Recognized Consensus Standards: Medical Devices
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Results per Page |
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) |
12/20/2021 | Biocompatibility | 2-292 | Complete | USP-NF | M98833_01_01 | <87> Biological Reactivity Test, In Vitro - Direct Contact Test |
12/19/2022 | Biocompatibility | 2-289 | Complete | ISO | 10993-12 Fifth edition 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
12/23/2016 | Biocompatibility | 2-93 | Complete | ASTM | F763-04 (Reapproved 2016) | Standard Practice for Short-Term Screening of Implant Materials |
05/29/2023 | Biocompatibility | 2-300 | Complete | ISO | 10993-2 Third edition 2022-11 | Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
12/21/2020 | Biocompatibility | 2-280 | Complete | ASTM | F1408-20a | Standard Practice for Subcutaneous Screening Test for Implant Materials |
12/20/2021 | Biocompatibility | 2-293 | Complete | USP-NF | M98833_01_01 | <87> Biological Reactivity Test, In Vitro - Elution Test |
12/19/2022 | Biocompatibility | 2-297 | Complete | ASTM | F763-22 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
05/29/2023 | Biocompatibility | 2-301 | Complete | ASTM | F1983-23 | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
07/26/2016 | Biocompatibility | 2-227 | Complete | ASTM | F1983-14 | Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
12/20/2021 | Cardiovascular | 3-177 | Complete | ASTM | F2606-08 (Reapproved 2021) | Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems |