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==Sandbox begins below==
==Sandbox begins below==
==1. Introduction to materials and materials testing laboratories==


What is a material? This question is surprisingly more complex for the layperson than may be expected. The definition of "material" has varied significantly over the years, dependent on the course of study, laboratory, author, etc. A 1974 definition by Richardson and Peterson that has seen some use in academic study defines a material as "any nonliving matter of academic, engineering, or commercial importance."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Chapter 1: Introduction to Analytical Methods |series=Materials science series |publisher=Academic Press |place=New York |page=2 |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> But recently biomaterials like biopolymers (as replacements for plastics)<ref>{{Cite journal |last=Das |first=Abinash |last2=Ringu |first2=Togam |last3=Ghosh |first3=Sampad |last4=Pramanik |first4=Nabakumar |date=2023-07 |title=A comprehensive review on recent advances in preparation, physicochemical characterization, and bioengineering applications of biopolymers |url=https://link.springer.com/10.1007/s00289-022-04443-4 |journal=Polymer Bulletin |language=en |volume=80 |issue=7 |pages=7247–7312 |doi=10.1007/s00289-022-04443-4 |issn=0170-0839 |pmc=PMC9409625 |pmid=36043186}}</ref> and even natural<ref>{{Cite journal |last=Kurniawan |first=Nicholas A. |last2=Bouten |first2=Carlijn V.C. |date=2018-04 |title=Mechanobiology of the cell–matrix interplay: Catching a glimpse of complexity via minimalistic models |url=https://linkinghub.elsevier.com/retrieve/pii/S2352431617301864 |journal=Extreme Mechanics Letters |language=en |volume=20 |pages=59–64 |doi=10.1016/j.eml.2018.01.004}}</ref> and engineered biological tissues<ref>{{Cite journal |last=Kim |first=Hyun S. |last2=Kumbar |first2=Sangamesh G. |last3=Nukavarapu |first3=Syam P. |date=2021-03 |title=Biomaterial-directed cell behavior for tissue engineering |url=https://linkinghub.elsevier.com/retrieve/pii/S246845112030057X |journal=Current Opinion in Biomedical Engineering |language=en |volume=17 |pages=100260 |doi=10.1016/j.cobme.2020.100260 |pmc=PMC7839921 |pmid=33521410}}</ref> may be referenced as "materials." (And to Richardson and Peterson's credit, they do add in the preface of their 1974 work that "[a]lthough the volumes are directed toward the physical sciences, they can also be of value for the biological scientist with materials problems."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Preface |series=Materials science series |publisher=Academic Press |place=New York |page=xiii |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> A modern example would be biodegradable materials research for tissue and medical implant engineering.<ref>{{Cite journal |last=Modrák |first=Marcel |last2=Trebuňová |first2=Marianna |last3=Balogová |first3=Alena Findrik |last4=Hudák |first4=Radovan |last5=Živčák |first5=Jozef |date=2023-03-16 |title=Biodegradable Materials for Tissue Engineering: Development, Classification and Current Applications |url=https://www.mdpi.com/2079-4983/14/3/159 |journal=Journal of Functional Biomaterials |language=en |volume=14 |issue=3 |pages=159 |doi=10.3390/jfb14030159 |issn=2079-4983 |pmc=PMC10051288 |pmid=36976083}}</ref>) Yet today more questions arise. what of matter that doesn't have "academic, engineering, or commercial importance"; can it now be called a "material" in 2023? What if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists? Indeed, the definition of "material" today is no easy task. This isn't made easier when even modern textbooks introduce the topic of materials science without aptly defining what a material actually is<ref>{{Cite book |last=Callister |first=William D. |last2=Rethwisch |first2=David G. |date= |year=2021 |title=Fundamentals of materials science and engineering: An integrated approach |url=https://books.google.com/books?id=NC09EAAAQBAJ&newbks=1&newbks_redir=0&printsec=frontcover |chapter=Chapter 1. Introduction |publisher=Wiley |place=Hoboken |pages=2–18 |isbn=978-1-119-74773-4}}</ref>, let alone what materials science is.<ref>{{Cite book |last=Sutton |first=Adrian P. |date=2021 |title=Concepts of materials science |edition=First edition |publisher=Oxford University Oress |place=Oxford [England] ; New York, NY |isbn=978-0-19-284683-9}}</ref> Perhaps the writers of said textbooks assume that the definitions of "material" and "materials science" have a "well duh" response.


