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) |
08/06/2013 | Software/ Informatics |
13-54 | Partial | ISO IEEE | 11073-10404 First edition 2010-05-01 | Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
05/29/2024 | General II (ES/ EMC) |
19-50 | Partial | IEC | TS 60601-4-2 Edition 1.0 2024-03 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
09/17/2018 | General II (ES/ EMC) |
19-19 | Partial | IEC | TR 60601-4-2 Edition 1.0 2016-05 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
06/07/2018 | Anesthesiology | 1-137 | Partial | ISO | 18562-4 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
12/18/2023 | Dental/ ENT |
4-319 | Partial | ISO | 17730 Second edition 2020-09 | Dentistry - Fluoride varnishes |
ANSI ADA | Standard No. 117-2022 | Dentistry - Fluoride Varnishes | ||||
01/14/2019 | Dental/ ENT |
4-257 | Partial | ISO | 17730 First edition 2014-11-01 | Dentistry - Fluoride varnishes |
06/07/2021 | Dental/ ENT |
4-280 | Partial | ANSI ADA | Standard No. 117-2018 | Fluoride varnishes |
05/29/2023 | Cardiovascular | 3-188 | Partial | ISO | 81060-3 First edition 2022-12 | Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
12/18/2023 | General Plastic Surgery/ General Hospital |
6-497 | Partial | ASTM | D7866-23 | Standard Specification for Radiation Attenuating Protective Gloves |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-496 | Partial | ASTM | F739-20 | Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact |