ASTM F2847-10

Standard Practice for Reporting and Assessment of Residues on Single Use Implants

SIGNIFICANCE AND USE
The quality and consequently the clinical performance of implants may be affected by residues. Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. Residues may also cause harm at locations away from the implant. Residues may originate from manufacturing materials used in the course of processing, or may be the result of handling and packaging (1-3).  
This practice shall be used to report the results of testing for residue. All residues cannot necessarily be detected. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set.  
Residues may be of inorganic, organic, or biological nature. They may exhibit as surface bound substance, or as an adsorbate (for example, electrostatically held), an efflorescence, or a mechanically held substance. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.  
Data generated in validation processes, that is, cleaning validation or sterility validation may be used as results or as basis for setting acceptance criteria in the report.
SCOPE
1.1 The purpose of this practice is to describe how the cleanliness of single use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods.
1.2 The practice does not address substances which are intrinsic to the implant properties or design. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.  
1.3 This practice does not address the cleanliness of implants which are re-processed, re-cleaned after unpacking for re-use in the hospital or by the manufacturer.  
1.4 This practice does not establish limit values for residues.
1.5 This practice suggests appropriate test methods for the general specification of residues and residue requirements of implants. This practice may also be used to characterize semi-finished components for implants.  
1.6 The test methods suggested and described herein refer to established analytical methods and to existing standard methods for chemical, biochemical, or biological analysis.  
1.7 This practice is intended solely to provide guidance regarding suitable test methods and reporting conventions for residues, which may or may not affect implant biocompatibility. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F748 or in ISO 10993-1.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Nov-2010
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaced By: ASTM F2847-17 - Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• Effective Date: 15-Sep-2017
• Referred By: ASTM D8179-18 - Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
• Effective Date: 01-Dec-2010
• Referred By: ASTM F3335-20 - Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
• Effective Date: 01-Dec-2010
• Referred By: ASTM F3127-22 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• Effective Date: 01-Dec-2010

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2847 − 10
Standard Practice for
Reporting and Assessment of Residues on Single Use
1
Implants
This standard is issued under the fixed designation F2847; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 The purpose of this practice is to describe how the
E996 Practice for Reporting Data in Auger Electron Spec-
cleanliness of single use implants as manufactured shall be
troscopy and X-ray Photoelectron Spectroscopy
reported. This practice proposes how to approach the identifi-
E1078 Guide for Specimen Preparation and Mounting in
cation of critical compounds and suggests different analytical
Surface Analysis
methods.
E1504 PracticeforReportingMassSpectralDatainSecond-
1.2 The practice does not address substances which are
ary Ion Mass Spectrometry (SIMS)
intrinsic to the implant properties or design. In particular, it
E1635 Practice for Reporting Imaging Data in Secondary
doesnotaddresssubstancesreleasedduringimplantresorption,
Ion Mass Spectrometry (SIMS)
implant coatings, or leachables by design.
E1829 Guide for Handling Specimens Prior to Surface
Analysis
1.3 This practice does not address the cleanliness of im-
F561 Practice for Retrieval and Analysis of Medical
plants which are re-processed, re-cleaned after unpacking for
Devices, and Associated Tissues and Fluids
re-use in the hospital or by the manufacturer.
F748 PracticeforSelectingGenericBiologicalTestMethods
1.4 Thispracticedoesnotestablishlimitvaluesforresidues.
for Materials and Devices
F1251 Terminology Relating to Polymeric Biomaterials in
1.5 This practice suggests appropriate test methods for the
3
Medical and Surgical Devices (Withdrawn 2012)
general specification of residues and residue requirements of
F1877 Practice for Characterization of Particles
implants. This practice may also be used to characterize
F2459 Test Method for Extracting Residue from Metallic
semi-finished components for implants.
Medical Components and Quantifying via Gravimetric
1.6 Thetestmethodssuggestedanddescribedhereinreferto Analysis
F2809 Terminology Relating to Medical and Surgical Mate-
established analytical methods and to existing standard meth-
ods for chemical, biochemical, or biological analysis. rials and Devices
G121 Practice for Preparation of Contaminated Test Cou-
1.7 This practice is intended solely to provide guidance
pons for the Evaluation of Cleaning Agents
regarding suitable test methods and reporting conventions for
G131 PracticeforCleaningofMaterialsandComponentsby
residues, which may or may not affect implant biocompatibil-
Ultrasonic Techniques
ity. This practice does not suggest or recommend test methods
G136 Practice for Determination of Soluble Residual Con-
for biocompatibility, which may be found in Practice F748 or
taminants in Materials by Ultrasonic Extraction
in ISO 10993-1.
4
2.2 ISO Standards:
1.8 This standard does not purport to address all of the
ISO 10993-1 Biological Evaluation of Medical Devices—
safety concerns, if any, associated with its use. It is the
Part 1: Evaluation and Testing
responsibility of the user of this standard to establish appro-
ISO 10993-17 Biological Evaluation of Medical Devices—
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland the ASTM website.
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee The last approved version of this historical standard is referenced on
F04.15 on Material Test Methods. www.astm.org.
4
Current edition approved Dec. 1, 2010. Published January 2011. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F2847–10. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2847 − 10
Part 17: Establishment ofAllowable Limits for Leachable 3.2.2 exhaustive extraction, n—extraction until the cumula-
Substances tive residue change is analytically insignificant or less than
ISO 10993-18 Biological Evaluation of Medical Devices— 10 % of the initial extract.
Part 18: Chemical Characterization of Materials
3.2.3 limit value, n—the max
...