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 | Dental/ ENT |
4-301 | Complete | ISO | 21563 Second edition 2021-08 | Dentistry - Hydrocolloid impression materials |
ANSI ADA | Standard No. 128-2022 | Hydrocolloid Impression 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 | ||||
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 | ||||
05/29/2023 | Dental/ ENT |
4-307 | Complete | ISO | 13504 First edition 2012-07 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment |
05/29/2023 | Dental/ ENT |
4-308 | Complete | ISO | 14708-7 Second edition 2019-12 | Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-486 | Complete | ISO | 10535 Third edition 2021-10 | Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-487 | Partial | ANSI AAMI | PB70:2022 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-488 | Complete | ASTM | F1671/F1671M-22 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-489 | Complete | IEC | 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION | Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-490 | Complete | ISO | 10555-6 First edition 2015-04-15 [Including AMD1:2019] | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)] |