Meet Industry Standards and Achieve Compliance with a LIMS for Materials Testing Labs

Meeting Industry Standards and Regulatory Compliance with a LIMS for Materials Testing Labs
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Beneath the surface of every steel beam, medical device, or electronic component lies a critical question: How reliable and safe is the material? The question finds its answer in the thorough work of materials testing labs that serve as the custodians of quality assurance. According to recent studies, the global material testing market size soared to an impressive US$ 6.4 Billion in 2023, projected to surge to US$ 8.9 Billion by 2032. This robust growth reflects the growing recognition of the role materials testing plays in ensuring product safety and reliability across diverse industries. From testing the tensile strength of metals to analyzing the quality of medical devices, materials testing labs safeguard consumer safety and industry integrity. They analyze the properties and performance of materials to ensure they meet stringent standards. However, are these standards uniform and consistent?

In this blog post, we explore the standards and regulations that govern materials testing labs, shine a spotlight on their importance, dwell on the disparity debate, and discuss the key players and organizations, and the ever-evolving landscape of compliance.

Why are standards crucial in materials testing?

Industry standards serve as the guiding principles that underpin the operations of materials testing labs. They provide a definitive framework for testing methodologies and procedures, ensuring consistency, accuracy, and reliability in the assessment of materials. These standards are crucial for upholding the safety, reliability, and quality of materials used across diverse industries, from construction and manufacturing to healthcare and beyond. Compliance with established standards not only enhances consumer safety but also instills confidence in the integrity of materials, building trust and boosting international trade. Standards play a vital role in safeguarding both industry stakeholders and end-users against potential risks and uncertainties.

Materials testing standards and the global consistency gap

Ideally, standardized test methods should serve as the cornerstone of materials testing, offering a universally accepted framework for assessing the properties and performance of various materials. Developed by experts in the field and endorsed by the international community, these standardized methods should not only ensure accuracy and reliability but also aid global consensus and boost consumer confidence. However, the reality is far from this. While some materials testing labs adhere strictly to globally recognized standards, others may opt for competing standards or even develop their own non-standard test methods, particularly for novel materials where existing standards may not apply. This variability is exacerbated by the absence of compulsory adherence to standards unless mandated by federal regulation or required by respected international bodies for accreditation.

Even when laboratory accreditation is pursued, discrepancies arise. Different accrediting bodies may impose varying sets of standardized test methods, leading to inconsistencies in testing protocols. Moreover, state regulations often necessitate modifications to existing standards, further complicating the landscape of materials testing and conformity assessment.

This lack of homogenization in materials testing, conformity assessment, and lab accreditation requirements creates a fragmented landscape across cities, states, and federal jurisdictions. The resulting redundancy in testing and certification requirements poses challenges, especially across geographical borders.

Recognizing the need for a more cohesive approach, calls have been made for the establishment of federal-level recognition programs aimed at promoting conformity to internationally recognized standards. Such programs would streamline laboratory conformity assessment, reduce regulatory inefficiencies, and foster quality-based competition in materials testing and certification.

Standards for testing of different materials

Material testing standards encompass several industries, offering essential guidance and methodologies for evaluating the properties of various materials. These standards cover polymers, fuels, composites, paints, electrical insulation, non-metallic materials, packaging, paving materials, protective clothing, rubber, carbon, and graphite, among others. For instance, ASTM D4762-18 provides guidance for testing polymer matrix composite materials, ensuring their structural integrity and performance. Fuel standards like ASTM D92-18 establish methods for determining flash and fire points, crucial for assessing fuel safety. In composites, ASTM E2580-17 offers practices for ultrasonic testing of flat panel composites used in aerospace applications, ensuring their reliability under operational conditions. Similarly, paint standards like ASTM D268-01(2012) provide guidelines for sampling and testing volatile solvents, ensuring paint quality and performance. These standards, among others, ensure the safety, quality, and reliability of materials across diverse industries.

Different types of material testing labs rely on a multitude of standards to ensure the safety, reliability, and quality of their products. Here, we explore some of the key standards that govern the testing of different materials across various industries.

