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) |
05/30/2022 | General Plastic Surgery/ General Hospital |
6-479 | Complete | ISO | 11608-5:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions |
01/14/2019 | Nanotechnology | 18-6 | Complete | ASTM | E2865-12 (Reapproved 2022) | Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials |
12/20/2021 | Cardiovascular | 3-179 | Complete | ASTM | F3172-15 (Reapproved 2021) | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
12/20/2021 | Cardiovascular | 3-176 | Complete | ISO | 18193 First edition 2021-08 | Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation |
05/30/2022 | Cardiovascular | 3-181 | Complete | ISO | 25539-2 Third edition 2020-09 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
12/19/2022 | Orthopedic | 11-395 | Complete | ASTM | F1814-22 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
12/19/2022 | Orthopedic | 11-396 | Complete | ISO | 7206-13 First edition 2016-07-01 [Including AMD1:2022] | Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
12/20/2021 | General II (ES/ EMC) |
19-41 | Complete | ANSI UL | 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 | Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements |
12/20/2021 | General Plastic Surgery/ General Hospital |
6-466 | Complete | USP-NF | M76070_03_01 | Sodium Chloride Injection |
12/19/2022 | Software/ Informatics |
13-123 | Complete | ANSI NEMA | HN 1-2019 | American National Standard Manufacturer Disclosure Statement for Medical Device Security |