(( DAkkS Deutsche Akkred iti e ru ngsstell e Deutsche Akkreditierungsstelle GmbH Anlage zur Akkreditierungsurkunde D-PL-18838-02-00 nach DIN EN ISO/lEe 17025:2005 1 und nach Richtlinie 93/42/EWG 2 GOltigkeitsdauer: 17.03.2017 bis 19.11.2018 Ausstellungsdatum: 17.03.2017 Urkundeninhaber: Endolab Mechanical Engineering GmbH Sebastian- Tiefenthaler-StraBe 13 83101 Rohrdorf/Thansau Bereich: Medizinprodukte Prufgebiete/Prufgegenstande: Physikalische und physikalisch-chemische PrUfungen von chirurgischen Implantaten verwendete Abkurzungen: siehe letzte Seite Seite 1 von 25
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(( DAkkSDeutscheAkkred iti eru ngsstell e
Deutsche Akkreditierungsstelle GmbH
Anlage zur Akkreditierungsurkunde D-PL-18838-02-00nach DIN EN ISO/lEe 17025:20051 und nach Richtlinie93/42/EWG2
GOltigkeitsdauer: 17.03.2017 bis 19.11.2018 Ausstellungsdatum: 17.03.2017
Prufung von metallischen Werkstoffen - Druckversuch anmetallischen zellularen Werkstoffen
Hochleistungskeramik - Mechanische Eigenschaftenmonolithischer Keramik bei Raumtemperatur-
Teil 2: Bestimmung des Elastizitatsmoduls, Schubmoduls und derPoissonzahl
DIN EN ISO 25539-2 : 2013-05
DIN 50134 : 2008-10
DIN EN 843-2 : 2007-03
DIN EN 843-4: 2005-08 Hochleistungskeramik - Mechanische Eigenschaftenmonolithischer Keramik bei Raumtemperatur-
Teil 4: Harteprufung nach Vickers, Knoop und Rockwell
Implants for surgery - Acrylic resin cements
Implants for surgery - Ultra-high-molecular-weight polyethylene -Part 3: Accelerated ageing methods
Implants for surgery - Skeletal pins and wires-
Part 1: Material and mechanical requirements
Implants for surgery - Skeletal pins and wires-
Part 2: Steinmann skeletal pins - Dimensions
Implants for surgery - Skeletal pins and wires-
Part 3: Kirschner skeletal wires
ISO 5833: 2002-05
ISO 5834-3 : 2005-07
ISO 5838-1: 2013
ISO 5838-2: 1991
ISO 5838-3: 1993
ISO 6474-1 : 2010-02 Implants for surgery - Ceramic materials-
Part 1: Ceramic materials based on high purity alumina
Implants for surgery - Ceramic materials-
Part 2: Composite materials based on a high-purity aluminamatrix with zirconia reinforcement
ISO 6474-2 : 2012-04
ISO 7198 : 1998-08 Cardiovascular implants - Tubular vascular prostheses
ISO 7206-1 : 2008-04 Implants for surgery - Partial and total hip joint prostheses-
Part 1: Classification and designation of dimensions
Implants for surgery - Partial and total hip joint prostheses-
Part 2: Articulating surfaces made of metallic, ceramic and plasticsmaterials
ISO 7206-2 : 2011-04
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ISO 7206-4 : 2010-06 Implants for surgery - Partial and total hip joint prostheses-
Part 4: Determination of endurance properties and performanceof stemmed femoral components
Implants for surgery - Partial and total hip joint prostheses-
Part 6: Endurance properties testing and performancerequirements of neck region of stemmed femoral components
Implants for surgery - Partial and total hip-joint prostheses-
Part 10: Determination of resistance to static load of modularfemoral heads
Implants for surgery - Components for partial and total knee jointprostheses - Part 1: Classification, definitions and designation ofdimensions
ISO 7206-6 : 2013
ISO 7206-10 : 2003-12
ISO 7207-1 : 2007-02
ISO 7207-2: 2011-07 Implants for surgery - Components for partial and total knee jointprostheses - Part 2: Articulating surfaces made of metal, ceramicand plastics materials
