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ASTM F 2847 : 2017 : REDLINE

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)

PDF

Language(s)

English

Published date

09-15-2017

CONTAINED IN VOL. 13.02, 2017 Defines how the cleanliness of single use implants as manufactured shall be reported. Also how to approach the identification of critical compounds and suggests different analytical methods.

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.

Committee
F 04
DocumentType
Redline
Pages
12
PublisherName
American Society for Testing and Materials
Status
Current

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ISO 17294-1:2004 Water quality — Application of inductively coupled plasma mass spectrometry (ICP-MS) — Part 1: General guidelines
ASTM E 1504 : 2011 : REDLINE Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ASTM G 131 : 1996 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
ASTM E 1829 : 2014 : REDLINE Standard Guide for Handling Specimens Prior to Surface Analysis
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 17294-2:2016 Water quality — Application of inductively coupled plasma mass spectrometry (ICP-MS) — Part 2: Determination of selected elements including uranium isotopes

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