The November 2016 ACS Nano editorial entitled “Standardizing Nanomaterials” highlighted the need for standardization and called for minimum material characterization requirements in nanotechnology-related research.(1) We strongly support this call as it is aligned with existing efforts to develop documentary standards in nanotechnology. International documentary standards are essential not only for academia as highlighted(1) but also for industry, regulators, governments, and nongovernmental organizations. We encourage all researchers to contribute to standardization efforts. The use of standards provides validation and increased confidence in an academic publication or a commercial innovation, enabling comparability between laboratories and ensuring that data are defendable. The fact that the editorial did not reference the substantial body of work produced by international, consensus-based, standards development organizations was a wake-up call for us. It is clear that we, and the standardization organizations we represent, have to invest more time and energy into disseminating our activities and outputs especially to academia, and this is the main reason for this response that was submitted back in 2017 and is published now. The table below shows the approximate participation and the numbers of standards(2) developed to date by expert groups in some technical committees of international standardization bodies. ISO, International Organization for Standardization; CEN,(3) The European Committee for Standardization; IEC,(4) International Electrotechnical Commission. The term “standard” used here includes technical reports, technical specifications, and standard test methods.(5) In addition to committees mentioned in Table 1, a large number of other standardization bodies and organizations develop standards(2) for the characterization of nanomaterials. These groups include the technical committees ISO/TC 24 and ASTM E29, ISO/TC 201 and ASTM E42, and ISO/TC 202 and ASTM D11, which cover particle characterization and surface chemical analysis, including scanning probe microscopy and electron microscopy, respectively. In addition, the Organization for Economic Cooperation and Development (OECD) publishes test guidelines based on the extensive testing program of its Working Party on Manufactured Nanomaterials. The editorial compared the development of standard measurement methods for nanomaterials to those for organic compounds.(1) The standard measurement toolbox for organic molecular characterization did not appear overnight; a process taking decades of innovative developments and validation studies was required. A similar process is occurring in the nanomaterial characterization field today, where instrumentation and protocols are evolving to improve measurement performance, reproducibility, and reliability. However, nanomaterials are often more complex and pose many characterization challenges that can be substantially different from well-defined organic compounds. Nanomaterials need to be described by physical and chemical characteristics that go beyond basic chemical composition and structure.(6,7) These characteristics and the resulting properties can, and often do, change over time and may depend on manufacturing processes and the medium in which the nanomaterial is present. Although the work in characterizing organic compounds is indeed more mature and more widely adopted than that for nanomaterials, nanotechnology standardization is progressing in developing agreed-upon terminology, reproducible characterization, and widely accepted safety methodologies. Unfortunately, academic research has been slow to adopt uniform terminology and validated measurement techniques. The editorial seems to suggest that most researchers are unaware of existing measurement standards, standardized terminology, and the need to verify vendor-provided material data independently.