SAE International Heat-Treating Standard Used in MedAccred Recognized by U.S. Food and Drug Administration

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SAE International’s technical standard AMS2750 – Pyrometry, has received complete recognition by the U.S. Federal Drug Administration (FDA) Center for Devices and Radiological Health, and has been added to its list of recognized consensus standards database, List #47.

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SAE International’s technical standard AMS2750 – Pyrometry, has received complete recognition by the U.S. Federal Drug Administration (FDA) Center for Devices and Radiological Health.

SAE International’s technical standard AMS2750 – Pyrometry, has received complete recognition by the U.S. Federal Drug Administration (FDA) Center for Devices and Radiological Health, and has been added to its list of recognized consensus standards database, List #47.

AMS2750 covers pyrometric requirements for thermal processing equipment used for heat treatment, including sensors, instrumentation, thermal processing equipment, system accuracy tests, and temperature uniformity surveys.

The standard also serves as the cornerstone standard for the Performance Review Institute’s(PRI) MedAccred heat treating Accreditation. MedAccred is an industry managed supply chain oversight program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. All MedAccred heat treating Accredited suppliers meet the requirements of the standard.

AMS2750 covers pyrometric requirements for thermal processing equipment used for heat treatment. This includes:

  •     Temperature sensors
  •     Instrumentation
  •     Thermal-processing
  •     System-accuracy tests
  •     Temperature uniformity surveys

Heat treating is used on myriad of medical devices. Examples of devices and components where the use of AMS2750 would be applicable include:

  •     Hypodermic needles
  •     Hypodermic needle safety guards that mount on the needle and prevent unintentional ‘sticks’
  •     Tunnelers
  •     Stents (implantable)
  •     Tantalum markers for stents which are part of the implanted stent
  •     Metallic joint replacement components (implantable)
  •     Battery cases (implantable)
  •     Heart wires
  •     Titanium staples
  •     Surgical tools and operation room tools
  •     Dental burs and dental tool holding devices
  •     3D Printed devices or components

For more information please contact Justin McCabe, MedAccred Co-lead, jmccabe(at)p-r-i(dot)org +1 724-799-0572

About PRI
Since being established as a not-for-profit trade association in 1990, PRI has become the global authority in facilitating industry-managed programs and administering special process accreditation programs as well as developing web based audit management software. Remaining cost-effective while continually identifying new ways to add value for our customers is our priority.

About SAE International
SAE International is a global association committed to being the ultimate knowledge source for the engineering profession. By uniting over 127,000 engineers and technical experts, we drive knowledge and expertise across a broad spectrum of industries. We act on two priorities: encouraging a lifetime of learning for mobility engineering professionals and setting the standards for industry engineering. We strive for a better world through the work of our charitable arm, the SAE Foundation, which helps fund programs like A World in Motion® and the Collegiate Design Series™.

http://www.sae.org

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