ASTM F2847-2017 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments《一次性使用植入物残留物和一次性无菌器械报告和评估的标准实施规程》.pdf

1、Designation: F2847 10F2847 17Standard Practice forReporting and Assessment of Residues on Single UseImplantsSingle-Use Implants and Single-Use SterileInstruments1This standard is issued under the fixed designation F2847; the number immediately following the designation indicates the year oforiginal

2、adoption or, in the case of revision, the year of last revision. 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 the cleanliness of s

3、ingle use single-use implants as manufactured shall bereported.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

4、, it does notaddress 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 inthe hospital or by the manufacturer.1.4 This practice does not

5、establish limit values for residues.1.5 This practice suggests appropriate test methods for the general specification of residues and residue requirements ofimplants. implants and single-use sterile instruments. This practice may also be used to characterize semi-finished components forimplants.1.6

6、The test methods suggested and described herein refer to established analytical methods and to existing standard methodsfor chemical, biochemical, or biological analysis.1.7 This practice is intended solely to provide guidance regarding suitable test methods and reporting conventions for residues,wh

7、ich may or may not affect implant biocompatibility. This practice does not suggest or recommend test methods forbiocompatibility, 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

8、 responsibilityof the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.9 This international standard was developed in accordance with internationally recognized principles o

9、n standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E29 Practice for Using Significant Digits

10、 in Test Data to Determine Conformance with SpecificationsE996 Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron SpectroscopyE1078 Guide for Specimen Preparation and Mounting in Surface AnalysisE1504 Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spe

11、ctrometry (SIMS)E1635 Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)E1829 Guide for Handling Specimens Prior to Surface AnalysisF561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and FluidsF748 Practice for Selecting Generic Biological

12、Test Methods for Materials and Devices1 This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15on Material Test Methods.Current edition approved Dec. 1, 2010Sept. 15, 2017. Published January 2

13、011October 2017. Originally approved in 2010. Last previous edition approved in 2010 asF2847 10. DOI: 10.1520/F284710.10.1520/F2847-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume info

14、rmation, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately d

15、epict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA

16、19428-2959. United States1F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)3F1877 Practice for Characterization of ParticlesF2459 Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric AnalysisF2809 Term

17、inology Relating to Medical and Surgical Materials and DevicesG121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning AgentsG131 Practice for Cleaning of Materials and Components by Ultrasonic TechniquesG136 Practice for Determination of Soluble Residual Contaminant

18、s in Materials by Ultrasonic Extraction2.2 ISO Standards:4ISO 10993-1 Biological Evaluation of Medical DevicesPart 1: Evaluation and TestingISO 10993-17 Biological Evaluation of Medical DevicesPart 17: Establishment ofAllowable Limits for Leachable SubstancesISO 10993-18 Biological Evaluation of Med

19、ical DevicesPart 18: Chemical Characterization of MaterialsISO 11737-1 Sterilization of Medical DevicesMicrobiological MethodsPart 1: Determination of a Population of Microor-ganisms on ProductsISO 17294-1 Water QualityApplication of Inductively Coupled Plasma Mass Spectrometry (ICP-MS)Part 1: Gener

20、alGuidelinesISO 17294-2 Water QualityApplication of Inductively Coupled Plasma Mass Spectrometry (ICP-MS)Part 2: Determinationof Selected Elements Including Uranium Isotopes2.3 United States Pharmacopeia (USP) Document:Documents:5Bacterial Endotoxin TestTransfusion and Infusion Assemblies and Simila

21、r Medical DevicesElemental Impurities LimitsElemental Impurities ProceduresChromatographyTotal Organic CarbonPlasma SpectrochemistryLoss on DryingSpectrophotometry and Light Scattering2.4 European Pharmacopoeia (PhEUR) Documents:62.2.23 Atomic Absorption Spectrometry2.2.24 Absorption Spectrophotomet

22、ry, Infrared2.2.25 Absorption Spectrophotometry, Ultraviolet and Visible2.2.28 Gas Chromatography2.2.29 Liquid Chromatography2.2.43 Mass Spectrometry2.2.44 Total Organic Carbon in Water for Pharmaceutical Use2.2.48 Raman Spectrometry2.2.55 Peptide Mapping2.2.57 Inductively Coupled Plasma-Atomic Emis

23、sion Spectrometry2.2.58 Inductively Coupled Plasma-Mass Spectrometry2.5 Association for the Advancement of Medical Instrumentation (AAMI) Document:7AAMI ST72 Bacterial EndotoxinsTest Methodologies, Routine Monitoring, and Alternatives to Batch Testing2.6 Other References:FDA Guideline on Validation

24、of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and AnimalParenteral Drugs, Biological Products, and Medical Device, 1987Guidance for Industry Pyrogen and Endotoxins Testing:Questions and Answers, June 20128200.7 EPA Methodologies for ICP98270C EPA Methodologies for G

25、C-MS93. Terminology3.1 Unless provided otherwise in 3.2, terminology shall be in conformance with Terminology F1251 and with TerminologyF2809.3 The last approved version of this historical standard is referenced on www.astm.org.4 Available from American National Standards Institute (ANSI), 25 W. 43r

26、d St., 4th Floor, New York, NY 10036, http:/www.ansi.org.5 Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http:/www.usp.org.6 Available from European Directorate for the Quality of Medicines and HealthCare (EDQM), 7 allee Kastner, CS 30026, F67081, Strasbour

27、g, France, http:/www.edqm.eu/en/News-and-General-Information-43.html.7 Available from Association for the Advancement of Medical Instrumentation (AAMI), 4301 North Fairfax Drive, Suite 301, Arlington, VA 22203, http:/www.aami.org.8 Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,