===2.1 Globally recognized manufacturing standards===
To complicate things further, a material can be defined based upon the context of use. Take for example the ISO 10303-45 standard by the [[International Organization for Standardization]] (ISO), which addresses the representation and exchange of material and product manufacturing information in a standardized way, specifically describing how material and other engineering properties can be described in the model/framework.<ref name="ISO10303-45">{{cite web |url=https://www.iso.org/standard/78581.html |title=ISO 10303-45:2019 ''Industrial automation systems and integration — Product data representation and exchange — Part 45: Integrated generic resource: Material and other engineering properties'' |publisher=International Organization for Standardization |date=November 2019 |accessdate=20 September 2023}}</ref><ref name=":0">{{Cite journal |last=Swindells |first=Norman |date=2009 |title=The Representation and Exchange of Material and Other Engineering Properties |url=http://datascience.codata.org/articles/abstract/10.2481/dsj.008-007/ |journal=Data Science Journal |language=en |volume=8 |pages=190–200 |doi=10.2481/dsj.008-007 |issn=1683-1470}}</ref> The context here is "standardized data transfer of material- and product-related data," which in turn involves [[Ontology (information science)|ontologies]] that limit the complexity of materials science discourse and help better organize materials and product data into information and knowledge. As such, the ISO 10303 set of standards must define "material," and 10303-45 complicates matters further in this regard (though it will be helpful for this guide in the end).


====2.1.1 Food and beverage====
In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard<ref name=":0" />:
Food and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries.


'''2.1.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)'''
<blockquote>The first edition of ISO 10303-45 was derived from experience of the testing of, so-called, "materials" properties, and the terminology used in the standard reflects this experience. However, the information modelling of an engineering material, such as alloyed steel or high density polyethylene, is no different from the information modelling of a "product." The "material" properties are therefore one of the characteristics of a product, just as its shape and other characteristics are. Therefore all "materials" are products, and the information model in ISO 10303-45 can be used for any property of any product.</blockquote>


In 1998, the [[wikipedia:British Retail Consortium|British Retail Consortium]] (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.<ref name="PavlovićWhat17">{{cite web |url=https://www.ideagen.com/thought-leadership/blog/what-is-brc-global-food-safety-standard-explained |title=What is BRC? Global food safety standard explained |author=Pavlović, A. |work=Ideagen Blog |publisher=Ideagen Limited |date=26 June 2017 |accessdate=21 April 2023}}</ref><ref name="PJBRCGS20">{{cite web |url=https://www.pjfsc.com/Downloads/BRC-Overview.pdf |format=PDF |title=BRCGS - British Retail Consortium Global Standard |publisher=Perry Johnson Food Safety Consulting, Inc |date=April 2020 |accessdate=21 April 2023}}</ref><ref name="EagleFood19">{{cite web |url=https://vertassets.blob.core.windows.net/download/45fe7af4/45fe7af4-0500-4163-bd2b-5dd34e824bfd/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf |format=PDF |title=Food Safety and Quality Regulations: A Guide to Global Standards |publisher=Eagle Product Inspection |date=May 2019 |accessdate=21 April 2023}}</ref><ref name="BRCGSFS8_18">{{cite web |url=https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf |format=PDF |title=Global Standard Food Safety |author=British Retail Consortium |publisher=British Retail Consortium |date=August 2018 |accessdate=21 April 2023}}</ref> The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.<ref name="PJBRCGS20" />
Put in other words, for the purposes of defining "material" for a broader, more standardized ontology, materials and products can be viewed as interchangeable. Mies puts this another way, stating that based on ISO 10303-45, a material can be defined as "a manufactured object with associated properties in the context of its use environment."<ref>{{Cite book |last=Mies, D. |date=2002 |editor-last=Kutz |editor-first=Myer |title=Handbook of materials selection |url=https://books.google.com/books?id=gWg-rchM700C&pg=PA499 |chapter=Chapter 17. Managing Materials Data |publisher=J. Wiley |place=New York |page=499 |isbn=978-0-471-35924-1}}</ref> But this representation only causes more confusion as we ask "does a material have to be manufactured?" After all, we have the term "raw material," which the Oxford English Dictionary defines as "the basic material from which a product is manufactured or made; unprocessed material."<ref name="OEDRawMat">{{cite web |url=https://www.oed.com/search/dictionary/?scope=Entries&q=raw+material |title=raw material |work=Oxford English Dictionary |accessdate=20 September 2023}}</ref> Additionally, chemical elements are defined as "the fundamental materials of which all matter is composed."<ref>{{Cite web |last=Lagowski, J.J.; Mason, B.H.; Tayler, R.J. |date=16 August 2023 |title=chemical element |work=Encyclopedia Britannica |url=https://www.britannica.com/science/chemical-element |accessdate=20 September 2023}}</ref> Taking into account the works of Richardson and Peterson, Mies, and Swindells, as well as ISO 10303-45, the concepts of "raw materials" and "chemical elements," and modern trends towards the inclusion of biomaterials (though discussion of biomaterials will be limited here) in materials science, we can land on the following definition for the purposes of this guide:


