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) |
01/30/2014 | Orthopedic | 11-75 | Complete | ISO | 5838-3 First edition 1993-09-15 | Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
01/30/2014 | Orthopedic | 11-74 | Complete | ISO | 5838-2 First edition 1991-01-15 | Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
12/19/2022 | Ophthalmic | 10-132 | Partial | ISO | 10942 Third edition 2022-01 | Ophthalmic instruments - Direct ophthalmoscopes |
12/20/2021 | Ophthalmic | 10-130 | Complete | ANSI | Z80.36-2021 | American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
12/20/2021 | Ophthalmic | 10-129 | Complete | ASTM | D790-17 | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
12/20/2021 | Ophthalmic | 10-127 | Complete | ANSI | Z80.21-2020 | American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
08/06/2013 | Ophthalmic | 10-78 | Complete | ISO | 11979-3 Third edition 2012-12-01 | Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
12/18/2023 | ObGyn/ Gastroenterology/ Urology |
9-150 | Complete | ISO | 7439 Fourth edition 2023-04 | Copper-bearing contraceptive intrauterine devices - Requirements and tests |
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 |