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 American Preclinical Services 8945 Evergreen Boulevard Minneapolis, MN 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. L2348 Certificate Number Certificate Valid: 11/30/ /21/2018 Version No. 001 Issued: 11/30/2017 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 American Preclinical Services 8945 Evergreen Boulevard Minneapolis, MN Kevin Catalano TESTING Valid to: December 21, 2018 Certificate Number: L2348 Biological Mammalian Erythrocyte Micronucleus Test Guinea Pig Maximization Test Closed-Patch Test (Buehler) Animal Irritation Test Intracutaneous Reactivity Test Vaginal Irritation Test Primary Buccal (mucosal) Irritation Test Acute Systemic Toxicity Test (OECD 474) BS/EN/ Part 5 BS/EN/ BS/EN/ BS/EN/ USP 88 Part 5 BS/EN/ BS/EN/ ISO USP 88 PFSB/EDL/OMDE Notification Page 1 of 4

3 Biological Materials Mediated Pyrogenicity Test; Rabbits Systemic Toxicity Test (Implant Method) Systemic Toxicity Test (Repeated Exposure Method) Thrombogenicity Test Implantation Test Agar Overlay; Cytotoxicity Direct Contact Cytotoxicity MEM Elution Cytotoxicity MTT Cytotoxicity Neutral Red Uptake Cytotoxicity Colony Formation Cytotoxicity In-Vitro Skin Sensitization ; Human Cell Line Activation Test ISO USP 151 ISO ISO BS/EN/ISO ISO BS/EN/ISO BS/EN/ ISO BS/EN/ISO BS/EN/ BS/EN/ BS/EN/ BS/EN/ BS/EN/ BS/EN/ Part 1 OECD 442E In-Vitro Skin Irritation OECD 439 Hemolysis Extract Method BS/EN/ ASTM F756 Part 8 Page 2 of 4

4 Biological Hemolysis ; Direct Method Partial Thromboplastin Time Prothrombin Time Complement Activation ; SC5b-9 Method Complement Activation ; C3a Method ASTM Platelet and Leukocyte Count Heparinized Blood Platelet and Leukocyte Count In Vitro Blood Loop Bacterial Endotoxin: Kinetic Chromogenic LAL Method Ames Bacterial Reverse Mutation Mouse Lymphoma Chromosome Aberration BS/EN/ ASTM F756 NIH EN/SIO ASTM F2382 BS/EN/ISO BS/EN/ISO BS/EN/ BS/EN/ ASTM F2888 ISO BS/EN/ ASTM F2888 BS/EN/ USP 85 USP 161 (OECD 471) Part 3 (OECD 476) Part 3 Finished Medical Devices and Finished Medical Devices and Page 3 of 4

5 Chemical Note: 1. This scope is formatted as part of a single document including Certificate of Accreditation No. L2348. High-Performance Liquid Chromatography (HPLC) Inductively Coupled Plasma Mass Spectrometry (ICPMS) Fourier Transform Infrared Spectroscopy (FTIR) Gas Chromatography Mass Spectrometry (GCMS) Page 4 of 4