The Process of Developing National Standards That Meet ANSI Guidelines

<div class="section abstract"> <div class="htmlview paragraph">This standard is to delineate the symbols used to identify controls, indicators, and tell-tales for automotive vehicles, trucks, off-the-road vehicles, construction equipment, industrial and recreational transportation and is for reference purposes only. The symbol application is to be found within the appropriate standards listed.</div> <div class="htmlview paragraph">Approved by AMERICAN NATIONAL STANDARDS INSTITUTE February 22, 1983</div> <div class="htmlview paragraph">An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he has approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest editions.</div> <div class="htmlview paragraph">The American National Standards Institute does not develop standards and will in no circumstances give an interpretation of any American National Standard. Moreover, no person shall have the right or authority to issue an interpretation of an American National Standard in the name of the American National Standards Institute.</div> <div class="htmlview paragraph">CAUTION NOTICE: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of approval. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute.</div></div>

During the time the European Economic Community (EC), through the Comite Europeen de Normalisation (CEN) was developing standards for Laser Processing Machines (by a mandate of the 89/392/EEC, “Machine Directive”), it became apparent to the Laser Products Group of the Association for Manufacturing Technology (AMT) that a similar standard would be useful for products made and used in the United States.AMT, among other activities, acts as the American National Standards Institute (ANSI) Secretariat for developing Machine Tool Standards, known as the ANSI B11 series. The B11.21 standard, like others in the B11 series, covers both manufacturers’ and users’ requirements for safety, as it spans the topics of Design, Construction, Care and Use. Since radiation and associated hazard information is covered primarily by existing laws and standards, such as 21 CFR and ANSI Z 136.1, the ANSI B11.21 acts as an information resource and as a comprehensive collection of these criteria.While it would be incorrect to term this standard a “spin-off” or copy of the EC efforts (e.g. ISO 11553 (EN 11553)), it has been an important element of B11.21’s creation that it contain recognition of the European work and harmonization with it. Two key elements of the standard make it especially useful for US manufacturers who wish to produce laser processing machines for both US delivery and the EC. The format of the B11.21, like other B11 standards contains a “normative” or requirement statement on the left side of each page, while the right hand column contains “informative” or explanatory information. In this standard, comparison to the EC requirements are listed to the right hand side for selected segments of the US standard. Additionally, throughout the B11.21 document, the concept of “Risk Assessment” and risk reduction, as a design element, is promoted, in accord with European standards which must comply with the Machine Directive.During the time the European Economic Community (EC), through the Comite Europeen de Normalisation (CEN) was developing standards for Laser Processing Machines (by a mandate of the 89/392/EEC, “Machine Directive”), it became apparent to the Laser Products Group of the Association for Manufacturing Technology (AMT) that a similar standard would be useful for products made and used in the United States.AMT, among other activities, acts as the American National Standards Institute (ANSI) Secretariat for developing Machine Tool Standards, known as the ANSI B11 series. The B11.21 standard, like others in the B11 series, covers both manufacturers’ and users’ requirements for safety, as it spans the topics of Design, Construction, Care and Use. Since radiation and associated hazard information is covered primarily by existing laws and standards, such as 21 CFR and ANSI Z 136.1, the ANSI B11.21 acts as an information resource and as a comprehensive collection of these criteria.While it would be incorrect to term ...

Applicability of standards for evaluations of educational programs, projects and materials in an international setting

The Association for the Advancement of Medical Instrumentation develops voluntary standards for medical devices so that manufacturers might provide information on their product and basic safety and performance criteria that should be considered in qualifying the instrument for clinical use. American national standards are generated through a consensus process by committees consisting of experts in research, development, and design from user, industry, and government communities. Draft standards are made available for public review and may become American national standards after review by the American National Standards Institute. The first American national standard for electronic and automated sphygmomanometers was published in monograph form in 1987. The objective of the revised 1992 standard for electronic and automated sphygmomanometers is to provide updated labeling, safety, and performance requirements that help ensure that consumers and health care professionals are supplied with safe, accurate devices for the indirect measurement of blood pressure, including ambulatory blood pressure recorders. This standard permits validation of the automatic or electronic device by comparison with either direct, intra-arterial blood pressure measurements or the noninvasive cuff/stethoscope technique, based on Korotkoff sounds identified by individuals trained in auscultation. This summary report of the 1992 American national standard for automatic sphygmomanometers provides recommendations for the methods of comparison, statistical analysis of the data, presentation of the results, and criteria for acceptability. Users, researchers, and instrument designers should refer to the American national standard monograph for detailed requirements.

