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ASTM F 2847 : 2017

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-09-2017

€56.53
Excluding VAT

The purpose of this practice is to describe how the cleanliness of single-use implants as manufactured shall be reported.

Committee
F 04
DocumentType
Standard Practice
Pages
9
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1The 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.

1.2The 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.

1.3This 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.

1.4This practice does not establish limit values for residues.

1.5This 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.

1.6The test methods suggested and described herein refer to established analytical methods and to existing standard methods for chemical, biochemical, or biological analysis.

1.7This 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.

1.8This 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.

1.9This 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.

ASTM F 3127 : 2016 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
ASTM D 8179 : 2018 Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices

ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
ASTM G 136 : 2003 : R2016 : EDT 1 Standard Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
ASTM F 1877 : 2005 Standard Practice for Characterization of Particles
ASTM E 1829 : 2014 Standard Guide for Handling Specimens Prior to Surface Analysis
ASTM E 29 : 2013 : R2019 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
ASTM E 1635 : 2006 : R2011 Standard Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM E 1078 : 2002 Standard Guide for Specimen Preparation and Mounting in Surface Analysis
ASTM E 1504 : 1992 : R2001 Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM E 1078 : 1997 Standard Guide for Procedures for Specimen Preparation and Mounting in Surface Analysis
ASTM G 131 : 1996 : R2023 : EDT 1 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
ASTM F 2459 : 2012 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
ASTM E 29 : 2002 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
ASTM G 136 : 2003 : R2023 : EDT 1 Standard Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
ASTM E 1635 : 2006 Standard Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM F 2809 : 2010 Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
ASTM F 2459 : 2018 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
ASTM F 2459 : 2005 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
ASTM E 1829 : 2002 Standard Guide for Handling Specimens Prior to Surface Analysis
ASTM E 1829 : 2009 Standard Guide for Handling Specimens Prior to Surface Analysis
ASTM E 1504 : 2011 Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM E 1504 : 1992 : R1996 Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM E 1078 : 2014 Standard Guide for Specimen Preparation and Mounting in Surface Analysis
ASTM E 1504 : 2006 Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM F 1877 : 2016 Standard Practice for Characterization of Particles
ASTM E 1635 : 2006 : R2019 Standard Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM F 1877 : 1998 Standard Practice for Characterization of Particles
ASTM E 1504 : 2011 : R2019 Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM F 1877 : 2005 : R2010 Standard Practice for Characterization of Particles
ASTM F 1877 : 2005 : EDT 1 Standard Practice for Characterization of Particles
ASTM E 1635 : 1995 : R2000 Standard Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
ASTM E 1829 : 1997 Standard Guide for Handling Specimens Prior to Surface Analysis
ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
ASTM E 1078 : 2009 Standard Guide for Specimen Preparation and Mounting in Surface Analysis
ASTM G 131 : 1996 : R2016 : EDT 1 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
ASTM E 29 : 2022 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

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