Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Medical Equipment test methods, standards, procedures or specifications.
ANSI 16142-2:2017 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ANSI TIR10993-19:2006 - Biological evaluation of medical devices - Part 19: Physio-chemical
CLSI M07 - Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
ASTM F1830 - Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
IEEE 11073 - IEEE Standard - Health Informatics - Personal Health Device Communication - Part 10404: Device Specialization - Pulse Oximeter
IEEE 11073-10404-2011 - Health informatics--Personal health device communication Part 10406: Device specialization--Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE 11073-10417- - Health informatics--Personal health device communication Part 10417: Device specialization- Glucose meter
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 11073-19425 - IEEE Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM)
IEEE 11073-10441 - IEEE/ISO International Standard - Health Informatics - Personal Health Device Communication - Part 10441: Device Specialization - Cardiovascular Fitness and Activity Monitor
IEEE 11073-10472 - Health informatics--Personal health device communication--Part 10472: Device specialization--Medication monitor
IEEE 1708 - IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices
IEEE 2010 - IEEE Recommended Practice for Neurofeedback Systems
ISO 8536 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 60601 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
ISO 10079 - Medical suction equipment - Part 1: Electrically powered suction equipment
ISO 60601 - Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
ISO 80601 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEEE 11073 - Health informatics--Device interoperability - Part 10420: Personal health device communication--Device specialization--Body composition analyzer
IEEE N42 - Performance Specifications for Health Physics Instrumentation. Occupational Airborne Radioactivity Monitoring Instrumentation
IEEE C63 - On-site, Ad-Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio Frequency Transmitters
CSA C22.2 NO. 80601-2-80:20 - Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
CSA Z386 - Safe use of lasers in health care
CSA C22.2 NO. 60601-2-31:20 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
ASTM E1061-01(2014) - Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
ISO 10651 - LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
ISO 80601 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
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