ASTM F2847-17
Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments

Standard No.

ASTM F2847-17

Release Date

2017

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2847-17

Scope

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.

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 ......

ASTM F2847-17 Referenced Document

• ASTM E1078 Standard Guide for Procedures for Specimen Preparation and Mounting in Surface Analysis
• ASTM E1504 Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
• ASTM E1635 Standard Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
• ASTM E1829 Standard Guide for Handling Specimens Prior to Surface Analysis
• ASTM E29 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
• ASTM E996 Standard Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy
• ASTM F1251 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
• ASTM F1877 Standard Practice for Characterization of Particles
• ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• ASTM F2809 Standard Terminology Relating to Medical and Surgical Materials and Devices
• ASTM F561 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM G121 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
• ASTM G131 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
• ASTM G136 Standard Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
• ISO 17294-1 Water quality
• ISO 17294-2 Water quality — Application of inductively coupled plasma mass spectrometry (ICP-MS) — Part 2: Determination of selected elements including uranium isotopes

ASTM F2847-17 history

• 2017 ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• 2010 ASTM F2847-10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants