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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
08/06/2013 General Plastic Surgery/
General Hospital		 6-179 Complete ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
12/23/2024 General II (ES/
EMC)		 19-51 Complete UL 1642 Sixth Edition September 29, 2020 Standard For Safety Lithium Batteries
12/22/2025 Ophthalmic 10-139 Complete ISO 11980 Fourth edition 2025-06 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-137 Complete ISO 23500-5 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ANSI AAMI ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
12/19/2022 Biocompatibility 2-289 Complete ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/18/2023 Cardiovascular 3-189 Complete ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
05/25/2026 Orthopedic 11-442 Complete ISO 7206-12 Second edition 2025-11 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for press-fit acetabular components
12/23/2024 General I (QS/
RM)		 5-143 Complete ISO 14630 Fffth edition 2024-09 Non-active surgical implants -- General requirements
12/22/2025 Tissue Engineering 15-69 Complete ASTM F2944-20 Standard Practice for Automated Colony Forming Unit (CFU) Assays - Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
08/21/2017 Materials 8-455 Complete ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric Implants
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