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ASTM F2554-22

(Practice)

Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

SIGNIFICANCE AND USE
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.
SCOPE
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.

General Information

Status
Published
Publication Date
31-Aug-2022
ICS
35.240.80 - IT applications in health care technology
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.38 - Computer Assisted Orthopaedic Surgical Systems
Current Stage
Ref Project

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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.
Designation: F2554 − 22
Standard Practice for
Measurement of Positional Accuracy of Computer-Assisted
1
Surgical Systems
This standard is issued under the fixed designation F2554; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope standard, except for angular measurements, which may be
reported in terms of radians or degrees.
1.1 This document provides procedures for measurement
1.4 This standard does not purport to address all of the
andreportingofbasicstaticperformanceofsurgicalnavigation
safety concerns, if any, associated with its use. It is the
and/or robotic positioning devices under defined conditions.
responsibility of the user of this standard to establish appro-
They can be performed on a subsystem (for example, tracking
priate safety, health, and environmental practices and deter-
only)orafullcomputer-aidedsurgerysystemaswouldbeused
mine the applicability of regulatory limitations prior to use.
clinically. Testing a subsystem does not mean that the whole
1.5 This international standard was developed in accor-
system has been tested. The functionality to be tested based on
dance with internationally recognized principles on standard-
thispracticeislimitedtotheperformance(accuracyintermsof
ization established in the Decision on Principles for the
biasandprecision)ofthesystemregardingpointlocalizationin
Development of International Standards, Guides and Recom-
space by means of a pointer. A point in space has no
mendations issued by the World Trade Organization Technical
orientation; only multidimensional objects have orientation.
Barriers to Trade (TBT) Committee.
Therefore, orientation of objects is not within the scope of this
practice. However, in localizing a point the different orienta-
2. Referenced Documents
tions of the pointer can produce errors. These errors and the
2
pointer orientation are within the scope of this practice. The
2.1 ASTM Standards:
aim is to provide a standardized measurement of performance
E456 Terminology Relating to Quality and Statistics
variables by which end users can compare within a system (for
E2281 Practice for Process Capability and Performance
example, with different reference elements or pointers) and
Measurement
between different systems (for example, from different manu-
3
2.2 Other References:
facturers). Parameters to be evaluated include (based upon the
ISO 10360 Geometrical Product Specifications (GPS)—
features of the system being evaluated):
Acceptance and Reverification Tests for Coordinate Mea-
(1) Accuracy of a single point relative to a coordinate
suring Machines (CMM)
system.
(2) Sensitivity of tracking accuracy due to changes in
3. Terminology
pointer orientation.
(3) Relative point-to-point accuracy.
3.1 Definitions:
1.1.1 This method covers all configurations of the evaluated 3.1.1 accuracy, n—the closeness of agreement between a
system as well as extreme placements across the measurement
measurement result and an accepted reference value. E456
volume. 3.1.1.1 Discussion—In the context of this standard, with the
definitions of bias and precision (see below), it can be
1.2 This practice defines a standardized reporting format,
considered that the accuracy of a measurement of a point will
which includes definition of the coordinate systems to be used
be subject to some bias error and some precision error.
for reporting the measurements, and statistical measures (for
3.1.2 bias, n—the difference between the expectation of the
example, mean, RMS, and maximum error).
measurement results and an accepted reference value. E456
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.38 on Computer Assisted Orthopaedic Surgical Systems. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 1, 2022. Published September 2022. Originally the ASTM website.
3
approved in 2010. Last previous edition approved in 2018 as F2554 – 18. DOI Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2554-22. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2554 − 18 F2554 − 22
Standard Practice for
Measurement of Positional Accuracy of Computer Assisted
1
Computer-Assisted Surgical Systems
This standard is issued under the fixed designation F2554; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice addresses the techniques of document provides procedures for measurement and reporting of basic static
performance (accuracy, repeatability, and so forth) of surgical navigation and/or robotic positioning devices under defined
conditions. The scope covers the tracking subsystem, testing only in this practice the accuracy and repeatabilityThey 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 to locate individual points in space. regarding point
localization in space by means of a pointer. A point in space has no orientation; only multi-dimensionalmultidimensional 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 localization tool pointer can produce errors. These errors and the orientation of the localization tool
pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables
by which end-users end users can compare within a system (for example, with different fixed reference frameselements or stylus
tools) pointers) and between different systems (for example, different manufacturers) different systems. from different
manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) LocationAccuracy of a single point relative to a coordinate system.
(2) Relative point to point accuracy (linear).Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Repeatability of coordinates of a single point.Relative point-to-point accuracy.
(4) For an optically based system, the range of visible orientations of the reference frames or tools.
(5) This method covers all configurations of tool arrays in the system.
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement
volume.
1.2 The system as defined in this practice includes only the tracking subsystem (optical, magnetic, mechanical, and so forth) stylus,
computer, and necessary hardware and software. As such, this practice incorporates tests that can be applied to a prescribed
phantom model in a laboratory or controlled setting.
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, standard deviation,RMS, and maximum error).
1.4 This practice will serve as the basis for subsequent standards for specific tasks (cutting, drilling, milling, reaming, biopsy
needle placement, and so forth) and surgical applications.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.38
on Computer Assisted Orthopaedic Surgical Systems.
Current edition approved Nov. 1, 2018Sept. 1, 2022. Published December 2018September 2022. Originally approved in 2010. Last previous edition approved in 20102018
as F2554F2554 – 18.–10. DOI 10.1520/F2554–18.10.1520/F2554-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2554 − 22
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this
standard.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
...