'''2.1.1.2 Codex Alimentarius'''
:A material is discrete matter that is elementally raw (e.g., native metallic and non-metallic elements), fundamentally processed (e.g., calcium oxide), or fully manufactured (by human, automation, or both; e.g., a fastener) that has an inherent set of properties that a human or automation-driven solution (e.g., an [[artificial intelligence]] [AI] algorithm) has identified for a potential or realized use environment.


The [[wikipedia:Codex Alimentarius|Codex Alimentarius]] is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the [[World Health Organization]] (WHO).<ref name="EagleFood19" /> The Codex "is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade."<ref name="FAOCodexAbout">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/about-codex/en/#c453333 |title=About Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref> Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.<ref name="FAOCodexAbout" /> It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.<ref name="FOAFood22">{{cite web |url=https://www.fao.org/food-safety/food-control-systems/policy-and-legal-frameworks/food-laws-and-regulations/en/ |title=Food laws & regulations |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref> Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)<ref name="FAOCodes22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/ |title=Codes of Practice |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref>, General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).<ref name="FAOContam22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/thematic-areas/contaminants/en/ |title=Contaminants |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref>
First, this definition more clearly defines the types of matter that can be included, recognizing that manufactured products may still be considered materials. Initially this may seem troublesome, however, in the scope of complex manufactured products such as automobiles and satellites; is anyone really referring to those types of products as "materials"? As such, the word "discrete" is included, which in manufacturing parlance refers to distinct components such as brackets and microchips that can be assembled into a greater, more complex finished product. This means that while both a bolt and an automobile are manufactured "products," the bolt, as a discrete type of matter, can be justified as a material, whereas the automobile can't. Second—answering the question of "what if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists?"—the definition recognizes that the material needs at a minimum recognition of a potential use case. This turns out to be OK, because if no use case has been identified, the matter still can be classified as an element, compound, or substance. It also insinuates that that element, compound, or substance with no use case isn't going to be used in the manufacturing of any material or product. Third, the definition also recognizes the recent phenomena of autonomous systems discovering new materials and whether or not those autonomous systems should be credited with inventorship.<ref>{{Cite journal |last=Ishizuki |first=Naoya |last2=Shimizu |first2=Ryota |last3=Hitosugi |first3=Taro |date=2023-12-31 |title=Autonomous experimental systems in materials science |url=https://www.tandfonline.com/doi/full/10.1080/27660400.2023.2197519 |journal=Science and Technology of Advanced Materials: Methods |language=en |volume=3 |issue=1 |pages=2197519 |doi=10.1080/27660400.2023.2197519 |issn=2766-0400}}</ref> The question of inventorship is certainly worth discussion, though it is beyond the scope of this guide. Regardless, the use of automated systems to match a set of properties of a particular matter to a real-world use case isn't likely to go away, and this definition accepts that likelihood.