Implants for surgery; determination of bending strength andstiffness of bone plates
Implants for surgery - Mechanical testing of implantable spinaldevices - Fatigue test method for spinal implant assemblies usingan anterior support
Dentistry - Torsion test of implant body/connecting part joints ofendosseous dental implant systems
Implants for surgery - Wear oftotal hip-joint prostheses-
Part 1: Loading and displacement parameters for wear-testingmachines and corresponding environmental conditions for test
Implants for surgery - Wear oftotal hip joint prostheses-
Part 2: Methods of measurement
ISO 9585: 1990-12
ISO 12189 : 2008-05
ISO/TS 13498 : 2011-08
ISO 14242-1 : 2014-10
ISO 14242-2 : 2000-09
ISO 14243-1 : 2009-11 Implants for surgery - Wear of total knee-joint prostheses-
Part 1: Loading and displacement parameters for wear-testingmachines with load control and corresponding environmentalconditions for test
ISO 14243-2 : 2009-11 Implants for surgery - Wear of total knee-joint prostheses-
Part 2: Methods of measurement
ISO 14243-3 : 2014-11 Implants for surgery - Wear oftotal knee-joint prostheses-
Part 3: Loading and displacement parameters for wear-testingmachines with displacement control and correspondingenvironmental conditions for test
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ISO 14879-1 : 2000-06
ISO 15142-1 : 2003-08
ISO 15142-2 : 2003-08
ISO 15142-3 : 2003-08
ISO 16402 : 2008-05
ISO 17853 : 2011-03
ISO 18192-1 : 2011-03
ISO 18192-2 : 2010-06
ISO 18754 : 2013-03
ISO 22214 : 2006-02
ANSI/AAMI NS 28 : 1988/12006
ASTM D638 - 14
ASTM E112 - 13
ASTM F136 - 13
ASTM F382 - 14
ASTM F384 - 12
ASTM F451- 08
ASTM F543 -Be
Implants for surgery - Total knee-joint prostheses-
Part 1: Determination of endurance properties of knee tibial trays
Implants for surgery - Metal intramedullary nailing systems-
Part 1: Intramedullary nails
Implants for surgery - Metal intramedullary nailing systems-
Part 2: Locking components
Implants for surgery - Metal intramedullary nailing systems-
Part 3: Connection devices and reamer diameter measurements
Implants for surgery - Acrylic resin cement - Flexural fatiguetesting of acrylic resin cements used in orthopaedics
Wear of implant materials - Polymer and metal wear particles -Isolation and characterization
Implants for surgery - Wear oftotal intervertebral spinal discprostheses - Part 1: Loading and displacement parameters forwear testing and corresponding environmental conditions for test
Implants for surgery - Wear of total intervertebral spinal discprostheses - Part 2: Nucleus replacements
Fine ceramics (advanced ceramics, advanced technical ceramics) -Determination of density and apparent porosity
Fine ceramics (advanced ceramics, advanced technical ceramics) -Test method for cyclic bending fatigue of monolithic ceramics atroom temperature
Intracranial pressure monitoring devices
Standard Test Method for Tensile Properties of Plastics
Standard Test Methods for Determining Average Grain Size
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)
Standard Specification and Test Method for Metallic Bone Plates
Standard Specifications and Test Methods for Metallic AngledOrthopedic Fracture Fixation Devices
Standard Specification for acrylic bone cement
Standard Specification and Test Methods for Metallic MedicalBone Screws
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ASTM F561 - 13 Standard Practice for Retrieval and Analysis of Medical Devices,and Associated Tissues and Fluids
Standard Specification and Test Methods for Metallic BoneStaples
