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U.S. Department of Health and Human Services

Recognized Consensus Standards
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06/27/2016 Tissue Engineering 15-46 ISO 22442-2 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling.
06/07/2018 Tissue Engineering 15-51 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 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
04/04/2016 Tissue Engineering 15-24 ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
07/06/2020 Tissue Engineering 15-61 ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
07/06/2020 Tissue Engineering 15-62 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)
08/21/2017 Tissue Engineering 15-49 ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
06/07/2018 Tissue Engineering 15-54 ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
01/14/2019 Tissue Engineering 15-56 ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
01/14/2019 Tissue Engineering 15-47 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.
07/09/2014 Tissue Engineering 15-40 ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
07/15/2019 Tissue Engineering 15-57 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
07/06/2020 Tissue Engineering 15-63 ASTM F2739-19 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
07/15/2019 Tissue Engineering 15-58 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
09/17/2018 Tissue Engineering 15-55 ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
03/16/2012 Tissue Engineering 15-31 ASTM F2312-11 (Reapproved 2020) Standard Terminology Relating to Tissue Engineered Medical Products
08/06/2013 Tissue Engineering 15-14 ASTM F2603-06 (Reapproved 2020) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
12/21/2020 Tissue Engineering 15-65 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 ASTM F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy
12/23/2016 Tissue Engineering 15-48 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)
04/04/2016 Tissue Engineering 15-43 ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
06/07/2018 Tissue Engineering 15-53 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
07/06/2020 Tissue Engineering 15-59 ASTM F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
06/07/2021 Tissue Engineering 15-67 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)
12/21/2020 Tissue Engineering 15-64 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 15-44 ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
06/27/2016 Tissue Engineering 15-45 ISO 22442-1 Second edition 2015-11-01 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
05/30/2022 Sterility 14-578 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
01/14/2019 Sterility 14-396 ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
07/06/2020 Sterility 14-515 ANSI AAMI ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 17664 Second edition 2017-10 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
01/30/2014 Sterility 14-334 ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
01/30/2014 Sterility 14-336 ANSI AAMI ISO 14161-2009/(R)2014 Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
ISO 14161 Second edition 2009-09-15 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
08/14/2015 Sterility 14-460 ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
05/30/2022 Sterility 14-572 ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
12/20/2021 Sterility 14-563 ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
12/20/2021 Sterility 14-571 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
01/30/2014 Sterility 14-424 ANSI AAMI ISO 13408-6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)]
ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)]
05/30/2022 Sterility 14-579 ISO 17664-2 First edition 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
05/30/2022 Sterility 14-576 ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
12/23/2016 Sterility 14-499 ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
12/23/2016 Sterility 14-497 ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
07/15/2019 Sterility 14-529 ANSI AAMI ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
07/06/2020 Sterility 14-540 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
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
04/04/2016 Sterility 14-337 ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
01/30/2014 Sterility 14-403 ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014 Sterility 14-430 ASTM ISO 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
06/27/2016 Sterility 14-481 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
06/27/2016 Sterility 14-483 ASTM ISO 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
12/21/2020 Sterility 14-550 ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
07/06/2020 Sterility 14-539 ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
01/30/2014 Sterility 14-406 ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
01/30/2014 Sterility 14-412 AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
08/21/2017 Sterility 14-501 ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
01/30/2014 Sterility 14-429 ASTM ISO 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
01/27/2015 Sterility 14-379 ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
01/27/2015 Sterility 14-389 ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
01/27/2015 Sterility 14-390 ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
01/30/2014 Sterility 14-413 AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
08/06/2013 Sterility 14-381 ASTM ISO 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing
08/21/2017 Sterility 14-502 ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
03/16/2012 Sterility 14-332 ANSI AAMI ISO 11140-5:2007/(R)2012 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
ISO 11140-5 Second edition 2007-03-15 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
06/07/2021 Sterility 14-562 ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
12/23/2016 Sterility 14-496 ASTM F1608-16 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
08/14/2015 Sterility 14-478 ANSI AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities
01/30/2014 Sterility 14-405 ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
06/27/2015 Sterility 14-484 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
07/15/2019 Sterility 14-532 ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
01/14/2019 Sterility 14-518 ANSI AAMI ST55:2016 Table-top steam sterilizers
12/21/2020 Sterility 14-554 ASTM F17-20 Standard Terminology Relating to Flexible Barrier Packaging
05/30/2022 Sterility 14-573 ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier Materials
05/30/2022 Sterility 14-575 ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
06/27/2016 Sterility 14-482 ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
09/09/2008 Sterility 14-142 ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
05/30/2022 Sterility 14-574 ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
01/30/2014 Sterility 14-401 ASTM F2217/F2217M-13 (Reapproved 2018) Standard Practice for Coating/Adhesive Weight Determination
01/30/2014 Sterility 14-402 ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-404 ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
09/17/2018 Sterility 14-293 ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
07/06/2020 Sterility 14-543 ANSI AAMI ISO TIR 11139:2006 Sterilization of health care products - Vocabulary
ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
07/06/2020 Sterility 14-544 ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
07/15/2019 Sterility 14-527 ASTM F2638-18 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
01/30/2014 Sterility 14-399 AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
09/17/2018 Sterility 14-275 ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
09/09/2008 Sterility 14-191 ANSI AAMI ISO 13408-4:2005/(R)2014 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products - Part 4: Clean-in-place technologies
09/09/2008 Sterility 14-240 ANSI AAMI ISO 13408-5:2006/(R)2015 Aseptic processing of health care products - Part 5: Sterilization in place
ISO 13408-5 First edition 2006-11-15 Aseptic processing of health care products - Part 5: Sterilization-in-place
07/09/2014 Sterility 14-286 ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
01/27/2015 Sterility 14-242 ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
04/04/2016 Sterility 14-277 ANSI AAMI ISO TIR 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
ISO TS 17665-2 First edition 2009-01-15 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
08/06/2013 Sterility 14-388 ANSI AAMI ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
09/17/2018 Sterility 14-516 ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
12/23/2016 Sterility 14-169 ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
01/30/2014 Sterility 14-395 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 AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014 Sterility 14-398 AOAC 6.3.05:2013 Official Method 966.04, Sporicidal Activity of Disinfectants Method I
09/17/2018 Sterility 14-294 ANSI AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
09/17/2018 Sterility 14-513 ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
08/14/2015 Sterility 14-463 ASTM ISO 51608 Second edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
12/21/2020 Sterility 14-553 ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
01/27/2015 Sterility 14-141 ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
09/17/2018 Sterility 14-512 ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
 
 
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