ASTM F2847-17

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

SIGNIFICANCE AND USE
5.1 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 from the manufacturing environment, or may be the result of handling and packaging (1-3).10  
5.2 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.  
5.3 Residues may be of inorganic, organic, or biological nature. They may exhibit as surface-bound substance, or as adsorbates (for example, electrostatically held), efflorescence, or mechanically held substances. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.  
5.4 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 and single-use sterile instruments. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 14-Sep-2017
• 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

• Refers: ASTM E1635-06(2019) - Standard Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
• Effective Date: 01-Nov-2019
• Refers: ASTM E996-10(2018) - Standard Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy
• Effective Date: 01-Nov-2018
• Refers: ASTM E996-19 - Standard Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy
• Effective Date: 01-Apr-2019
• Refers: ASTM E1504-11(2019) - Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
• Effective Date: 01-Nov-2019
• Refers: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Apr-2016
• Refers: ASTM G131-96(2016) - Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
• Effective Date: 01-May-2016
• Refers: ASTM G136-03(2016) - Standard Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
• Effective Date: 01-May-2016
• Refers: ASTM F1877-16 - Standard Practice for Characterization of Particles
• Effective Date: 01-Oct-2016
• Refers: ASTM F2459-18 - Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• Effective Date: 01-Feb-2018
• Refers: ASTM G121-18 - Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
• Effective Date: 01-Dec-2018
• Refers: ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Jan-2019
• Referred By: ASTM D8179-18 - Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
• Effective Date: 15-Sep-2017
• 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: 15-Sep-2017
• Referred By: ASTM F3127-22 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• Effective Date: 15-Sep-2017

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2847 − 17
Standard Practice for
Reporting and Assessment of Residues on Single-Use
1
Implants and Single-Use Sterile Instruments
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 1.9 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 The purpose of this practice is to describe how the
ization established in the Decision on Principles for the
cleanliness of single-use implants as manufactured shall be
Development of International Standards, Guides and Recom-
reported. This practice proposes how to approach the identifi-
mendations issued by the World Trade Organization Technical
cation of critical compounds and suggests different analytical
Barriers to Trade (TBT) Committee.
methods.
1.2 The practice does not address substances which are
2. Referenced Documents
intrinsic to the implant properties or design. In particular, it
2
2.1 ASTM Standards:
doesnotaddresssubstancesreleasedduringimplantresorption,
E29 Practice for Using Significant Digits in Test Data to
implant coatings, or leachables by design.
Determine Conformance with Specifications
1.3 This practice does not address the cleanliness of im-
E996 Practice for Reporting Data in Auger Electron Spec-
plants which are re-processed, re-cleaned after unpacking for
troscopy and X-ray Photoelectron Spectroscopy
re-use in the hospital or by the manufacturer.
E1078 Guide for Specimen Preparation and Mounting in
Surface Analysis
1.4 Thispracticedoesnotestablishlimitvaluesforresidues.
E1504 PracticeforReportingMassSpectralDatainSecond-
1.5 This practice suggests appropriate test methods for the
ary Ion Mass Spectrometry (SIMS)
general specification of residues and residue requirements of
E1635 Practice for Reporting Imaging Data in Secondary
implants and single-use sterile instruments. This practice may
Ion Mass Spectrometry (SIMS)
also be used to characterize semi-finished components for
E1829 Guide for Handling Specimens Prior to Surface
implants.
Analysis
1.6 Thetestmethodssuggestedanddescribedhereinreferto
F561 Practice for Retrieval and Analysis of Medical
established analytical methods and to existing standard meth-
Devices, and Associated Tissues and Fluids
ods for chemical, biochemical, or biological analysis.
F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1.7 This practice is intended solely to provide guidance
F1251 Terminology Relating to Polymeric Biomaterials in
regarding suitable test methods and reporting conventions for
3
Medical and Surgical Devices (Withdrawn 2012)
residues, which may or may not affect implant biocompatibil-
F1877 Practice for Characterization of Particles
ity. This practice does not suggest or recommend test methods
F2459 Test Method for Extracting Residue from Metallic
for biocompatibility, which may be found in Practice F748 or
Medical Components and Quantifying via Gravimetric
in ISO 10993-1.
Analysis
1.8 This standard does not purport to address all of the
F2809 Terminology Relating to Medical and Surgical Mate-
safety concerns, if any, associated with its use. It is the
rials and Devices
responsibility of the user of this standard to establish appro-
G121 Practice for Preparation of Contaminated Test Cou-
priate safety, health, and environmental practices and deter-
pons for the Evaluation of Cleaning Agents
mine the applicability of regulatory limitations prior to use.
G131 PracticeforCleaningofMaterialsandComponentsby
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 15, 2017. Published October 2017. Originally the ASTM website.
3
approved in 2010. Last previous edition approved in 2010 as F2847 – 10. DOI: The last approved version of this historical standard is referenced on
10.1520/F2847-17. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2847 − 17
Ultrasonic Te
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2847 − 10 F2847 − 17
Standard Practice for
Reporting and Assessment of Residues on Single Use
ImplantsSingle-Use Implants and Single-Use Sterile
1
Instruments
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
1.1 The purpose of this practice is to describe how the cleanliness of single use 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. implants and single-use sterile instruments. 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E996 Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy
E1078 Guide for Specimen Preparation and Mounting in Surface Analysis
E1504 Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
E1635 Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
E1829 Guide for Handling Specimens Prior to Surface Analysis
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15
on Material Test Methods.
Current edition approved Dec. 1, 2010Sept. 15, 2017. Published January 2011October 2017. Originally approved in 2010. Last previous edition approved in 2010 as
F2847 – 10. DOI: 10.1520/F2847–10.10.1520/F2847-17.
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 the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2847 − 17
3
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
F1877 Practice for Characterization of Particles
F2459 Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
F2809 Terminology Relating to Medical and Surgical Materials and Devices
...