LIMS Q&A:What standards and regulations affect a materials testing laboratory?

Title: What standards and regulations affect a materials testing laboratory?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: November 2023

Introduction

When examining the state of materials testing, we find that accreditation and regulatory requirements often drive standardized test methods, and those test methods vary significantly depending upon the material being tested. That material may require physical, mechanical, chemical, or even biological analyses, or some combination of these analyses. However, not every lab does things the same way, and there may even be differences in test methods and standards from one entity to another, muddying the waters further for materials testing laboratories. This is why it's important to investigate the state of standards, accreditation, and regulation in the industry, to better understand how these labs are affected.

This short topical article will examine why testing to a standardized test method is the norm, even if it's not consistent across even state lines. It will also several U.S. regulations as they relate to materials testing, highlighting how materials testing labs need to not only know how they are regulated but how their potential clients are regulated.

Materials testing to a standard test method

A standard test method is a result-yielding analytical procedure that is "definite, unambiguous, and experimentally viable, as well as being reproducibly effective," typically developed by a collection of experts in the field of measurement being analyzed. Standard-based methods developed from the input of the international community in theory represent a more global consensus on an analytical test and lend strength to international trade and overall consumer confidence. Or as the National Research Council puts it: "Testing against specific standards provides independent data to support manufacturer's declarations of conformity to purchaser specifications or government regulations."

However, unless mandated by federal regulation or a respected international accreditation body, such standards are not compulsory, and materials testing labs may turn to a competing standard or even develop their own non-standard test methods for newly discovered materials for which existing standard-based methods can't be applied. Even when laboratory accreditation is involved, one accrediting body may require the lab to use one set of standardized test methods, while another accrediting body may have a slightly different set of standardized test methods that are recommended. Throw in state regulations that require small modifications to existing standards, and the testing picture gets even more complex.

From this picture we realize that the landscape for materials testing, conformity assessment, and lab accreditation requirements, at least in the United States, is highly heterogeneous across cities, states, and the federal government, and this has been the case for decades. With testing and certification requirements for materials and the products made from them having redundancy, especially across state and local borders, the promotion of a more uniform federal-level recognition program that involves the positive assessment of conformity assessment accreditors of laboratories has been called for. Such federal recognition programs encourage the homogenization of laboratory conformity assessment and testing to a set of internationally-recognized standards, with the potential for reducing regulatory- and standards-based inefficiencies and increasing quality-based competition in laboratory testing and certification of materials. Such federal recognition programs have gradually come online, such as the U.S. Food and Drug Administration's (FDA's) Standards and Conformity Assessment Program (and the related FDA Standards Recognition Program) for those evaluating materials for and developing medical devices in the U.S. That said, the sheer breadth of testing and certification standards in the realm of materials testing is nonetheless still highlighted through the dearth of federal recognition programs for laboratory testing and accreditation.

An arguably representative sample of entities developing standardized test methods for materials testing includes:

• Aerospace Industries Association (AIA/NAS/NASM)
• American Architectural Manufacturers Association (AAMA)
• American Association of Textile Chemists and Colorists (AATCC)
• American National Standards Institute (ANSI)
• American Petroleum Institute (API)
• AOAC International (Association of Official Agricultural Chemists; AOAC)
• ASTM International (ASTM)
• Automakers (Ford, GM, Honda, PACCAR, Peugeot, Subaru, Tesla, Toyota, Volvo, etc.)
• Canadian Standards Association (CSA)
• Deutsches Institut für Normung (DIN)
• European Telecommunications Standards Institute (ETSI)
• Government and military entities (Consumer Product Safety Commission, CSFA, EPA, FDA, MIL, MMM, NAVSEA, United Nations Economic Commission for Europe, etc.)
• Industrial Fasteners Institute (IFI)
• International Electrotechnical Commission (IEC)
• International Maritime Organization (IMO)
• International Organization for Standardization (ISO)
• International Safe Transit Association (ISTA)
• Japanese Standards Association (JAS/JIS)
• NACE International (National Association of Corrosion Engineers; NACE)
• National Fire Protection Association (NFPA)
• New York State Department of Transportation (NNSSCM/SCM)
• Pressure Sensitive Tape Council (PSTC)
• Suppliers of Advanced Composite Materials Association (SACMA)
• SAE International (SAE/AMS/AS)
• TAPPI (Technical Association of the Pulp and Paper Industry; TAPPI)
• Truss Plate Institute (TPI)
• United States Pharmacopeia Convention (USP)

From these entities we find standard-based methods such as:

• AATCC TM035-TM35-TM 35 Test Method for Water Resistance: Rain
• DIN 25410 Nuclear facilities - Surface cleanliness of components
• IFI-124:2002 Test Procedures for the Performance of Nonmetallic Resistant Element Prevailing-Torque Screws
• PSTC 101 Peel Adhesion of Pressure Sensitive Tape
• TAPPI/ANSI T 804 OM:2020 Compression test of fiberboard shipping containers

Regulations involving materials testing

It is not unusual for regulations to require the use of engineering, manufacturing, and test method standards, particularly where the regulation is in place to protect public safety. For example, the U.S. Federal Highway Administration, Department of Transportation has standards in place for regulations affecting the design of highways and bridges, in the form of U.S. 23 CFR 625.4. That regulation incorporates AASHTO LRFD Bridge Design Specifications and AASHTO LRFD Bridge Construction Specifications, which in turn incorporates ASTM F3125 Standard Specification for High Strength Structural Bolts, Steel and Alloy Steel, Heat Treated, 120 ksi (830 MPa) and 150 ksi (1040 MPa) Minimum Tensile Strength, Inch and Metric Dimensions. The materials testing lab isn't affected directly by the regulation, as such, but if the lab specializes in testing fasteners, it surely will want to be aware of the regulations that in turn drive the test methods the lab will want to use to serve its client base.

Another example involves the transport of hazardous materials, as regulated by U.S. 49 CFR Part 171. A wide variety of materials testing standards are incorporated within this regulation, including ASTM A370 Standard Test Methods and Definitions for Mechanical Testing of Steel Products and ASTM E290 Standard Test Methods for Bend Testing of Material for Ductility. In this case, pressurized tank car tanks are mandated to be constructed a certain way to more safely transport hazardous materials, and the materials used in them are affected by these standardized test methods. Like the fasteners in the previous example, the materials lab isn't directly affected by these regulations, but the lab testing or certifying to these standards is part of the overall manufacturing chain and inevitably has at least a small interest in understanding who is impacted down the manufacturing chain.

An example of regulations affecting materials testing laboratories more directly involves the element of safety. The analysis of hazardous chemicals, radioactive materials, and even some construction materials will involve additional mindfulness due to those materials' physical, chemical, and biological characteristics. As such, regulations such as U.S. 29 CFR § 1910.1450 - Occupational exposure to hazardous chemicals in laboratories will affect materials testing laboratories handling materials that fall under the umbrella of the regulation. Similarly, 10 CFR § 20.1101 - Radiation protection programs will affect materials testing laboratories with a radioactive materials license, helping them ensure personnel and the public are safe while testing radioactive materials.

Conclusion

Materials testing is as diverse as the available material types and industrial applications of those material types. By extension, the standard test methods associated with those material types and applications are also broadly diverse. These standard test methods are created by numerous national and international entities and adopted by accrediting organizations, regulatory bodies, and the materials testing labs themselves. This great diversity of standard test methods and their adoption, however, is heterogeneous in the U.S. and can be burdensome for some materials testing laboratories. Regardless, these standard test methods are often incorporated in safety-driven regulations, and the materials testing lab is well-served to, at a minimum, understand how those regulations drive business and testing demand.