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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 050 Date of Entry 09/17/2018 
FR Recognition Number 8-470
Standard
ASTM  F2102-17
Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
Scope/Abstract
1.1 This guide covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl absorptions (>C=O) centered near 1720 cm-1 is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) are not captured by this guide.
1.2 Although this guide may give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recognized that other forms of chemically bound oxygen may be important contributors to these materials' characteristics.
1.3 The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centered near 1370 cm-1 to normalize for the sample's thickness, has been validated by an Interlaboratory Study (ILS)conducted according to Practice E691.
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*
Guidance for Industry and FDA: Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis, Issued April 2002.

Guidance for Industry and FDA: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses, Issued January 2003.

Guidance for Industry and FDA Staff: Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis, Issued October 2000.

Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components, Issued May 1995.

Guidance for Industry and FDA Staff: Spinal System 510(k)s, Issued May 2004.

Guidance for Industry and/or FDA Reviewers/Staff: Guidance Document for the Preparation of IDEs for Spinal Systems, Issued January 2000.

Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs, Issued April 2008.

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
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
 Jinrong (Jinny) Liu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3160
  jinrong.liu@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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