校准、检验和验证
标准物质是具有一种或多种均匀和很好地确定了的特性的物质或材料。它们在为了保证测量准确度而进行的方法校准、测量方法验证、测量不确定度评估或材料赋值中发挥重要作用。
标准物质是分析检验流程和更广泛质量保证计划的关键组成部分。它们在严格的要求下生产，所提供数据的认定和溯源性不同于其他实验室试剂。 从有证标准物质/有证参考物质(CRM)和其他标准物质质量等级到分析证书、计量溯源性以及其他概念，标准物质的概念范畴宽泛却又容易混淆。
标准物质根据质量等级分为5个主要类别，从国家计量和其他主要标准品到有证标准物质(CRM)、标准物质(RM)、分析标准品和研究级或研究化学品。认证和溯源性要求随质量等级的升高而增加。最高级别的标准化由各国政府提供，而CRM和RM的标准化则来自特定的ISO准则。ISO要求包括ISO 17034、ISO/IEC 17025和ISO指南31。
标准物质制造商的CRM或RM生产必须满足这些ISO要求。认证参考物质都必须提供分析证书，证书内容规范基于之前提及的ISO准则。最后两个级别的质量标准由独立制造商各自负责制定，无需依靠各国政府或CRM和RM特定的ISO认可。
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图 2.标准物质层级——有哪些不同类别？
根据方法要求或产品可用性，标准物质有三种形式可供使用：粉末、溶液或基质。选择适合的标准物质对于实验室的检验十分重要，因为结果仅与标准一样准确。
按照检测目标选择标准物质
仪器检验和校准需建立和保持其溯源性。选定标准物质可帮助实验室完成这一点。在每日常规系统适用性应用中，可能比较重要的是确认实用和易于使用的标准物质，并且其还具有适合日常使用的可靠性和经济性。在方法验证中，使用高度准确和精密的标准物质对于表明实验室方法准确而精密十分重要。对于标识和筛选目的，标准物质的重要属性包括已验证的真实性和标识。在涉及定量、检测或稳定性评估的应用中，需要稳定和准确的标准物质。
专用标准物质的选择取决于多种因素，例如监管要求、可用性、检测应用类型、准确度水平和样品基质。
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