SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005

Transcription

1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 COOK RESEARCH INCORPORATED (CRI) 1 Geddes Way West Lafayette, IN Margaret McClure Phone: MECHANICAL Valid To: June 30, 2016 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: MRI Testing (Displacement Force, Torque, RF Heating and Image Artifact) 1 ASTM F2052, F2119, F2182, F2213; Internal document MRI-400 Immersion Corrosion ASTM G31; Internal document ACOR-100, -716; ISO Annex A (See details below) Electrochemical Corrosion ASTM F2129, ASTM G59, ASTM G71; Internal document ECOR-001 Pulsatile Fatigue 2 ASTM F2477; Internal document FATG -320 Tensile (up to 5000N) Stress/Strain Maximum Force Internal document PULT-202, -204, -205, -210, -211 Torque ASTM A938; Internal document TORQ-553 Particulate Matter Generation Internal document PART -02, -03, -04, -05 Bench Deployment 2 ASTM F2079, F2081; Internal document DPLY-01, -02, -03 Electrosurgical Accessory Electrical Testing IEC (Section , ), (Section ); Internal document ECT-491 (A2LA Cert. No ) Revised 10/09/2015 Page 1 of 5

2 Physical Bench Examination and Mechanical Bench Measurements 2 Fatigue (Flat Plate, Low and High Cycle Longitudinal, Bending, Axial, Torsional) Internal document EXAM-100; MEAS-825, -829, -830, -832, -900 ASTM F2942; ISO Section D.5.2.2; Internal document FATG-401, -500, -600, -610, -700, -710, -800, -900 Flow Internal document FLOW-100, -302, -307; ISO Annex C,D,E,F (See details below) Internal document PRES-191, -195, -197; ISO Annex A, ISO Annex A,B,C (See details below) Securement ASTM F2394; Internal document MEAS-100 Radial Force Internal document RF-300 Radiopacity 2 ASTM F640 Methods A & B; Internal document RAD-01 Compression ASTM F2606; Internal document COMP-220 Abrasion ASTM D4158; Internal document ABRD-100; MART-100 ISO 7198 Cardiovascular Implants Tubular Vascular Prostheses ISO , -2, -4 Intravascular Catheters Sterile and Singleuse Catheters Part 1: General Requirements Part 2: Angiographic Catheters Part 4: Balloon Dilatation Catheters ISO Amendment 1 Annex D Cardiovascular Implants Endovascular Devices Part 1: Endovascular Prostheses ISO Cardiovascular Implants Endovascular Devices Part 2:Vascular Stents See page 3 for details See page 3 for details See page 4 for details See page 5 for details (A2LA Cert. No ) Revised 10/09/2015 Page 2 of 5

3 ISO 7198 Details Cardiovascular Implants Tubular Vascular Prostheses Visual Inspection ISO 7198 Section 8.1 Liquid Leakage ISO 7198 Section 8.2 Porosity Water Permeability Integral Water Permeability/Leakage Water Entry Strength Testing Circumferential Tensile Strength ISO 7198 Section 8.3 Longitudinal Tensile Strength Burst Strength Strength After Repeated Puncture Usable Length ISO 7198 Section 8.4 Relaxed Internal Diameter ISO 7198 Section 8.5 Pressurized Internal Diameter ISO 7198 Section 8.6 Wall Thickness ISO 7198 Section 8.7 Suture Retention Strength ISO 7198 Section 8.8 Kink Diameter/Radius ISO 7198 Section 8.9 Dynamic Compliance ISO 7198 Section 8.10 ISO , -2, and -4 Details Intravascular Catheters Sterile and Single-use Catheters Part 1: General Requirements Part 2: Angiographic Catheters Part 4: Balloon Dilatation Catheters Test Method for Corrosion Resistance Method for Determining Peak Tensile Force Test Method for Liquid Leakage Under Test Method for Air Leakage into Hub Assembly During Aspiration Determination of Flow Rate Test for Burst Under Static Conditions Power Injection Test for Flow Rate and Device Test for Freedom from Leakage and Damage Under High Static Conditions Test for Balloon Rated Burst Balloon Fatigue Test for Freedom from Leakage and Damage on Inflation Test for Balloon Deflation Time Test for Balloon Diameter to Inflation ISO Annex A ISO Annex B ISO Annex C ISO Annex D ISO Annex E ISO Annex F ISO Annex F ISO Annex A ISO Annex A ISO Annex B ISO Annex C ISO Annex D (A2LA Cert. No ) Revised 10/09/2015 Page 3 of 5

