ASTM-F2847 2010

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F2847-10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants

Published By	Publication Date	Number of Pages
ASTM	2010	9

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology Summary of Practice Significance and Use
3	Reporting of Residues on Implants Quality Assurance TABLE 1
4	Limit Values Keywords A1. RESIDUE ANALYSIS A1.1 A1.2 Decision Tree for Sample Preparation and Analysis A1.3 Sample Preparation
5	FIG. A1.1
6	A1.4 Localized in situ Analysis A1.5 Analysis of Eluates
7	X1. SPECIAL CHARACTERISTIC OF ANALYTICAL METHODS TABLE X1.1 X1.1 Inductively Coupled Plasma Optical Emission Spec-troscopy or Atomic Emission Spectroscopy (ICP-OES/ICP-AES) X1.2 Atomic Absorption Spectroscopy (AAS)
8	X1.3 FTIR/RAMAN Spectroscopy X1.4 Energy Dispersive X-ray Spectroscopy (EDS/EDX/EDXA) X1.5 X-ray Photoelectron Spectroscopy (XPS/ESCA) X1.6 Time-of-Flight Secondary Ion Mass Spectrometry (TOF-SIMS) X1.7 Gravimetric Analysis of Extracts X1.8 Endotoxin
9	X1.9 Total Organic Carbon (TOC) REFERENCES

Additional information

Standard Title	F2847-10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
Published Code	ASTM
Publication Date	2010
Pages Count	9
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F2847 2010

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