  • Metallic material testing standards: Metallic material testing standards include a comprehensive array of methodologies aimed at evaluating the properties and performance of metals across various applications. These standards span essential aspects such as hardness, tensile strength, fatigue resistance, impact resistance, and weld integrity, providing a multifaceted approach to materials assessment. For instance, ISO 4384-1:2019 and ISO 4384-2:2022 establish parameters for hardness testing of bearing metals, ensuring the reliability of crucial components in mechanical systems. Similarly, ASTM F1801-20 and ASTM E745-80(2009) outline procedures for corrosion fatigue testing, important for assessing the durability of metallic implant materials and containment systems. Standards such as ASTM E8/E8M-21 and ISO 6892-1:2019 define methods for tensile testing, offering insights into the mechanical properties of metallic materials under various conditions. From verifying the structural integrity of welds with ISO 17635:2016 to assessing the ductility of porous metals with ISO 17340:2020, these standards ensure the quality and performance of metallic components and structures by specifying rules for various types of testing, for either the methodology or the acceptance criteria for metallic materials.
  • Medical materials testing standards: Medical materials testing is critical for ensuring the safety and efficacy of materials and products designed for use within the human body. From dental materials to joint prostheses and other medical devices, adherence to rigorous testing standards is paramount for safeguarding patient health and well-being. For example, ISO/TR 14569-1:2007 and ISO/TR 14569-2:2001 provide guidance on wear testing methods for dental materials, evaluating their resilience to toothbrushing and occlusal wear. Similarly, ISO/TS 11405:2015 offers protocols for testing the adhesion of dental restorative materials to tooth structure, ensuring their durability and clinical efficacy. ASTM F2118-14(2020) and ASTM F2064-17 delineate procedures for fatigue testing of acrylic bone cement and alginates, respectively, crucial for assessing the reliability of orthopedic materials. ASTM F732-17 outlines wear testing methodologies for polymeric materials used in total joint prostheses, enabling the evaluation of their long-term performance under simulated physiological conditions. Adhering to these standardized testing protocols, medical materials testing labs ensure the safety, reliability, and quality of materials and devices intended for medical applications.
  • Flammable material testing standards: Fire-related material testing standards are critical for ensuring safety across various industries, including personal protective equipment (PPE), aerospace, construction, and insulation. These standards include a range of test procedures aimed at evaluating flammability, burning characteristics, heat transfer, and other vital parameters of materials. ASTM D1929-20 outlines a method for determining the ignition temperature of plastics, providing essential data for assessing their fire safety properties. Similarly, IEC/TS 60695-11-21 Ed. 1.0 b:2005 offers specific methodologies for testing the burning characteristics of polymeric materials, crucial for ensuring their suitability in various applications. Additionally, standards such as ASTM D7309-21b employ microscale combustion calorimetry to assess the flammability characteristics of materials, providing valuable insights for material development and research. These standards not only contribute to product quality and performance but also play a fundamental role in enhancing fire safety standards across industries.
  • Radiation hardness material testing standards: Radiation-hardness material testing standards offer comprehensive guidance and practices for assessing the resilience of electronic devices and materials to radiation exposure. These standards cover various methods applicable to electronics, with some extending to other materials, ensuring the evaluation of both radiation sources and detectors. ASTM E722-19 provides procedures for characterizing neutron fluence spectra, crucial for radiation-hardness testing. ASTM E668-20 focuses on determining absorbed dose using thermoluminescence dosimetry systems, essential for assessing electronic device resilience to ionizing radiation. ASTM E721-16 and ASTM E720-16 complement each other by guiding the determination and selection of neutron sensors for radiation-hardness testing, ensuring accurate neutron spectra determination. Additionally, ASTM E1249-15(2021) and ASTM E1250-15(2020) address dosimetry errors and low energy gamma component assessment in radiation-hardness testing, respectively, enhancing the accuracy of testing results. Finally, ASTM E512-94(2020) provides procedures for combined, simulated space environment testing of thermal control materials, crucial for developing materials resilient to space radiation environments. These standards ensure the reliability and resilience of materials and devices exposed to radiation.
  • Concrete testing standards: Concrete testing standards ensure the quality, durability, and safety of concrete structures, ubiquitous in construction projects. These standards cover a wide range of topics, including strength requirements, sampling procedures, and material specifications, catering to the diverse applications of concrete. For instance, ONORM EN 12390-3:2019 provides a method for determining the compressive strength of solid-concrete test specimens, essential for assessing the structural integrity of concrete elements. ASTM C31/C31M-21a outlines practices for making and curing concrete test specimens in the field, ensuring consistency and accuracy in testing procedures. CSA A23.1-19/CSA A23.2-2019 offers comprehensive guidance on concrete materials and methods of construction, including test methods and standard practices for concrete, contributing to the overall quality assurance of concrete structures. These standards not only establish uniform testing methodologies but also promote safety and reliability in concrete construction practices, ultimately enhancing the performance and longevity of concrete infrastructure. 
  • Paper production and safety standards: Paper production and safety standards include a broad spectrum of methodologies aimed at ensuring the quality, safety, and performance of paper and paper-related products. These standards, developed by organizations such as ISO and ASTM, cover various aspects of paper production, from physical characteristics like air permeance and friction coefficients to chemical properties such as chlorine concentration and presence of aromatic amines. For instance, ISO 21993:2020 specifies a laboratory test method for the deinkability of printed paper products, essential for recycling processes and environmental sustainability. On the safety front, BS EN 1010-1:2004+A1:2010 outlines safety requirements for the design and construction of printing and paper-converting machines, ensuring worker safety and accident prevention in manufacturing environments. 