28、 Rockville, MD 20857, http:/www.fda.gov.9 Available from United States Environmental Protection Agency (EPA), Ariel Rios Bldg., 1200 Pennsylvania Ave., NW, Washington, DC 20460, http:/www.epa.gov.F2847 1723.2 Definitions:3.2.1 action value, nthe amount(s) of substance(s) tolerated at the surface of

29、an implant by the manufacturer before it willinterfere with the manufacturing process.3.2.2 exhaustive extraction, nextraction until the cumulative residue change is analytically insignificant or less than 10 % ofthe initial extract.3.2.3 limit value, nthe maximum allowable amount(s) of substance(s)

30、 at the surface of an implant not yet found to be harmfulfor the surrounding tissues and organs. Its value is established and defined by the manufacturer.3.2.4 model residue, na single substance or a mixture of substances that reflect the process materials likely to be encounteredand used during the

31、 manufacturing of the device.3.2.5 residue, na substance present at the surface of an implant or embedded therein that is not explicitly recognized anddefined as part of the implant specification (special definition for residue analysis of surfaces). It includes process-based residuesas well as cont

32、amination by environmental factors (adsorbates).3.2.6 single use single-use implant, na medical device which is intended use is to be implanted permanently and that is notre-cleaned or re-worked for a second implantation after eventual removal.3.2.7 soiling, nprocedure of applying known amounts of a

33、 substance onto a medical device for determination of processcapability, that is, cleaning efficiency and extraction yields.3.2.8 spiking, nprocedure of applying exact quantities of a substance to an analyte for instrumental calibration anddetermination reaction yield.3.2.9 surface area, nthe projec

34、ted surface area of a part. This area does not include the internal porosity of parts withcancellous, porous, or wire structure. It does include factors that correct for the estimated surface roughness.4. Summary of Practice4.1 This practice describes how to report residues on implant surfaces and i

35、ndicates useful and typical applicable analyticalmethods.4.2 Application of the test methods contained within this practice does not guarantee clinical success of a finished implant, butit will help to ensure consistency in its cleanliness.5. Significance and Use5.1 The quality and consequently the

36、clinical performance of implants may be affected by residues. Residues may induce notissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may leadto failure in short-term or long-term use. Residues may also cause harm at locations

37、away from the implant. Residues may originatefrom manufacturing materials used in the course of processing, or processing or from the manufacturing environment, or may bethe result of handling and packaging (1-3).105.2 This practice shall be used to report the results of testing for residue.All resi

38、dues cannot necessarily be detected. It suggestsstandard 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 surface-bound substance,or as an adsorbate

39、 adsorbates (for example, electrostatically held), an efflorescence, or a mechanically held substance.substances.Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.5.4 Data generated in validation processes, thatprocesses (that is, cleaning valida

40、tion or sterility validationvalidation) may beused as results or as basis for setting acceptance criteria in the report.6. Reporting of Residues on Implants6.1 The reporting of cleanliness of implants shall include a table that lists at least sections on (1) the chemical categories, (2)the results o

41、f validation studies or of routine analysis, (3) the acceptance criteria if applicable, (4) the detection limits of themethods used, and (5) the methods of analysis (see Table 1).6.2 Categories of Residues:6.2.1 Residues shall be classified, as needed, according to the common description and reporte

42、d accordingly as (I) inorganic,(II) organic, (III) biologic, (IV) microbiological, and (V) particulate residues.6.2.2 In this practice, inorganic residues are referred to as substances of all elements with the exception of carbon-containingsubstances. Carbonates, graphite carbides, graphite, or grap

43、hite-like structures (for example, diamond like diamond-like coatings)are traditionally listed as inorganic substances.10 The boldface numbers in parentheses refer to the list of references at the end of this standard.F2847 1736.2.3 In this practice, organic residues are referred to as synthetic and

44、 natural carbon-based substances. It includes substances,including both small molecules with low molecular mass (for example, paraffin or low viscosity oil) and high molecular mass basedsynthetic polymers. Polysilanes and -oxanes are also considered organic residues.6.2.3.1 In this practice, microbi

45、ologic residues are to be listed separately and differentiated as bioburden and endotoxin. Itshould be noted that for medical devices sold sterile, bioburden testing is often part of sterilization validation and is monitored ona predetermined schedule for the purpose of dose audits or process contro

46、l.6.2.4 In this practice, particulate residues are referred to as material insoluble in aqueous media or organic solvent, which canbe removed from the surface of an implant by physical-chemical physical and/or chemical means without interfering with theintegrity of the implant surface. Even though p

47、articulates shall be reported separately, they belong to one of the chemical classesmentioned above.6.3 Reported Units:6.3.1 Results of inorganic and organic analysis shall be reported as mass per implant and/oror mass per surface area area, orboth (use SI units).6.3.2 Results of biological analysis

48、 shall be reported in the specific units per implant, that is, enumeration methods such ascolony forming unit (CFU), or enzymatic assays such as for example, endotoxin units (EU).(EUs).6.3.3 Results of particulate analysis shall be reported in mass per implant, mass per surface area, number per devi

49、ce, numberper surface area, or atomic-%, or fraction per surface area. The size range of particulates considered in the analysis (for example,based on filter pore sizes, capillaries, diffraction settings) shall be reported.6.3.4 Results of surface analysis shall be reported as atomic-%, molecular-%, or fraction per surface area.6.4 Identification of ResiduesResidues that have been identified shall be listed separately in the report if they are consideredsignificant by the practitioner of this practice.7. Quality Assurance7.1 The cleanliness of the