With the rapidly increasing number of electronic ballast manufacturers and ballast products entering the market recently, the compatibility of fluorescent lamps with electronic ballasts has become one of the major concerns among specifiers and users. In 1993, the American National Standards Institute (ANSI) published ANSI C82.11-1993, which describes recommendations for high-frequency operation of fluorescent lamp ballasts. To address compatibility issues for lamp starting, ANSI C82.11 limits the average value of the RMS glow current to a maximum of 25 mA and lamp preheat time to a minimum of 500 ms. ANSI's definitions of glow current and preheat time are made on an ideal lamp starting curve. In reality, some electronic ballasts produce lamp starting curves very different from ANSI's definition, creating difficulties in practical measurements of glow current and preheat time. This research work tested lamp starting characteristics of 17 different electronic ballasts on 2-F40T12 lamps. The results showed that the starting performance of electronic ballasts varied; some met ANSI's requirements, but some did not. The results also showed that using electrode voltage can better define preheat time and glow current, which can better characterize the starting performance of electronic ballasts and ensure reliable testing procedures.

Evaluations of After-School Programs: A Meta-Evaluation of Methodologies and Narrative Synthesis of Findings

This report is the fourth of four that stem from a study of the Impact of Approved Induction

The American National Standards Institute (ANSI) standard for respiratory protection (ANSI Z88.2 1992) lists assigned protection factors (APFs) for various respirators. The committee that developed the APFs based its decisions on a review of available studies of respirator performance. If workplace studies were available, these formed the basis for the number assigned. If no such studies were available, then laboratory studies, design analogies, and other information were used to decide what value to assign. For half-mask air purifying respirators, four workplace protection factor studies were consulted to arrive at an APF. For loose-fitting facepiece powered air purifying respirators (PAPRs), five workplace studies and two laboratory studies were reviewed. For full-face air purifying, helmet/hooded PAPRs, and most supplied air respirators no workplace studies were available. The APF was based on laboratory studies or decided by analogy to other equipment. For the remaining respirators only single workplace protection factor studies were available, and these were used by the committee to assign an APF. The database available to the ANSI committee was limited. Most of the studies available for review were not published. The committee in a sense was required to perform peer review on the information to use the data. Studies completed after the ANSI committee finished its deliberations, when added to the data used, continue to support the APFs assigned by ANSI.

Metaevaluation is the evaluation of an evaluation or evaluation system (Scriven, 1969). It serves as a mechanism to ensure quality in evaluation approaches and implementation. Operationally metaevaluation is defined as “the process of delineating, obtaining, and applying descriptive information and judgmental information – about the utility, feasibility, propriety, and accuracy of an evaluation and its systematic nature, competent conduct, integrity/honesty, respectfulness, and social responsibility to guide the evaluation and/or report its strengths and weaknesses” (Stufflebeam, 2001, p.185). This study was a metaevaluation of an assessment system designed for accreditation requirements to support continuous improvement in teacher education programs at the University of Louisville. The study was intended to serve as a formative metaevaluation to identify strengths and weaknesses in the University of Louisville, College of Education and Human Development’s (CEHD) teacher education assessment system to support improvement of the system and better support continuous improvement of teacher education programs. The study took careful consideration of accountability and accreditation requirements, as well as evaluation and metaevalaution standards and practices. The study utilized Stufflebeam’s structure for metaevaluation (2001), which supports strategic and contextual analysis of the evaluation or evaluation system to address alignment with stakeholders needs. The study employed mixed methods to address four research questions. The research questions were focused on the application of data from the CEHD’s assessment system in driving program improvement and also the reliability and validity of instruments used in the assessment system. The first research question was focused on identifying the types of assessments that best support program improvement in teacher education. A qualitative case study analysis revealed a lack of explicit connections to data within the CEHD’s SLO action plans in which faculty identify plans for improving programs. Implied connections to data, included references to the 10 Unit Key Assessments, Hallmark Assessment Tasks (HATs), and indirect assessment data (QMS student satisfaction survey data. These results indicate that a variety of assessments support program improvement and are in alignment with CAEP standards (2013), the American Evaluation Association (2013), and the Joint Committee on Standards for Educational Evaluation (2011), multiple measures are necessary in sound evaluation and evaluation systems. This study resulted in recommendations to modify SLO templates and action plan prompts to ensure more explicit connections of data to the action plans and even follow-through on action plans. The second research question was intended to identify how assessment data are used to drive continuous improvement in