'''2.1.1.3 Global Food Safety Initiative (GFSI)'''
Finally, this leads us to the realization that materials, by definition, are inherently linked to the act of intentional human- or automation-driven creation, i.e., manufacturing and construction.


The [[wikipedia:Global Food Safety Initiative|GFSI]] is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.<ref name="EagleFood19" /> Previously known as the GFSI Guidance Document<ref name="GFSIRelease17">{{cite web |url=https://mygfsi.com/press_releases/gfsi-releases-new-edition-of-benchmarking-requirements/ |title=GFSI Releases New Edition of Benchmarking Requirements |publisher=Global Food Safety Initiative |date=28 February 2017 |accessdate=21 April 2023}}</ref>, the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements "demonstrates an organization’s serious commitment to food safety to customers and potential customers across the world."<ref name="EagleFood19" /> An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.<ref name="GFSICert22">{{cite web |url=https://mygfsi.com/how-to-implement/certification/ |title=Certification |publisher=Global Food Safety Initiative |date=2022 |accessdate=21 April 2023}}</ref> GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.


'''2.1.1.4 Hazard analysis and critical control points (HACCP)'''
===1.1 Materials testing labs, then and now===


The [[wikipedia:Hazard analysis and critical control points|hazard analysis and critical control points]] or HACCP system has been adopted and integrated in various ways over the years<ref name="WeinrothHist18">{{Cite journal |last=Weinroth |first=Margaret D |last2=Belk |first2=Aeriel D |last3=Belk |first3=Keith E |date=2018-11-09 |title=History, development, and current status of food safety systems worldwide |url=https://academic.oup.com/af/article/8/4/9/5087923 |journal=Animal Frontiers |language=en |volume=8 |issue=4 |pages=9–15 |doi=10.1093/af/vfy016 |issn=2160-6056 |pmc=PMC6951898 |pmid=32002225}}</ref>, but at its core, the system directs organizations to focus on key areas or "critical control points" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.<ref name="EagleFood19" /> Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.<ref name="WeinrothHist18" /><ref name="61FR38806">{{cite web |url=https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary |title=61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems |work=Federal Register |publisher=U.S. Government Publishing Office |date=25 July 1996 |accessdate=21 April 2023}}</ref> HACCP also found its way into other standards benchmarked by the GFSI.<ref name="WeinrothHist18" /> The concept of HACCP has perhaps changed slightly over the years, but the main principles remain<ref name="EagleFood19" />:
====1.1.1 Materials testing 2.0====


#Conduct a hazard analysis.
*https://onlinelibrary.wiley.com/doi/full/10.1111/str.12434
#Identify CCPs.
*https://onlinelibrary.wiley.com/doi/full/10.1111/str.12370
#Establish critical limits for those CCPs.
#Establish monitoring procedures for those CCPs.
#Establish corrective action for failed limits.
#Establish verification procedures.
#Establish record keeping and documentation procedures.


'''2.1.1.5 International Featured Standards (IFS)'''


The IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that "IFS does not specify what these processes must look like but merely provides a risk-based assessment"<ref name="IFSHome">{{cite web |url=https://www.ifs-certification.com/en/ |title=IFS: Global Safety and Quality Standards |publisher=IFS Management GmbH |accessdate=21 April 2023}}</ref> or "uniform evaluation system"<ref name="EagleFood19" /> for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).<ref name="IFSHome" />
===1.2 Industries, products, and raw materials===


'''2.1.1.6 International Organization for Standardization (ISO) 22000'''