Standard Practice for Fluorescent Penetrant Inspection of MetallicSurgical Implants
Ultra-High-Molecular-Weight Polyethylene Powder and StandardSpecification for Fabricated Form for Surgical Implants
Standard Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint Prostheses
Standard Test Method for Measuring Fretting Corrosion ofOsteosynthesis Plates and Screws
Standard Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic Coatings
Standard Test Method for Corrosion of Surgical Instruments
Standard Test Method for Tension Testing of Calcium Phosphateand Metallic Coatings
Standard Test Method for Shear and Bending Fatigue Testing ofCalcium Phosphate and Metallic Medical and Composite CalciumPhosphate/Metallic Coatings
Standard Test Method for Determination of Total KneeReplacement Constraint
Standard Specification and Test Methods for IntramedullaryFixation Devices
ASTM F564 -10 (2015)
ASTM F60l - 13
ASTM F648 - 14
ASTM F732 - 00(2011)
ASTM F897 -02(2013)
ASTM Fl044 - 05(2011)e
ASTM Fl089 - 10
ASTM F1147 - 05 (2011)
ASTM Fl160 - 14
ASTM Fl223 - 14
ASTM F1264 - 16
ASTM F1357 - 14
ASTM F1378 - 12
ASTM F1541- 02(2015)
Standard Specification for Articulating Total Wrist Implants
Standard Specification for Shoulder Prostheses
Standard Specification and Test Methods for External SkeletalFixation Devices
ASTM F1582 - 98(2011)
ASTM F1672 - 14
ASTM Fl714 - 96(2013)
Standard Terminology Relating to Spinal Implants
Standard Specification for Resurfacing Patellar Prosthesis
Standard Guide for Gravimetric Wear Assessment of ProstheticHip-Designs in Simulator Devices
Standard Test Methods for Spinal Implant Constructs in aVertebrectomy Model
Standard Specification for Elastomeric Flexible Hinge Finger TotalJoint Implants
ASTM F1717 -15
ASTM F1781-15
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ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties ofInterconnection Mechanisms and Subassemblies Used in SpinalArthrodesis Implants
Standard Practice for Cyclic Fatigue Testing of Metal Tibial TrayComponents of Total Knee Joint Replacements
Standard Guide for Evaluating Modular Hip and Knee JointComponents
Standard Test Method for Determining the Axial DisassemblyForce of a Modular Acetabular Device
Standard Specification for Urereal Stents
ASTM F1800 - 12
ASTM F1814 - 15
ASTM F1820 - 13
ASTM F1828 - 97(2014)
ASTM F1829 - 98(2009) Standard Test Method for Static Evaluation of the Glenoid LockingMechanism in Shear
ASTM F1839 - 08(2012)e Standard Specification for Rigid Polyurethane Foam for Use as aStandard Material for Testing Orthopaedic Devices andInstruments
ASTM F1854 - 15 Standard Test Method for Stereological Evaluation of PorousCoatings on Medical Implants
Standard Practice for Fretting Corrosion Testing of ModularImplant Interfaces: Hip Femoral Head-Bore and Cone TaperInterface
Standard Practice for Characterization of Particles
ASTM F1875 - 98(2014)
ASTM F1877 - 05(2010)
ASTM F1926 - 14 Standard Test Method for Dissolution Testing of CalciumPhosphate Granules, Fabricated Forms, and Coatings
ASTM F1978 - 12 Standard Test Method for Measuring Abrasion Resistance ofMetallic Thermal Spray Coatings by Using the Taber Abraser
Standard Guide for Accelerated Aging of Ultra-High MolecularWeight Polyethylene
Standard Test Method for Determining the Axial DisassemblyForce of Taper Connections of Modular Prostheses
Standard Practice for Gravimetric Measurement of PolymericComponents for Wear Assessment
