ASTM F2847-2010 Standard Practice for Reporting and Assessment of Residues on Single Use Implants《报告和评定一次性植入物上残留物的标准操作规程》.pdf
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1、Designation: F2847 10Standard Practice forReporting and Assessment of Residues on Single UseImplants1This standard is issued under the fixed designation F2847; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisi
2、on. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 The purpose of this practice is to describe how thecleanliness of single use implants as manufactured shall bereported. This prac
3、tice proposes how to approach the identifi-cation of critical compounds and suggests different analyticalmethods.1.2 The practice does not address substances which areintrinsic to the implant properties or design. In particular, itdoes not address substances released during implant resorption,implan
4、t coatings, or leachables by design.1.3 This practice does not address the cleanliness of im-plants which are re-processed, re-cleaned after unpacking forre-use in the hospital or by the manufacturer.1.4 This practice does not establish limit values for residues.1.5 This practice suggests appropriat
5、e test methods for thegeneral specification of residues and residue requirements ofimplants. This practice may also be used to characterizesemi-finished components for implants.1.6 The test methods suggested and described herein refer toestablished analytical methods and to existing standard meth-od
6、s for chemical, biochemical, or biological analysis.1.7 This practice is intended solely to provide guidanceregarding suitable test methods and reporting conventions forresidues, which may or may not affect implant biocompatibil-ity. This practice does not suggest or recommend test methodsfor biocom
7、patibility, which may be found in Practice F748 orin ISO 10993-1.1.8 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the appl
8、ica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E996 Practice for Reporting Data in Auger Electron Spec-troscopy and X-ray Photoelectron SpectroscopyE1078 Guide for Specimen Preparation and Mounting inSurface AnalysisE1504 Practice for Reporting Mass Spec
9、tral Data in Sec-ondary Ion Mass Spectrometry (SIMS)E1635 Practice for Reporting Imaging Data in SecondaryIon Mass Spectrometry (SIMS)E1829 Guide for Handling Specimens Prior to SurfaceAnalysisF561 Practice for Retrieval and Analysis of Medical De-vices, and Associated Tissues and FluidsF748 Practic
10、e for Selecting Generic Biological Test Meth-ods for Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical DevicesF1877 Practice for Characterization of ParticlesF2459 Test Method for Extracting Residue from MetallicMedical Components and Quantifying via Gr
11、avimetricAnalysisF2809 Terminology Relating to Medical and Surgical Ma-terials and DevicesG121 Practice for Preparation of Contaminated Test Cou-pons for the Evaluation of Cleaning AgentsG131 Practice for Cleaning of Materials and Componentsby Ultrasonic TechniquesG136 Practice for Determination of
12、Soluble Residual Con-taminants in Materials by Ultrasonic Extraction2.2 ISO Standards:3ISO 10993-1 Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct respon
13、sibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Dec. 1, 2010. Published January 2011. DOI: 10.1520/F284710.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volum
14、e information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428
15、-2959, United States.ISO 10993-17 Biological Evaluation of Medical DevicesPart 17: Establishment of Allowable Limits for LeachableSubstancesISO 10993-18 Biological Evaluation of Medical DevicesPart 18: Chemical Characterization of MaterialsISO 11737-1 Sterilization of Medical DevicesMicrobiological
16、MethodsPart 1: Determination of aPopulation of Microorganisms on Products2.3 United States Pharmacopeia (USP) Document:4Bacterial Endotoxin Test2.4 European Pharmacopoeia (PhEUR) Documents:52.2.23 Atomic Absorption Spectrometry2.2.24 Absorption Spectrophotometry, Infrared2.2.25 Absorption Spectropho
17、tometry, Ultraviolet and Vis-ible2.2.28 Gas Chromatography2.2.29 Liquid Chromatography2.2.43 Mass Spectrometry2.2.44 Total Organic Carbon in Water for PharmaceuticalUse2.2.48 Raman Spectrometry2.2.55 Peptide Mapping2.2.57 Inductively Coupled Plasma-Atomic Emission Spec-trometry2.2.58 Inductively Cou
18、pled Plasma-Mass Spectrometry2.5 Association for the Advancement of Medical Instrumen-tation (AAMI) Document:6AAMI ST72 Bacterial EndotoxinsTest Methodologies,Routine Monitoring, and Alternatives to Batch Testing2.6 Other References:FDA Guideline on Validation of the Limulus AmebocyteLysate Test as
19、an End-Product Endotoxin Test for Humanand Animal Parenteral Drugs, Biological Products, andMedical Device, 19877200.7 EPA Methodologies for ICP88270C EPA Methodologies for GC-MS83. Terminology3.1 Unless provided otherwise in 3.2, terminology shall bein conformance with Terminology F1251 and with Te
20、rminol-ogy F2809.3.2 Definitions:3.2.1 action value, nthe amount(s) of substance(s) toler-ated at the surface of an implant by the manufacturer before itwill interfere with the manufacturing process.3.2.2 exhaustive extraction, nextraction until the cumula-tive residue change is analytically insigni
21、ficant or less than10 % of the initial extract.3.2.3 limit value, nthe maximum allowable amount(s) ofsubstance(s) at the surface of an implant not yet found to beharmful for the surrounding tissues and organs. Its value isestablished and defined by the manufacturer.3.2.4 model residue, na single sub
22、stance or a mixture ofsubstances that reflect the process materials likely to beencountered and used during the manufacturing of the device.3.2.5 residue, na substance present at the surface of animplant or embedded therein that is not explicitly recognizedand defined as part of the implant specific
23、ation (specialdefinition for residue analysis of surfaces). It includes process-based residues as well as contamination by environmentalfactors (adsorbates).3.2.6 single use implant, na medical device which in-tended use is to be implanted permanently and that is notre-cleaned or re-worked for a sec
24、ond implantation after even-tual removal.3.2.7 soiling, nprocedure of applying known amounts of asubstance onto a medical device for determination of processcapability, that is, cleaning efficiency and extraction yields.3.2.8 spiking, nprocedure of applying exact quantities ofa substance to an analy
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