Medical Technology Laboratory Testing and Scientific Research:
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Medical Technology Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Medical Technology test methods,standards, procedures or specifications.
ANSI 14117:2012 - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers
ANSI 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
ISO - Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants.
ANSI 10993-3:2014 - Biological evaluation of medical devices-Part 3: Tests for genotoxicity
IEC 80601-2-35:2009 - Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets
ISO 8600 - Endoscopes Medical endoscopes and endotherapy devices
ISO 7151:1988 - Surgical instruments Non-cutting
ASTM D7661 - Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
EN 13612: - Performance evaluation of in-vitro diagnostic devices
IEEE 449.1 - American National Standard Procedures for Periodic Inspection of Cobalt-60 and Cesium-137 Teletherapy Equipment
IEEE 11073 - Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor
IEEE 1708 - IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices
IEC 60601 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 11137 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 23034 - Method to estimate cellular uptake of carbon nanomaterials using optical absorption
IEC 80601 - Medical electrical equipment
IEC 60601- - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEEE 11073-10404-2011 - Health informatics--Personal health device communication Part 10406: Device specialization--Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE 11073-10420 - EEE Health informatics -- Personal health device communication Part 10420: Device specialization -- Body composition analyzer
IEEE 11073-10421 - IEEE Standard - Health informatics--Personal health device communication Part 10421: Device specialization--Peak expiratory flow monitor (peak flow)
IEEE 11073-10422 - Health informatics--Personal health device communication Part 10422: Device Specialization--Urine Analyzer
IEEE 11073-10472 - Health informatics--Personal health device communication--Part 10472: Device specialization--Medication monitor
IEEE 11073 - Health informatics--Device interoperability - Part 10420: Personal health device communication--Device specialization--Body composition analyzer
IEEE 11073-10407 - Health informatics--Personal health device communication Part 10407: Device specialization--Blood pressure monitor
IEEE N449 - Procedures for Periodic Inspection of Cobalt-60 and Cesium-137 Teletherapy Equipment
CSA Z386 - Safe use of lasers in health care
ASTM F2884-12 - Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
ASTM F640 - 20 - Standard Test Methods for Determining Radiopacity for Medical Use
ASTM F2131-02(2012) - Standard Test Method For In Vitro Biological Activity Of Recombinant Human Bone Morphogenetic Protein-2 (RhBMP-2) Using The W-20 Mouse Stromal Cell Line
ASTM F2212-19 - Standard Guide For Characterization Of Type I Collagen As Starting Material For Surgical Implants And Substrates For Tissue Engineered Medical Products (TEMPs)
ISO 80601 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
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