What Is ASTM And Why Is It Relevant To The Medical Manufacturing Industry?


Patriot Medical Devices
2/6/2023

If you work in the medical industry, or many other manufacturing or industrial industries, you may have heard of ASTM when it comes to the quality of products you use. We’ve spent a lot of time testing and improving our products to achieve the highest level of ASTM standards for our 3 ply face masks and many of our other products. Below, we dive into who ASTM is and what value they bring the to the medical manufacturing industry. 

Who is ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized organization that develops and publishes technical standards for various industries. ASTM has been a key player in the development and maintenance of standards for medical products for over a century. 

ASTM was founded in 1898 with the aim of establishing standard testing methods and materials specifications for various industries. In its early years, the organization primarily focused on the iron and steel industries, but as the years passed, it expanded its scope to include other industries, including the medical industry.

Entering Medical Standards

The first ASTM standards for medical products were published in the 1930s and covered topics such as surgical instruments, diagnostic equipment, and implantable devices. These standards established guidelines for the materials, testing procedures, labeling, and performance requirements of medical products. This was an important step towards ensuring the safety and effectiveness of medical products and promoting consistency and compatibility among different products.

Over the years, ASTM has continued to expand its standards for medical products, covering an increasingly wide range of topics. Today, the organization has over 12,000 standards for various industries, including medical products. The ASTM standards for medical products are recognized as some of the most comprehensive and widely used in the world and are used by manufacturers, regulators, and health care professionals to ensure the safety and quality of medical products.

ASTM’s Impact

The impact of ASTM on the medical industry has been significant. The standards it has established have helped to ensure the safety and effectiveness of medical products, and have helped to prevent medical errors and improve patient outcomes. Additionally, the standards have promoted consistency and compatibility among different medical products, making it easier for health care professionals to use and integrate different products into their practices.

ASTM has played a critical role in the development and maintenance of standards for medical products for over a century. Today, ASTM remains a key player in the development of standards for medical, industrial and other manufactured products and continues to play a critical role in promoting the safety and quality of medical products worldwide.

Learn more about ASTM

Return to the Patriot Post