ISO 17025: The universal standard for all types of material testing laboratories

ISO 17025 is an internationally recognized standard that outlines the general requirements for the competence of testing and calibration laboratories, including materials testing labs. Compliance with ISO 17025 demonstrates a laboratory’s commitment to quality and reliability, as it includes stringent guidelines for testing procedures, calibration of equipment, record keeping, staff qualifications, and quality assurance/quality control (QA/QC) processes. Adherence to ISO 17025 is crucial for all kinds of material testing including metals, medical materials, concrete, and more, as it validates the credibility of test results. To meet ISO 17025 compliance, material testing labs must implement a robust quality management system, ensure regular training and competency assessments for staff, and maintain proper records of all testing and calibration activities. Achieving and maintaining ISO 17025 accreditation signifies that a material testing laboratory not only meets rigorous international standards but also continually improves its processes to maintain excellence in its services.

Regulations involving materials testing

Regulatory bodies like the FDA and EPA often require adherence to engineering, manufacturing, and test method standards to safeguard public safety and environmental well-being. For instance, regulations set by the U.S. Federal Highway Administration, outlined in U.S. 23 CFR 625.4, incorporate standards such as AASHTO LRFD Bridge Design Specifications and ASTM F3125 for structural bolts, indirectly impacting materials testing labs specializing in fastener testing. Similarly, regulations like U.S. 49 CFR Part 171 for transporting hazardous materials incorporate standards like ASTM A370 and ASTM E290 for mechanical and bend testing, influencing materials used in pressurized car tanks. Moreover, regulations such as U.S. 29 CFR § 1910.1450 for hazardous chemicals in laboratories and 10 CFR § 20.1101 for radiation protection programs directly affect materials testing laboratories, ensuring safety measures are in place when handling hazardous or radioactive materials. These regulations underscore the importance of compliance with standardized testing methods to uphold safety and regulatory standards across various industries.

Meeting standards and regulations with a LIMS for material testing labs

A Laboratory Information Management System (LIMS) plays a crucial role in supporting materials testing labs in meeting standards and regulatory compliance. By providing a centralized platform for managing data, workflows, and documentation, a LIMS for materials testing labs ensures that testing procedures adhere to established standards and regulations. With inbuilt features such as instrument calibration tracking and audit trails, a LIMS for materials testing labs helps labs maintain accuracy, consistency, and traceability in their testing processes. Additionally, by automating tasks such as sample tracking, result calculations, and report generation, a LIMS minimizes the risk of human error and ensures that all testing activities are conducted in accordance with regulatory requirements. A LIMS empowers materials testing labs to maintain the highest standards of quality assurance, enabling them to deliver reliable and compliant testing services. 

Conclusion

Materials testing standards and regulations form the backbone of several industries worldwide, ensuring the safety, reliability, and quality of products we encounter daily. The exponential growth of the materials testing market reflects a growing recognition of its role in ensuring consumer safety and industry integrity. While standards provide a critical framework for testing methodologies and procedures, the materials testing landscape lacks global harmonization in standards. However, efforts are being made towards establishing federal-level recognition programs and promoting conformity to internationally recognized standards for a more cohesive approach. Additionally, a LIMS for materials testing labs plays a crucial role in aiding compliance with standards and regulations, ensuring traceability, accuracy, and integrity throughout the testing process. As industries continue to evolve, adherence to standardized testing protocols remains paramount, safeguarding consumer safety, trust, and confidence in the materials that shape our world.

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