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) |
12/21/2020 | Biocompatibility | 2-279 | Complete | ASTM | F750-20 | Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse |
12/21/2020 | Biocompatibility | 2-282 | Complete | ISO | 14155 Third edition 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice |
12/21/2020 | Biocompatibility | 2-283 | Complete | ASTM | F619-20 | Standard Practice for Extraction of Materials Used in Medical Devices |
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 |
12/20/2021 | Biocompatibility | 2-292 | Complete | USP-NF | M98833_01_01 | <87> Biological Reactivity Test, In Vitro - Direct Contact Test |
12/20/2021 | Biocompatibility | 2-293 | Complete | USP-NF | M98833_01_01 | <87> Biological Reactivity Test, In Vitro - Elution Test |
12/20/2021 | Biocompatibility | 2-294 | Partial | USP-NF | M98834_01_01 | <88> Biological Reactivity Tests, In Vivo |
12/20/2021 | Biocompatibility | 2-295 | Partial | USP-NF | M98900_01_01 | <151> Pyrogen Test (USP Rabbit Test) |
12/19/2022 | Biocompatibility | 2-296 | Partial | ISO | 10993-10 Fourth edition 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
12/19/2022 | Biocompatibility | 2-297 | Complete | ASTM | F763-22 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |