Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 07/06/2020 | ObGyn/ Gastroenterology/ Urology |
9-126 | Complete | ISO CIE | 11664-3 First edition 2019-06 | Colorimetry - Part 3: CIE tristimulus values |
| 07/06/2020 | ObGyn/ Gastroenterology/ Urology |
9-127 | Complete | ISO CIE | 11664-4 First edition 2019-06 | Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
| 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 |
| 05/29/2023 | ObGyn/ Gastroenterology/ Urology |
9-148 | Complete | ISO CIE | 11664-6 Second edition 2022-08 | Colorimetry - Part 6: CIEDE2000 colour-difference formula |
| 07/06/2020 | ObGyn/ Gastroenterology/ Urology |
9-128 | Complete | ISO CIE | 11664-6 First edition 2014-02-01 | Colorimetry - Part 6: CIEDE2000 colour-difference formula |
| 10/19/2020 | Software/ Informatics |
13-116 | Complete | FIRST | CVSS v3.0 | Common Vulnerability Scoring System version 3.0 |
| 05/29/2023 | Sterility | 14-588 | Complete | AAMI | TIR17:2017/(R)2020 | Compatibility of materials subjected to sterilization |
| 07/06/2020 | Radiology | 12-325 | Complete | NEMA | Standards Publication XR 25 -2019 | Computed Tomography Dose Check |
| 06/07/2018 | ObGyn/ Gastroenterology/ Urology |
9-115 | Complete | ISO | 29943-1 First edition 2017-07. | Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports |
| 06/07/2018 | ObGyn/ Gastroenterology/ Urology |
9-116 | Complete | ISO | 29943-2 First edition 2017-07 | Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports. |
| 07/15/2019 | General Plastic Surgery/ General Hospital |
6-423 | Complete | IEC | 60601-2-6 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| 12/23/2016 | Radiology | 12-304 | Complete | IEC | 60731 Edition 3.1 2016-04 | Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| 12/19/2022 | InVitro Diagnostics | 7-313 | Complete | CLSI | EP27 2nd Edition | Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
| 01/14/2019 | Sterility | 14-396 | Partial | ANSI AAMI | ST77:2013/(R)2018 | Containment devices for reusable medical device sterilization |
| 12/18/2023 | ObGyn/ Gastroenterology/ Urology |
9-150 | Complete | ISO | 7439 Fourth edition 2023-04 | Copper-bearing contraceptive intrauterine devices - Requirements and tests |
| 03/16/2012 | InVitro Diagnostics | 7-227 | Complete | CLSI | M53-A (Replaces M53-P) | Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
| 01/30/2014 | InVitro Diagnostics | 7-224 | Complete | CLSI | EP28-A3c (Formerly C28-A3c) | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition |
| 12/20/2021 | Dental/ ENT |
4-285 | Complete | ANSI ADA | Standard No. 37-1986 (R2020) | Dental Abrasive Powders |
| 12/19/2022 | Dental/ ENT |
4-294 | Complete | ANSI ADA | Standard No. 139-2020 | Dental Base Polymers |
| 01/14/2019 | Dental/ ENT |
4-255 | Complete | ANSI ADA | Standard No. 131-2015 (R2020) | Dental CAD/CAM Machinable Zirconia Blanks |
| 12/21/2020 | Dental/ ENT |
4-271 | Complete | ANSI ADA | Standard No. 34-2013 | Dental Cartridge Syringes |
| 12/20/2021 | Dental/ ENT |
4-286 | Complete | ANSI ADA | Standard No. 87-1995 (R2014) | Dental Impression Trays |
| 06/07/2018 | Dental/ ENT |
4-241 | Complete | ISO | 7491 Second edition 2000-09-01 | Dental materials - Determination of colour stability |
| ANSI ADA | Standard No. 80-2001 (R2020) | Dental Materials-Determination of Color Stability | ||||
| 08/21/2017 | Dental/ ENT |
4-215 | Complete | ANSI ADA | Standard No. 96-2012 | Dental Water-based Cements |
| 01/30/2014 | Dental/ ENT |
4-153 | Complete | ISO | 9917-1 Second edition 2007-10-01 | Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| 01/27/2015 | Dental/ ENT |
4-219 | Complete | ISO | 29022 First edition 2013-06-01 | Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 12/18/2023 | Dental/ ENT |
4-310 | Complete | ISO | 22112 Second edition 2017-08 | Dentistry - Artificial teeth for dental prostheses |
| ANSI ADA | Standard No. 15-2021 | Artificial Teeth for Dental Prostheses | ||||
| 01/30/2014 | Dental/ ENT |