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5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
1.1 This practice facilitates the interoperability of X-ray computed tomography (CT) imaging equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE test results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to X-ray CT test methods.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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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ASTM
ASTM E2891-20(Guide)
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.  
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:  
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;  
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;  
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;  
4.2.4 Appropriately trained staff;  
4.2.5 Appropriate standard operating procedures; and  
4.2.6 Life-cycle management.  
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:  
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
1.2.4 Qualified and competent personnel; and  
1.2.5 Life-cycle management of MVDA model.  
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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ASTM
ASTM A370-23(Test Method)
Standard Test Methods and Definitions for Mechanical Testing of Steel Products

SIGNIFICANCE AND USE
4.1 The primary use of these test methods is testing to determine the specified mechanical properties of steel, stainless steel, and related alloy products for the evaluation of conformance of such products to a material specification under the jurisdiction of ASTM Committee A01 and its subcommittees as designated by a purchaser in a purchase order or contract.  
4.1.1 These test methods may be and are used by other ASTM Committees and other standards writing bodies for the purpose of conformance testing.  
4.1.2 The material condition at the time of testing, sampling frequency, specimen location and orientation, reporting requirements, and other test parameters are contained in the pertinent material specification or in a general requirement specification for the particular product form.  
4.1.3 Some material specifications require the use of additional test methods not described herein; in such cases, the required test method is described in that material specification or by reference to another appropriate test method standard.  
4.2 These test methods are also suitable to be used for testing of steel, stainless steel and related alloy materials for other purposes, such as incoming material acceptance testing by the purchaser or evaluation of components after service exposure.  
4.2.1 As with any mechanical testing, deviations from either specification limits or expected as-manufactured properties can occur for valid reasons besides deficiency of the original as-fabricated product. These reasons include, but are not limited to: subsequent service degradation from environmental exposure (for example, temperature, corrosion); static or cyclic service stress effects, mechanically-induced damage, material inhomogeneity, anisotropic structure, natural aging of select alloys, further processing not included in the specification, sampling limitations, and measuring equipment calibration uncertainty. There is statistical variation in all aspects of mechanical testin...
SCOPE
1.1 These test methods2 cover procedures and definitions for the mechanical testing of steels, stainless steels, and related alloys. The various mechanical tests herein described are used to determine properties required in the product specifications. Variations in testing methods are to be avoided, and standard methods of testing are to be followed to obtain reproducible and comparable results. In those cases in which the testing requirements for certain products are unique or at variance with these general procedures, the product specification testing requirements shall control.  
1.2 The following mechanical tests are described:    
Sections  
Tension  
7 to 14  
Bend  
15  
Hardness  
16  
Brinell  
17  
Rockwell  
18  
Portable  
19  
Impact  
20 to 30  
Keywords  
32  
1.3 Annexes covering details peculiar to certain products are appended to these test methods as follows:    
Annex  
Bar Products  
Annex A1  
Tubular Products  
Annex A2  
Fasteners  
Annex A3  
Round Wire Products  
Annex A4  
Significance of Notched-Bar Impact Testing  
Annex A5  
Converting Percentage Elongation of Round Specimens to
Equivalents for Flat Specimens  
Annex A6    
Testing Multi-Wire Strand  
Annex A7  
Rounding of Test Data  
Annex A8  
Methods for Testing Steel Reinforcing Bars  
Annex A9  
Procedure for Use and Control of Heat-cycle Simulation  
Annex A10  
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.5 When these test methods are referenced in a metric product specification, the yield and tensile values may be determined in inch-pound (ksi) units then converted into SI (MPa) units. The elongation determined in inch-pound gauge lengths of 2 in. or 8 in. may be report...

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ASTM
ASTM F3565-23(Practice)
Standard Practice for Electrofusion Joining Polyethylene (PE) Pipe and Fittings for Pressure Pipe Service

SIGNIFICANCE AND USE
4.1 Using the procedures and apparatus in Sections 8 and 9 and the manufacturer's instructions, pressure-tight joints as strong as the pipe itself can be made between manufacturer-recommended combinations of pipe and fittings. See Specification F1055 for performance requirements of polyethylene electrofusion fittings.
SCOPE
1.1 This practice describes procedures for making joints suitable for pressure service with polyethylene (PE) pipe and fittings by means of electrofusion joining techniques in, but not limited to, a field environment. Other suitable electrofusion joining procedures are available from various sources including fitting manufacturers. This standard does not purport to address all possible electrofusion joining procedures, or to preclude the use of qualified procedures developed by other parties that have been proven to produce reliable electrofusion joints. (Note 1)
Note 1: Reference to the manufacturer in this practice refers to the electrofusion fitting manufacturer.  
1.2 The parameters and procedure are applicable only to joining polyethylene pipe and fittings (Note 2) which are intended for PE fuel gas pipe per Specification D2513 and PE potable water, sewer and industrial pipe manufactured per Specification F714, Specification D3035, Specification F2619, and AWWA C901 and C906.
Note 2: Commercially available materials classified with a thermoplastic pipe material designation code beginning with PE 14, PE 23, PE 24, PE 27, PE 33, PE 34, PE 36, and PE 46, and PE 47 in accordance with Specification D3350 and Terminology F412 are generally acceptable for electrofusion joining using this practice. Consult with the pipe or fitting manufacturer for specific compatibility information.  
1.3 Parts that are within the dimensional tolerances given in present ASTM specifications are required to produce sound joints between polyethylene pipe and fittings when using the joining techniques described in this practice.  
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.5 The text of this practice references notes, footnotes, and appendices which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the practice.  
1.6 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.  
1.7 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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