SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017

Transcription

1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 COOK RESEARCH INCORPORATED (CRI) 1 Geddes Way West Lafayette, IN Margaret McClure Phone: MECHANICAL Valid To: June 30, 2020 Certificate Number: In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following tests on medical devices: GENERAL TESTS OR Abrasion Abrasion Testing ASTM D4966 Lab Developed Method MART-100 Bend and Free Recovery Bend and Free Recovery ASTM F2082 Lab Developed Method BFR-100 Corrosion Immersion Corrosion Testing ASTM G31 BS EN 1618 BS EN ISO 9626 BS ISO ISO ISO Amd.1 JIS T 3214 JIS T 3215 JIS T 3216 JIS T 3260 Lab Developed Method ACOR-716 Electrochemical Corrosion Testing ASTM F2129 ASTM F3044 ASTM G5 ASTM G59 ASTM G71 BS ISO Amd.1 Lab Developed Method ECOR-001 (A2LA Cert. No ) 07/25/2018 Page 1 of 11

2 Deployment 1 Electrosurgical Bench Deployment Testing of Balloon Expandable Stents Bench Deployment Testing of Vascular Graft Components Bench Deployment Testing of Self- Expanding Implants Electrosurgical Accessory Electrical Testing ASTM F2079 ISO Amd.1 Lab Developed Method DPLY-01 ANSI/AAMI VP20 ASTM F2081 Amd.1 Lab Developed Method DPLY-02 ASTM F2081 Lab Developed Method DPLY-03 IEC (Section , ) IEC (Section ) Lab Developed Method ECT-491 Examination Examination Lab Developed Method EXAM-100 Fatigue Pulsatile Fatigue Testing ASTM F2477 Amd.1 Lab Developed Method FATG-320 Flat Plate Fatigue Testing Sling Radial Fatigue Testing Lab Developed Method FATG-401 Lab Developed Method FATG-500 (A2LA Cert. No ) 07/25/2018 Page 2 of 11

3 Fatigue (continued) Flow Low Cycle Longitudinal Fatigue Testing Low Cycle Longitudinal Fatigue Testing of External Sutures Bending Fatigue Testing Longitudinal Fatigue Testing Torsional Fatigue Testing Simulated Ureteral Flow Model Testing Lab Developed Method FATG-600 Lab Developed Method FATG-610 Lab Developed Method FATG-700 Lab Developed Method FATG-800 Lab Developed Method FATG-900 ASTM F1828 ISO ISO Lab Developed Method FLOW-100 Flow Testing BS EN ISO BS EN 1616 BS EN 1618 BS EN Lab Developed Method FLOW-225 (A2LA Cert. No ) 07/25/2018 Page 3 of 11

4 Flow (continued) Pressurized Leak and Water Permeability Force Compression Testing ASTM F2606 Particulate Counting Stent Securement Force Measurement Particulate Counts of Endovascular Devices Using the Hiac Royco Liquid Particle Counter Acute Simulated Use Particulate Counts of Endovascular Devices with Continuous Flow Particulate Counts of Endovascular Devices during Pulsatile Fatigue Particulate Counts of Endovascular Devices during Axial Fatigue ANSI/AAMI VP20 BS EN 1618 ISO ISO Lab Developed Method FLOW-302 Lab Developed Method COMP-220 ASTM F2394 Lab Developed Method MEAS-100 Amd.1 Lab Developed Method MEAS-900 USP 788 AAMI TIR42 Lab Developed Method PART-02 Lab Developed Method PART-03 Lab Developed Method PART-04 Lab Developed Method PART-05 (A2LA Cert. No ) 07/25/2018 Page 4 of 11

