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AS 1166-2004 Milk and milk products - Guidance on sampling 被代替 发布日期 :  2004-06-04 实施日期 : 

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ISO 9001:2000 Insight Guidance CD ISO 9001:2000 Insight Guidance CD 被代替 发布日期 :  2001-02-15 实施日期 : 

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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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ASTM ISO/ASTM51900-23 Standard Guidance for Dosimetry for Radiation Research Active 发布日期 :  1970-01-01 实施日期 : 

4.1 Reliable dosimetry is indispensable for research on the effects of ionizing radiation on materials and products. Without reliable dosimetry valid conclusions cannot be reached, or the wrong conclusions might be reached.4.2 This document is intended to provide direction on how to conduct dosimetry for research and experiments on the effects of ionizing radiation on materials and products, and on the reporting of dosimetry results. Requirements on dosimetry and on dose ranges might differ between the various types of experiments to be carried out.4.3 Proper reporting of the manner in which the irradiation was carried out is important since the degree of radiation effect might be a function of various factors, other than absorbed dose, such as the radiation source, the absorbed-dose rate, energy of the incident radiation, ambient environmental conditions during irradiation, and the type of incident radiation. This document attempts to highlight the information, including the methodology and results of the absorbed-dose measurements, necessary for an experiment to be repeatable by other researchers.4.4 In most cases an experiment should be designed to irradiate the sample as uniformly as possible. In practice, a certain variation in absorbed dose will exist throughout the sample. Absorbed-dose mapping is used to determine the magnitude, location, and reproducibility of the maximum (Dmax) and minimum absorbed dose (Dmin) for a given set of experimental parameters. Dosimeters used for dose mapping must be capable of operation over the expected range of doses and must have sufficient spatial resolution to determine likely dose gradients (see ISO/ASTM 52303).4.5 Computer simulations might provide useful information about absorbed-dose distribution in the irradiated sample, especially near material interfaces (see ASTM E2232), but are not a substitute for dosimetry.1.1 This document covers essential recommendations for dosimetry needed to conduct research on the effects of ionizing radiation on materials, products and biological samples. Such research includes establishment of the quantitative relationship between absorbed dose and the relevant effects. This document also describes the overall need for dosimetry in such research, and for reporting of the results. Dosimetry should be considered an integral part of the experiment, and the researcher is responsible for ensuring the accuracy and applicability of the dosimetry system used.NOTE 1: For research involving food products, note that the Codex Alimentarius Commission has developed an international General Standard and a Code of Practice that address the application of ionizing radiation to the treatment of foods and which strongly emphasizes the role of dosimetry for ensuring that irradiation will be properly performed (1).2NOTE 2: This document includes tutorial information in the form of Notes. Researchers should also refer to the references provided at the end of the standard, and other applicable scientific literature, to assist in the experimental methodology as applied to dosimetry (2-5).1.2 This document covers research conducted using the following types of ionizing radiation: gamma radiation (typically from Cobalt-60 or Cesium-137 sources), X-radiation (bremsstrahlung, typically with energies between 50 keV and 7.5 MeV), and electrons (typically with energies ranging from 80 keV to more than 10 MeV). See ISO/ASTM 51608, 51649, 51818 and 51702.1.3 This document describes dosimetry recommendations for establishing the experimental method. It does not include dosimetry recommendations for installation qualification or operational qualification of the irradiation facility. These subjects are treated in ISO/ASTM 51608, 51649, 51818 and 51702.1.4 This document is not intended to limit the flexibility of the researcher in the determination of the experimental methodology. The purpose of the document is to ensure that the radiation source and experimental methodology are chosen such that the results of the experiment will be useful and understandable to other scientists and regulatory agencies. The total uncertainty in the absorbed-dose measurement results and the absorbed-dose variation within the irradiated sample should be taken into account in the interpretation of the research results (see ISO/ASTM Guide 51707).1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628. This document is thus intended to be read in conjunction with ISO/ASTM 52628.1.6 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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4.1 The major use of factory-reared insects is in sterile insect release programs (for example, Sterile Insect Technique, or SIT) for suppressing or eradicating pest populations (2, 3). Large numbers of reproductively sterile (irradiated) insects are released into an area where a wild “target population” of the same species exists, or sterile insects are released into an area as a preventative measure to protect against the wild pest establishing. The wild population is reduced to the extent that the sterile males are successful in mating with wild females. The radiation dose absorbed by the factory-reared insects should be within a range that induces the desired level of sterility without substantially reducing the ability of factory-reared males to compete with wild males for mates. In some cases, sterile females may also be released as part of an SIT program. Species targeted by SIT programs are typically major pests affecting agriculture or human health, so the assurance by standardized dosimetry that insects have been properly irradiated is of crucial importance to agriculture growers, agricultural regulators, public health officials, and the public (3). The irradiator operator