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3.1 Expiration dates are often marked on the packages of perishable products to indicate the presumed end of their shelf lives. Since the shelf lives of most perishable products are temperature dependent, the expiration date is determined by assuming the product will be kept within a prescribed temperature range for its entire life. A problem with this method is that there is no way to determine if the shelf life of a product has been shortened by exposure to a higher temperature. A time-temperature indicator solves this problem when attached to the package because it reaches its end point sooner when exposed to a higher temperature.3.2 In order to directly indicate the end of the shelf life, the time-temperature indicator characteristics should be matched as closely as possible to the quality characteristics of the product. When kept at the standard storage temperature for the product, the indicator should reach its end point at the same time as the product's shelf life. In addition, to determine the accuracy of the match at other temperatures, the change of shelf life with temperature should be known for both the product and the indicator. The Arrhenius relationship is a common and convenient method of describing the change of shelf life with temperature. In cases where it is not applicable, individual time-temperature points for the product may be established and an approximate correlation with the TTI obtained.3.3 When attached to the package of a perishable product, a time-temperature indicator may supplement, or in some cases replace, the expiration date code. The addition of a TTI provides a greater level of confidence that the perishable product is within its shelf life because it responds to the actual temperature conditions to which the product has been exposed.3.4 In the case of minimally processed refrigerated foods, the rapid growth of pathogenic bacteria at elevated temperatures may pose a serious health hazard even before the deterioration of the quality of the product becomes apparent to the consumer. In this case, an expiration date may be used for storage at the standard temperature, while a threshold-temperature TTI is used to indicate the exposure to temperatures at which growth becomes measurable. It is also possible to use a dual-function TTI, in which case the standard TTI would indicate the shelf life at the correct storage temperature while the threshold-temperature part would indicate the exposure to higher temperatures.1.1 This guide covers information on the selection of commercially available time-temperature indicators (TTIs) for noninvasive external package use on perishable products, such as food and pharmaceuticals. When attached to the package of a perishable product, TTIs are used to measure the combined time and temperature history of the product in order to predict the remaining shelf life of the product or to signal the end of its usable shelf life. It is the responsibility of the processor of the perishable product to determine the shelf life of a product at the appropriate temperatures and to consult with the indicator manufacturer to select the available indicator which most closely matches the quality of the product as a function of time and temperature.NOTE 1: Besides time-temperature indicator, TTI is also an abbreviation for time-temperature monitor and time-temperature integrator.1.2 Time-temperature indicators may be integrated into a Hazard Analysis and Critical Control Point (HACCP) plan. Appropriate instructions should be established for handling products for which either the indicator has signaled the end of usable shelf life or the shelf life of the product at its normal storage temperature has been reached.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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This guide is intended to document principal ideas which are necessary and sufficient to assign value to health classification. This guide shall serve governments, funding agencies, terminology developers, terminology integration organizations, and the purchasers and users of this classification system toward improved terminological development and recognition of value in classification. This international standard will also provide classification developers and authors with the quality guidelines needed to construct useful, maintainable classifications. It is applicable to all areas of health about which information is kept or utilized, and is intended to complement and utilize those notions already identified by other national and international standards bodies. These tenets do not attempt to specify all of the richness which can be incorporated into a classification. However, this standard does specify the minimal requirements, which if not adhered to will assure that the classification will have limited generalizability and will be very difficult if not impossible to maintain.1.1 This international standard is intended to document principal ideas which are necessary and sufficient to assign value to a classification. The standard will serve as a guide for governments, funding agencies, terminology developers, terminology integration organizations, and the purchasers and users of classification systems toward improved terminological development and recognition of value in a classification. It is applicable to all areas of health about which information is kept or utilized. Appropriately, classifications should be evaluated within the context of their stated scope and purpose. It is intended to complement and utilize those notions already identified by other national and international standards bodies. This standard explicitly refers only to classifications. This international standard will also provide classification developers and authors with the quality guidelines needed to construct useful, maintainable classifications. These tenets do not attempt to specify all of the richness which can be incorporated into a classification. However, this standard does specify the minimal requirements, which if not adhered to will assure that the classification will have limited generalizability and will be very difficult if not impossible to maintain. We have used the word “Shall” to indicate mandatory requirements and the word “Should” to indicate those requirements which we feel are desirable but may not be widely achievable in current implementations. Classifications, which do not currently meet these criteria, can be in compliance with this standard by putting in place mechanisms to move toward these goals. This standard will provide classification developers with a sturdy starting point for the development of useful classifications. This foundation serves as the basis from which classification developers will build robust concept systems.