5 Pressure Burst Pressure Testing ANSI/AAMI VP20 ISO ISO ISO Amd.1 Pressurized Dimensional Measurement Balloon Inflation/Deflation Time and Fatigue Testing Lab Developed Method PRES-191 ANSI/AAMI VP20 ISO ISO Amd.1 Lab Developed Method PRES-195 Tensile Suture Retention Strength ASTM E8 / E8M Circumferential Tensile Strength Testing Longitudinal Tensile Strength Test of Tubular Graft Materials ANSI/AAMI VP20 ISO ISO Amd.1 Lab Developed Method PRES-197 Lab Developed Method PULT-202 Lab Developed Method PULT-204 Lab Developed Method PULT-205 (A2LA Cert. No ) 07/25/2018 Page 5 of 11

6 Tensile (continued) Tensile Testing Maximum Force ASTM E8 / E8M ASTM F1828 BS EN 1617 BS EN 1618 ISO ISO JIS T 3215 JIS T 3216 JIS T 3229 JIS T 3242 JIS T 3243 JIS T 3244 JIS T 3245 JIS T 3246 JIS T 3247 JIS T 3260 JIS T 3270 Tensile Stress and Tensile Strain Testing Lab Developed Method PULT-210 ASTM F2516 ASTM E8 / E8M Lab Developed Method PULT-211 Radiopacity 1 Radiopacity Testing ASTM F640 Lab Developed Method RAD-01 Radial Force Automated Radial Force ASTM F3067 Lab Developed Method RF-300 Torque Acute Automated Torque Testing ASTM A938 Lab Developed Method TORQ-553 (A2LA Cert. No ) 07/25/2018 Page 6 of 11

7 Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches ISO Intravascular Catheters Sterile and Single-Use Catheters Part 1: General Requirements ISO Intravascular Catheters Sterile and Single-Use Catheters Part 2: Angiographic Catheters ISO Intravascular Catheters Sterile and Single-Use Catheters Part 4: Balloon Dilation Catheters Visual Inspection Section 8.7 Porosity Section Water Permeability Section Integral Water Permeability/Leakage Section Water Entry Pressure Section Circumferential Tensile Strength Section Longitudinal Tensile Strength Section Pressurized Burst Strength Section Length Section Relaxed Internal Diameter Section Pressurized Internal Diameter Section Wall Thickness Section Suture Retention Strength Section Kink Diameter/Radius Section Dynamic Radial Compliance Section Test Method for Corrosion Resistance Method for Determining Peak Tensile Force Test Method for Liquid Leakage Under Pressure Test Method for Air Leakage into Hub Assembly During Aspiration Determination of Flowrate Through Catheter Test for Burst Pressure under Static Conditions Power Injection Test for Flowrate and Device Pressure Test for Freedom from Leakage and Damage under High Static Pressure Conditions Test for Balloon Rated Burst Pressure Balloon Fatigue Test for Freedom from Leakage and Damage on Inflation Test for Balloon Deflation Time Test for Balloon Diameter to Inflation Pressure Annex A Annex B Annex C Annex D Annex E Annex F Annex G Annex A Annex A Annex B Annex C Annex D (A2LA Cert. No ) 07/25/2018 Page 7 of 11

8 Cardiovascular Implants Endovascular Devices Part 1: Endovascular Prostheses Amendment 1: Test Methods Annex D Dimension Verification of the Endovascular System Sizing-Related Testing Hemostasis Simulated Use Visibility Force to Deploy for Self-Expanding Endovascular Prostheses Balloon Deflation Time Balloon Rated Burst Pressure for Non- Compliant Balloons Balloon Volume to Burst Balloon Rated Fatigue Tensile Bond Strength Torsional Bond Strength Dimensional Verification of Implant Implant Diameter to Balloon Inflation Pressure (Balloon-Expandable Endovascular Prostheses) Implant Length to Diameter Relationship (Endovascular Prostheses that have Clinically Relevant Length Changes with Diameter Changes) Recoil (Balloon-Expandable Endovascular Prostheses) Integral Water Leakage Water Entry Pressure (Non-Textile Materials) Water Permeability (Textile Materials) Burst Crush Resistance to Perpendicularly Applied Load (Self-Expanding, Non- Aortic Endovascular Prostheses) Resistance to Kinking (Flexibility) Crush Resistance with Perpendicularly Applied Load (Balloon-Expandable Non-Aortic Endovascular Prostheses) Longitudinal Tensile Strength Migration Resistance Separation Force for Overlapping Endovascular Prostheses Radial Force (Self-Expanding Endovascular Prostheses) Strength After Repeated Puncture (Endovascular Prostheses for Vascular Access) Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D (A2LA Cert. No ) 07/25/2018 Page 8 of 11

