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Standard Guide for Sample Chain-of-Custody Procedures 样品保管链程序的标准指南
发布日期: 2018-08-15
1.1 本指南全面讨论了样品监管链计划在水分析中的潜在要求,并描述了样品监管链中涉及的程序。这些程序的目的是提供从样品收集到样品处理期间样品完整性的责任和文件。 1.2 这些程序旨在记录样品生命周期的每个阶段,即收集、装运、储存和分析过程中的样品持有情况。 1.3 样本监管链只是数据可防御性这一更大问题的一个方面(参见 3.2.2 和 附录X1 ). 1.4 充分的监管链过程,即在法律或监管环境中提供足够证据证明样本完整性的过程,取决于具体情况。本指南中介绍的程序通常被认为足以确保样品完整性的法律辩护。在特定情况下,不太严格的措施可能就足够了。本指南的用户有责任确定其确切需求。可能需要法律顾问来作出这一决定。 1.5 本标准并非旨在解决与其使用相关的所有安全问题(如有)。 本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 监管链程序是计划中的一个必要元素,以确保从采集样本到处理样本期间,能够充分支持数据和结论。 在法律或监管情况下,仅保管文件是不够的。应遵循适合特定情况的完整数据防御方案。 5.2 在应用本指南中的监管链程序示例时,假设已应用了数据可防御性的所有其他元素(如适用)。 5.3 由于没有明确的计划可以保证在任何给定情况下数据完整性的法律抗辩性,本指南提供了托管链计划可能元素的全面列表的描述和讨论,所有这些元素都已在实际计划中使用,但作为开发特定链的选项提供- 监护计划。此外,在特定的监管链要素中,本指南禁止了某些活动,以确保如果选择了这些选项,它们将得到适当实施。
1.1 This guide contains a comprehensive discussion of potential requirements, in the analysis of water, for a sample chain-of-custody program and describes the procedures involved in sample chain-of-custody. The purpose of these procedures is to provide accountability for and documentation of sample integrity from the time samples are collected until sample disposal. 1.2 These procedures are intended to document sample possession during each stage of a sample’s life cycle, that is, during collection, shipment, storage, and the process of analysis. 1.3 Sample chain-of-custody is just one aspect of the larger issue of data defensibility (see 3.2.2 and Appendix X1 ). 1.4 A sufficient chain-of-custody process, that is, one that provides sufficient evidence of sample integrity in a legal or regulatory setting, is situationally dependent. The procedures presented in this guide are generally considered sufficient to assure legal defensibility of sample integrity. In a given situation, less stringent measures may be adequate. It is the responsibility of the users of this guide to determine their exact needs. Legal counsel may be needed to make this determination. 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. ====== Significance And Use ====== 5.1 Chain-of-custody procedures are a necessary element in a program to assure one’s ability to support data and conclusions adequately from the time samples are collected until sample disposal. In a legal or regulatory situation custody documentation alone is not sufficient. A complete data defensibility scheme should be followed that fits the given situation. 5.2 In applying the sample chain-of-custody procedures in this guide, it is assumed that all of the other elements of data defensibility have been applied, if applicable. 5.3 Because there is no definitive program that guarantees legal defensibility of data integrity in any given situation, this guide provides a description and discussion of a comprehensive list of possible elements of a chain-of-custody program, all of which have been employed in actual programs but are given as options for the development of a specific chain-of-custody program. In addition, within particular chain-of-custody elements, this guide proscribes certain activities to assure that if these options are chosen, they will be implemented properly.
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归口单位: D19.02
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