The [[wikipedia:ISO 22000|ISO 22000]] series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.<ref name="ISO22000">{{cite web |url=https://www.iso.org/iso-22000-food-safety-management.html |title=ISO 22000 Food safety management |publisher=International Organization for Standardization |accessdate=21 April 2023}}</ref> ISO 22000 is based off the [[ISO 9000]] family of [[quality management system]] standards and, like other standards, incorporates elements of HACCP.<ref name="WeinrothHist18" /> The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.<ref name="ISO22000Home">{{cite web |url=https://committee.iso.org/home/tc34sc17 |title=ISO/TC34/SC17 |publisher=International Organization for Standardization |accessdate=21 April 2023}}</ref> Major standards applicable to manufacturers with laboratories include:
===1.3 Laboratory roles and activities in the industry===


*ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety — Part 1: Food manufacturing''<ref name="ISO22002-1">{{cite web |url=https://www.iso.org/standard/44001.html |title=ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing |publisher=International Organization for Standardization |date=December 2009 |accessdate=21 April 2023}}</ref>
====1.3.1 R&D roles and activities====
*ISO/TS 22002-4:2013 ''Prerequisite programmes on food safety — Part 4: Food packaging manufacturing''<ref name="ISO22002-4">{{cite web |url=https://www.iso.org/standard/60969.html |title=ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing |publisher=International Organization for Standardization |date=December 2013 |accessdate=21 April 2023}}</ref>
*ISO/TS 22002-6:2016 ''Prerequisite programmes on food safety — Part 6: Feed and animal food production''<ref name="ISO22002-6">{{cite web |url=https://www.iso.org/standard/66126.html |title=ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production |publisher=International Organization for Standardization |date=April 2016 |accessdate=21 April 2023}}</ref>


'''2.1.1.7 Safe Quality Food (SQF) Program'''
====1.3.2 Pre-manufacturing and manufacturing roles and activities====


The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food "safety-plus-quality" management certification mechanism that covers the food supply chain from farm to fork.<ref name="EagleFood19" /> Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.<ref name="SQFCode">{{cite web |url=https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/ |title=SQF Code – Edition 9 Downloads |publisher=SQF Institute |date=24 May 2021 |accessdate=21 April 2023}}</ref> Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.
====1.3.3 Post-production quality control and regulatory roles and activities====


====2.1.2 Materials====
==References==
 
{{Reflist|colwidth=30em}}
====2.1.3 Pharmaceutical and medical devices====
 
====2.1.4 Other industries====
 
 
===2.2 Regulations and laws around the world===
 
====2.2.1 Food and beverage====
 
====2.2.2 Materials====
 
====2.2.3 Pharmaceutical and medical devices====
 
====2.3.4 Other industries====
 
 
===2.3 Other influencing factors===
 
====2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)====
 
====2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)====

Latest revision as of 23:51, 20 September 2023

Sandbox begins below

1. Introduction to materials and materials testing laboratories

What is a material? This question is surprisingly more complex for the layperson than may be expected. The definition of "material" has varied significantly over the years, dependent on the course of study, laboratory, author, etc. A 1974 definition by Richardson and Peterson that has seen some use in academic study defines a material as "any nonliving matter of academic, engineering, or commercial importance."[1] But recently biomaterials like biopolymers (as replacements for plastics)[2] and even natural[3] and engineered biological tissues[4] may be referenced as "materials." (And to Richardson and Peterson's credit, they do add in the preface of their 1974 work that "[a]lthough the volumes are directed toward the physical sciences, they can also be of value for the biological scientist with materials problems."[5] A modern example would be biodegradable materials research for tissue and medical implant engineering.[6]) Yet today more questions arise. what of matter that doesn't have "academic, engineering, or commercial importance"; can it now be called a "material" in 2023? What if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists? Indeed, the definition of "material" today is no easy task. This isn't made easier when even modern textbooks introduce the topic of materials science without aptly defining what a material actually is[7], let alone what materials science is.[8] Perhaps the writers of said textbooks assume that the definitions of "material" and "materials science" have a "well duh" response.

To complicate things further, a material can be defined based upon the context of use. Take for example the ISO 10303-45 standard by the International Organization for Standardization (ISO), which addresses the representation and exchange of material and product manufacturing information in a standardized way, specifically describing how material and other engineering properties can be described in the model/framework.[9][10] The context here is "standardized data transfer of material- and product-related data," which in turn involves ontologies that limit the complexity of materials science discourse and help better organize materials and product data into information and knowledge. As such, the ISO 10303 set of standards must define "material," and 10303-45 complicates matters further in this regard (though it will be helpful for this guide in the end).

