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) |
05/29/2024 | General Plastic Surgery/ General Hospital |
6-501 | Complete | ISO | 15747 Third edition 2018-09 | Plastic containers for intravenous injections |
05/29/2024 | General Plastic Surgery/ General Hospital |
6-500 | Complete | IEC | 63045 Edition 1.0 2020-05 | Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields |
05/29/2024 | General Plastic Surgery/ General Hospital |
6-499 | Complete | ISO | 10555-1 Third edition 2023-11 | Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements |
05/29/2024 | General Plastic Surgery/ General Hospital |
6-498 | Complete | ISO | 10555-4 Third edition 2023-11 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters |
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 |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-495 | Complete | ISO | 20698 First Edition 2018-07 | Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-494 | Complete | ASTM | F3352/F3352M-23a | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-492 | Complete | ASTM | F2100-23 | Standard Specification for Performance of Materials Used in Medical Face Masks |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-491 | Complete | ASTM | F1670/F1670M-17a | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |