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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/21/2020 Tissue Engineering 15-65 Complete ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
06/07/2021 Tissue Engineering 15-66 Complete ASTM F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy
04/04/2016 Tissue Engineering 15-44 Partial ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
12/21/2020 Tissue Engineering 15-64 Partial ISO 22442-1 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
04/04/2016 Tissue Engineering 15-24 Complete ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
07/15/2019 Tissue Engineering 15-57 Complete ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
07/15/2019 Tissue Engineering 15-58 Complete ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
07/06/2020 Tissue Engineering 15-63 Complete ASTM F2739-19 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
07/06/2020 Tissue Engineering 15-59 Complete ASTM F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
07/06/2020 Tissue Engineering 15-61 Complete ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
03/16/2012 Tissue Engineering 15-31 Complete ASTM F2312-11 (Reapproved 2020) Standard Terminology Relating to Tissue Engineered Medical Products
09/17/2018 Tissue Engineering 15-55 Complete ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
06/07/2018 Tissue Engineering 15-54 Complete ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
01/14/2019 Tissue Engineering 15-47 Complete ISO 22442-3 First edition 2007-12-15 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
01/14/2019 Tissue Engineering 15-56 Complete ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
07/06/2020 Tissue Engineering 15-62 Complete ASTM F2602-18 Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
04/04/2016 Tissue Engineering 15-43 Complete ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
08/06/2013 Tissue Engineering 15-14 Complete ASTM F2603-06 (Reapproved 2020) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
08/21/2017 Tissue Engineering 15-49 Complete ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
06/07/2018 Tissue Engineering 15-53 Complete ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
06/07/2018 Tissue Engineering 15-51 Complete ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
06/07/2018 Tissue Engineering 15-52 Complete ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
12/23/2016 Tissue Engineering 15-48 Complete ASTM F2605-16 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
06/07/2021 Tissue Engineering 15-67 Complete ASTM F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
07/09/2014 Tissue Engineering 15-40 Complete ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
01/14/2019 Sterility 14-396 Partial ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
07/15/2019 Sterility 14-532 Complete ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
08/21/2017 Sterility 14-501 Complete ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
08/14/2015 Sterility 14-460 Partial ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
01/30/2014 Sterility 14-334 Partial ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
01/30/2014 Sterility 14-336 Partial ISO 14161 Second edition 2009-09-15 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ANSI AAMI ISO 14161-2009/(R)2014 Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
05/30/2022 Sterility 14-578 Partial ISO 17664-1 First edition 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
05/30/2022 Sterility 14-572 Partial ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
07/15/2019 Sterility 14-533 Complete ISO TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
05/30/2022 Sterility 14-574 Complete ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
12/20/2021 Sterility 14-565 Complete USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
05/30/2022 Sterility 14-577 Complete ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
06/07/2021 Sterility 14-562 Complete ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
02/20/2023 Sterility 14-575 Complete ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
12/23/2016 Sterility 14-497 Complete ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
12/19/2022 Sterility 14-580 Complete ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
12/19/2022 Sterility 14-581 Complete ASTM F2638-22 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
12/19/2022 Sterility 14-582 Complete AAMI ISO TIR11137-4:2022 Sterilization of health care products - Radiation - Part 4: Guidance on process control
ISO TS 11137-4 First edition 2020-06 Sterilization of health care products - Radiation - Part 4: Guidance on process control
12/19/2022 Sterility 14-583 Complete ANSI AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
12/23/2016 Sterility 14-169 Complete ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
09/09/2008 Sterility 14-142 Complete ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
01/14/2019 Sterility 14-518 Complete AAMI ANSI ST55:2016/(R)2023 Table-top steam sterilizers
01/15/2013 Sterility 14-213 Complete AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/15/2013 Sterility 14-215 Complete AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/15/2013 Sterility 14-217 Complete AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
01/27/2015 Sterility 14-242 Complete ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
01/27/2015 Sterility 14-243 Complete ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
07/09/2014 Sterility 14-437 Complete ISO ASTM 52701 First edition 2013-11-15 (R2020) Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
05/29/2023 Sterility 14-587 Complete AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources
07/06/2020 Sterility 14-540 Complete ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI AAMI ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020 Sterility 14-541 Complete ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
07/09/2014 Sterility 14-434 Complete ASTM F2228-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/09/2014 Sterility 14-256 Complete ASTM F2095-07 (Reapproved 2021) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
07/09/2014 Sterility 14-435 Complete ASTM F2251-13 (Reapproved 2023) Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-290 Complete ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
12/23/2019 Sterility 14-538 Complete ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
01/30/2014 Sterility 14-427 Complete ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
01/27/2015 Sterility 14-390 Complete ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
01/27/2015 Sterility 14-141 Complete ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
12/18/2023 Sterility 14-590 Complete ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)
01/30/2014 Sterility 14-401 Complete ASTM F2217/F2217M-13 (Reapproved 2018) Standard Practice for Coating/Adhesive Weight Determination
12/18/2023 Sterility 14-593 Complete ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
09/17/2018 Sterility 14-516 Complete ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
12/18/2023 Sterility 14-591 Complete ISO 14644-10 Second edition 2022-05 Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
12/18/2023 Sterility 14-589 Complete ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
12/20/2021 Sterility 14-563 Complete ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
12/20/2021 Sterility 14-571 Complete ISO 11138-8 First edition 2021-07 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
04/04/2016 Sterility 14-340 Complete ISO 20857 First edition 2010-08-15 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 20857:2010/(R)2015 (Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
07/15/2019 Sterility 14-530 Complete ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
12/20/2021 Sterility 14-564 Complete USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
01/27/2015 Sterility 14-379 Complete ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
12/20/2021 Sterility 14-569 Complete USP-NF M98810_01_01 <71> Sterility Tests
05/29/2023 Sterility 14-584 Complete ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
01/30/2014 Sterility 14-404 Complete ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
01/30/2014 Sterility 14-405 Complete ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
01/30/2014 Sterility 14-406 Complete ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
05/29/2023 Sterility 14-585 Complete AAMI ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 Second edition 2021-11 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
01/30/2014 Sterility 14-402 Complete ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/27/2015 Sterility 14-456 Complete ANSI AAMI ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
06/07/2018 Sterility 14-510 Complete ISO 11137-3 Second edition 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ANSI AAMI ISO 11137-3:2017/(R)2023 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
09/09/2008 Sterility 14-239 Complete ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
04/04/2016 Sterility 14-333 Complete ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
01/30/2014 Sterility 14-429 Complete ISO ASTM 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
01/15/2013 Sterility 14-212 Complete AOAC 6.2.02:2006 Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
01/27/2015 Sterility 14-389 Complete ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
07/15/2019 Sterility 14-531 Complete ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ANSI AAMI ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
01/30/2014 Sterility 14-395 Complete ISO 14698-2 First edition 2003-09-15 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
01/30/2014 Sterility 14-397 Complete AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014 Sterility 14-398 Complete AOAC 6.3.05:2013 Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/30/2014 Sterility 14-399 Complete AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
01/30/2014 Sterility 14-400 Complete ASTM F2203-13 (Reapproved 2022) Standard Test Method for Linear Measurement Using Precision Steel Rule
08/06/2013 Sterility 14-381 Complete ISO ASTM 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing
06/27/2016 Sterility 14-481 Complete ISO 14644-2 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
 
 
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