documented and available for review.1.3 Computed tomography (CT) systems use a set of transmission measurements made along a set of paths projected through the examination object from many different directions. Each of the transmission measurements within these views is digitized and stored in a computer, where they are subsequently conditioned (for example, normalized and corrected) and reconstructed by one of a variety of techniques. An in-depth treatment of CT principles is given in Guide E1441.1.4 Computed tomography (CT), as with conventional radiography and radioscopic examinations, is broadly applicable to any material or examination object through which a beam of penetrating radiation may be passed and detected, including metals, plastics, ceramics, metallic/nonmetallic composite material and assemblies. The principal advantage of CT is that it provides densitometric (that is, radiological density and geometry) images of thin cross sections through an object. Because of the absence of structural superposition, images are much easier to interpret than conventional radiological images. The new purchaser can quickly learn to read CT data because images correspond more closely to the way the human mind visualizes 3-D structures than conventional projection radiology. Further, because CT images are digital, the images may be enhanced, analyzed, compressed, archived, input as data into performance calculations, compared with digital data from other nondestructive evaluation modalities, or transmitted to other locations for remote viewing. While many of the details are generic in nature, this guide implicitly assumes the use of penetrating radiation, specifically X rays and gamma rays.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Computed Tomography (CT) System Selection

ASTM E1695-95(2013) 计算机断层扫描 (CT) 系统性能测量的标准试验方法

4.1 Two factors affecting the quality of a CT image are geometrical unsharpness and random noise. Geometrical unsharpness limits the spatial resolution of a CT system, that is, its ability to image fine structural detail in an object. Random noise limits the contrast sensitivity of a CT system, that is, its ability to detect the presence or absence of features in an object. Spatial resolution and contrast sensitivity may be measured in various ways. ASTM specifies spatial resolution be quantified in terms of the modulation transfer function (MTF) and contrast sensitivity be quantified in terms of the contrast discrimination function (CDF) (see Guide E1441 and Practice E1570). This test method allows the purchaser or the provider of CT systems or services, or both, to measure and specify spatial resolution and contrast sensitivity. 1.1 This test method provides instruction for determining the spatial resolution and contrast sensitivity in X-ray and γ-ray computed tomography (CT) images. The determination is based on examination of the CT image of a uniform disk of material. The spatial resolution measurement is derived from an image analysis of the sharpness at the edge of the disk. The contrast sensitivity measurement is derived from an image analysis of the statistical noise at the center of the disk. 1.2 This test method is more quantitative and less susceptible to interpretation than alternative approaches because the required disk is easy to fabricate and the analysis is immune to cupping artifacts. This test method may not yield meaningful results if the disk image occupies less than a significant fraction of the field of view. 1.3 This test method may also be used to evaluate other performance parameters. Among those characteristics of a CT system that are detectable with this test method are: the mid-frequency enhancement of the reconstruction kernel, the presence (or absence) of detector crosstalk, the undersampling of views, and the clipping of unphysical (that is, negative) CT numbers (see Air Force Technical Report WL-TR-94-40212). It is highly likely that other characteristics as well can be detected with this test method. 1.4 The values stated in SI units are to be regarded as the standard. Inch-pound units are provided for information only. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Measurement of Computed Tomography (CT) System Performance

ASTM E1762-95(2009) 医疗保健信息的电子鉴定用的标准指南

This guide serves three purposes: To serve as a guide for developers of computer software providing, or interacting with, electronic signature processes, To serve as a guide to healthcare providers who are implementing electronic signature mechanisms, and To be a consensus standard on the design, implementation, and use of electronic signatures.1.1 This guide covers: 1.1.1 Defining a document structure for use by electronic signature mechanisms (Section 4), 1.1.2 Describing the characteristics of an electronic signature process (Section 5), 1.1.3 Defining minimum requirements for different electronic signature mechanisms (Section 5), 1.1.4 Defining signature attributes for use with electronic signature mechanisms (Section 6), 1.1.5 Describing acceptable electronic signature mechanisms and technologies (Section 7), 1.1.6 Defining minimum requirements for user identification, access control, and other security requirements for electronic signatures (Section 9), and 1.1.7 Outlining technical details for all electronic signature mechanisms in sufficient detail to allow interoperability between systems supporting the same signature mechanism (Section 8 and Appendix X1-Appendix X4). 1.2 This guide is intended to be complementary to standards under development in other organizations. The determination of which documents require signatures is out of scope, since it is a matter addressed by law, regulation, accreditation standards, and an organization's policy. 1.3 Organizations shall develop policies and procedures that define the content of the medical record, what is a documented event, and what time constitutes event time. Organizations should review applicable statutes and regulations, accreditation standards, and professional practice guidelines in developing these policies and procedures.