It is important that hearing assistance devices/systems (HADS) be evaluated electroacoustically to verify performance relative to published results and to compare performance across similar devices. The guidelines for verification prepared by professional organizations address the comparison of the HADS to personal amplification systems. The current document by the American Academy of Audiology includes guidelines for wireless systems integrated with hearing aids, classroom audio distribution systems, and induction loop systems. A new standard by the American National Standards Institute (ANSI) is now available, which provides specifications for systematic electroacoustic measurements that can be compared across manufacturers. Although many of the measurements are similar to those in the ANSI Standard for the Electroacoustic Evaluation of Hearing Aids, there are recommendations regarding position of wireless microphones and receivers that are specific to procedures for the evaluation of HADS. The ANSI standard for Electroacoustic Evaluation of HADS will be reviewed with particular application to systems with wireless transmitters and receivers.

Standardization of the virtual device metafile and the virtual device interface

Oxygen permeability (Dk) was determined for 37 available rigid contact lens materials in a masked fashion. The results were compared with those of an earlier study that included different lots of 14 test materials assessed in the current study. Six lenses of different thicknesses in each test and reference material were obtained. Test materials were arranged in sets of six to eight materials per set. Each set of materials, with inclusion of at least two reference materials for the purpose of simultaneous calibration, was measured to obtain preliminary amperages. Four preliminary measures were performed per thickness, resulting in 24 per material, in a schedule designed to spread the potential effects of machine drift and other factors. The mean preliminary amperages were used to derive corrected Dk values according to American National Standards Institute (ANSI) Z80.20-1998, and the values were linearly calibrated using the measured and established Dk values of the reference materials. The resistance (t/Dk) vs. thickness (t) plots for the 37 test and seven reference materials were approximated linearly. In 54 of 57 linear regressions, the coefficients of determination (R2) were >0.96, and in 48 instances were >0.98. Fourteen Dk values from the current study and an earlier study were linearly correlated (R2 = 0.9846), with a slope close to unity (+1.056) and intercept close to zero (-0.292). Ten of the current values fell within 10% of their corresponding earlier values. Only three current Dk values fell outside of the ANSI Z80.20-1998 tolerance for Dk (+/-20%). Two of these Dk values met the product tolerance when an obvious outlying point was graphically identified and omitted from the linear resistance (t/Dk) vs. thickness (t) regression. Omission of a single outlying point from a linear resistance vs. thickness regression can help provide a more valid Dk value. The ANSI Z80.20-1998 tolerance of +/-20% on Dk and the measurement reproducibility of +/-10% were achieved for the overwhelming majority of rigid contact lens materials up to at least 160 Dk units. The corrected, calibrated Dk values for the 37 test materials, in ANSI units, ranged from 13.8 to 175.1, having an overall mean of 43.2, median of 31.9, and standard error of 6.57 (N = 37).

The authors describe two of the organizations involved in standards development in the US: the American National Standards Institute (ANSI) and the National Information Standards Organization (NISO). They discuss the mechanism for standards development, the life cycle of a standard, and the revision of American National Standard Z39.18-1974, Guidelines for Format and Production of Scientific and Technical Reports.

The mandate of ASA Working Group S12/WG11 has been to develop "laboratory and/or field procedure(s) that yield useful estimates of field performance" of hearing protection devices (HPDs). A real-ear attenuation at threshold procedure was selected, devised, tested for one earmuff and three earplugs via an interlaboratory study involving five laboratories and 147 subjects, and incorporated into a new standard that was approved in 1997 [Royster et al., "Development of a new standard laboratory protocol for estimating the field attenuation of hearing protection devices. Part I. Research of Working Group 11, Accredited Standards Committee S 12, Noise," J. Acoust. Soc. Am. 99, 1506-1526; ANSI, S12.6-1997, "American National Standard method for measuring real-ear attenuation of hearing protectors" (American National Standards Institute, New York, 1997)]. The subject-fit methodology of ANSI S12.6-1997 relies upon listeners who are audiometrically proficient, but inexperienced in the use of HPDs. Whenever a new method is adopted, it is important to know the effects of variability on the power of the measurements. In evaluation of protector noise reduction determined by experimenter-fit, informed-user-fit, and subject-fit methods, interlaboratory reproducibility was found to be best for the subject-fit method. Formulas were derived for determining the minimum detectable difference between attenuation measurements and for determining the number of subjects necessary to achieve a selected level of precision. For a precision of 6 dB, the study found that the minimum number of subjects was 4 for the Bilsom UF-1 earmuff, 10 for the E.A.R Classic earplug, 31 for the Willson EP100 earplug, and 22 for the PlasMed V-51R earplug.

Interoperability: Linking Design and Tolerancing with Metrology