must demonstrate by means of accurate absorbed-dose measurements that all insects have received absorbed dose within the specified range.4.2 Another use of factory-reared insects is in the production of parasitoids for release against populations of insect pests (4). Parasitoids are insects that spend the larval stage feeding within or on the body of a “host” species, typically killing the host. In some parasitoid programs, factory-reared host insects are irradiated before being offered to parasitoids. This eliminates the need to separate unparasitized hosts from parasitoids so that fertile, unparasitized host insects are not inadvertently released into the field.4.3 An additional use of factory-reared insects is for testing detection traps for fruit flies and moths, and testing mating disruption products for moths.4.4 Factory-reared insects may be treated with ionizing radiation, such as gamma radiation from 137Cs or 60Co sources, or X-radiation or electrons from accelerators. Gamma irradiation of insects is often carried out in small, fixed-geometry, dry-storage irradiators (5). Dosimetry methods for gamma and X-ray irradiation of insects have been demonstrated and include useful procedures for measuring the absorbed dose distribution throughout the volume of the irradiation container(s) in these small irradiators (ASTM Practice 52116 and Refs (1, 6)) as well as large-scale gamma irradiators (ISO/ASTM Practice 51702 and Ref (7)).4.5 Specifications for irradiation of factory-reared insects include a lower limit of absorbed dose and may include a central target dose and an upper limit. These values are based on program requirements and on scientific data on effects of absorbed dose on the sterility, viability, and competitiveness of the factory-reared insects.4.6 To demonstrate control of the radiation process, the absorbed dose must be measured using a calibrated dosimetry system. Regulations or policies under which the facility operates may require the calibration to be traceable to appropriate national or international standards. The radiation-induced change in the dosimeter is evaluated and related to absorbed dose through calibration (ISO/ASTM Practice 51261).4.7 For each irradiator, absorbed-dose rate at a reference position within the irradiated volume of insects or simulated product is measured using a transfer or reference standard dosimetry system. That measurement provides a basis for calculating the duration of irradiation, conveyor speed, or other parameter required to deliver the specified absorbed dose to the insects.4.8 Absorbed-dose mapping for establishing magnitudes and locations of minimum dose (Dmin) and maximum dose (Dmax) is performed using actual product or simulated product (5).1.1 This document outlines dosimetric procedures to be followed for the radiation-induced reproductive sterilization of live insects for use in pest management programs. The primary use of such insects is in the Sterile Insect Technique, where large numbers of reproductively sterile insects are released into the field to mate with and thus control pest populations of the same species. A secondary use of sterile insects is as benign hosts for rearing insect parasitoids. A third use is for testing detection traps for fruit flies and moths, and testing mating disruption products for moths. The procedures outlined in this document will help ensure that insects processed with ionizing radiation from gamma, electron, or X-ray sources receive absorbed doses within a predetermined range. Information on effective dose ranges for specific applications of insect sterilization, or on methodology for determining effective dose ranges, is not within the scope of this document.NOTE 1: Dosimetry is only one component of a total quality assurance program to ensure that irradiated insects are adequately sterilized and fully competitive or otherwise suitable for their intended purpose.1.2 This document provides information on dosimetry for the irradiation of insects for these types of irradiators: self-contained dry-storage 137Cs or 60Co irradiators, self-contained low-energy X-ray irradiators (maximum processing energies from 150 keV to 300 keV), large-scale gamma irradiators, and electron accelerators (electron and X-ray modes).NOTE 2: Additional, detailed information on dosimetric procedures to be followed in installation qualification, operational qualification, performance qualification, and routine product processing can be found in ISO/ASTM Practices 51608 (X-ray [bremsstrahlung] facilities processing at energies over 300 keV), 51649 (electron beam facilities), 51702 (large-scale gamma facilities), and 52116 (self-contained dry-storage gamma facilities), and in Ref (1)2 (self-contained X-ray facilities).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 the non-SI units of minute (min) hour (h) and day (d). These non-SI units are accepted for use within the SI system.1.4 This document is one of a set of standards that provides recommendations for properly implementing and utilizing radiation processing. It is intended to be read in conjunction with ISO/ASTM Practice 52628.1.5 The absorbed dose for insect sterilization is typically within the range of 20 Gy to 600 Gy.1.6 This document refers, throughout the text, specifically to reproductive sterilization of insects. It is equally applicable to radiation sterilization of invertebrates from other taxa (for example, Acarina, Gastropoda) and to irradiation of live insects or other invertebrates for other purposes (for example, inducing mutations), provided the absorbed dose is within the range specified in 1.5.1.7 This document also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the insects have been irradiated (see ISO/ASTM Guide 51539).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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CSA Preface This is the first edition of CAN/CSA-Z14161, Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results, which is an adoption, with Canadian deviations, of the identically t

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This is the second edition of CAN/CSA-ISO 14001, Environmental management systems - Requirements with guidance for use, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 14001

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