Standard Test Methods for Dynamic Evaluation of GlenoidLoosening or Disassociation
Standard Specification for Total Hip Joint Prosthesis and HipEndoprosthesis Bearing Surfaces Made of Metallic, Ceramic, andPolymeric Materials
ASTM F2003 - 02(2015)
ASTM F2009 - 00(2011)
ASTM F2025 - 06(2012)
ASTM F2028 - 14
ASTM F2033 - 12
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ASTM F2068 - 09
ASTM F2077 - 14
ASTM F2079 - 09(2013)
Standard Specification for Femoral Prostheses-Metallic Implants
Test method for intervertebral body fusion devices
Standard Test Method for Measuring Intrinsic Elastic Recoil ofBalloon-Expandable Stents
Standard Guide for Characterization and Presentation 20ft heDimensional Attributes of Vascular Stents
Standard Specification for Total Knee Prosthesis
Standard Specification for Acetabular Prostheses
Test Method for Constant Amplitude of Force Controlled FatigueTesting of Acrylic Bone Cement Materials
Standard Test Method for Conducting Cyclic PotentiodynamicPolarization Measurements to Determine the CorrosionSusceptibility of Small Implant Devices
Standard Specification for Metallic Implantable Strands andCables
Standard Test Method for Small Punch Testing of Ultra-HighMolecular Weight Polyethylene Used in Surgical Implants
Standard Specifications and Test Methods for Components Usedin the Surgical Fixation 20ft he Spinal Skeletal System
Standard Test Method for Measuring Load Induced Subsidence ofIntervertebral Body Fusion Device Under Static Axial Compression
Standard Test Methods for Determination of Static and CyclicFatigue Strength of Ceramic Modular Femoral Heads
Standard Test Methods for Static and Dynamic Characterization ofSpinal Artificial Discs
Standard Guide for Measuring Securement of Balloon ExpandableStent Mounted on Delivery System
Standard Guide for Functional, Kinematic, and Wear Assessmentof Total Disc Prostheses
Standard Test Methods for in vitro Pulsatile Durability Testing ofVascular Stents
ASTM F2081- 06(2013)
ASTM F2083 - 12
ASTM F2091- 15
ASTM F2118 - 14
ASTM F2129 - 15
ASTM F2180 - 02(2015)
ASTM F2183 - 02(2008)
ASTM F2193 - 14
ASTM F2267 - 04(2011)
ASTM F2345 - 03(2013)
ASTM F2346 - 05 (2011)
ASTM F2394 - 07(2013)
ASTM F2423 -11
ASTM F2477 - 07(2013)
ASTM F2502 - 11 Standard Specification and Test Methods for Bioabsorbable Platesand Screws for Internal Fixation Implants
Standard Guide for Finite Element Analysis (FEA) of MetallicVascular Stents Subjected to Uniform Radial Loading
Standard Test Method for Tension Testing of Nickel-Titanium
ASTM F2514 - 08 (2014)
ASTM F2516 - 14
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ASTM F2528 - 06(2014)
Superelastic Materials
Standard Test Methods for Enteral Feeding Devices with aRetention Balloon
ASTM F2580 - 13 Standard Test Method for Evaluation of Modular Connection ofProximally Fixed Femoral Hip Prosthesis
Standard Test Method for Impingement of Acetabular Prostheses
Standard Guide for Three-Point Bending of Balloon ExpandableVascular Stents and Stent Systems
Standard Test Method for Static, Dynamic, and Wear Assessmentof Extra-Discal Single Level Spinal Constructs
Standard Specification for Total Ankle Replacement Prosthesis
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumba r Total Facet Prostheses
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a VertebrectomyModel
ASTM F2582 - 14
ASTM F2606 - 08(2014)
ASTM F2624 - 12
ASTM F2665 - 09(2014)
ASTM F2694 - 07(2013)
ASTM F2706 - 08(2014)
