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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 8-389
Standard
ISO 15309 First edition 2013-12-01
Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
Scope/Abstract
This International Standard specifies a method for the thermal analysis of Poly Ether Ether Ketone (PEEK) that is for use in the manufacture of implantable medical devices, using differential scanning calorimetry (DSC).

The transition temperatures to be determined are the glass transition temperature (Tg), the melting temperature (Tm) and the crystallization temperature on cooling (Tc).
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.
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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