Perspective - (2021) Volume 7, Issue 6
Date of Submission: 05-Nov-2021
Citation: Zhou, Xiaobao. “How ISO Standardization of Dental Materials is Misused: An Overview.” Oral Heath Case Rep 7(2021): 38.
Copyright: © 2021 Zhou X. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Scientists in the area of dental materials encounter a wide range of obstacles. Mechanical testing, in particular, involves a number of limits and possible interferences that, if not handled, might taint, if not invalidate the data and consequently the conclusions formed, with ramifications for future research and product use. Indeed, in each situation, one must be certain that the test used can produce findings that are relevant to the context of a material's or product's actual service circumstances. Fundamentally, one must guarantee that both the manner of load or the failure mechanism are indicative of services, taking into consideration preparation procedures and environment, and also stress distribution, and that the findings are interpretable – indeed, valuable, and suitable for purpose.
As a general proposition, it is concerning that several tests are employed solely because they have been used before, usually for a long period of time, without those requirements being acknowledged, much alone issues being rectified. For a variety of reasons, it is reasonable to argue that testing items intended for use in the mouth dry and at room temp could be justifiable sans proof of validity. That proof of legitimacy never materializes. Another important component that influences the result but is frequently overlooked is the major challenges. This appears to indicate an incorrect wide generality, rather than the desired specific ‘standardization' of Quality Control (QC) processes for certification reasons. It's a widespread mistake that shows up in many forms in numerous articles and for other standards, often tacitly. While International Standards (IS) development can (and should) be led by the best available information, resulting in accurate and informative procedures, the purpose of such an ISO is to simply evaluate safety and efficacy via the use of sufficiently discriminate but readily replicated methodologies.
Numerous test values have been merely assumed to correspond with effective performance since they have not contributed trouble in the past for the quality assurance and accredited reasons of standards, which are typically focused on the expertise of product lines with such a service history – and emphatically not on theoretical behaviour or significance level. To argue that a benchmark may be used as a research instrument demonstrates a lack of comprehension. In reality, at least in dentistry, it's fair to say that ISO approaches are frequently essentially simplified versions of best practice. They are just unsuitable for basic research.
ISO methods have functionality in improving product comparability in certain scenarios and motivating factors, such as when investigational formulations are researched with the goal of becoming certifiable and therefore marketable, or to investigate their authenticity for QC purposes – "suitable for application," but a very meticulous declaration of rationalization would be obligated to be aware of the purpose of not obeying best practice. The scientist must guarantee that a procedure is up-to-date, conceptually sound, appropriate, and easy to interpret, that is, completely justified, even with the drawbacks which can be prevented, as with any method employed in a research project. This is something that editors and reviewers ought to be aware of.
In truth, ISO declares no such claim about the scientific suitability of any methodology, testing, or procedure. ISO, in fact, takes no liability for how its regularized are implemented. The acceptance of any ISO is a question of special regulations or legislation in every country, some of which do, others of which do not, but such acceptance imposes no duty on scientists to adopt the guidelines.