ASTM F2722 - 15 Standard Test Method for Evaluating Mobile Bearing Knee TibialBaseplate Rotational Stops
Standard Test Method for Evaluating Mobile Bearing Knee TibialBaseplate/Bearing Resistance to Dynamic Disassociation
Standard Test Method for Evaluating Mobile Bearing KneeDislocation
ASTM F2723 - 13a
ASTM F2724 - 08(2014)
ASTM F2743 - 11 Standard Guide for Coating Inspection and Acute ParticulateCharacterization of Coated Drug-Eluting Vascular Stent Systems
Standard Test Method for Evaluating Knee Bearing (Tibial Insert)Endurance and Deformation Under High Flexion
Standard Guide for Mechanical and Functional Characterization ofNucleus Devices
ASTM F2777 - 10
ASTM F2789 -10(2015)
ASTM F2790 -10(2014) Standard Practice for Static and Dynamic Characterization ofMotion Preserving Lumbar Total Facet Prosthesesc
Standard Guide for Assessment of Surface Texture of Non-PorousBiomaterials in Two Dimensions
ASTM F2791- 15
ASTM F2887 - 12
ASTM F2942 - 13
Standard Specification for Total Elbow Prostheses
Standard Guide for in vitro Axial, Bending, and TorsionalDurability Testing of Vascular Stents
Standard Guide for Determining the Mean Darcy PermeabilityASTM F2952 - 14
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Coefficient for a Porous Tissue Scaffold
ASTM F2979 - 14 Standard Guide for Characterization of Wear from the ArticulatingSurfaces in Retrieved Metal-on-Metal and other Hard-on-Hard HipProstheses
ASTM F2996 - 13 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
Standard Test Method for Penetration Testing of Needles Used inSurgical Sutures
Standard Guide for Testing Absorbable Stents
Test Method for Standard Test Method for Evaluating thePotential for Galvanic Corrosion for Medical Implants
Standard Guide for High Demand Hip Simulator Wear Testing ofHard-on-Hard Articulations
Guide for Radial Loading of Balloon Expandable and SelfExpanding Vascular Stents
Standard Specification for Acrylic Molding Resin for MedicalImplant Applications
Standard Guide for Total Knee Replacement Loading Profiles
Standard Test Method for Finite Element Analysis (FEA) ofMetallic Orthopaedic Total Knee Femoral Components underClosing Conditions
Standard Guide for Design Verification Device Size and SampleSize Selection for Endovascular Devices
ASTM F3014 - 14
ASTM F3036 - 13
ASTM F3044 - 14
ASTM F3047M -15
ASTM F3067 - 14
ASTM F3087 - 15
ASTM F3141- 15
ASTM F3161- 16
ASTM F3172 -15
ASTM Gl02 - 89 (2015)el Standard Practice for Calculation of Corrosion Rates and RelatedInformation from Electrochemical Measurements
PI-3 : 2007-04
PI-ll : 2014-11
PI-12 : 1998-02
PI-14 : 2015-12
PI-17 : 2014-11
PI-19 : 2010-02
PI-27 : 2014-11
PI-28 : 2014-11
PI-29 : 2014-11
Bestimmung des Luxationsverhaltens ohne Schaft-Pfanne Kontakt
Druckversuch statisch/dynamisch Pfanneninserts
Scherfestigkeit im push-out Versuch
Druckversuch statisch/dynamisch HUftgelenkkugeln
Druckverteilung von Knieendoprothesen
Dauerschwingversuch Gleitnagel
Pen Injector 60 IU Stop
Pen Injector 300 IU Stop
Pen Injector Fluid Solvent Exposure
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PI-30 : 2014-11
PI-31 : 2014-11
PI-32 : 2014-11
PI-33 : 2014-11
PI-35 : 2014-11
PI-36 : 2014-11
PI-37 : 2014-11
PI-38 : 2014-11
Pen Injector Dose accuracy different dose pattern
Pen Injector Drop Test Resistance with Increased Demands
Pen Injector Cap Removal Force Test
Pen Injector Needle Cover Interference
Pen Injector Dispense Force Test
Pen Injector Dialing torque to set a dose
Pen Injector Dial Stop Torque 0 I.U.