4-151 | Complete | ISO | 22112 First edition 2005-11-01 | Dentistry - Artificial teeth for dental prostheses |
| ANSI ADA | Standard No. 15-2008 (R2013) | Artificial Teeth for Dental Prostheses | ||||
| 08/21/2017 | Dental/ ENT |
4-232 | Complete | ISO | 20795-1 Second edition 2013-03-01 | Dentistry - Base polymers - Part 1: Denture base polymers |
| 08/21/2017 | Dental/ ENT |
4-233 | Complete | ISO | 20795-2 Second edition 2013-03-01 | Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 01/27/2015 | Dental/ ENT |
4-218 | Complete | ISO | 27020 First edition 2010-12-15 | Dentistry - Brackets and tubes for use in orthodontics |
| ANSI ADA | Standard No.100-2012 | Orthodontic Brackets and Tubes | ||||
| 12/18/2023 | Dental/ ENT |
4-313 | Complete | ISO | 27020 Second edition 2019-06 | Dentistry - Brackets and tubes for use in orthodontics |
| ANSI ADA | Standard No.100-2020 | Orthodontic Brackets and Tubes | ||||
| 12/21/2020 | Dental/ ENT |
4-264 | Complete | ISO | 9333 Second edition 2006-07 | Dentistry - Brazing materials |
| ANSI ADA | Standard No. 88-2019 | Dental Brazing Alloys | ||||
| 05/29/2023 | Dental/ ENT |
4-303 | Complete | ISO | 9333 Third edition 2022-08 | Dentistry - Brazing materials |
| 05/29/2023 | Dental/ ENT |
4-305 | Partial | ISO | 10637 Second edition 2018-05 | Dentistry - Central suction source equipment |
| ANSI ADA | Standard No. 177-2020 | Central Suction Source Equipment | ||||
| 01/14/2019 | Dental/ ENT |
4-251 | Complete | ISO | 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] | Dentistry - Ceramic materials |
| ANSI ADA | Standard No. 69-2020 | Dental Ceramic | ||||
| 07/06/2020 | Dental/ ENT |
4-263 | Complete | ISO | 9693 Third edition 2019-10 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| ANSI ADA | Standard No. 38-2020 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems | ||||
| 05/29/2023 | Dental/ ENT |
4-306 | Partial | ISO | 22052 First edition 2020-06 | Dentistry - Compressed air source equipment |
| ANSI ADA | Standard No. 94-2021 | Central Compressed Air Source Equipment | ||||
| 12/21/2020 | Dental/ ENT |
4-265 | Complete | ISO | 10271 Third edition 2020-08 | Dentistry - Corrosion test methods for metallic materials |
| ANSI ADA | Standard No. 97-2020 | Corrosion Test Methods for Metallic Materials | ||||
| 12/21/2020 | Dental/ ENT |
4-269 | Complete | ISO | 3964 Third edition 11-2016 | Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| 04/04/2016 | Dental/ ENT |
4-224 | Complete | ISO | 24234 Second edition 2015-05-01 | Dentistry - Dental Amalgam |
| 12/18/2023 | Dental/ ENT |
4-315 | Complete | ISO | 24234 Third edition 2021-08 | Dentistry - Dental Amalgam |
| 04/04/2016 | Dental/ ENT |
4-221 | Complete | ISO | 7494-2 Second edition 2015-04-01 | Dentistry - Dental units - Part 2: Air, water, suction and waste water systems |
| 12/20/2021 | Dental/ ENT |
4-284 | Complete | ISO | 10873 Second edition 2021-07 | Dentistry - Denture adhesives |
| 05/29/2023 | Dental/ ENT |
4-304 | Complete | ISO | 21606 Second edition 2022-08 | Dentistry - Elastomeric auxiliaries for use in orthodontics |
| 12/21/2020 | Dental/ ENT |
4-267 | Complete | ISO | 21606 First edition 2007-06 | Dentistry - Elastomeric auxiliaries for use in orthodontics |
| ANSI ADA | Standard No. 105-2010 (R2015) | Orthodontic Elastomeric Materials | ||||
| 06/07/2021 | Dental/ ENT |
4-278 | Complete | ISO | 4823 Fifth edition 2021-02 | Dentistry - Elastomeric impression and bite registration materials |
| ANSI ADA | Standard No. 19-2022 | Elastomeric Impression and Bite Registration | ||||
| 12/18/2023 | Dental/ ENT |
4-309 | Complete | ISO | 6877 Third edition 2021-09 | Dentistry - Endodontic obturating materials |
| ANSI ADA | Standard No. 78-2021 | Dentistry - Endodontic Obturating Materials | ||||
| 12/23/2019 | Dental/ ENT |
4-261 | Complete | ISO | 7405 Third edition 2018-10 Corrected version 2018-12 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| 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 | ||||
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