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Uncertainty of measurement — Part 4: Role of measurement uncertainty in conformity assessment 测量不确定度第4部分:测量不确定度在合格评定中的作用
发布日期: 2012-11-19
ISO/IEC指南98-4:2012提供了评估项目(实体、对象或系统)是否符合规定要求的指南和程序。例如,物品可能是量块、杂货秤或血样。在以下条件存在的情况下,可以应用这些程序:通过单个标量(可测量的属性)来区分项目,该标量定义的详细程度足以合理地表示为本质上唯一的真值;特性的允许值间隔由一个或两个公差限值规定;可以测量该特性,并以符合GUM原理的方式表达测量结果,以便通过(a)概率密度函数,(b)分布函数,(c)此类函数的数值近似,或(d)最佳估计,合理描述该特性的价值,以及覆盖间隔和相关的覆盖概率。 本文件中制定的程序可用于实现相关财产允许测量值的间隔,称为验收间隔。可选择验收限值,以平衡与验收不合格品(消费者风险)或拒收合格品(生产商风险)相关的风险。 讨论了两类合格评定问题。第一个是设置验收限值,以确保单个测量项目达到预期的一致性概率。第二个是设置验收极限,以确保在测量多个(名义上相同的)项目时,平均达到可接受的置信水平。为他们的解决方案提供了指导。 本文件包含示例以说明所提供的指南。所提出的概念可以扩展到基于一组标量测量值的更一般的合格评定问题。 本文件的受众包括质量经理、标准开发组织成员、认证机构以及测试和测量实验室、检验机构、认证机构、监管机构、学者和研究人员的工作人员。
ISO/IEC Guide 98-4:2012 provides guidance and procedures for assessing the conformity of an item (entity, object or system) with specified requirements. The item might be, for example, a gauge block, a grocery scale or a blood sample. The procedures can be applied where the following conditions exist: the item is distinguished by a single scalar quantity (a measurable property) defined to a level of detail sufficient to be reasonably represented by an essentially unique true value; an interval of permissible values of the property is specified by one or two tolerance limits; the property can be measured and the measurement result expressed in a manner consistent with the principles of the GUM, so that knowledge of the value of the property can be reasonably described by (a) a probability density function, (b) a distribution function, (c) numerical approximations to such functions, or (d) a best estimate, together with a coverage interval and an associated coverage probability. The procedures developed in this document can be used to realize an interval, called an acceptance interval, of permissible measured values of the property of interest. Acceptance limits can be chosen so as to balance the risks associated with accepting non-conforming items (consumer's risk) or rejecting conforming items (producer's risk). Two types of conformity assessment problems are addressed. The first is the setting of acceptance limits that will assure that a desired conformance probability for a single measured item is achieved. The second is the setting of acceptance limits to assure an acceptable level of confidence on average as a number of (nominally identical) items are measured. Guidance is given for their solution. This document contains examples to illustrate the guidance provided. The concepts presented can be extended to more general conformity assessment problems based on measurements of a set of scalar measurands. The audience of this document includes quality managers, members of standards development organizations, accreditation authorities and the staffs of testing and measuring laboratories, inspection bodies, certification bodies, regulatory agencies, academics and researchers.
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