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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5.1 This test method provides guidelines and basic test methods for the accuracy verification of infrared thermometers. It includes test set-up and calculation of uncertainties. It is intended to provide the user with a consistent method, while remaining flexible in the choice of calibration equipment. It is understood that the uncertainty obtained depends in large part upon the apparatus and instrumentation used. Therefore, since this guide is not prescriptive in approach, it provides detailed instruction in uncertainty evaluation to accommodate the variety of apparatus and instrumentation that may be employed.5.2 This test method is intended primarily for calibrating handheld infrared thermometers. However, the techniques described in this guide may also be appropriate for calibrating other classes of radiation thermometers. It may also be of help to those calibrating thermal imagers.5.3 This test method specifies the necessary elements of the report of calibration for an infrared thermometer. The required elements are intended as a communication tool to help the end user of these instruments make accurate measurements. The elements also provide enough information, so that the results of the calibration can be reproduced in a separate laboratory.1.1 This test method covers electronic instruments intended for measurement of temperature by detecting the intensity of thermal radiation exchanged between the subject of measurement and the sensor.1.2 The devices covered by this test method are referred to as infrared thermometers in this document.1.3 The infrared thermometers covered in this test method are instruments that are intended to measure temperatures below 1000°C, measure thermal radiation over a wide bandwidth in the infrared region, and are direct-reading in temperature.1.4 This test method covers best practice in calibrating infrared thermometers. It addresses concerns that will help the user perform more accurate calibrations. It also provides a structure for calculation of uncertainties and reporting of calibration results to include uncertainty.1.5 Details on the design and construction of infrared thermometers are not covered in this test method.1.6 This test method does not cover infrared thermometry above 1000°C. It does not address the use of narrowband infrared thermometers or infrared thermometers that do not indicate temperature directly.1.7 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.8 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.1.9 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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This test method covers the testing of the spectral bandwidth and wavelength accuracy of fluorescence spectrometers that use a monochromator for emission wavelength selection and photomultiplier tube detection. The method can be applied to instruments that use multi-element detectors, such as diode arrays, but results must be interpreted carefully. Atomic lines between 250 nm and 1000 nm are used in the method. The difference between the apparent wavelength and the known wavelength for a series of atomic emission lines is used as a test for wavelength accuracy. The apparent width of some of these lines is used as a test for spectral bandwidth.1.1 This test method covers the testing of the spectral bandwidth and wavelength accuracy of fluorescence spectrometers that use a monochromator for emission wavelength selection and photomultiplier tube detection. This test method can be applied to instruments that use multi-element detectors, such as diode arrays, but results must be interpreted carefully. This test method uses atomic lines between 250 nm and 1000 nm.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 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.1.4 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 This guide is intended to be used for verifying the resistance-temperature relationship of industrial platinum resistance thermometers that are intended to satisfy the requirements of Specification E1137/E1137M. It is intended to provide a consistent method for calibration and uncertainty evaluation while still allowing the user some flexibility in the choice of apparatus and instrumentation. It is understood that the limits of uncertainty obtained depend in large part upon the apparatus and instrumentation used. Therefore, since this guide is not prescriptive in approach, it provides detailed instruction in uncertainty evaluation to accommodate the variety of apparatus and instrumentation that may be employed.5.2 This guide is intended primarily to satisfy applications requiring compliance to Specification E1137/E1137M. However, the techniques described may be appropriate for applications where more accurate calibrations are needed.5.3 Many applications require tolerances to be verified using a minimum test uncertainty ratio (TUR). This standard provides guidelines for evaluating uncertainties used to support TUR calculations.1.1 This guide describes the techniques and apparatus required for the accuracy verification of industrial platinum resistance thermometers constructed in accordance with Specification E1137/E1137M and the evaluation of calibration uncertainties. The procedures described apply over the range of -200 °C to 650 °C.1.2 This guide does not intend to describe procedures necessary for the calibration of platinum resistance thermometers used as calibration standards or Standard Platinum Resistance Thermometers. Consequently, calibration of these types of instruments is outside the scope of this guide.1.3 Industrial platinum resistance thermometers are available in many styles and configurations. This guide does not purport to determine the suitability of any particular design, style, or configuration for calibration over a desired temperature range.1.4 The evaluation of uncertainties is based upon current international practices as described in JCGM 100:2008 “Evaluation of measurement data—Guide to the expression of uncertainty in measurement” and ANSI/NCSL Z540.2-1997 “U.S. Guide to the Expression of Uncertainty in Measurement.”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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 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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