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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2023 Cardiovascular 3-186 Complete ISO 14708-2 Third edition 2019-09 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
05/29/2023 Cardiovascular 3-187 Complete ISO 14708-6 Second edition 2019-09 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
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
05/29/2023 Dental/
ENT		 4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
05/29/2023 Dental/
ENT		 4-299 Complete ISO 3107 Fifth edition 2022-09 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
ANSI ADA Standard No. 30-2023 Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements
05/29/2023 Dental/
ENT		 4-300 Complete ISO 22674 Third edition 2022-08 Dentistry - Metallic materials for fixed and removable restorations and appliances
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		 4-302 Complete ISO 10477 Fourth edition 2020-10 Dentistry - Polymer-based crown and veneering materials
ANSI ADA Standard No. 53-2022 Polymer-Based Crown and Veneering Materials
05/29/2023 Dental/
ENT		 4-303 Complete ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
05/29/2023 Dental/
ENT		 4-304 Complete ISO 21606 Second edition 2022-08 Dentistry - Elastomeric auxiliaries for use in orthodontics
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