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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/15/2019 Anesthesiology 1-144 Complete ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
07/06/2020 General I (QS/
RM)		 5-126 Complete ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-135 Complete ISO 23500-3 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
ANSI AAMI ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-136 Complete ISO 23500-4 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
ANSI AAMI ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
07/15/2019 Materials 8-518 Complete ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
12/23/2019 Radiology 12-328 Complete IEC 61223-3-5 Edition 2.0 2019-09 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
12/21/2020 InVitro Diagnostics 7-299 Complete CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
12/23/2019 Materials 8-502 Complete ASTM F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
07/15/2019 Materials 8-510 Complete ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
07/09/2014 Radiology 12-281 Complete IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
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