(1) There are already great numbers of standards,(2) including internationally accepted terminology in nanotechnology published by our organizations. Of note, ISO offers free access to all its terms and definitions through the Online Browsing Platform,(8) and standards are often accessible free of charge through university subscriptions. More substantial involvement by experts in academia, industry, and government agencies would ultimately lead to timelier, technically relevant, and useful standards. To ensure that documentary standards, and especially measurement standards, are developed with high levels of quality, i.e., relevance and reliability, the standardization communities rely on published peer-reviewed research that details the scientific evidence supporting method validation. Relevance, reproducibility, and reliability of methods, including pretreatment and preparation of samples, have to be carefully demonstrated. Such publications may include reports of international inter-laboratory tests, which investigate the degree of agreement between results from independent laboratories for example, from the international VAMAS organization(9) or ASTM International’s Interlaboratory Study Program.(10) Papers describing evaluation and validation, including uncertainty analysis, not only for new techniques and methods but also for existing ones, are very welcome and needed. We commend the editorial because it supports incorporating standard measurement techniques into published research. Declaring the use of well-established standardized techniques and methods will benefit researchers because the measured data and results will be accepted with higher confidence. This inclusion would also simplify editorial acceptance of articles. However, the reality is that the application of these techniques to different nanomaterials, nanoenabled products, and specific applications is not always trivial.(11,12) The discussion, as presented in the last paragraph of the editorial, in our opinion, understates both the breadth and the difficulty of nanotechnology standardization, a principal theme of recent Global Summits on Regulatory Science organized by the U.S. National Institutes of Health(13) and the European Commission’s Joint Research Centre regulatory event.(14) Information on the applicability of measurement techniques and methods as well as sample preparation for different nanomaterials should be compiled and good practices shared by academic, government, and industrial communities. We believe that providing researchers and engineers with such useful information is an important role of the standardization community. The editorial also states that “It is appropriate to consider creating a prescribed or expected set of characterization requirements for publication.” The MINChar Initiative(15) and others tried to establish this set a few years ago, but unfortunately, at the time, were not successful. The reasons were varied, but we support the launch of a new, coordinated effort to achieve this objective as invited by the editorial. The growing pressure from regulatory agencies(16) and legislation(17) to distinguish and to classify different forms of nanomaterials may well play decisive roles in this matter. The