In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard[10]:

The first edition of ISO 10303-45 was derived from experience of the testing of, so-called, "materials" properties, and the terminology used in the standard reflects this experience. However, the information modelling of an engineering material, such as alloyed steel or high density polyethylene, is no different from the information modelling of a "product." The "material" properties are therefore one of the characteristics of a product, just as its shape and other characteristics are. Therefore all "materials" are products, and the information model in ISO 10303-45 can be used for any property of any product.

Put in other words, for the purposes of defining "material" for a broader, more standardized ontology, materials and products can be viewed as interchangeable. Mies puts this another way, stating that based on ISO 10303-45, a material can be defined as "a manufactured object with associated properties in the context of its use environment."[11] But this representation only causes more confusion as we ask "does a material have to be manufactured?" After all, we have the term "raw material," which the Oxford English Dictionary defines as "the basic material from which a product is manufactured or made; unprocessed material."[12] Additionally, chemical elements are defined as "the fundamental materials of which all matter is composed."[13] Taking into account the works of Richardson and Peterson, Mies, and Swindells, as well as ISO 10303-45, the concepts of "raw materials" and "chemical elements," and modern trends towards the inclusion of biomaterials (though discussion of biomaterials will be limited here) in materials science, we can land on the following definition for the purposes of this guide:

A material is discrete matter that is elementally raw (e.g., native metallic and non-metallic elements), fundamentally processed (e.g., calcium oxide), or fully manufactured (by human, automation, or both; e.g., a fastener) that has an inherent set of properties that a human or automation-driven solution (e.g., an artificial intelligence [AI] algorithm) has identified for a potential or realized use environment.

First, this definition more clearly defines the types of matter that can be included, recognizing that manufactured products may still be considered materials. Initially this may seem troublesome, however, in the scope of complex manufactured products such as automobiles and satellites; is anyone really referring to those types of products as "materials"? As such, the word "discrete" is included, which in manufacturing parlance refers to distinct components such as brackets and microchips that can be assembled into a greater, more complex finished product. This means that while both a bolt and an automobile are manufactured "products," the bolt, as a discrete type of matter, can be justified as a material, whereas the automobile can't. Second—answering the question of "what if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists?"—the definition recognizes that the material needs at a minimum recognition of a potential use case. This turns out to be OK, because if no use case has been identified, the matter still can be classified as an element, compound, or substance. It also insinuates that that element, compound, or substance with no use case isn't going to be used in the manufacturing of any material or product. Third, the definition also recognizes the recent phenomena of autonomous systems discovering new materials and whether or not those autonomous systems should be credited with inventorship.[14] The question of inventorship is certainly worth discussion, though it is beyond the scope of this guide. Regardless, the use of automated systems to match a set of properties of a particular matter to a real-world use case isn't likely to go away, and this definition accepts that likelihood.

Finally, this leads us to the realization that materials, by definition, are inherently linked to the act of intentional human- or automation-driven creation, i.e., manufacturing and construction.