9 Cardiovascular Implants Endovascular Devices Part 1: Endovascular Prostheses Amendment 1: Test Methods Annex D (continued) Cardiovascular Implants Endovascular Devices Part 2: Vascular Stents Annex D Strength After Repeated Puncture (Endovascular Prostheses for Vascular Access) Strength of the Connection(s) Between the Graft Material and a Discrete Fixation System(s) Corrosion Assessment Fatigue and Durability Test in Vitro Testing Dimension Verification and Component Dimension Compatibility Profile/Diameter Test Simulative Use Visibility Force to Deploy Balloon Inflation and Deflation Time Balloon Rated Burst Pressure Balloon Rated Fatigue Bond Strength Torsional Bond Strength Stent Diameter to Balloon Inflation Pressure Dimensional Verification and Stent Length to Diameter Relationship Recoil Crush Resistance with Radially Applied Load Crush Resistance with Parallel Plates Flex/Kink Local Compression Radial Force Corrosion Assessment Fatigue Durability Test Dislodgment Force Dogboning Profile Effect/Flaring Acute Coating Integrity Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D Section D (A2LA Cert. No ) 07/25/2018 Page 9 of 11

10 Cardiovascular Implants Endovascular Devices Part 3: Vena Cava Filters Dimension Verification and Component Dimension Compatibility Simulated Use Force to Deploy Visibility Fatigue Durability Test Filter Dimensional Verification Filter Tensile Strength Migration Resistance Radial Force Visual Inspection Tensile Strength Torsional Bond Strength Catheter Burst Power Injection Tensile Strength Torsional Bond Strength Dimension Verification and Component Dimension Compatibility Simulated Use Force to Retrieve/Convert Visibility Tensile Strength Torsional Bond Strength Catheter Burst Power Injection Tensile Strength Torsional Bond Strength D D D D D D D D D D D D D D D D D D D D D D D D D D Radiographic activity, when performed as part of these tests, is performed at: Purdue University Lynn Hall 625 Harrison St. West Lafayette, IN Purdue University Martin Jischke Hall 206 S Martin Jischke Dr. West Lafayette, IN (A2LA Cert. No ) 07/25/2018 Page 10 of 11

11 I. Dimensional Testing 2 Parameter Range Technique / Method Thickness Measurement 3 Up to 12.7 mm Digimatic Indicator (Thickness Gauge) ISO 5084 Amd.1 Lab Developed Method MEAS-825 Kink Radius Testing 3 (4.0 to 79.0) mm Kink Radius Template BS EN Amd.1 Lab Developed Method MEAS-829 Automated Dimensional Measurement 3 Up to 50.8 mm Laser Micrometer Amd.1 Lab Developed Method MEAS This laboratory does not offer commercial dimensional testing. 3 This test is not equivalent to that of a calibration. (A2LA Cert. No ) 07/25/2018 Page 11 of 11

12 Accredited Laboratory A2LA has accredited COOK RESEARCH INCORPORATED (CRI) West Lafayette, IN for technical competence in the field of Mechanical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 25 th day of July President and CEO For the Accreditation Council Certificate Number Valid to June 30, 2020 For the tests to which this accreditation applies, please refer to the laboratory s Mechanical Scope of Accreditation.