USP 643 Accredited Testing Labs Worldwide
15 accredited laboratories in 4 countries hold USP 643 in their ISO/IEC 17025 scope. Primary accreditors include American Association for Laboratory Accreditation, Deutsche Akkreditierungsstelle. In the register, USP 643 scope entries most often cover Total Organic Carbon, Bacteriostasis, Bca Protein in Drinking water, Infant formula, Cables.
Available in 4 Countries
Top matrices for USP 643
Top analytes for USP 643
- Total Organic Carbon (4)
- Bacteriostasis (1)
- Bca Protein (1)
- Bioburden (1)
- Carbon Organique Total (1)
- Conductivity (1)
- Bacteria (1)
- Elementary Inorganic Extractables (1)
Sample labs
UNITE TECHNIQUE 2 : PHYSICO-CHIMIE / EMBALLAGES PORTEE FIXE/FLEX 1 PRODUITS CHIMIQUES ET BIOLOGIQUES, EQUIPEMENTS MEDICAUX / DISPOSITIFS MEDICAUX / Analyses physico-chimiques OBJET CARACTERISTIQUE MESUREE OU RECHERCHEE PRINCIPE DE
CHEMICAL Test(s): Test Method(s): Chemical Conductivity USP <645> Total Organic Carbon USP <643> Extractable Leachable Testing ISO 10993-18
Test Method(s) Laboratory Procedure Sterility Testing: Bacteriostasis/ Fungistasis Testing AAMI/ANSI/ISO 11737-2/ USP <71> Q08-WI-001728 Sterility Test Procedure AAMI/ANSI/ISO 11737-2/ USP <71> Q08-WI-001720 Bioburden T
USP 643 Determination of Volatile Extractables in Medical Devices by HS-GC/MS ISO 10993-18 1 Assessment to the U.S. FDA GLP (21 CFR 58) Regulations does not imply acceptance by the FDA.
SCOPE OF ACCREDITATION TO ISO/IEC 17025:20171 NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA) 1265 Kennestone Circle Marietta, GA 30066 Heather Laird Phone: 888-847-6633 CHEMICAL Valid To: January 31, 2027
Prüfgebiet Prüfgegenstand Produkt(kategorie) Prüfungsart Prüfung Regelwerk Prüfverfahren Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485: 20212, Abs. 6.4 und Abs. 7.5 Chemisch
Prüfgebiet Prüfgegenstand Produkt(kategorie) Prüfungsart Prüfung Regelwerk Prüfverfahren Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485 : 2021 2, Abs. 6.4 und Abs. 7.5 Mikrob
Testing field Test item Device (category) Type of testing Test Regulation Testing method Microbiological- hygienic including physical tests Information for the reprocessing of medical devices Testings within the scope of validat
Datum 2024-10-11 2023/2611 Bilaga 1 Kemisk analys Teknikområde Parameter Metod Mätprincip Mätområde Provtyp Flex Typ av flex Fält Anmärkning Vattenanalys Totalt organiskt kol, TOC USP <643> Förbränning Avloppsvatten/Lakvatten Ja 2 Nej För
Testing area Test item device (category) Type of testing test Regulation testing method Environmental monitoring in the manufacture and testing of the cleanliness of the products in accordance with DIN EN ISO 13485: 2021 1, para. 6.
#ENVIRONNEMENT / QUALITE DE L’EAU / Analyses microbiologiques (Analyses microbiologiques des eaux - LAB GTA 23) OBJET CARACTERISTIQUE MESUREE OU RECHERCHEE PRINCIPE DE LA METHODE REFERENCE DE LA METHODE Eaux des établissements de
USP 643 Viscosity ASTM D445 Powder Characterization Laser Light Diffraction (Microtrac) - Particle Size ASTM B821, B822, C1070 Sieve Analysis - Particle Size ASTM B214, D1214 Hall Flow Rate / Apparent Density ASTM B212, B213
Test(s) Analyte(s) Method(s) Direct Microscope Examination (DME) Microscopic Examination of Fungal Spores, Fungal Structures, Hyphae, Pollen, Insect Fragments, and Fibrous Material from Surface Samples ASTM D7658-17 MIC 02 Mycobacter
USP 643 Wet Chemistry pH ASTM D1293 (Method B), E70 ICP – Inductively Coupled Plasma CLP-017; ASTM E3061, E2371, E2594, D1976 Ion Chromatography ASTM D4327 XRD ISO 13779-3; CLP-056 X-Ray Fluorescence (XRF) Posi
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 EUROFINS SF ANALYTICAL – GMP MICROBIOLOGY 215 Witmer Road Horsham, PA 19044 Maureen Dougherty Phone: (267) 282-2100 BIOLOGICAL Valid To: March 31, 2027