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4.1 This guide provides methods for developing environmental sustainability KPIs at the manufacturing process level.4.2 This guide provides standard approaches for systematically identifying, defining, selecting, and organizing KPIs for determining the impact of manufacturing processes on the environment.4.3 This guide is intended for those who need effective KPIs to assess manufacturing process performance, raise understanding, inform decision-makers, and establish objectives for improvement.4.4 If the number of stakeholders is small and the manufacturing processes are simple, KPI developers can follow the first two steps (5.2 Establishing KPI Objectives and 5.3 Defining needed KPIs) of this guide. The steps that follow include KPI selection, normalization and weighting, and KPI organization. They can be applied to larger groups of stakeholders and more complex manufacturing processes. Users of this guide can determine the number of steps they will follow because the decision is highly dependent upon the products that they make and the processes that they use.4.5 The guide enables the development of tools for KPI management and performance evaluation that will support decision-making capabilities in a manufacturing facility, including the development and extension of standardized data, performance information, and environmental knowledge.4.6 Procedures outlined in this guide are intended for environmental KPIs, and they also can be applied to broader sustainability KPIs as in Guide E2986.4.7 A quick guide on how to use this guide can be found in Appendix X7.1.1 This guide addresses Key Performance Indicators (KPIs) for environmental aspects of manufacturing processes.1.2 This guide provides a procedure for identifying candidate KPIs from existing sources for environmental aspects of manufacturing processes.1.3 This guide provides a procedure for defining new candidate KPIs that are not available from existing sources for environmental aspects of manufacturing processes.1.4 This guide defines a methodology for selecting effective KPIs from a list of candidate KPIs based on KPI criteria selected from Appendix X3 or defined by users.1.5 This guide provides a procedure for normalizing KPIs, assigning weights to those KPIs, and aligning them to environmental objectives.1.6 KPIs of Manufacturing Operation Management activities as defined in IEC 62264-1 are out of the scope since they are specifically addressed in ISO 22400-2.1.7 How to evaluate environmental impacts is out of the scope since it is addressed in Guide E2986.1.8 This guide can be used to complement other standards that address environmental aspects of manufacturing processes, for example, Guide E2986, Terminology E2987/E2987M, and Guide E3012.1.9 This guide does not purport to address the security risks associated with manufacturing and environmental information. It is the responsibility of the user of this standard to follow practices and establish appropriate information technology related security measures.1.10 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.1.11 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 BPI is designed to yield quantitative information concerning neutron beam and image system parameters that contribute to film exposure and, thereby, affect overall image quality. For proper measurements of film exposure due to the neutron beam constituents, the BPI must be fabricated in accordance with this practice.5.2 This practice shall be followed for the fabrication of all Beam Purity Indicators to be used with Test Method E545 to determine image quality in direct thermal neutron radiography.1.1 This practice covers the material and fabrication of a Beam Purity Indicator (BPI), which can be used to determine the relative quality of radiographic images produced by direct, thermal neutron radiographic examination.1.2 Units—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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4.1 Indicators may be used to show that products have been exposed to a radiation source. They should be used only to provide a qualitative indication of radiation exposure and may be used to distinguish process loads that have been irradiated from unirradiated loads.NOTE 1: The use of indicators does not eliminate the need for other process-control procedures, such as quantitative dosimetry or the controlled segregation of irradiated from nonirradiated products.NOTE 2: See ISO/ASTM Standards 51608, 51649, 51702, 51939, and 51940 for information on the use of indicators in the various types of processing facilities and for unique product applications.4.2 The indicator manufacturer is obliged to supply a statement regarding the approximate dose level at which the examiner (20/20 vision), at standard illumination (unfiltered daylight, or artificial light of the spectrum and intensity defined by the proper ASTM standard), is able to determine the visual change in the indicator.1.1 This document covers procedures for using radiation-sensitive indicators (referred to hereafter as indicators) in radiation processing. These indicators may be labels, papers, inks or packaging materials which undergo a visual change when exposed to ionizing radiation (1-5).21.2 The purpose for using indicators is to determine visually whether or not a product has been irradiated, rather than to measure different dose levels.1.3 Indicators are not dosimeters and should not be used as a substitute for proper dosimetry. Information about dosimetry systems for radiation processing is provided in other ASTM and ISO/ASTM documents (see ISO/ASTM Guide 51261).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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