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 | 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 | 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 |
9-147 | Complete | ISO CIE | 11664-2 First edition 2022-08 | Colorimetry - Part 2: CIE standard illuminants |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-145 | Complete | ASTM | D7661-18 | Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-143 | Partial | ISO | 20696 First edition 2018-06; Corrected 2019-12 | Sterile urethral catheters for single use |
12/19/2022 | ObGyn/ Gastroenterology/ Urology |
9-142 | Complete | ASTM | D1894-14 | Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
12/19/2022 | ObGyn/ Gastroenterology/ Urology |
9-141 | Complete | ISO | 8637-3 First Edition 2018-07 | Extracorporeal systems for blood purification - Part 3: Plasmafilters |
12/19/2022 | ObGyn/ Gastroenterology/ Urology |
9-140 | Partial | ISO | 8637-2 First Edition 2018-07 | Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
ANSI AAMI ISO | 8637-2:2018 | Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters | ||||
05/30/2022 | ObGyn/ Gastroenterology/ Urology |
9-139 | Complete | CIE ISO | 11664-5:2016 | Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram |
06/07/2021 | ObGyn/ Gastroenterology/ Urology |
9-138 | Complete | ISO | 20695 First edition 2020-03 | Enteral feeding systems - Design and testing |