Recognized Consensus Standards: Medical Devices
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Entry |
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Group Area |
Recognition
Number |
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Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
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 |
05/29/2023 | General Plastic Surgery/ General Hospital |
6-493 | Complete | ASTM | F2101-23 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
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 |
6-495 | 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 |
6-496 | 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 | InVitro Diagnostics | 7-315 | Complete | CLSI | EP12 3rd Edition | Evaluation of Qualitative, Binary Output Examination Performance |
05/29/2023 | InVitro Diagnostics | 7-316 | Complete | CLSI | NBS01 7th Edition | Dried Blood Spot Specimen Collection for Newborn Screening |
05/29/2023 | InVitro Diagnostics | 7-317 | Partial | CLSI | M100, 33rd Edition | Performance Standards for Antimicrobial Susceptibility Testing |
05/29/2023 | Materials | 8-597 | Complete | ASTM | F2003-02(2022) | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
05/29/2023 | Materials | 8-598 | Complete | ASTM | F3109-22 | Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |