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) |
07/09/2014 | Sterility | 14-282 | Complete | ASTM | F2338-09 (Reapproved 2020) | Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method |
01/27/2015 | Dental/ ENT |
4-218 | Complete | ISO | 27020 First edition 2010-12-15 | Dentistry - Brackets and tubes for use in orthodontics |
ANSI ADA | Standard No.100-2012 | Orthodontic Brackets and Tubes | ||||
01/27/2015 | Dental/ ENT |
4-219 | Complete | ISO | 29022 First edition 2013-06-01 | Dentistry - Adhesive - Notched-edge sheer bond strength test |
01/27/2015 | General I (QS/ RM) |
5-48 | Complete | ANSI | Z1.9-2003 (R2018) | Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming |
01/27/2015 | Materials | 8-171 | Complete | ASTM | F1609-08 (Reapproved 2014) | Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
01/27/2015 | Orthopedic | 11-281 | Complete | ASTM | F1672-14 (Reapproved 2019) | Standard Specification for Resurfacing Patellar Prosthesis |
01/27/2015 | Software/ Informatics |
13-71 | Partial | RII | Version 2.48 | Logical Observation Identifiers Names and Codes (LOINC) |
01/27/2015 | Software/ Informatics |
13-72 | Complete | IEEE | Std 11073-10425-2014 | Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM) |
01/27/2015 | Sterility | 14-141 | Complete | ISO | 14644-4 First edition 2001-04-01 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
01/27/2015 | Sterility | 14-390 | Complete | ISO | 14644-10 First edition 2013-03-01 | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |