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 | Materials | 8-600 | Complete | ASTM | F1978-22 | Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
05/29/2023 | Materials | 8-601 | Complete | ASTM | F2516-22 | Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
05/29/2023 | Materials | 8-602 | Complete | ASTM | F2503-23 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
05/29/2023 | Materials | 8-603 | Complete | ASTM | F1472-23 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
05/29/2023 | Nanotechnology | 18-23 | Complete | ASTM | E3025-22 | Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-143 | Partial | ISO | 20696 First edition 2018-06; Corrected 2019-12 | Sterile urethral catheters for single use |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-147 | Complete | ISO CIE | 11664-2 First edition 2022-08 | Colorimetry - Part 2: CIE standard illuminants |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-148 | Complete | ISO CIE | 11664-6 Second edition 2022-08 | Colorimetry - Part 6: CIEDE2000 colour-difference formula |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-149 | Complete | IEC | 60601-2-39 Edition 3.0 2018-04 | Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
05/29/2023 | Orthopedic | 11-399 | Complete | ASTM | F1357-23 | Standard Specification for Articulating Total Wrist Implants |