editorial calls for increased effort and rigor with respect to the standardization of nanomaterial measurements and reporting. We believe this aspiration requires a cooperative approach involving peer-reviewed journals, standards development organizations, and leaders in the field from academia, industry, and government. After all, the ultimate goal is to advance reproducible science leading to the safe and sustainable development of innovative nanotechnology. Reproducibility and comparability of scientific results not only make great publications, but yield faster and more cost-effective research often funded by national and international programs, and in the era of pandemics, this action may mean lives saved. An earlier version of this Comment was received in 2017. Our Reply was published in our September 2020 editorial “Tutorials and Articles on Best Practices” DOI: 10.1021/acsnano.0c07588.(18) We apologize to the authors of the original comment for the long delay. As a result of these conversations, in part, we are looking forward to publishing a series of articles on standards in nanomaterials. This article references 18 other publications.

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对 ACS Nano 社论“纳米材料标准化”的回应

2016 年 11 月ACS Nano题为“标准化纳米材料”的社论强调了标准化的必要性，并呼吁纳米技术相关研究中的最低材料表征要求。(1) 我们强烈支持这一呼吁，因为它与制定纳米技术文献标准的现有努力相一致。国际文献标准不仅对学术界至关重要(1)，而且对工业界、监管机构、政府和非政府组织也至关重要。我们鼓励所有研究人员为标准化工作做出贡献。标准的使用提供了对学术出版物或商业创新的验证和增强的信心，实现实验室之间的可比性并确保数据是可辩护的。这篇社论没有提及基于共识的国际标准制定组织所做的大量工作，这一事实给我们敲响了警钟。显然，我们以及我们所代表的标准化组织必须投入更多的时间和精力来传播我们的活动和成果，特别是向学术界传播，这是 2017 年提交并现在发布的回应的主要原因。下表显示了国际标准化机构一些技术委员会中专家组迄今为止制定的标准(2)的大致参与情况和数量。ISO，国际标准化组织；CEN，(3) 欧洲标准化委员会；IEC，(4) 国际电工委员会。这里使用的术语“标准”包括技术报告、技术规范和标准测试方法。(5) 除了表1中提到的委员会外，大量其他标准化机构和组织制定了纳米材料表征的标准(2) 。这些小组包括 ISO/TC 24 和 ASTM E29、ISO/TC 201 和 ASTM E42 以及 ISO/TC 202 和 ASTM D11 技术委员会，它们分别涵盖颗粒表征和表面化学分析，包括扫描探针显微镜和电子显微镜。此外，经济合作与发展组织（OECD）根据其人造纳米材料工作组的广泛测试计划发布了测试指南。社论将纳米材料标准测量方法的发展与有机化合物标准测量方法的发展进行了比较。（1）有机分子表征的标准测量工具箱不是一朝一夕出现的；需要一个经过数十年创新开发和验证研究的过程。如今，纳米材料表征领域正在发生类似的过程，其中仪器和协议不断发展，以提高测量性能、再现性和可靠性。然而，纳米材料通常更加复杂，并带来许多表征挑战，这些挑战可能与明确的有机化合物有很大不同。纳米材料需要通过超出基本化学成分和结构的物理和化学特性来描述。(6,7) 这些特性和由此产生的特性可以而且经常会随着时间的推移而变化，并且可能取决于制造工艺和其中的介质。存在纳米材料。尽管表征有机化合物的工作确实比纳米材料更成熟、更广泛采用，但纳米技术标准化在开发商定的术语、可重复的表征和广泛接受的安全方法方面正在取得进展。不幸的是，学术研究在采用统一术语和经过验证的测量技术方面进展缓慢。这篇社论似乎表明，大多数研究人员不知道现有的测量标准、标准化术语以及独立验证供应商提供的材料数据的必要性。(1) 已经有大量标准，(2) 包括国际公认的纳米技术术语由我们的组织发布。值得注意的是，ISO 通过在线浏览平台免费提供其所有术语和定义(8)，并且通常可以通过大学订阅免费访问标准。学术界、工业界和政府机构专家的更多实质性参与最终将导致更及时、技术相关、和有用的标准。为确保制定高质量的文件标准，特别是测量标准，IE、相关性和可靠性，标准化团体依赖于已发表的同行评审研究，其中详细介绍了支持方法验证的科学证据。必须仔细证明方法的相关性、重现性和可靠性，包括样品的预处理和制备。此类出版物可能包括国际实验室间测试的报告，这些报告调查独立实验室（例如国际 VAMAS 组织 (9) 或 ASTM 国际实验室间研究计划 (10)）结果之间的一致性程度。 (10) 描述评估和验证的论文，包括不确定性分析，不仅对于新技术和方法，而且对于现有技术和方法，都是非常受欢迎和需要的。我们赞扬这篇社论，因为它支持将标准测量技术纳入已发表的研究中。宣布使用完善的标准化技术和方法将使研究人员受益，因为测量的数据和结果将以更高的可信度被接受。这种纳入还将简化文章的编辑接受。然而，现实情况是，将这些技术应用于不同的纳米材料、纳米产品和特定应用并不总是微不足道的。(11,12) 我们认为，社论最后一段中提出的讨论低估了两者纳米技术标准化的广度和难度，这是最近由美国国立卫生研究院 (13) 和欧盟委员会联合研究中心举办的监管科学全球峰会的主要主题。(14) 有关测量技术适用性的信息学术界、政府和工业界应编制不同纳米材料的方法和样品制备方法，并分享良好实践。我们相信，为研究人员和工程师提供此类有用的信息是标准化社区的重要作用。社论还指出，“考虑为出版制定一套规定或预期的特征要求是适当的。” MINChar Initiative(15) 和其他人几年前尝试建立这个集合，但不幸的是，当时并没有成功。原因多种多样，但我们支持按照社论的邀请发起一项新的、协调一致的努力来实现这一目标。来自监管机构(16)和立法(17)的日益增长的压力，要求区分和分类不同形式的纳米材料，很可能在这个问题上发挥决定性作用。该社论呼吁在纳米材料测量和报告的标准化方面加大努力和严格程度。我们相信，这一愿望需要一种合作方式，涉及同行评审期刊、标准制定组织以及学术界、工业界和政府领域的领导者。毕竟，最终目标是推进可重复的科学，从而实现创新纳米技术的安全和可持续发展。科学结果的可重复性和可比性不仅可以发表出色的出版物，而且可以产生更快、更具成本效益的研究，这些研究通常由国家和国际项目资助，在大流行时代，这一行动可能意味着拯救生命。此评论的早期版本于 2017 年收到。我们的回复发表在我们 2020 年 9 月的社论“最佳实践教程和文章”DOI：10.1021/acsnano.0c07588。(18) 我们对原始评论的作者表示歉意长时间延迟。作为这些对话的部分结果，我们期待发表一系列有关纳米材料标准的文章。本文引用了其他 18 篇出版物。