4 ISO Amendment 1 Annex D Details Cardiovascular Implants Endovascular Devices Part 1:Endovascular Prostheses Dimension Verification and Component Dimensional Compatibility 2 ISO Annex D Profile/Diameter Test ISO Annex D Assessment of Hemostasis ISO Annex D Simulated Use Models 2 ISO Annex D Visibility 2 ISO Annex D Force to Deploy ISO Annex D Balloon Inflation and Deflation Time ISO Annex D5.2.1 Balloon Rated Burst ISO Annex D5.2.2 Balloon Volume to Burst ISO Annex D5.2.3 Balloon Rated Fatigue ISO Annex D5.2.4 Bond Strength ISO Annex D5.2.5 Torsional Bond Strength ISO Annex D5.2.6 Tubing Longitudinal Tensile Strength ISO Annex D5.2.7 Dimensional Verification ISO Annex D5.3.1 Implant Diameter to Balloon Inflation ISO Annex D5.3.2 Implant Length to Diameter Relationship ISO Annex D5.3.3 Recoil ISO Annex D5.3.4 Integral Water Permeability/Leakage ISO Annex D5.3.5 Water Entry ISO Annex D5.3.6 Water Permeability ISO Annex D5.3.7 Burst/Circumferential Strength ISO Annex D5.3.8 Crush Resistance ISO Annex D5.3.9 Flex/Kink ISO Annex D Local Compression ISO Annex D Longitudinal Tensile Strength ISO Annex D Migration Resistance ISO Annex D Pull Test for Modular Components ISO Annex D Radial Force ISO Annex D Strength After Repeated Puncture ISO Annex D Strength of Graft to Stent/Attachment ISO Annex D System Bond Corrosion Assessment ISO Annex D Fatigue and Durability Test (Pulsatile) ISO Annex D (A2LA Cert. No ) Revised 10/09/2015 Page 4 of 5

5 ISO Details Cardiovascular Implants Endovascular Devices Part 2:Vascular Stents Dimension Verification and Component Dimensional Compatibility 2 ISO Annex D Profile/Diameter Test ISO Annex D Simulative Use 2 ISO Annex D Visibility 2 ISO Annex D Force to Deploy ISO Annex D Balloon Inflation and Deflation Time ISO Annex D5.1.6 Balloon Rated Burst ISO Annex D5.1.7 Balloon Rated Fatigue ISO Annex D5.1.8 Bond Strength ISO Annex D5.2.1 Torsional Bond Strength ISO Annex D5.2.2 Stent Diameter to Balloon Inflation ISO Annex D Dimensional Verification and Stent ISO Annex D5.3.2 Length to Diameter Relationship Recoil ISO Annex D5.3.3 Crush Resistance with Radially Applied ISO Annex D5.3.4 Load Crush Resistance with Parallel Plates ISO Annex D5.3.5 Flex/Kink ISO Annex D5.3.6 Local Compression ISO Annex D5.3.7 Radial Force ISO Annex D5.3.8 Corrosion Assessment ISO Annex D5.3.9 Fatigue Durability Test ISO Annex D Dislodgment Force ISO Annex D Dogboning ISO Annex D Profile Effect/Flaring ISO Annex D Stent Free Surface Area and Stent Outer ISO Annex D Surface Area Acute Coating Integrity ISO Annex D MRI testing is conducted using clinical scanners at offsite facilities. These locations are available from A2LA upon request. 2 Radiographic activity, when performed as part of these tests, is performed at: Purdue University Lynn Hall 625 Harrison St. West Lafayette, IN (A2LA Cert. No ) Revised 10/09/2015 Page 5 of 5

6 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 17025:2005 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 8 January 2009). Presented this 13 th day of August President & CEO For the Accreditation Council Certificate Number Valid to June 30, 2016 Revised October 9, 2015 For the tests to which this accreditation applies, please refer to the laboratory s Mechanical Scope of Accreditation.