CERTIFICATE OF ACCREDITATION

Transcription

1 CERTIFICATE OF ACCREDITATION ANSI-ASQ National Accreditation Board 500 Montgomery Street, Suite 625, Alexandria, VA 22314, This is to certify that Toxikon Corporation Wiggins Avenue Bedford, MA has been assessed by ANAB and meets the requirements of international standard ISO/IEC 17025:2005 while demonstrating technical competence in the field of TESTING Refer to the accompanying Scope of Accreditation for information regarding the types of tests to which this accreditation applies. AT-1340 Certificate Number Certificate Valid: 07/03/ /24/2020 Version No. 004 Issued: 07/03/2018 This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005. 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).

2 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Toxikon Corporation Wiggins Avenue Bedford, MA Nancy DiGiulio Ext TESTING Biological Valid to: July 24, 2020 Certificate Number: AT-1340 Tests for Genotoxicity ISO Bacterial Reverse Mutation (Ames) Test (OECD 471) SOP In Vitro Mammalian Chromosome Aberration Test (OECD 473) SOP ; Mammalian Erythrocyte Micronucleus Test (OECD 474) SOP SOP In vitro Mammalian Cell Gene Mutation Test-Mouse Lymphoma Assay (OECD 476) SOP Colony Counters Microscopes Semi-quantitative BD FACS Flow Cytometer Page 1 of 4

3 Biological ISO In Vitro Hemocompatibility (SOP , ) WBC. RBC, Platelet Counts, Erythrocyte Indices Advia & hematology counter Tests for Interaction with Blood PT / UPTT /APTT/ Lee and White Coagulation Time (SOP , SOP , SOP , and ) Start4 Hemostasis Analyzer Packs 4 Aggregometer Tests for In vitro Cytotoxicity Tests for Local Effects after Implantation Time for platelet aggregation (SOP ) Complement Activation (SOP ) Thrombogenicity (SOP ) Hemolysis (SOP and SOP ) ISO Mem Elution / Cytotoxicity or Direct Contact (SOP ) Agar Diffusion (SOP ) MTT Cytotoxicity Assay (SOP ) Neutral Red Uptake (NRU) Cytotoxicity Assay (SOP ) ISO Implant Test (SOP ) Subcutaneous Implant (SOP ) Bone Implant (SOP ) ELISA, plate reader Spectrophotometer Cell culture equipment / microscope Plate reader Animal system Explant and histological evaluation / pathology Page 2 of 4

4 Biological Tests for Irritation and Sensitization Tests for Systemic Toxicity ISO Kligman Sensitization (SOP ) Buehler Sensitization (SOP ) Ocular, Vaginal,Buccal, Skin, Penile Irritation (SOPs , , , ) Intracutaneous (SOP ) Murine Lymph Node Assay (SOP ) ISO Pyrogen Test (SOP ) Systemic Injection Test (SOP ) 14 Day Intravenous Toxicity (SOP ) 21/28 Day Repeat Dose Study (SOP ) Systemic Toxicity via Intramuscular or Subcutaneous Implantation (SOP ) Animal systems-clinical observations and tissue evaluations Scintillation counter Animal Systems Thermometer readings Clinical observations Scoring Tissue Evaluations Advia automatic hematology counter Cobas automatic clinical chemistry analyzer Chemical Ethylene Oxide Sterilization Residuals ISO SOP 11.2 Agilent 6890 GC-FID Page 3 of 4

5 Chemical Leachables and Extractables Testing ISO GC (SOPs , , 11.67, 11.68) GC/MS (SOP , 11.67, 11.68, 11.95) HPLC (SOP ) LC/MS (SOP 10.15, 10.19,11.94) TOC and TIC (SOP , ) ICP (SOP , 11.96, 11.97) ICP/MS (SOP , 10.15) FTIR (SOP ) (Detection limits vary with analyte & matrix) Agilent 5890 and 6890 GC and GC/MS Agilent 1100 HPLC and LC/MS systems Tekmar Dohrman Phoenix 8000 TOC & Tekmar TOC Fusion Thermo Fisher 6300 ICP Thermo Fisher 61E and X Series ICP w/ms Perkin Elmer IR Microbiological Note: Bioburden Testing Sterility Test Methods ISO Sterilization of Medical Devices -- Estimation of Organisms on Products SOP / USP, AAMI ISO Sterilization of Medical Devices -- Validation of a Sterilization Process USP, AAMI and This scope is formatted as part of a single document including Certificate of Accreditation No. AT Autoclave, incubators, HEPA hood Sterile Room Autoclave, incubators, HEPA hood Page 4 of 4