1.1 Materials testing labs, then and now

1.1.1 Materials testing 2.0


1.2 Industries, products, and raw materials

1.3 Laboratory roles and activities in the industry

1.3.1 R&D roles and activities

1.3.2 Pre-manufacturing and manufacturing roles and activities

1.3.3 Post-production quality control and regulatory roles and activities

References

  1. Richardson, James H.; Peterson, Ronald V. (1974). "Chapter 1: Introduction to Analytical Methods". Systematic Materials Analysis, Part 1. Materials science series. New York: Academic Press. p. 2. doi:10.1016/B978-0-12-587801-2.X5001-0. ISBN 978-0-12-587801-2. https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false. 
  2. Das, Abinash; Ringu, Togam; Ghosh, Sampad; Pramanik, Nabakumar (1 July 2023). "A comprehensive review on recent advances in preparation, physicochemical characterization, and bioengineering applications of biopolymers" (in en). Polymer Bulletin 80 (7): 7247–7312. doi:10.1007/s00289-022-04443-4. ISSN 0170-0839. PMC PMC9409625. PMID 36043186. https://link.springer.com/10.1007/s00289-022-04443-4. 
  3. Kurniawan, Nicholas A.; Bouten, Carlijn V.C. (1 April 2018). "Mechanobiology of the cell–matrix interplay: Catching a glimpse of complexity via minimalistic models" (in en). Extreme Mechanics Letters 20: 59–64. doi:10.1016/j.eml.2018.01.004. https://linkinghub.elsevier.com/retrieve/pii/S2352431617301864. 
  4. Kim, Hyun S.; Kumbar, Sangamesh G.; Nukavarapu, Syam P. (1 March 2021). "Biomaterial-directed cell behavior for tissue engineering" (in en). Current Opinion in Biomedical Engineering 17: 100260. doi:10.1016/j.cobme.2020.100260. PMC PMC7839921. PMID 33521410. https://linkinghub.elsevier.com/retrieve/pii/S246845112030057X. 
  5. Richardson, James H.; Peterson, Ronald V. (1974). "Preface". Systematic Materials Analysis, Part 1. Materials science series. New York: Academic Press. p. xiii. doi:10.1016/B978-0-12-587801-2.X5001-0. ISBN 978-0-12-587801-2. https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false. 
  6. Modrák, Marcel; Trebuňová, Marianna; Balogová, Alena Findrik; Hudák, Radovan; Živčák, Jozef (16 March 2023). "Biodegradable Materials for Tissue Engineering: Development, Classification and Current Applications" (in en). Journal of Functional Biomaterials 14 (3): 159. doi:10.3390/jfb14030159. ISSN 2079-4983. PMC PMC10051288. PMID 36976083. https://www.mdpi.com/2079-4983/14/3/159. 
  7. Callister, William D.; Rethwisch, David G. (2021). "Chapter 1. Introduction". Fundamentals of materials science and engineering: An integrated approach. Hoboken: Wiley. pp. 2–18. ISBN 978-1-119-74773-4. https://books.google.com/books?id=NC09EAAAQBAJ&newbks=1&newbks_redir=0&printsec=frontcover. 
  8. Sutton, Adrian P. (2021). Concepts of materials science (First edition ed.). Oxford [England] ; New York, NY: Oxford University Oress. ISBN 978-0-19-284683-9. 
  9. "ISO 10303-45:2019 Industrial automation systems and integration — Product data representation and exchange — Part 45: Integrated generic resource: Material and other engineering properties". International Organization for Standardization. November 2019. https://www.iso.org/standard/78581.html. Retrieved 20 September 2023. 
  10. 10.0 10.1 Swindells, Norman (2009). "The Representation and Exchange of Material and Other Engineering Properties" (in en). Data Science Journal 8: 190–200. doi:10.2481/dsj.008-007. ISSN 1683-1470. http://datascience.codata.org/articles/abstract/10.2481/dsj.008-007/. 
  11. Mies, D. (2002). "Chapter 17. Managing Materials Data". In Kutz, Myer. Handbook of materials selection. New York: J. Wiley. p. 499. ISBN 978-0-471-35924-1. https://books.google.com/books?id=gWg-rchM700C&pg=PA499. 
  12. "raw material". Oxford English Dictionary. https://www.oed.com/search/dictionary/?scope=Entries&q=raw+material. Retrieved 20 September 2023. 
  13. Lagowski, J.J.; Mason, B.H.; Tayler, R.J. (16 August 2023). "chemical element". Encyclopedia Britannica. https://www.britannica.com/science/chemical-element. Retrieved 20 September 2023. 
  14. Ishizuki, Naoya; Shimizu, Ryota; Hitosugi, Taro (31 December 2023). "Autonomous experimental systems in materials science" (in en). Science and Technology of Advanced Materials: Methods 3 (1): 2197519. doi:10.1080/27660400.2023.2197519. ISSN 2766-0400. https://www.tandfonline.com/doi/full/10.1080/27660400.2023.2197519.