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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 8-459
Standard
SAE  AMS2750 Rev. E 2012-07
Pyrometry
Scope/Abstract
This specification covers pyrometric requirements for thermal processing equipment used for heat treatment. It covers temperature sensors, instrumentation, thermal processing equipment, system accuracy tests, and temperature uniformity surveys. These are necessary to ensure that parts or raw materials are heat treated in accordance with the applicable specification(s).
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Terry O. Woods
  FDA/OC/CDRH/OSPTI/ORR/DSCA
  301-796-2503
  terry.woods@fda.hhs.gov
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
Standards Development Organization
SAE SAE International https://www.sae.org
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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