Pen Injector Dose number character height Dose WindowDistortion
PI-39 : 2014-11
PI-40 : 2014-11
PI-41 : 2014-11
PI-52: 2015-10
PI-53: 2010-11
PI-54: 2010-11
PI-55: 2010-12
PI-57: 2013-10
Pen Injector Dose accuracy after dial stop break torque
Pen Injector Disassembly Force Test
Pen Injector Dust Ingress
Expulsion test - spinal implants
Fatigue testing of stemmed femoral TKA components
Mechanical Test - VBR spinal implants
Femoral condyle - fatigue test
DIN EN 12006-3 : 2009-08 - Nichtaktive chirurgische Implantate-Besondere Anforderungen an Herz- und GefaBimplantate-
Teil 3: BlutgefaBstents und Hohlvenenfilter
ISO 7206-8 - Endurance performance of stemmed femoralcomponents with application oftorsion
ISO 7206-9 - Determination of resistance to torque of headfixation of stemmed femoral components
ISO 6474 (1994): Implants for surgery - Ceramic materials basedon high purity alumina
Reverse Shoulder System Wear Test
Anatomic Shoulder System Wear Test
Total Ankle Replacement System Wear Test
Total hip joint prostheses - 3D Frictional torque
Determination of Total Ankle Replacement Contact Pressure
(WK45235) Standard Test Method for Cyclic Fatigue Testing ofMetal Tibial Tray Components of Unicondylar Knee JointReplacements
PI-58 :2013-10
PI-59: 2013-10
PI-60 : 2014-10
PI-61 : 2014-10
PI-62 : 2014-10
PI-63 : 2014-10
PI-64: 2014-11
PI-65: 2016-02
PI-67: 2016-02
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PI-68: 2016-02 (WK52025) Standard Test Method for Metallic Bone Plates Usedin Small Bone Fracture Fixation
PI-69: 2016-02 (WK28883) Standard Test Method for Environmental FatigueTesting of Acetabular Devices for Total Hip Replacement
(WK28214) Practice for Accelerated Fretting Corrosion Testing ofModular Head and Neck Taper Junctions Used in Total HipReplacement
(WK34814) Standard Guide for Collection and Evaluation ofMetallic Products from Environmental Tests
PI-70: 2016-02
PI-71: 2016-02
PI-73: 2016-02
(WK24686) Standard Guide for Assessment of Hard-on-Hard TotalHip Replacement Devices of Acetabular Devices for Total HipReplacement
(WK51649) Standard Test Method for Fatigue Testing of TotalKnee Femoral Components under Closing Conditions
(WK45142) Standard Practice for Mechanical Characterization ofSpinous Process Plates
(ISO 11492.2) Implants for surgery - Test method for impactresistance of ceramic femoral heads for hip joint prostheses
(ISO 14242-4) Implants for surgery - wear of total hip-jointprostheses - Part 4: Testing total hip joint prostheses undervariations in surgical positioning
PI-72: 2016-02
PI-76: 2016-02
PI-77: 2016-02
PI-78: 2016-02
PI-79: 2016-07 (ISO 14243-5) Implants for surgery - Wear oftotal kneeprostheses - Part 5: Durability performance ofthe patellofemoraljoint - Loading and displacement parameters for testing machinesand corresponding environmental conditions for test
(ISO 7206-12) Implants for surgery - Partial and total hip jointprostheses - Part 12: Deformation test method for acetabularcomponents
(ISO 7206-13) Implants for surgery - Partial and total hip jointprostheses - Part 13: Determination of resistance to torque ofhead fixation of stemmed femoral components
PI-80: 2016-02
PI-81: 2016-02
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Abkurzungen
ANSI/AAMI American National Standards Institute/Association for the Advancement ofMedical Instrumentation
ASTM
DIN
EN
ISO
TS
PI
American Society for Testing and Materials
Deutsches Institut fUr Normung
Europaische Norm
International Organization for Standardization
Technical Specification
PrOfanweisung der Endolab Mechanical Engineering GmbH
1 DIN EN ISO/IEC17025 : 2005-08 Allgemeine Anforderungen an die Kompetenz von Priif- und Kalibrierlaboratorien Richtlinie2 93/42/EWG des Ratesvom 14. Juni 1993 iiber Medizinprodukte,3 Zu den Ubergangsfristen vergl. die Liste harmonislerter Normen auf der Homepage der EU.
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