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5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.1.3 All units of measure will be reported as millimeters for this standard.1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):(1) Accuracy of a single point relative to a coordinate system.(2) Sensitivity of tracking accuracy due to changes in pointer orientation.(3) Relative point-to-point accuracy.1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error).1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1. Scope 1.1 This Standard specifies the requirements for the quality assurance program applicable to the design, development, maintenance, modification, and use of analytical, scientific, and design computer programs that are used in nuclear power pl

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5.1 RADT Object Model as a Basis for Communication—The RADT object model is the first model used to create a common library of consistent entities (objects) and their attributes in the terminology of object analytical models as applied to the healthcare domain. These object models can be used to construct and refine standards relating to healt care information and its management. Since the RADT object model underpins the design and implementation of specific systems, it provides the framework for establishing the systematics of managing observations made during health care. The observations recorded during health care not only become the basis for managing an individual's health care by practitioners but are also used for research and resource management. They define the common language for abstracting and codifying observations. The inconsistency and incompleteness of the data recorded in paper records is well known and has been noted by the Institute of Medicine's study (4). The ability to build the recommended EHR begins with RADT, as noted in Practice E1239. A more detailed specification of the RADT process and its specific functional domain shall begin with a formal model. Furthermore, following agreement on the initial model, that model shall evolve as knowledge accumulates and the initial view of the healthcare domain extends to other social and psychologic processes that link healthcare with other functional domains of society. The management of lifelong cases of care, such as those of birth defects in newborns, will involve interactions with social work and educational functional domains of experience. It has been recognized for some time (5) that a “healthcare team,” in the broader sense, is involved in dealing with these complex cases. The RADT model is the core to linking these functional domains together in a transparent way. For that reason, the object terminology is used to enable the most global view and vernacular that will facilitate communication among technical specialties that participate in managing some aspect of health care or that build systems to manage the required information.5.2 Common Terminology as a Basis for Education—The use of models and their associated terminology implies that education of the healthcare practitioners shall incorporate this view to a significant extent. While a detailed specification of systems requires extensive lexicons of carefully defined terms, a more understandable terminology shall evolve for the process of educating practitioners during their formal education as well as continuing to educate current practioners concerning how this new technology can be integrated with their existing practices. This challenge has yet to be met, but the objects and modeling concepts presented here are intended to be named with the most intuitive titles in order to promote clear understanding during their use in instruction. Nevertheless, relating these objects and their properties to everyday practice remains a significant challenge, for both the implementors of systems and educators. The perspectives cataloged here can be used in the creation of system documentation and curricula represented in a variety of media.1.1 This practice is intended to amplify Practice E1239 and to complement Practice E1384 by detailing the objects that make up the reservation, registration, admitting, discharge, and transfer (RADT) functional domain of the computer-based record of care (CPR). As identified in Practice E1239, this domain is seminal to all patient record and ancillary system functions, including messaging functions used in telecommunications. For example, it is applicable to clinical laboratory information management systems, pharmacy information management systems, and radiology, or other image management, information management systems. The object model terminology is used to be compatible with other national and international standards for healthcare data and information systems engineering or telecommunications standards applied to healthcare data or systems. This practice is intended for those familiar with modeling concepts, system design, and implementation. It is not intended for the general computer user or as an initial introduction to the concepts.

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This part of ISO/IEC 14776 defines the SCSI commands that are mandatory and optional for all SCSI devices. It also defines the SCSI commands that may apply to any device model.

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