Recognized Consensus Standards: Medical Devices
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Date of
Entry |
Specialty Task
Group Area |
Recognition
Number |
Extent of
Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-488 | Complete | ASTM | F1671/F1671M-22 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
12/23/2016 | Biocompatibility | 2-94 | Complete | ASTM | F981-04 (Reapproved 2016) | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
07/06/2020 | ObGyn/ Gastroenterology/ Urology |
9-125 | Complete | ISO CIE | 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 | Colorimetry - Part 2: CIE standard illuminants |
07/09/2014 | Orthopedic | 11-276 | Complete | ASTM | F1798-13 | Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
12/23/2019 | General Plastic Surgery/ General Hospital |
6-425 | Complete | ASTM | F2100-19 | Standard Specification for Performance of Materials Used in Medical Face Masks |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-147 | Complete | ISO CIE | 11664-2 First edition 2022-08 | Colorimetry - Part 2: CIE standard illuminants |
01/14/2019 | Cardiovascular | 3-66 | Complete | ASTM | F2081-06 (Reapproved 2017) | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
10/04/2004 | InVitro Diagnostics | 7-104 | Complete | CLSI | H7-A3 | Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
01/30/2014 | Dental/ ENT |
4-137 | Complete | ISO | 6877 Second edition 2006-04-01 | Dentistry - Root-canal obturating points |
ANSI ADA | Standard No. 78-2013 | Dental obturating cones | ||||
12/18/2023 | Dental/ ENT |
4-310 | Complete | ISO | 22112 Second edition 2017-08 | Dentistry - Artificial teeth for dental prostheses |
ANSI ADA | Standard No. 15-2021 | Artificial Teeth for Dental Prostheses |