Standard Guide for Electronic Authentication of Health Care Information

ASTM E1578-93(1999) 实验室信息管理系统(LIMS)标准指南

1.1 This guide describes computer systems used to manage laboratory information. The term Laboratory Information Management Systems (LIMS) describes this class of computer systems. 1.2 This guide covers LIMS ranging from small laboratories with simple requirements to large multi-site laboratories with complex requirements. The elements of the LIMS guide may be selected based on specific laboratory requirements. 1.3 The audience of this document includes: (1) end users of LIMS, (2) implementers of LIMS, (3) LIMS vendors, (4) instrument vendors, and (5) individuals who must approve LIMS funding. 1.4 The purpose of this guide includes: (1) help educate new users of Laboratory Information Management Systems (LIMS), (2) provide standard terminology that can be used by LIMS vendors and end users, (3) establish minimum requirements for primary LIMS functions, (4) provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation, and (5) provide an example of a LIMS function checklist. 1.5 Information contained in this guide will benefit a broad audience of people who work or interact with a laboratory. New LIMS users can use this guide to understand the purpose and functions of LIMS. The guide can help prospective LIMS users in understanding terminology, configurations, features, design, and costs. Individuals who are purchasing a LIMS can use this guide to identify functions that are recommended for specific laboratory environments. LIMS vendor Research and Development staffs can use the guide as a tool to evaluate, identify, and correct areas that need improvement. LIMS vendor sales staffs can use the guide to accurately represent functions of their LIMS product to prospective customers. This guide does not define laboratory instrument interfaces. 1.6 This guide can be used by laboratories of all sizes. The guide addresses complex issues that impact primarily large LIMS implementations. Small laboratories should review issues that may impact their environments. The implementation times and recommendations listed in this guide are directed at medium and large laboratories.

Standard Guide for Laboratory Information Management Systems (LIMS)

ASTM E1029-84(1997) 临床实验室计算机系统文献工作的标准指南

1.1 This guide covers documentation for a computer system operating in a clinical laboratory.1.2 Documentation is defined as the information needed to install, use, maintain, or modify the system. This information shall be in a reusable form, and may exist in other forms as well. These forms may include printed manuals, online help screens, prompts, computer readable text, computer assisted instruction, audio tapes, or equivalent media. As technology and software techniques change, the form of the documentation may also change. It is a central component of the processes by which system life cycles are managed. Hereafter, the term "documentation" shall encompass all such possible forms.1.2.1 This documentation includes information that explains how the users interact with and operate the system. This may include a terminal operator's guide, training documentation, system operation descriptions, and database and file maintenance instructions.1.2.2 Documentation also includes reference documents that describe functional and internal characteristics of the system, such as software reference manuals, source code, descriptions of file structures, hardware reference manuals, schematics, and flow charts. Paragraphs and might apply when some of this information is proprietary.1.2.3 Documentation includes test procedures to establish whether the system is installed correctly and continues to operate properly. The frequency that the tests are to be performed, the test data sets to be used, and whether the results are to be compared to manual methods should be provided.1.3 The computer systems under consideration are those designed to assist the general work flow of the laboratory. They typically include some or all of the following features: sample tracking, data gathering, report generation, record keeping, quality assurance, management aids, and hospital communications. They may range from very large to small computer systems. Computers dedicated only to a single instrument are not the primary focus.1.4 This standard does not purport to address the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Documentation of Clinical Laboratory Computer Systems